Congressional Record, Volume 158 Issue 76 (Thursday, May 24, 2012)

[Congressional Record Volume 158, Number 76 (Thursday, May 24, 2012)]
[Senate]
[Pages S3536-S3608]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

FOOD AND DRUG ADMINISTRATION SAFETY AND INNOVATION ACT

The ACTING PRESIDENT pro tempore. Under the previous order, the
Senate will resume consideration of S. 3187, which the clerk will
report.
The assistant legislative clerk read as follows:

A bill (S. 3187) to amend the Federal Food, Drug, and
Cosmetic Act to revise and extend the user-fee programs for
prescription drugs and medical devices, to establish user-fee
programs for generic drugs and biosimilars, and for other
purposes.

Pending:

Durbin/Blumenthal amendment No. 2127, to require
manufacturers of dietary supplements to register dietary
supplement products with the Food and Drug Administration.
Sanders amendment No. 2109, to revoke the exclusivity of
certain entities that are responsible for violations of the
Federal Food, Drug, and Cosmetic Act, the False Claims Act,
and other certain laws.
Coburn/Burr amendment No. 2131, to require an independent
assessment of the Food and Drug Administration's review of
drug applications.
Coburn/Burr amendment No. 2132, to provide that a portion
of the performance awards of each employee of the Center for
Drug Evaluation and Research, the Center for Devices and
Radiological Health, and the Center for Biologics Evaluation
and Research be connected to an evaluation of the employee's
contribution to goals under the user fee agreements.
Burr/Coburn amendment No. 2130, to ensure transparency in
Food and Drug Administration user fee agreement negotiations.
Murkowski amendment No. 2108, to prohibit approval by the
Food and Drug Administration of genetically engineered fish
unless the National Oceanic and Atmospheric Administration
concurs with such approval.
Paul amendment No. 2143, to amend the Federal Food, Drug,
and Cosmetic Act concerning claims about the effects of foods
and dietary supplements on health-related conditions and
disease, to prohibit employees of the Food and Drug
Administration from carrying firearms and making arrests
without warrants, and to adjust the mens rea of certain
prohibited acts under the Federal Food, Drug, and Cosmetic
Act to knowing and willful.

Mr. REID. Mr. President, I suggest the absence of a quorum.
The ACTING PRESIDENT pro tempore. The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. McCAIN. Mr. President, I ask unanimous consent that the order for
the quorum call be rescinded.
The ACTING PRESIDENT pro tempore. Without objection, it is so
ordered.

Amendment No. 2107

Mr. McCAIN. I ask unanimous consent to call up amendment No. 2107 and
make it pending.
The ACTING PRESIDENT pro tempore. Without objection, it is so
ordered. The clerk will report.
The assistant legislative clerk read as follows:

The Senator from Arizona [Mr. McCain] proposes an amendment
numbered 2107.

Mr. McCAIN. Mr. President, I ask unanimous consent that the reading
of the amendment be dispensed with.
The ACTING PRESIDENT pro tempore. Without objection, it is so
ordered.
The amendment is as follows:

(Purpose: To allow the importation by individuals of safe and
affordable drugs from Canada)

At the end of title XI, add the following:

SEC. 11__. SAFE AND AFFORDABLE DRUGS FROM CANADA.

Chapter VIII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 381 et seq.), as amended by this Act, is further
amended by adding at the end the following:

``SEC. 810. IMPORTATION BY INDIVIDUALS OF PRESCRIPTION DRUGS
FROM CANADA.

``(a) In General.--Notwithstanding any other provision of
this Act, not later than 180 days after the date of enactment
of this section, the Secretary shall promulgate regulations
permitting individuals to safely import into the United
States a prescription drug (other than a controlled
substance, as defined in section 102 of the Controlled
Substances Act) that--
``(1) is purchased from an approved Canadian pharmacy;
``(2) is dispensed by a pharmacist licensed to practice
pharmacy and dispense prescription drugs in Canada;
``(3) is purchased for personal use by the individual, not
for resale, in quantities that do not exceed a 90-day supply;
``(4) is filled using a valid prescription issued by a
physician licensed to practice in the United States; and
``(5) has the same active ingredient or ingredients, route
of administration, dosage form, and strength as a
prescription drug approved by the Secretary under chapter V.
``(b) Approved Canadian Pharmacy.--
``(1) In general.--In this section, an approved Canadian
pharmacy is a pharmacy that--
``(A) is located in Canada; and
``(B) that the Secretary certifies--
``(i) is licensed to operate and dispense prescription
drugs to individuals in Canada; and
``(ii) meets the criteria under subsection (c).
``(2) Publication of approved canadian pharmacies.--The
Secretary shall publish on

[[Page S3537]]

the Internet Web site of the Food and Drug Administration a
list of approved Canadian pharmacies, including the Internet
Web site address of each such approved Canadian pharmacy,
from which individuals may purchase prescription drugs in
accordance with subsection (a).
``(c) Additional Criteria.--To be an approved Canadian
pharmacy, the Secretary shall certify that the pharmacy--
``(1) has been in existence for a period of at least 5
years preceding the date of enactment of this section and has
a purpose other than to participate in the program
established under this section;
``(2) operates in accordance with pharmacy standards set
forth by the provincial pharmacy rules and regulations
enacted in Canada;
``(3) has processes established by the pharmacy, or
participates in another established process, to certify that
the physical premises and data reporting procedures and
licenses are in compliance with all applicable laws and
regulations, and has implemented policies designed to monitor
ongoing compliance with such laws and regulations;
``(4) conducts or commits to participate in ongoing and
comprehensive quality assurance programs and implements such
quality assurance measures, including blind testing, to
ensure the veracity and reliability of the findings of the
quality assurance program;
``(5) agrees that laboratories approved by the Secretary
shall be used to conduct product testing to determine the
safety and efficacy of sample pharmaceutical products;
``(6) has established, or will establish or participate in,
a process for resolving grievances and will be held
accountable for violations of established guidelines and
rules;
``(7) does not resell products from online pharmacies
located outside Canada to customers in the United States; and
``(8) meets any other criteria established by the
Secretary.''.

Mr. McCAIN. Mr. President, this is not a new issue. This has been
before this body on several occasions. I want to assure my colleagues
that if the lobbyists for the pharmaceutical companies in this town are
able to block this, we will be revisiting this issue. This is an issue
of fundamental fairness and decency and giving Americans the
opportunity to have access to very important medication that in many
cases is lifesaving. It has been blocked by one of the most powerful
lobbies in Washington, that of the pharmaceutical companies.
For years, along with many other Senators and the current occupant of
the White House--the President of the United States, when he was a U.S.
Senator, supported this amendment. I would love to see the
administration weigh in and take the same position that then-Senator
Obama took on this issue of basic and fundamental decency and fairness
to people who are badly in need of medicine to, in many cases,
literally save their lives.
Industry opponents of the comprehensive importation proposals have
found various ways to confuse the issue, raise red herrings about
safety, or cut secret deals to block passage of reasonable and widely
supported prescription drug importation programs.
Let me give an example--this recently came up--of the activities of
the pharmaceutical companies in the formulation of ObamaCare. ``GOP
probe uncovers deal between Obama and drug companies,'' by Philip
Klein, the senior editorial writer of the Washington Examiner.

Three years ago, President Obama cut a secret deal with
pharmaceutical company lobbyists to secure the industry's
support for his national health care law. Despite Obama's
promises during his campaign to run a transparent
administration, the deal has been shrouded in mystery ever
since. But internal emails obtained by House Republicans now
provide evidence that a deal was struck and GOP investigators
are promising to release more details in the coming weeks.
What the hell?'' White House Deputy Chief of Staff Jim
Messina, who is now Obama's campaign manager, complained to a
lobbyist for the Pharmaceutical Research and Manufacturers of
America (PhRMA) in January 15, 2010 email. ``This wasn't part
of our deal.''
This reference to ``our deal'' came two months before the
final passage of Obamacare in an email with the subject line,
``FW: TAUZIN EMAIL.''
At the time Billy Tauzin was president and CEO of PhRMA--

And I might add, one of the highest paid lobbyists in history,
millions of dollars--

the e-mail was uncovered as a part of Obama's closed-door
health care negotiations that was launched by the House
Energy and Commerce Committee oversight panel:
``In the coming weeks the Committee intends to show what
the White House agreed to do as part of its deal with the
pharmaceutical industry and how the full details of this
agreement were kept from both the public and the House of
Representatives,'' the committee's Republican members wrote
in a memo today.
On June 20, 2009, Obama released a terse 296-word statement
announcing a deal between pharmaceutical companies and the
Senate that didn't mention any involvement by the White
House.
``The investigation has determined that the White House,
primarily through Office of Health Reform Director Nancy Ann
DeParle and Messina, with involvement from Chief of Staff
Rahm Emmanuel, was actively engaged in these negotiations
while the role of Congress was limited,'' the committee
members wrote. For example, three days before the June 20th
statement, the head of PhRMA--

That is Mr. Tauzin--

promised Messina, ``we will deliver a final yes to you by
morning.''
Meanwhile, Ms. DeParle all but confirmed that half of the
Legislative Branch was shut out in an e-mail to a PhRMA
representative: ``I think we should have included the House
in the discussions, but maybe we never would have gotten
anywhere if we had.''

What went on in the formulation of ObamaCare is still one of the
worst, sleaziest exercises I have seen in my many years here, and this
involvement by the pharmaceutical companies was probably the most
egregious. All this amendment does is allow U.S. consumers who need
more affordable prescription drug options to either go without their
medications or pay higher prices than they could get from legitimate
Canadian pharmacies. But that is not a reason. It is not a reason for
us to stop fighting for those in the United States who need more
affordable prescription medications.
There are Americans in this country today who cannot afford their
medications. They have a choice between eating or taking their
prescription drugs. Meanwhile, there is a way for them to get much
cheaper drugs, and this amendment does that.
We will hear from the pharmaceutical company supporters in the Senate
who will talk about safety and how Canadians don't have the same
standards we do. Really? Do we really believe the Canadian regulations
and oversight are any better or worse than the United States? To ensure
that U.S. patients have at least one option, this amendment takes a
very narrow approach to safe importation by focusing on legitimate
Canadian pharmacies.
Under this amendment the Secretary of Health and Human Services will
certify ``approved Canadian pharmacies'' based on certain safety and
quality criteria. To ensure that patients are not exposed to unsafe
medications ``approved Canadian pharmacies'' can only sell drugs to
U.S. customers that are the same as U.S. approved drugs. To protect
U.S. patients against rouge distributors, a list of approved Canadian
pharmacies must be published by the Secretary of Health and Human
Services so Americans know which Canadian pharmacies are legitimate.
The cost of health care, including prescription drugs, continues to
increase. However, there is nothing in the underlying FDA bill that
will bring down the cost of prescription drugs. I wonder if the bill
should be enacted when it doesn't do anything to address costs. The
quality of pharmaceuticals in this country is outstanding, and I
recognize that. But don't we all know how expensive it is?
For example, don't we know that in the United States of America,
Nexium, 20-milligram, 30 tabs, is $195.99. The Canadian brand is
$108.55, and Canadian generic is $69. For Plavix, the U.S. brand is
$195; the Canadian brand, $132.
I am sure many Americans whose health coverage does not include these
very expensive pharmaceuticals would be eager to take advantage of the
same quality brand of prescription drugs that are available at these
pharmacies in Canada.
As we all know, unemployment remains over 8 percent, and millions of
families have mothers and fathers who remain unemployed or
underemployed and have no health insurance coverage. But the unemployed
and uninsured still have health conditions, and they need medications.
Millions continue to search for more affordable ways to get their
needed prescription drugs.
Unfortunately, in my State many of my fellow citizens who cannot
afford it go to Mexico to get drugs, and I cannot guarantee what they
purchase there will always be what it is purported to be. That is not a
criticism of my friends south of the border. But the fact is in Canada
they have the same kind of process we do. Despite there being no
official program to import medications from Canada, approximately 1
million U.S. consumers use

[[Page S3538]]

their own money to safely get their medications from legitimate
Canadian pharmacies.
In Arizona, over 20,000 patients purchase their medications safely
from Canadian pharmacies. In Florida over 85,000 patients purchase
their medications safely from Canadian pharmacies. A recent study from
Roger Bate, an AEI scholar, confirms that in drugs dispensed from
legitimate Canadian pharmacies there was no failure of authenticity
between drug samples obtained online from U.S. pharmacies compared to
the same drug from Canadian pharmacies. Within the verified pharmacies
U.S. prices on average were 52.5 percent higher than Canadian pharmacy
prices. In other words, the drugs from Canadian pharmacy sites are the
same dosage, form, and potency as drugs in the United States, only much
less expensive.
The drugs are the same as I mentioned. This amendment doesn't
authorize insurance companies, huge pharmacy chains, or drug
wholesalers to import massive quantities into the U.S. system. This is
about safely allowing uninsured, unemployed, and the underemployed to
individually import these drugs they need.
So, please, somebody explain to me how we tell the struggling family
who needs their medications that they cannot use their own money to get
the same drug from legitimate Canadian pharmacies where the costs can
be more than 50 percent lower than U.S. prices. It is not about the
alarms of safety because this amendment requires the Secretary of
Health and Human Services to promulgate regulations permitting
individuals to safely import medications from Canada, and the following
safety criteria must be met for a patient to import drugs from FDA-
approved Canadian pharmacies: The prescribed drug must be dispensed by
a licensed Canadian pharmacist; the prescribed drug must be for
personal use in quantities that don't exceed a 90-day supply; the
prescribed drug must be dispensed in accordance with a valid
prescription issued by a physician licensed to practice in the United
States; the imported drug must have ``the same active ingredient or
ingredients, route of administration, dosage form, and strength as a
prescription drug approved by the Secretary.''

The amendment recognizes that approved Canadian pharmacies meeting
safety criteria can and should provide needed alternatives to U.S.
patients using their own money to affordably obtain their medications.
The Secretary is required to publish on the FDA Web site a list of
``approved Canadian pharmacies'' that meet the following stringent
criteria: The pharmacy has been in existence for 5 years prior to
enactment of the program and has a purpose other than to participate in
the U.S.-Canadian safe drug importation program; the pharmacy operates
in accordance with provincial pharmacy rules and regulations; the
pharmacy complies with all inspection and data reporting procedures;
the pharmacy agrees that labs approved by the Secretary shall be used
to conduct product testing to determine the safety and efficacy of
sample pharmaceutical products; the pharmacy does not resell products
from online pharmacies located outside Canada to consumers in the
United States.
Safe drug importation is a bipartisan issue. People in all of our
States are still struggling with family budgets, and the Senate cannot
do anything to give patients more choices about where they can get
their needed drugs because the drug industry opposes allowing
individual Americans to use their own money to safely get the same
drugs from Canada, and it doesn't make sense.
Just a word about the types of medications that are eligible. I have
been asked by colleagues whether biologic medicines can be part of the
program. The answer is not unless they can be safely imported under the
provisions of the amendment and regulations issued by the Secretary.
The amendment doesn't discriminate against the type of conditions or
medicines that patients should be able to safely import under this
program. Not all biologics are the same. Some biologic medicines are
available in capsules; others are injectable medications that require
refrigeration. Some injectables don't require refrigeration and are
shipped to patients throughout the United States every day.
I don't believe U.S. patients should be necessarily prevented from
saving money on biologics. If a biologic medicine cannot meet the
various safety provisions in the amendment, it should not be eligible.
If it can meet the requirements of the amendment, then a biologic can
be available to U.S. patients.
If the past is a prologue, then obviously this amendment will go
down. Then after this amendment is rejected, I hope none of my
colleagues have any curiosity about the way the American people feel
about us; about the incredible, inordinate, illegitimate, outrageous
influence of the pharmaceutical companies in America over the average
American citizen. American citizens should be able to purchase
pharmaceuticals from an approved pharmacy in Canada that many times is
saving them half the money.
I am sure the distinguished chairman, my friend from Iowa, knows how
many families do not have prescription drug coverage who are making a
choice today between eating and medicine. What are we going to do? We
are going to turn down this commonsense amendment.
Congratulations ahead of time to the corrupt pharmaceutical companies
and their influence in the United States Senate and Capitol.
Mr. President, I ask for the yeas and nays on the amendment.
The ACTING PRESIDENT pro tempore. Is there a sufficient second?
There appears to be a sufficient second.
The yeas and nays were ordered.
Mr. McCAIN. Mr. President, I suggest the absence of a quorum.
The ACTING PRESIDENT pro tempore. The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. HARKIN. Mr. President, I ask unanimous consent that the order for
the quorum call be rescinded.
The ACTING PRESIDENT pro tempore. Without objection, it is so
ordered.
Mr. HARKIN. Mr. President, I understand the Republican leader is
about to come to the floor to give his leader remarks.
I just wish to let Senators know we are moving ahead on the bill.
Senator McCain just brought up his amendment and spoke about it. I know
there are some who want to speak in opposition to the McCain amendment.
We still have amendment No. 2111 by Senator Bingaman to be called up.
We have two amendments, No. 2146 and No. 2145, by Senator Portman that
need to be called up. I ask Senators to please come over and call up
their amendments so we can debate them and move ahead to expeditiously
voting on those amendments and final passage of the bill.
I see the Republican leader is on the floor, and I yield the floor.

Recognition of the Minority Leader

The ACTING PRESIDENT pro tempore. The Republican leader is
recognized.
Mr. McCONNELL. Mr. President, I think we are under a time agreement
on the bill; is that correct?
The ACTING PRESIDENT pro tempore. The leader is correct.
Mr. McCONNELL. I wish to proceed under my leader time.
The ACTING PRESIDENT pro tempore. The Senator has that right.

Student Loan Interest Rates

Mr. McCONNELL. Mr. President, today we will once again attempt to
prevent student loan interest rates from going up. This problem could
have been solved literally weeks ago, but our friends on the other side
were not interested in solving the problem; they wanted a scapegoat
more than a solution.
So this afternoon we will vote on two different ways of addressing
the issue. The Democratic plan is designed to fail. In order to cover
the cost of a temporary rate freeze that both parties actually want,
they propose to divert $6 billion from Medicare and to raise taxes on
small businesses, hurting the very companies we are counting on to hire
today's college graduates. They have known for months that we would not
support this tax hike and that it couldn't pass this Chamber or the
House of Representatives. It has already failed, but they are proposing
it anyway, for a second time.
If our Democratic friends would allow it, the chairman and ranking

[[Page S3539]]

member could write a bill that could actually pass. But since passage
isn't their goal, our friends on the other side huddled behind closed
doors, out of sight of the public and the press, and produced the tax
hike instead of letting the committee actually do its work.
We already know how this story is going to end. We know exactly,
already, how the story will end. So why are the Democrats forcing us to
vote on their failed proposal yet again? Because, as I have said, they
are more interested in drawing our opposition--of trying to create a
bad guy--than in actually solving the problem.
When it comes to college graduates today, the bigger issue is the
President's economic agenda which has created an environment in which
most of them can't find a decent job. So I can understand why our
Democratic friends want to change the subject, but if we are actually
going to do something to solve the problem, we are going to need to get
past the political theatrics.
If Senate Democrats reject the bipartisan fix the House already
passed--one that doesn't raise taxes or divert a single dollar away
from Medicare and is an offset they have used themselves before--then I
hope they will turn around and work with us on a bipartisan fix that
doesn't tax small businesses--a proposal that is actually designed to
pass and become law.
But let's be clear about something. The real issue isn't the fact
that certain students are going to see an interest rate hike because we
will address that concern; it is that so many young people today can't
find a job that will enable them to pay off their loans in the first
place. That is the much larger problem. The solution is a progrowth
agenda that would make it easier for U.S. businesses to hire, not a tax
hike that will actually make it harder for them to hire.
In the short term, Republicans are ready to work to offer this
temporary relief, but we are still waiting on the Democratic leadership
to propose a solution of their own that can actually pass either one or
two Chambers of Congress.
I would, once again, urge the President to get involved. If the
President has time to run around to late-night comedy shows and college
campuses talking about this issue, then he can pick up the phone and
work out a solution with Democrats in the Senate.
Last week at the White House, I pressed the President to get involved
in order to prevent the student interest rates from going up--a goal we
all share. Think about it. If the President wants to pass this bill so
badly, then why on Earth hasn't he picked up the phone and called the
chairman or ranking Republican of the relevant committee? As with so
many pressing issues, the President has not led on this issue. He has
campaigned on it, but he has not worked to actually fix it.
The American people are tired of the posturing and the games. It is
time for the President to lead. It is time for Senate Democrats to stop
the political theater and to find a real solution.

Thanking Senator Enzi

Mr. President, on another matter, I wish to take a moment to thank my
good friend, the senior Senator from Wyoming, Mike Enzi, for the work
he has done shepherding the FDA bill through the markup and across the
Senate floor. This is an incredibly complex piece of legislation that
strikes a difficult balance of protecting consumers while avoiding the
stifling regulation that slows the process of bringing lifesaving drugs
and devices to market.
Throughout a lengthy process, Mike has shown the command of complex
topics, steady leadership, and interest in his colleagues' priorities
that have characterized his tenure at the HELP Committee. For that,
those of us on this side of the aisle would like to thank him very
much.

Honoring Our Armed Forces

Specialist David W. Taylor

Mr. McCONNELL. Mr. President, I wish to address one other matter. I
have a sad task today of informing my colleagues that a valued and
honorable Kentuckian who enlisted in the U.S. Army has fallen in the
performance of his duty. On March 29, 2012, SPC David W. Taylor of
Dixon, KY, died from injuries sustained in an accident at an
ammunitions supply point in Kandahar Province, Afghanistan. He was 20
years old.
For his service in uniform, Specialist Taylor received several
awards, medals, and decorations, including the Army Commendation Medal,
the Army Good Conduct Medal, the National Defense Service Medal, the
Afghanistan Campaign Medal with Bronze Service Star, the Global War on
Terrorism Service Medal, the Army Service Ribbon, the Overseas Service
Ribbon, the NATO Medal, the Parachutist Badge, and the Overseas Service
Bar.
After his tragic death at entirely too young an age, one of
Specialist Taylor's commanders, Sergeant Addington, delivered a tribute
to his fallen brother in arms. This is what he said:

When his country called for young lives to offer themselves
up for the preservation of freedom, young David Taylor
answered the call and said, ``Here am I, take me.''
Specialist Taylor was my soldier, my battle buddy, and my
friend. He was a fast learner and my greatest student. He
sacrificed himself so we might be free.

Before he was a soldier, his mother Sarah Taylor recalled that David
was a compassionate, dedicated young man. From a young age, he was
always looking for ways to help others. Sarah says of her son: ``One
Christmas he had received a large amount of gifts.''
David asked his parents ``if he could give some of his gifts to a
classmate of his who he knew would not receive many items.''
David was a great athlete who played football and soccer and ran
track. He loved to hunt and hunted turkey and deer, but his real
passion was for duck hunting. He had many friends, was the life of the
party, and he was popular with the girls. David ``would change outfits
multiple times before going to school, as his hair and clothes had to
be perfect,'' Sarah says.
David was also very dedicated to physical fitness. He worked out
multiple times a week to stay in shape. Perhaps that is because young
David knew his body was his instrument, and he had made up his mind to
join the military by age 14.
David's high school did not have an ROTC program, so David worked
hard to graduate 6 months early and eagerly enlisted. He skipped both
the prom and graduation to take up his more important pursuit,
enlisting in January 2010. He even waived his signing bonus saying,
``It is every young man's duty to serve.''
David planned to make the military his career and hoped to go into
the medical field. He dedicated himself to the military handbook and
doing everything ``by the book.'' He went on to serve as a paratrooper
in a parachute infantry regiment, one of the most demanding specialties
in the Army.
LT Eric Fitzgerald was Specialist Taylor's platoon leader. He says:

David was one of the most outstanding paratroopers in the
whole platoon, just striving to be the best. When you wanted
something done, when you wanted it done right, you went to
Taylor for it.

CPT Brian Bifulco, David's company commander, concurs:

It was evident since the day I met him that David had all
the qualities desirable in a paratrooper: Smart, aggressive,
committed, and reliable. He displayed them readily in
everything he did.

David maintained his rigorous workout schedule in the Army by
following the Crossfit physical fitness programs 5 to 6 days a week so
he could excel at the Army's physical fitness test. He could run his 2-
mile fitness test in a full minute faster than anyone else in his
platoon. Specialist Taylor was assigned to D Company, 2nd Battalion,
508th Parachute Infantry Regiment, 82nd Airborne Division, based out of
Fort Bragg, NC. He deployed to Afghanistan for Operation Enduring
Freedom in February of this year for what would be his first and only
deployment.
David's fellow soldiers from his platoon named the small gym in their
Afghanistan outpost in his honor as a remembrance of David's commitment
to excellence. Nearly every soldier in the platoon wears a metal
bracelet honoring Specialist Taylor. SFC Russ Kelley had this to say:

For many of the guys, this is the first friend they've ever
lost to combat. They wear the bracelets to remember.

At this time we are thinking of SPC David W. Taylor's family and his
friends as I recount his story for the Senate, including his mother
Sarah Taylor, his grandmother Laura Klutey,

[[Page S3540]]

and many other beloved family members and friends. David was preceded
in death by his father Kevin Taylor.
David's mother Sarah says David loved the Army and was excited to be
in Afghanistan.
Sergeant Addington remembers:

David seemed to live for the job, and while others would
whine and complain in the field, David would just sling up
his hammock and settle in. He was at home in the woods, a
natural outdoorsman.
David, who grew up in the woods, fit in perfectly. He
seemed born to do this job, and I felt sorry for any Taliban
that he was bound to run into in Afghanistan. The Taliban got
lucky this time.

Even if that is the case, the tragedy of Specialist Taylor's death is
certainly not lucky for anyone else, most of all not for the family he
has left behind or his friends and fellow soldiers.
I know it is small solace in place of what they have lost, but I want
them to know this Senate holds SPC David W. Taylor in the highest
regard for his service on behalf of our country. We are honored, just a
few days before Memorial Day, to recognize his enormous sacrifice on
behalf of this Nation.
I yield the floor.
The ACTING PRESIDENT pro tempore. The Senator from New Jersey is
recognized.
Mr. MENENDEZ. Mr President, I rise in strong support of the
underlying bill we are debating, the Food and Drug Administration
Safety and Innovation Act.
This legislation, which has been the model of bipartisanship and
effective legislating on the part of Chairman Harkin and Ranking Member
Enzi, is critically important to the people of New Jersey and the
Nation.
This bill is about more than drug safety. It is about more than
protecting patients. It is about improving the approval process to
speed access to new lifesaving, life-enhancing drugs and devices, and
making sure the FDA is a partner in the production of safe and
effective products.
This bill does this and accomplishes several key goals that are
critically important to our Nation's health care system. Not only does
it reauthorize the key user fee agreements for prescription drugs and
medical devices, but it establishes agreements for generic drugs and
generic biologic drugs called biosimilars.
Together, these user fee agreements will provide the FDA with the
resources necessary to improve the drug and device approval process to
more quickly and efficiently bring new products to market. It will
enhance communication between manufacturers and the agency to foster a
more cooperative environment, and it will allow for better and more
thorough postmarket reviews to ensure continued patient safety and
product efficacy.
There is more to this bill than the FDA user fees.
It permanently reauthorizes two vital programs that are a lifeline to
our Nation's children--the Best Pharmaceuticals for Children Act and
the Pediatric Research Equity Act, which are incredibly important to
our children. It helps reduce and mitigate the ongoing problem of drug
shortages we have heard about throughout the country. It provides for
enhancements to the prescription drug supply chain and increases the
accountability and transparency of the Food and Drug Administration.
It is good for children. It is good for business. It is good for
patients. It makes the FDA a more effective partner in the process, and
it demonstrates that we can reach across the aisle and work together to
tackle tough issues and find solutions that benefit the people we
collectively represent.
This just touches the surface of what this bill will accomplish.
However, this incredibly hard work could very easily be unraveled by
some of the amendments being considered.

Amendment No. 2107

It seems that, once again, despite the countless times--the countless
times--the Senate has rejected the policy my friend from Arizona
pursues, he has brought us an amendment that I believe puts Americans
at risk, undermines FDA's authority, and would have a devastating
ripple effect throughout our country's drug supply by allowing
untraceable foreign pharmaceuticals into our country.
This amendment would ostensibly only allow drugs from Canada into the
United States. However, nothing in the amendment comes close to
ensuring that is the case. In fact, this amendment would easily allow
Web-based pharmacies within Canada to provide untraceable,
unaccountable drugs from all over the globe into the U.S. market
without any FDA oversight whatsoever.
This amendment does not provide the FDA with any additional resources
to monitor the drugs coming in from Canada, and even the Canadian
authorities have said they cannot be expected to monitor all the drugs
coming through their country and into ours. Once one of those drugs
hits and causes consequences to some family, then we will all be
running and saying: How did we allow that to happen?
The Senate has soundly and repeatedly voted against this type of drug
importation because we understand the implications it has on bringing
counterfeit and dangerous products into our Nation. As we work to
strengthen the FDA, I ask my colleagues to join me in opposing this
amendment, which would significantly weaken the agency and put
Americans at risk.

Amendment No. 2109

Additionally, I wish to address another critically important issue
brought up by my friend from Vermont. The Sanders amendment would lead
to a radical change in how our Nation's biotech and pharmaceutical
industry achieves the process of bringing lifesaving, life-enhancing
drugs into the marketplace.
I certainly respect the passion for the issues he pursues. But there
are over 200,000 people in New Jersey who work in the biopharmaceutical
industry every day who take pride in the work they do creating
breakthrough, lifesaving, life-enhancing drugs, and I take issue with
this characterization of an industry which is responsible for some of
the world's most important medical breakthroughs that have saved
millions of lives. If you are one of those people waiting for one of
those drugs to come to the marketplace, hoping that for your mother's
Alzheimer's--the Alzheimer's that took my mother's life--we will
finally have a breakthrough; that for your husband with Parkinson's, we
will finally have a breakthrough; that for your loved one with cancer,
we will finally have a breakthrough, you want to see that come to the
marketplace.
This industry is responsible for finding the cures and treatments for
diseases that kill people and destroy family incomes. This is the
industry that has more than 1,600 active clinical trials in New Jersey
on drugs to treat cancer, cardiovascular disease, diabetes, HIV/AIDS,
mental and behavior disorders, and, especially important to me
personally, trials for drugs treating Alzheimer's and other forms of
dementia. Families look forward to those breakthroughs coming to the
market to help cure their loved ones.
This work is what keeps our Nation competitive and on the cutting
edge of medical science, providing billions of dollars in economic
impact annually--roughly $900 billion nationally and more than $35
billion in New Jersey--and it provides countless people across the
globe with lifesaving medications.
The amendment being offered could have a chilling effect on all
this--all the hope for new treatments and perhaps new cures for
diseases, having an opportunity for that to be turned around, to stop
having those families lose a loved one who succumbs to a disease,
ruining countless lives. It has the potential to dry up investment in
the next cure and severely curtail the number of high-skill, high-
paying jobs and billions of dollars in economic investment in
the biopharmaceutical industry.

I know my friend from Vermont wants to prevent fraudulent behavior,
and I wholeheartedly agree that bad actors who willfully commit fraud
need to be punished, which is why we have the most incredible, stiff
civil and criminal penalties in current law to prosecute those who
commit fraud. But ultimately taking away the incentives we have in
place to attract investment in this important research, especially when
the penalties could be triggered by a minor, unrelated offense--the way
the amendment is written--is just plain and simple bad policy. It is
akin to having the death penalty for a simple assault.

[[Page S3541]]

The current intellectual property laws that protect pharmaceutical
products provide researchers and their investors with a stable and
predictable timeline that allows them to recoup the risky investments
in research and development of new drugs.
We only think about the drugs that have success. But remember, out of
every 5,000 to 10,000 potential drug compounds identified, only 1--only
1--of those 5,000 to 10,000 potential drug compounds will result in a
new medicine on the market.
Do we want the companies not to take the risk of going through all
those thousands and thousands of compounds to come up with the one that
can be the cure for so many lives and save so much money in the
government under Medicare and Medicaid and in our entire health care
system? That is risky investing by anybody's standard, so removing
incentives is bad policy for the public health of the United States.
This amendment will lead to uncertainty among investors. It will dry
up capital. It will further delay access to new medical products. It
will pull us back from the cutting-edge research and development that
has always made this Nation great.
As I have said--and as my friends who are managing this bill have
said--this FDA reauthorization is too important not to pass. So I urge
my colleagues to reject these harmful amendments so we can move forward
and have an FDA that has the ability to do its job on behalf of the
American people to create a process that will be safe but will give us
the lifesaving, life-enhancing cures that ultimately will lead to a
better life for all of us.
With that, I yield the floor and suggest the absence of a quorum.
The ACTING PRESIDENT pro tempore. The clerk will call the roll.
The legislative clerk proceeded to call the roll.
Mr. HARKIN. Mr. President, I ask unanimous consent that the order for
the quorum call be rescinded.
The ACTING PRESIDENT pro tempore. Without objection, it is so
ordered.
Mr. HARKIN. Mr. President, I ask unanimous consent that the time in
quorum calls be evenly divided on the McCain amendment.
The ACTING PRESIDENT pro tempore. Without objection, it is so
ordered.
Mr. HARKIN. Mr. President, I again say we are rapidly coming to a
close. Again, the sooner we can get to voting, the sooner we will close
out the business for the day and probably for the week.
I again would point out that we have Senator Bingaman's amendment No.
2111 yet to be called up. Senator Portman has two amendments--Nos. 2146
and 2145. Those basically are the only ones left to be brought up. So I
would urge them to come and others who have indicated they want to come
and speak on the amendments that are pending. The McCain amendment, the
Sanders amendment, the Murkowski amendment, the Durbin amendment, and
the Paul amendment are still pending. People have indicated they want
to come over and speak on these various amendments. I would hope they
would do so, so we can perhaps get to voting on the amendments and
final passage of the bill sooner rather than later.
With that, I suggest the absence of a quorum.
The ACTING PRESIDENT pro tempore. The clerk will call the roll.
The legislative clerk proceeded to call the roll.
Mr. GRASSLEY. Mr. President, I ask unanimous consent that the order
for the quorum call be rescinded.
The ACTING PRESIDENT pro tempore. Without objection, it is so
ordered.

Amendment No. 2107

Mr. GRASSLEY. Mr. President, I support Senator McCain's amendment.
That amendment would allow drug importation from approved pharmacies in
Canada. I have been a long-time proponent of safe drug importation. I
am currently a cosponsor of the Pharmaceutical Market Access and Drug
Safety Act, a bill I have worked on for many years with Senator Snowe
and Senator McCain.
In 2002 and 2003, I supported amendments similar to the one before us
today that would permit the importation of prescription drugs from
Canada. In the year 2004, the late Senator Kennedy and I worked
together on a bill that would authorize drug importation, but it did
not survive the partisan politics of this Chamber.
I then introduced my own comprehensive drug importation bill in 2004.
I entitled that bill the Reliable Entry of Medicine and Everyday
Discounts Through the Importation of Effective Safeguard Act, and that
naturally works out to an acronym. we called it the REMEDIES Act.
In 2005, I combined that bill with the proposal sponsored by then-
Senator Dorgan and Senator Snowe. And in 2007 and 2009, we reintroduced
the version of that legislation with hopes that our combined efforts
would finally lower the cost of prescription drugs for all Americans.
During the health care reform debate in 2009, drug importation had a
much better chance to pass than ever before. We had a Democratic
supermajority in Congress and we had a Democratic President who
supported drug importation in the past. But in backroom deals between
the Obama White House and the pharmaceutical industry, those deals
prevented us from finally lowering the drug costs for all Americans.
So after all of this decade-and-a-half effort, we are back here again
trying to accomplish the same goal with Senator McCain's amendment. I
have always considered drug importation a free-trade issue. Imports
create competition and keep domestic industry more responsive to
consumers. Consumers in the United States pay far more for prescription
drugs than those in other countries.
For instance, U.S. prices are, on average, 52\1/2\ percent higher
than Canadian pharmacy prices. If Americans could legally and safely
access drugs outside the United States, then drug companies would be
forced to reevaluate their pricing strategies. They would no longer be
able to gouge American consumers by making them pay more than their
fair share for the high cost of research and development. Because that
is a fact. We pay for most of the research and development of new drugs
because other countries are getting by dirt cheap and there is not
enough money coming in from those countries to pay for all of the
research it takes, because, as you know, most of the cost of a drug is
the research and development, it is not the manufacture of that little
pill or a big pill, for that matter.
In the United States, it is a fact. We import everything consumers
want. So why not pharmaceuticals? In fact, I look back at all my years
working on trying to free up trade around the world through efforts to
pass free-trade agreements, through efforts to get the President trade
promotion authority, everything that would make global policies
available to American consumers, and I can only think of two things our
law prevents consumers in America from importing from other countries
when everything else the consumers buy they can buy anywhere in the
world if they want to--but not for pharmaceuticals or not for Cuban
cigars.
Some opponents of this amendment have concerns about what drug
importation would mean to the safety of drugs. Obviously, we have to be
concerned about drug safety because that is what the FDA is all about--
two things, making sure drugs are safe, and, No. 2, to make sure they
are effective.
Everyone who knows me knows I care deeply about the safety of drugs.
I would not be standing here today urging support for Senator McCain's
amendment if I did not think it would properly protect the safety of
the Nation's prescription drug supply chain. The fact is that the
unsafe situation is what we have today. Today patients who need a
cheaper alternative are ordering drugs over the Internet from who knows
where, and the FDA does not have the resources to do much of anything
about it. The fact is the McCain amendment would not only help to lower
the cost of prescription drugs for all Americans but will also
establish a system where American patients can be certain that the
drugs they are importing are safe.
The amendment has requirements that a pharmacy must meet before the
Secretary may approve them for participation. This includes product
testing in labs designated by the Secretary. A list of approved
pharmacies

[[Page S3542]]

will be published on the FDA Web site. Patients who are already forced
to purchase their medications outside the United States would be able
to access the list to choose a safe option. Additionally, the amendment
lays out criteria that must be met before any patient may import drugs
from an FDA-approved pharmacy. Patients must have a valid prescription
from a physician licensed to practice in our country. The purchase must
be for personal use, and the drug must have the same active ingredient,
route of administration, dosage form, and strength as a prescription
drug approved by the Secretary of HHS.
The McCain amendment would improve drug safety, it would not threaten
drug safety. It would open trade to lower-cost drugs, and it would make
other consumers around the world start paying for some of the research
and development the American consumer is paying such a high price to
provide. We should do all we can to get miracle drugs originated and
developed, but the American consumer should not be paying the entire
bill. We need to make sure Americans have even greater, more affordable
access to lifesaving drugs by opening the doors to competition in the
global pharmaceutical industry.
Obviously, after a decade and a half, I am continuing to urge my
colleagues to join in this effort on the importation of drugs, and in
this particular area to give support to Senator McCain and support his
amendment. I applaud him for the leadership he has shown in this area
over a long period of time.
I yield the floor.
The ACTING PRESIDENT pro tempore. The Senator from Wyoming.
Mr. ENZI. Mr. President, I rise in opposition to the McCain amendment
No. 2107, which would facilitate the importation of prescription drugs
from Canada. We are not talking about bus trips of seniors to reputable
brick-and-mortar pharmacies right across the border. We are talking
Canadian Internet pharmacies, which may not even be in Canada, which
pose a significant threat to American patient safety.
This amendment would require the Food and Drug Administration to
allow individuals to import prescription drugs into the United States
from Canada, notwithstanding any other provision of the Federal Food
Drug and Cosmetic Act.
Drugs that supposedly come from Canada can originate in any country
in the world, and merely be shipped to the United States from Canada.
Canadian law does not prohibit the shipment of drugs from any country
into Canada and then into the United States. They do not care.
In 2005, FDA conducted an investigation of drugs that American
patients thought they were ordering from Canada. Eighty-five percent of
the drugs represented as coming from Canada actually came from 27 other
countries. A number of drugs were found to be counterfeit.
A letter from Assistant Deputy Minister of Health, Canada, to the
U.S. Surgeon General again said that Canada does not assure that
products being sold to U.S. citizens are safe, effective, and of high
quality, and does not intend to do so in the future.
The pending amendment would allow importation from Canadian Internet
pharmacies. Canadian Internet pharmacies openly acknowledge they obtain
most of their drugs from other countries. The specific language of the
pending amendment gives rise to the additional safety concerns. For
example, it will not prevent the importation of drugs that need special
handling, such as refrigerated or photosensitive drugs. It would not
prevent the importation of special drugs, such as those inhaled during
surgery or administered intravenously.
The pending amendment would not require Canadian wholesalers that
would be involved in the importation to be licensed or registered in
any way. There would be a list but not a licensing or registration. Do
we want anyone, even someone under investigation or with a suspended or
revoked license, to be in the business of importing drugs, given the
well-known risks?
FDA advises consumers that some imported drugs, including those that
bear the name of U.S.-approved products, may, in fact, be counterfeit
versions that are unsafe or completely ineffective. You know, they can
have all of the ingredients to it, but if it is not put together the
right way, it will not even dissolve as it goes through the body, and
therefore there would be no benefit from that drug, even though it
looked like the real thing, it tasted like the real thing, it went down
like the real thing. But if it is not the real thing, it can cause some
real trouble with people's health.
This is not a hypothetical concern. Last year Homeland Security
Secretary Napolitano testified that counterfeit drugs are a growing
problem. Two months ago, FDA testified about the dangers of purchasing
counterfeit, unapproved, or diverted prescription drugs on line. My
colleague Senator Mikulski has highlighted the growing involvement of
organized crime in this area. Prescription drug counterfeiting can be
dramatically more profitable than narcotic smuggling. Imported drugs
pose additional dangers because their labels may lack important
information or warnings.
FDA advises consumers that an imported medication may lack
information allowing patients to be promptly and correctly treated for
dangerous side effects.
We know imported drugs pose severe risks to American patients. The
FDA and the Department of Health and Human Services have repeatedly
said they cannot assure the safety of imported drugs. A side-by-side
amendment that we used to put on this all the time was that you could
import drugs as long as the Secretary of Health and Human Services said
it was safe. Well, there hasn't been a Secretary of Health and Human
Services who has been willing to sign that drugs imported from
anywhere--even Canada--are safe.
FDA's Web site advises consumers that imported drugs--including drugs
imported from Canada--may not have been manufactured under quality
assurance procedures designed to produce a safe and effective product.
That is the FDA Web site.
The Federal Food, Drug, and Cosmetic Act represents over 100 years of
lawmaking to protect the public health. It gives the FDA authority to
make sure drugs are properly approved, manufactured, labeled, shipped,
handled, and stored, that factories are inspected, and that numerous
other protections are in place for American patients. Adopting this
amendment would endanger American patients, and I therefore urge my
colleagues to oppose it.
There is a lot more that could be said. I have been saying this for
years and trying to find a way it could be done. At the present time,
the safety of it makes me oppose this particular amendment. They keep
revising the amendment. It is still online and everybody knows how
things online can be redone. They talked about putting an official seal
on each Web site, but I know fourth graders who can duplicate any seal
you can put on the Internet. Any list can be changed--and who checks
lists, anyway? The problem is not knowing where the drugs come from
that go through Canada to the United States. If they are counterfeit,
they can sell them for less. The Canadian secretary of health also
doesn't want to be the pharmaceutical supplier to the United States.
They have a little different system up there. It is a way of driving
prices down, which is something we would not stand for in the United
States, a mechanism where they have to bid on the drugs. The people who
make hard medicine bid against each other, and your doctor might prefer
the one that doesn't win the bid. That is how they drive the price
down. It is probably something we would not allow in the United States.
I ask my colleagues to oppose the amendment.
I yield the floor.
The ACTING PRESIDENT pro tempore. The Senator from Arizona.
Mr. KYL. Mr. President, I will speak about two amendments that we
will vote on later.

Amendment No. 2111

First is the Bingaman amendment. I urge my colleagues to oppose it.
It ignores fundamental economic realities of pharmaceutical patent
litigation, and it would ultimately result in fewer generic drugs being
brought to market and delays in the launch of many of the generic drugs
that do go to market.
Under current law, a generic drug company that is the first to file
an abbreviated new drug application for an

[[Page S3543]]

existing patented drug is entitled to 180 days of market exclusivity
once the generic drug is approved. In other words, they have the
exclusive market on it for half a year. This creates a powerful
incentive for drug companies to bring generic drugs to market.
The present amendment would dilute this right of 180 days of
exclusivity and potentially require the exclusivity period to be shared
with another drug company's product. Under the amendment, the only way
a generic drug company that files the first ANDA could be assured of
getting 180 days of market exclusivity is by litigating a challenge to
the validity of the branded drug's patent all the way to a final
judgment.
This is not a sound approach. First of all, patent litigation is very
expensive. Full litigation of a drug patent suit typically costs
between $3 million and $5 million. Second, most drug patents are
ultimately found by the courts to be not invalid; that is, most
validity challenges to these patents fail.
Generic drug companies, as everyone else, have limited litigation
budgets. As a practical matter, if we force them to litigate every
patent case to a final judgment in order to preserve their exclusivity
rights, they will pursue fewer abbreviated new drug applications, and
fewer ANDAs means fewer generic drugs and higher costs for consumers.
Finally, it is often the case that part way into a drug patent
lawsuit, the generic drug company comes to the conclusion that the
brand's patent is strong and that the challenge to the patent is likely
to lose. In such a situation, everyone is better off if the suit is
settled. Typically, such settlements allow the generic drug to go to
market somewhat earlier but still preserve the bulk of the patent term.
Obviously if the generic drug company is forced to litigate this all
the way to judgment in order to potentially receive exclusivity and
they lose, the full patent term will run and there will be no early
generic market entry. This hurts both the generic drug companies and,
more importantly, the consumers.
For these reasons, I urge my colleagues to oppose the Bingaman
amendment.

Amendment No. 2109

Second, I urge my colleagues to oppose the Sanders amendment. This
amendment would undermine the government's ability to fight fraud and
will harm patients and U.S. competitiveness by eviscerating existing
incentives to invest in medical innovation.
The Sanders amendment would result in the automatic revocation of any
remaining regulatory exclusivity on a product when a company is
convicted or even enters into a settlement agreement for certain
violations of the Food, Drug, and Cosmetic Act, or any violations of
the False Claims Act or several other listed statutes.
There are several reasons why this is the wrong approach. First and
foremost, the amendment will result in less lifesaving drugs ever
getting to patients. Obviously, we should be fighting for lifesaving
drugs getting to patients even faster. We provide these periods for
exclusivity, as I mentioned earlier, for a reason: to enable companies
to recoup the significant investments they make--as high as $1.2
billion per drug--to develop new medicines. Some of the exclusivities
the amendment would revoke are those we enacted to encourage companies
to ensure the safe use of pharmaceuticals in children or to find a cure
for rare diseases that affect a very small number of people.
Indeed, orphan drug exclusivity is a great example of how these
exclusivity periods benefit patients. Since 1983, the year the Orphan
Drug Act was signed into law, more than 350 medicines have been
approved to treat rare diseases, compared to fewer than 10 in the
1970s. Why would we want to jeopardize such a great success story?
Second, reduced investment in U.S. drug development is not only bad
for patients but for the economy. Because the Sanders amendment would
create a disincentive to invest in drug development, the National
Venture Capital Association has already expressed concerns, stating
that the amendment has ``the potential to inadvertently undermine
innovation and undermine decades of policies enacted by Congress with
the goal of fostering medical innovation.'' Defined periods of
exclusivity provide some small measure of predictability in what is
otherwise a risky process, and companies and venture capitalists rely
on these periods of exclusivity to make development and investment
decisions.

By threatening the elimination of exclusivities for conduct that is
likely many years removed from the development process, the Sanders
amendment would introduce even greater uncertainty into the R&D
process.
Let me restate that we need to reconsider the overall favorability of
the environment for innovation in the United States. Yet here we are
considering an amendment that, if enacted, would make the U.S.
investment climate far less attractive for these companies, even as
other countries are actively courting the biopharmaceutical industry.
Third, while the amendment purports to fight fraud, in reality it
would actually undermine the ability of the government to fight fraud
by undermining its ability to settle cases. The Sanders amendment would
revoke exclusivity not only upon conviction--even if that conviction is
later overturned on appeal--but also upon settlement. This is a huge
problem because it creates a disincentive for companies to ever settle,
as it would make more sense to drag out the district court litigation
while any relevant exclusivity period is still running for the company.
Fourth, and finally, the amendment is not even necessary because the
outcome called for by the Sanders amendment can already be achieved
under current law in appropriate cases, because the government can, and
does, have the power to negotiate the relinquishment of exclusivity as
a condition of settlement. It can already do this. For example, this
past January, the Department of Justice negotiated the relinquishment
of a company's 180-day exclusivity as part of a settlement for
violations of the Food, Drug, and Cosmetic Act. Mandating this serious
outcome in every case undermines the government's ability to use it as
leverage to negotiate settlements.
Large penalties already apply for violations of the statutes listed
in the Sanders amendment. The world of drug manufacturing and marketing
is very heavily regulated, and noncompliance is subject to considerable
penalties under current law. This amendment is not necessary. Rather
than being outraged by settlements that occur, perhaps we ought to take
them as an indicator that the government is doing a good job of using
existing authority to go after those who seek to defraud the health
care system.
I urge my colleagues to oppose the Sanders amendment.
The ACTING PRESIDENT pro tempore. The Senator from Maine is
recognized.
Ms. SNOWE. Mr. President, I rise to speak in support of the amendment
offered by the Senator from Arizona.

Nuclear Submarine Fire

Before I do that, I want to recognize and acknowledge the tremendous
and outstanding and remarkable work done by the crew at the Portsmouth
Naval Shipyard and the local firefighters from numerous departments
from the State of Maine, as well as from New Hampshire, because of the
fire that occurred on the nuclear-powered submarine at the shipyard
last evening, which was burning for more than 9 hours.
It was the extraordinary teamwork and coordination among all of the
crews, as well as the firefighters and departments from both States,
that managed to put out the fire. It is now smoldering. I offer my
commendations and congratulations to those who did the exceptional and
outstanding work, which exemplifies the kind of teamwork that already
occurs at that shipyard. I wanted to offer my recognition to that
extraordinary work in a very difficult circumstance.

Amendment No. 2107

I rise in support of the amendment offered by the Senator from
Arizona, Senator McCain, in authorizing a very limited drug importation
program, whereby Americans can purchase medications from accredited
online Canadian pharmacies. I am supporting this amendment, as I have
in the past. In fact, we have had broader amendments offered on the
floor of the Senate for almost more than a decade with respect to
allowing importation of prescriptions from other countries that offer
more competitive prices.
I applaud Senator McCain, who obviously has been a very valuable ally
in

[[Page S3544]]

this effort for many years. But he proposed a very limited approach to
address those who have concerns with the idea of importing prescription
drugs. I, for one, cannot understand why there is such a fundamental
concern about this issue because, first of all, Americans have been
facing tremendous increases in prescription drug prices for far too
long. I think it is at a point at which Congress should address this
issue, and precisely on this particular piece of legislation that is
before us today. It could not be more appropriate to have this
amendment offered on this legislation.
In 2010, AARP found that retail prices for the most popular brandname
drugs increased 41.5 percent, while the Consumer Price Index rose just
13 percent. In other words, the cost of prescription drugs rose more
than three times as much as the inflation rate. That is completely
unacceptable.
What has occurred as a result of this trend? First of all, American
consumers are increasingly choosing to risk living without taking
critical medications. According to the Commonwealth Fund, in 2010, 48
million Americans did not fill a prescription due to high costs. That
represents an increase of 66 percent since 2001.
If the Senate and the overall Congress were to adopt the McCain
amendment, it would allow Americans to purchase safe medications at a
lower price than they are available for us in this country. We could
begin to turn this disturbing trend around. I know people in Maine
deserve access to affordable drug prices. Millions of Americans, and
certainly those in Maine, have purchased drugs from Canada safely, at a
significant savings over the years. They have had to go to great
lengths in order to purchase lower price medications. They have taken
bus trips to Canada to purchase that medication because that was the
only way they could have access to the prescriptions they so
desperately need. The McCain amendment builds on that foundation.

If we look at this first chart, Mr. President, an April 27, 2012,
survey comparing average Canadian drug prices against major U.S. retail
pharmacy prices, we find the average U.S. price for a 90-day supply of
Nexium, which is a common blood thinner, is $560 in America but only
$265 in Canada. So Americans are paying twice as much for Nexium as
Canadians do. I think that is simply outrageous. Why should American
consumers pay twice as much for a medication that so many Americans
depend upon?
Here is another example of a drug that is a blood-thinning drug that
is also very crucial in this process, and that is Plavix. That costs
$585 in the United States versus $398 in Canada for a 90-day supply.
So, again, American consumers are paying 50 percent higher costs for
the same prescription drugs as Canadians do.
Then let's look at the very popular anticholesterol medication
Lipitor. This chart illustrates, again, what Lipitor costs the American
consumer. The cost is $478 in the United States as compared to $278 in
Canada for a 90-day supply.
So for patients who are already trying to make ends meet in this very
difficult economy by rationing their medications, splitting their
pills, or even skipping medications entirely, why would we deny them
access to safe drug products at these dramatically lower prices? That
is why I have cosponsored Senator McCain's amendment. It would allow
Americans to import medication from accredited Canadian pharmacies from
a list approved by the Secretary of Health and Human Services. These
accredited pharmacies must commit to ongoing quality assurance programs
and product testing to determine the safety and efficacy of these
products.
This amendment is more narrowly focused than even the one that our
former colleague Senator Dorgan and I had offered previously. This
provides a pathway to a more limited approach for Americans to access
affordable medications. In fact, there has been a very recent study
conducted by Roger Bate of the American Enterprise Institute entitled
``Unveiling the Mystery of Online Pharmacies: An Audit Study.'' Let me
quote from him as to what he discovered:

If some foreign Web sites sell safe prescription drugs with
substantial price discounts, but American consumers are
guided to buy from U.S. Web sites only, the FDA could
potentially discourage price competition between the U.S. and
foreign pharmacies and, thereby, reduce drug affordability
within the United States. The danger of reducing price
competition depends on whether consumers can distinguish
trustworthy Web sites from the vast pool of foreign Web
sites.

So here we have the documentation by a very significant study that
talks about how Americans can access these affordable medications. We
shouldn't be discouraging price competition, as this study illustrates.
That is one of the points I have been arguing over the years; that the
real problem in this country with respect to prices for prescriptions
is that we don't have competition within the industry and competition
for those medications.
Americans have learned that citizens in other countries use the very
same medications as we do. They are made in the very same plants. Yet
they pay less. We talk about injecting greater free market competition
in the health care marketplace as a way of achieving greater
affordability, and this amendment attempts to address that very issue.
As we look at what other countries do, when we are talking about
accessing cheaper medications, we know in Canada that is the case, and
it is certainly true in other industrialized nations.
I should add, in fact, they pay 35 to 55 percent less for their drugs
because of the higher prices Americans pay, which is about $90 billion
more for prescription drugs every year than we would otherwise. I think
that is totally unacceptable. Why should American consumers be paying
35 to 55 percent more or nearly $90 billion more than consumers in
other countries for the very same medications? It simply doesn't make
sense.
According to former Pfizer CEO Hank McKinnell--looking at the quote
on this chart:

Competition is good medicine for economies. . . . Name an
industry in which competition is allowed to flourish--
computers, telecommunications, small package shipping,
retailing, entertainment--and I will show you lower prices,
higher quality, more innovation, and better customer service.
There's nary an exception. Okay, there's one. So far, the
health care industry seems immune to the discipline of
competition.

When we last considered the legislation I introduced along with
former colleague Senator Dorgan, we allowed importation only from
Canada, the European Union, Australia, New Zealand, and Japan, and the
Congressional Budget Office estimated the Federal Government would save
almost $20 billion--$20 billion--if we allowed the importation of those
medications. So we know for a fact allowing drug importation generates
considerable cost savings to the government, to individuals, and
businesses that provide health insurance coverage to their employees.
The bottom line is where nations institute safe, regulated trade in
pharmaceuticals they achieve results. When Sweden entered the European
Union system of trade, they saw a reduction of 12 to 19 percent in the
price of traded drugs. In fact, Europe has had parallel trading for
more than 30 years and has never had an incident.
Industries see the advantage in being a part of the global market
when it comes to manufacturing costs. For example, according to a Pew
study in 2011, the number of prescription drugs made at non-U.S. sites
doubled between 2001 and 2008. That means they doubled at a sizable
increase with respect to the number of prescription drugs that are made
at non-U.S. sites. There are more than 50 plants where our medications
are manufactured, and not all of those facilities are even inspected--
not even inspected. Yet those are medications we use in this country
because they are manufactured at other plants in other countries. As I
said, there are more than 50 countries in which we have our
prescriptions manufactured.
So let me see if I have this straight. It is fine for some foreign
countries to manufacture drugs in their own plants for the U.S. market,
ship those drugs here where the American people are given the privilege
of paying higher prices than anywhere else in the world, but somehow we
can't safely import those very drugs into the United States directly.
It simply doesn't make sense.
The American taxpayer is underwriting more than $30 billion of
research--basic and applied research--at the National Institutes of
Health alone, so consumers in all those other

[[Page S3545]]

nations are benefiting from the investments the American taxpayer is
making with respect to research. That U.S. research produces these
medications and these prescriptions that other nations pay 35 to 55
percent less for than the American consumer. The American taxpayer is
paying more for those drugs, as I said, and also paying more of their
tax dollars for the research that is ongoing at the National Institutes
of Health. It simply doesn't make sense.

With all of the additional profit, industry invests nearly equally in
R&D in the United States and in Europe and is increasingly moving
research to low-cost Asian countries. So paying the world's highest
prices for drugs doesn't ensure us more research, but it decreases our
access to drugs. So that is the contradiction that Americans confront
each and every day when they are purchasing their medications at a much
higher cost than consumers in other countries.
The amendment that is offered by the Senator from Arizona is allowing
importation solely from Canada, and it is for online pharmacies based
on a list that has been drafted by the Department of Health and Human
Services. That is a very prescribed, targeted, limited approach to
allowing American consumers to benefit from those lower priced drugs
that are offered in Canada.
It is very important we take this step. It is important for American
consumers who otherwise are not going to be able to afford these
medications when they are paying two to three times more than their
counterparts in Canada, for example. The prices are rising five times
more than the inflation rate year after year, so the compounding effect
is significant and overwhelming for most American consumers and
families. So what I hope is we will support the amendment that has been
offered by Senator McCain.
Some have suggested that providing support for the McCain amendment
will hinder efforts to quickly move on the underlying legislation for
the FDA. That concern is certainly not persuasive because the McCain
amendment is a very narrowly focused approach. It represents a good-
faith effort to find common ground. It has included strong safety-
related measures and is done under very limited circumstances so the
American consumer can take advantage of the lower prices I have
demonstrated today with regard to some of the commonly used drugs, such
as the anticholesterol medication Lipitor and the drug-thinning drugs
such as Plavix. It is explicitly designed to make it more broadly
acceptable to those who might have concerns in taking the approach of
drug importation.
We must create a more competitive, more affordable health care system
for the American people. The prescription drug market needs
competition. Competition will lower prices. For some reason, even
though we are underwriting all of the research that benefits consumers
in so many other countries, and even though our medications are
manufactured at other plants in 50 countries, the American consumers
are paying up to 55 percent more than their counterparts around the
world. It simply doesn't make sense. In fact, I would suggest it is
outrageous.
So that is why I am supporting this amendment. We need to take this
limited, modest first step that I think goes a long way to addressing
any reservations anyone might have in this Chamber with respect to the
issue of importation. I hope we will allow American consumers to
benefit from the much lower prices, especially during these very
difficult economic times. This is a first step toward a larger system
of safe, regulated drug importation.
I commend the Senator from Arizona for offering this amendment, and I
hope the Senate will adopt it.
I yield the floor.
The PRESIDING OFFICER (Mr. Brown of Ohio). The Senator from Iowa.

Amendments Nos. 2142, as Modified, 2145, As Modified, and 2146, as
Modified En Bloc

Mr. HARKIN. Mr. President, prior to Senator Bingaman bringing up his
amendment, I ask unanimous consent that the following amendments be in
order and made pending: Leahy No. 2142, as modified, with the changes
that are at the desk; Portman No. 2145, as modified, with the changes
that are at the desk; and Portman No. 2146, as modified, with the
changes that are at the desk.
The PRESIDING OFFICER. Is there objection?
Without objection, it is so ordered. The clerk will report.
The assistant legislative clerk read as follows:

The Senator from Iowa [Mr. Harkin], for himself, Mr. Leahy,
Mr. Portman, Mr. Whitehouse, and Mr. Schumer, proposes
amendments en bloc numbered 2142, as modified, 2145, as
modified, and 2146, as modified.

The amendments, as modified, are as follows:

AMENDMENT NO. 2142, AS MODIFIED

(Purpose: To modify and limit certain exemptions to the Freedom of
Information Act)

On page 192, strike line 10 through line 21 and insert the
following:
(2) by adding at the end the following:
``(b) Ability to Receive and Protect Confidential
Information Obtained From Foreign Governments.--
``(1) In general.--The Secretary shall not be required to
disclose under section 552 of title 5, United States Code
(commonly referred to as the Freedom of Information Act), or
any other provision of law, any information described in
subsection (c)(3) obtained from a foreign government agency,
if--
``(A) the information is provided or made available to the
United States Government voluntarily and on the condition
that the information not be released to the public; and
``(B) the information is covered by, and subject to, a
certification and written agreement under subsections (c)(1)
and (c)(2).
``(2) Time limitations.--The written agreement described in
subsection (c)(2) shall specify the time period for which the
non-disclosure requirements under paragraph (1) shall apply
to the voluntarily disclosed information. The non-disclosure
requirements under paragraph (1) shall not apply after the
date specified, but all other applicable legal protections,
including section 552 of title 5, United States Code and
section 319L(e)(1) of the Public Health Service Act, shall
continue to apply to such information, as appropriate. If no
date is specified in the written agreement, the non-
disclosure protections described in paragraph (1) shall not
exceed 3 years.
``(3) Disclosures not affected.--Nothing in this section
authorizes any official to withhold, or to authorize the
withholding of, information from Congress or information
required to be disclosed pursuant to an order of a court of
the United States.
``(4) Public information.--For purposes of section 552 of
title 5, United States Code, this subsection shall be
considered a statute described in section 552(b)(3)(B).''.

amendment no. 2145, as modified

(Purpose: To facilitate the development of recommendations on
interoperability standards to inform and facilitate the exchange of
prescription information across State lines)

At the end of title XI, add the following:

SEC. 11__. RECOMMENDATIONS ON INTEROPERABILITY STANDARDS.

[[Page S3546]]

monitoring programs with other technologies and databases
used for detecting and reducing fraud, diversion, and abuse
of prescription drugs.
(2) Contents.--The report required under paragraph (1)
shall include--
(A) an assessment of legal, technical, fiscal, privacy, or
security challenges that have an impact on interoperability;
(B) a discussion of how State prescription monitoring
programs could increase the production and distribution of
unsolicited reports to prescribers and dispensers of
prescription drugs, law enforcement officials, and health
professional licensing agencies, including the enhancement of
such reporting through interoperability with other States and
relevant technology and databases; and
(C) any recommendations for addressing challenges that
impact interoperability of State prescription monitoring
programs in order to reduce fraud, diversion, and abuse of
prescription drugs.

amendment no. 2146, as modified

(Purpose: To amend the Controlled Substances Act to place synthetic
drugs in Schedule I)

At the end of title XI, insert the following:

Subtitle D--Synthetic Drugs

SECTION 1141. SHORT TITLE.

This subtitle may be cited as the ``Synthetic Drug Abuse
Prevention Act of 2012''.

SEC. 1142. ADDITION OF SYNTHETIC DRUGS TO SCHEDULE I OF THE
CONTROLLED SUBSTANCES ACT.

(a) Cannabimimetic Agents.--Schedule I, as set forth in
section 202(c) of the Controlled Substances Act (21 U.S.C.
812(c)) is amended by adding at the end the following:
``(d)(1) Unless specifically exempted or unless listed in
another schedule, any material, compound, mixture, or
preparation which contains any quantity of cannabimimetic
agents, or which contains their salts, isomers, and salts of
isomers whenever the existence of such salts, isomers, and
salts of isomers is possible within the specific chemical
designation.
``(2) In paragraph (1):
``(A) The term `cannabimimetic agents' means any substance
that is a cannabinoid receptor type 1 (CB1 receptor) agonist
as demonstrated by binding studies and functional assays
within any of the following structural classes:
``(i) 2-(3-hydroxycyclohexyl)phenol with substitution at
the 5-position of the phenolic ring by alkyl or alkenyl,
whether or not substituted on the cyclohexyl ring to any
extent.
``(ii) 3-(1-naphthoyl)indole or 3-(1-naphthylmethane)indole
by substitution at the nitrogen atom of the indole ring,
whether or not further substituted on the indole ring to any
extent, whether or not substituted on the naphthoyl or
naphthyl ring to any extent.
``(iii) 3-(1-naphthoyl)pyrrole by substitution at the
nitrogen atom of the pyrrole ring, whether or not further
substituted in the pyrrole ring to any extent, whether or not
substituted on the naphthoyl ring to any extent.
``(iv) 1-(1-naphthylmethylene)indene by substitution of the
3-position of the indene ring, whether or not further
substituted in the indene ring to any extent, whether or not
substituted on the naphthyl ring to any extent.
``(v) 3-phenylacetylindole or 3-benzoylindole by
substitution at the nitrogen atom of the indole ring, whether
or not further substituted in the indole ring to any extent,
whether or not substituted on the phenyl ring to any extent.
``(B) Such term includes--
``(i) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-
hydroxycyclohexyl]-phenol (CP 47,497);
``(ii) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-
hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP 47,497
C8-homolog);
``(iii) 1-pentyl-3-(1-naphthoyl)indole (JWH 018 and AM678);
``(iv) 1-butyl-3-(1-naphthoyl)indole (JWH 073);
``(v) 1-hexyl-3-(1-naphthoyl)indole (JWH 019);
``(vi) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole
(JWH 200);
``(vii) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH 250);
``(viii) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH
081);
``(ix) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH 122);
``(x) 1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH 398);
``(xi) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201);
``(xii) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694);
``(xiii) 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR 19 and
RCS 4);
``(xiv) 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole
(SR 18 and RCS 8); and
``(xv) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH
203).''.
(b) Other Drugs.--Schedule I of section 202(c) of the
Controlled Substances Act (21 U.S.C. 812(c)) is amended in
subsection (c) by adding at the end the following:
``(18) 4-methylmethcathinone (Mephedrone).
``(19) 3,4-methylenedioxypyrovalerone (MDPV).
``(20) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C E).
``(21) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C D).
``(22) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C C).
``(23) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C I).
``(24) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C
T 2).
``(25) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine
(2C T 4).
``(26) 2-(2,5-Dimethoxyphenyl)ethanamine (2C H).
``(27) 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C N).
``(28) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C
P).''.

SEC. 1143. TEMPORARY SCHEDULING TO AVOID IMMINENT HAZARDS TO
PUBLIC SAFETY EXPANSION.

Section 201(h)(2) of the Controlled Substances Act (21
U.S.C. 811(h)(2)) is amended--
(1) by striking ``one year'' and inserting ``2 years''; and
(2) by striking ``six months'' and inserting ``1 year''.

SEC. 1144. PROHIBITION ON IMPOSING MANDATORY MINIMUM
SENTENCES.

Section 401(b)(1)(C) of the Controlled Substances Act (21
U.S.C. 841(b)(1)(C)) is amended by adding at the end the
following: ``Any mandatory minimum term of imprisonment
required to be imposed under this subparagraph shall not
apply with respect to any controlled substance added to
schedule I by the Synthetic Drug Abuse Prevention Act of
2012.''.

synthetic drugs

Mr. LEAHY. Mr. President, I ask to engage in a colloquy with Senator
Harkin.
I thank the Senator from Iowa for his hard work as chairman of the
Committee on Health, Education, Labor, and Pensions and, in particular,
on the Food and Drug Administration Safety and Innovation Act that the
Senate is now considering. I appreciate Senator Harkin reaching out to
me about those amendments to his bill that fall within the jurisdiction
of the Judiciary Committee. One of those amendments concerns the issue
of synthetic drugs--a major problem that the committee has been
addressing.
Mr. HARKIN. Amendment 2146, as modified, filed by Senator Portman,
places a number of synthetic drugs within schedule I under the
Controlled Substances Act.
Mr. LEAHY. Yes. That amendment is the same in substance as three
bills that the Senate Judiciary Committee passed last year--the
Combating Dangerous Synthetic Stimulants Act, S. 409; the Combating
Designer Drugs Act, S. 839; and the Dangerous Synthetic Drug Control
Act, S. 605. It addresses substances commonly known as bath salts and
other synthetic drugs that have no legitimate use and can too easily be
obtained under current law. Bath salts have resulted in a number of
reports of individuals acting violently in the United States, including
in Vermont, and have led to injuries to those using them and to others.
Mr. HARKIN. I am glad that those bills and, therefore, the substance
of this amendment have already been given careful consideration by the
Senate Judiciary Committee. That gives me comfort in including this
amendment among those to which the managers of the bill consent.
Mr. LEAHY. I agree. I want to be sure that the amendment to be
included will be Senator Portman's amendment that corresponds precisely
to the bills that were considered by the Judiciary Committee. Adding
chemicals to schedule I of the Controlled Substances Act has serious
consequences and is not a step that we should undertake without careful
consideration. Do you understand that the consent to include Senator
Portman's amendment is not consent to further amend the Controlled
Substances Act, that it is limited to these chemicals and matters
contained in that amendment, and that have been considered and approved
by the Senate Judiciary Committee?
Mr. HARKIN. Absolutely.
Mr. LEAHY. It is unfortunate that the three synthetic drug bills that
the Judiciary Committee passed last summer have been unable to move on
the Senate floor because they have been held up by one Senator. They
have been cleared for Senate passage on the Democratic side for some
time.
Mr. HARKIN. It is too bad that so much progress has been blocked by
so few in this Congress. I am glad that the Food and Drug
Administration Safety and Innovation Act may provide an opportunity to
make progress on this important issue.
Mr. LEAHY. I thank the Senator for his assistance on this matter.

[[Page S3547]]

Mr. HARKIN. Mr. President, I ask unanimous consent that the following
pending amendments be agreed to: Leahy No. 2142, as modified; Portman
No. 2145, as modified; and Coburn No. 2131; and that the Coburn
amendment No. 2132 be withdrawn.
The PRESIDING OFFICER (Mr. Brown of Ohio). Is there objection?
Without objection, it is so ordered.

amendment no. 2142, as modified

Mr. LEAHY. Mr. President, I commend the Senate for unanimously
adopting my amendment to address Freedom of Information Act, FOIA,
concerns with section 708 of the Food and Drug Administration Safety
and Innovation Act. I especially thank Senators Harkin and Enzi--the
distinguished Chairman and Ranking Member of the HELP Committee--for
working with me to protect the American public's ability to access
important health and safety information under FOIA.
My amendment improves the bill by allowing the Food and Drug
Administration, FDA, to obtain important information about drug
inspections and drug investigations undertaken by foreign governments,
while at the same time ensuring that the American public has access to
information about potential health and safety dangers. Specifically,
the amendment narrows the scope of the FOIA exemption in the original
bill to No. 1 cover only information obtained from foreign government
agencies and No. 2 clarify that the information to be withheld must be
voluntarily provided to the FDA pursuant to a written Memorandum of
Understanding. The amendment also preserves the right of the Congress
to obtain this information. Lastly, the amendment places a 3 year time
limit for withholding information pursuant to the exemption, unless a
different time period is specified by the foreign government agency--so
that the information will not automatically be shielded from the public
indefinitely.
For more than four decades, the Freedom of Information Act has been
an indispensible tool for the public to obtain Government information.
This law carefully balances the need for the Government to keep some
information confidential, with the need to ensure free flow of
information in our Democratic society. I am pleased that by unanimously
adopting my amendment, the Senate has worked in a bipartisan manner to
ensure that this careful balance is maintained regarding FDA drug
inspections and investigations.
I thank the many open government and consumer groups--including
OpenTheGovernment.org and Public Citizen--that supported this
amendment. Again, I also thank and congratulate the lead sponsors of
this bill on the passage of this important legislation.

Amendment No. 2146, as Modified

Mr. HARKIN. Mr. President, it is my understanding that we are ready
to act on the Portman amendment No. 2146, as modified.
The PRESIDING OFFICER. Is there further debate on the amendment? If
there is no further debate, the question is on the adoption of the
amendment.
The amendment (No. 2146), as modified, was agreed to.
Mr. HARKIN. Mr. President, I yield the floor.
The PRESIDING OFFICER. The senior Senator from New Mexico.

Amendment No. 2111

(Purpose: To provide substantial savings in health care costs to the
Federal government and consumers by fostering competition among generic
pharmaceutical manufacturers and ensuring that anti-competitive ``pay-
for-delay'' settlements between brand-name and generic pharmaceutical
manufacturers do not block generic drugs from entering the market)

Mr. BINGAMAN. Mr. President, I call up amendment No. 2111.
The PRESIDING OFFICER. The clerk will report the amendment by number.
The assistant legislative clerk read as follows:

The Senator from New Mexico [Mr. Bingaman], for himself,
Mr. Vitter, Mr. Franken, Mrs. Shaheen, Mr. Kohl, Mr. Udall of
New Mexico, Mr. Johnson of South Dakota, Ms. Klobuchar, Mr.
Merkley, and Mr. Sanders, proposes an amendment numbered
2111.

Mr. BINGAMAN. I ask unanimous consent that the reading be dispensed
with.
The PRESIDING OFFICER. Without objection, it is so ordered.
(The amendment is printed in the Record of Thursday, May 17, 2012
under ``Text of Amendments.'')
Mr. BINGAMAN. Mr. President, this amendment is one that is a
bipartisan amendment. Senator Vitter is cosponsoring this with me, also
Senators Franken, Shaheen, Kohl, Tom Udall, Tim Johnson, Klobuchar,
Merkley, Sanders, and the Presiding Officer, Senator Brown.
This amendment addresses the very same issue that the Senator from
Maine was talking about; that is, how do we bring down the price of
prescription drugs? How do we get competition into the market for
prescription drugs?
We have a circumstance today in which an anticompetitive,
anticonsumer practice is engaged in, and our amendment will change the
law so that practice can no longer be engaged in. The practice I am
talking about is the entering into so-called pay-for-delay settlements
between brand-name drugs--brand-name pharmaceutical companies and
generic manufacturers.
These pay-for-delay settlements have the effect of delaying timely
access to generic drugs. These agreements between companies shield
billions of dollars in sales each year from effective competition. The
pharmaceutical companies benefit from this lack of competition and they
do so at the expense of consumers and they do so at the expense of the
Federal Government, since the Federal Government is a very large
consumer and purchases a substantial amount of prescription drugs for
the military and in other ways.
A preliminary estimate from the CBO indicates that this amendment
will reduce direct spending by hundreds of millions of dollars at a
minimum. Frankly, I believe it will, in fact, save us billions of
dollars annually at the Federal Government level. The CBO also
indicates that the amendment will reduce the average cost for
prescription drugs and lower the cost of health insurance plans.
Early access to generic drugs is a key to saving money in the health
care system. Kaiser Family Foundation has found this. They concluded
that spending in the United States for prescription drugs reached
$259.1 billion in 2010. That is nearly six times as much as we spent on
prescription drugs in 1990. Since generic drugs are on average four
times less expensive--or another way to put that is one-quarter of the
cost of the brand-name alternatives--they can be a very important
source for reducing the cost in our health care system. To actually
receive these savings, consumers have to have access to these generic
drugs and have access to them in a timely manner.
In 1984, Congress passed the bipartisan Hatch-Waxman Act to create
market-based incentives for generic pharmaceutical companies to bring
their drugs to market as quickly as possible. The purpose of the law
was to incentivize the early generic drug competition while preserving
incentives for pioneer companies to develop innovative new medicines.
Unfortunately, pay-for-delay settlements between brand-name drugs that
already have their products in the market and generic pharmaceutical
manufacturers who have not yet brought their products to market have
become commonplace, and these agreements, these so-called settlements,
have stifled competition and delayed access to generic drugs at a
significant cost to everyone who is involved in the health care system.
There is a table I want to put up. It relates to three particular
drugs, and I will talk about the second two of these drugs because this
gives some context to what I am concerned about.
This second drug is Lipitor. Everybody knows about Lipitor. It is a
cholesterol-lowering drug. It is familiar to most people. It is the
best-selling pharmaceutical ever in the history of the world.
According to a 2008 New York Times report, a pay-for-delay settlement
delayed generic entry into that market--the entry of a generic version
of Lipitor--by 20 months. The same report stated the generic version of
the drug was estimated to sell for less than one-third the cost of the
brand-name Lipitor. It pointed out that the brand-named Lipitor had
earned $12.7 billion in sales the year before.
According to a letter sent to the FDA Director Hamburg last year from
some of my colleagues in the Senate indicating that the Federal
Government was spending $2.4 billion a year on

[[Page S3548]]

Lipitor, they estimated that bringing a generic version to market would
generate somewhere between $4 billion and $6.7 billion in savings
annually to people who are purchasing this drug in this country.
The second example is Provigil. This is a sleep disorder drug. Due to
the pay-for-delay settlement entered into there, a generic version of
Provigil just came to market this year. Had this amendment we are
offering as part of this bill been law, generics very likely would have
entered the market 6 years ago with the expiration of exclusivity.
The chief executive officer of Cephalon--which is the brand-name
manufacturer of Provigil--is quoted as saying:

We were able to get six more years of patent protection.
That's $4 billion in sales that no one expected.

In other words, the Provigil case represents 6 years and millions of
dollars of lost savings to consumers, the largest consumer being the
U.S. Government and particularly the U.S. military.
I have a chart that relates to the U.S. military's potential savings
from this amendment. This translates this into dollars that are being
paid out by the U.S. military as part of the defense budget, which we
are going to be passing later this year.
Assuming that a generic version of Provigil would have been released
in 2006, the Department of Defense alone would have saved $159 million
from this one drug between 2006 and 2011. That is over $150 million
from a single prescription drug.
If enacted, this amendment would foster more generic competition,
would bring generic drugs to the market sooner, and would do so in a
manner that is consistent with the original intent of the Hatch-Waxman
Act. Passage of the amendment would significantly cut prescription drug
costs for American consumers and help reduce the Federal deficit.

Let me also allude to an article on the front page of the New York
Times. I know some of my colleagues take exception to the New York
Times occasionally, but this is an article entitled ``New Fervor for
Cutting Costs Among Hospitals and Insurers.'' The reporter is Reed
Abelson. About three paragraphs into the article, he states:

After years of self-acknowledged profligacy, hospitals,
doctors and health insurers say there is a strong effort
under way to bring medical costs under control.

I was struck by that phrase ``self-acknowledged profligacy in the
health care system.'' I think that is what we have engaged in, in the
Congress, frankly, is self-acknowledged profligacy in the health care
system. This amendment will help to correct that.
The amendment has the strong support of AARP, of Families USA,
Consumer Federation of America, U.S. PIRG, Consumers Union, the Center
for Medicare Advocacy, AFL CIO, AFSME, Walmart, the National Committee
to Preserve Social Security and Medicare, among other groups and
organizations.
If my colleagues favor competition, this amendment helps to promote
competition. If we want to see reduced costs to the taxpayer for health
care, then this amendment helps to reduce the cost to the taxpayer. If
we want to reduce what patients and hospitals and insurance companies
have to pay for prescription drugs, this amendment helps to do that as
well.
I think this is something that is long past time we corrected this
problem. This is a great opportunity for us to do so. I believe it is
one of the first amendments that will be considered on this
legislation. I hope my colleagues will put aside whatever other
considerations they might have had in the past and go ahead and vote
for this correction in Federal law. This is a problem, frankly, that we
passed legislation that provided the opportunity--unfortunately. It was
not intended. But an unintended consequence of the earlier legislation
that we passed, the Hatch-Waxman Act, was to allow this kind of
blocking, these kinds of pay-for-delay settlements to be entered into.
We can correct that today. I hope very much we will.
I urge my colleagues to support the amendment, and I yield the floor.
Mr. SCHUMER addressed the Chair.
The PRESIDING OFFICER. On whose time is the Senator speaking?
Mr. SCHUMER. I am speaking on the majority's time.
The PRESIDING OFFICER. On the Bingaman amendment?
Mr. SCHUMER. No. I am speaking on the McCain amendment.
The PRESIDING OFFICER. The senior Senator from New York is
recognized.

Amendment No. 2146

Mr. SCHUMER. Mr. President, I am going to speak for a brief moment on
the amendment No. 2146 and then on a different issue, which is the
reaction of some to the proposal Senator Casey and I made about Eduardo
Saverin and others who renounced their citizenship for tax purposes.
First, on 2146. I am glad this amendment has now finally passed the
Senate. It places synthetic drugs on schedule I of the Controlled
Substances Act as totally banned substances, which are where they
belong.
These synthetic substances are also known as bath salts or, in the
case of synthetic marijuana, Spice incense. Synthetic drugs aren't sold
on street corners by slingers who keep hidden stashes; instead, these
drugs are legal--even though they are dangerous--and can be found in
local corner stores across the country. They are as easy to buy as a
lollipop or a carton of milk but far more dangerous, even more
dangerous than the common illegal drug on which they are based.
By passing this amendment, we finally get these poisonous drugs off
our shelves and keep our Nation's youth out of emergency rooms.
I wish to thank Senators Klobuchar and Grassley for working with me
on this amendment, as well as Chairman Harkin and Senator Enzi,
Chairman Leahy, Senator Grassley, and Senator Feinstein for their
leadership, and I want to thank Senator Harkin and Enzi particularly
for getting us in this package and Senator Portman for working with us
on this amendment.

Eduardo Saverin

On the issue of Eduardo Saverin, last week, Senator Casey and I
introduced the Ex-Patriot Act. It is a bill that makes sure that people
that renounce their citizenship for tax purposes do not escape what
they owe and cannot come back without repaying all that they avoided
paying this great country.

It is a modest proposal, made in response to the regrettable effort
by a person named Eduardo Saverin, who renounced his American
citizenship to avoid paying even the historically low level of 15
percent on capital gains for the several billion dollars in windfall
profit he is set to receive from the Facebook IPO.
Mr. Saverin is no longer involved in the day-to-day running of the
company, and it bears mentioning that the current, active leadership of
Facebook is comprised of responsible corporate citizens who meet all of
their responsibilities and obligations.
Mr. Saverin, on the other hand, has chosen to disown the United
States to save some money on his taxes.
Senator Casey and I have proposed a response. Our bill would bar
Saverin--and others like him--from reentering the country. It would
also re-impose taxes on investment income earned in the United States
even if an expatriate is living abroad.
I believe that the vast majority of Americans, of all parties and
persuasions, think that renouncing citizenship in America to avoid
taxes is troubling, unwarranted and ungrateful.
It is upsetting, to say the least, when a person who has benefitted
so thoroughly from being an American--a person who accessed and enjoyed
so many exceptional aspects of American society--just takes the money
and runs, rather than doing the right thing and repaying the debt he
owes to a nation that nurtured, facilitated and cheered his success.
And I think that the vast majority of Americans are receptive to
suggestions for how we can address this kind of unacceptable behavior.
Look, nobody enjoys paying taxes, but Americans know that we would
not have a functioning society without them. We argue and debate about
the proper rates, and what is fair, and what level will sustain and
grow our economy and our middle class.
But I think that most Americans agree that paying a mere 15 percent
in capital gains taxes on a sum of $3 billion or $4 billion is not too
much to ask a person, especially a person who fled

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their own homeland because their native society could not provide a
reasonable level of security to their family.
While the real point here is not just about this one case--our bill
addresses a small group of evaders over the last decade or so--it is
worth pointing out that in this particular case the Saverin family
found security here thanks to taxpayer funded cops and stability thanks
to a taxpayer funded military, and a world-class university system,
like that at Harvard--again underpinned by public support.
And they also found an expansive middle class that would become the
market for his product. And a dynamic, entrepreneurial, free market
economy that allows for significant accumulation of wealth. And
functioning capital markets that were recently saved from the brink of
catastrophic collapse through who? The American taxpayer.
And they found a government that invests in research and development,
in things like creating the internet, and the web, and GPS, and
microprocessors, all of which are necessary precursors to what Saverin
and his cohorts created via Facebook.
And let's not forget, a non-corrupt legal system, which decided a
case in his favor that made him a billionaire.
Yes, Eduardo Saverin did well by being in America.
And I think that most Americans know full well that what he
accomplished was not done in a vacuum and that his success is the also
the outgrowth of his participation in an extraordinary American
society--a society that we collectively support.
No one gets rich in America on their own. And when people do well in
America, they should do well by America.
I believe the vast majority of Americans believe this, too. So when I
introduced our legislation I was sure it would garner wide and deep
support, and in general, it has.
That is why it is baffling that extreme right wing Republicans,
people like Grover Norquist, the de-facto leader of the Republican
Party on tax matters, would rush to the defense of a man who is turning
his back on America by dodging taxes.
Amazingly, the extreme right-wing echo chamber has made Saverin into
a cause celebre, defending his decision to disown the country as
somehow ``heroic''--Their words, not mine.
I was amazed. Just amazed. I took it as a given that citizenship--and
all that it implies in terms of loyalty and duty to America--was
axiomatic.
But that is no longer the case. Here is just some of what was said.
Forbes said that ``For De-Friending The U.S., Facebook's Eduardo
Saverin Is An American Hero.'' An American hero? Renouncing your
citizenship now qualifies as heroic for the hard right wing? George
Washington was heroic. Rosa Parks was heroic. John McCain and Gabby
Giffords are heroic. Navy SEALS are heroic. Eduardo Saverin is not.
National Review's Mario Loyola says, ``It is the foolish and counter-
productive tax policies of the left that are chasing Eduardo Saverin to
another country. . . .'' I'm sorry. 15 percent capital gains rate on
several billion dollars is so onerous that it is chasing him away? I am
sure any American worker would love to have that rate.
And if 15 percent is too high, what does Mr. Loyola or Mr. Norquist
think the proper capital gains rate should be? Do they think we should
have even lower taxes on capital gains, which disproportionately goes
to the highest income earners?
What is the proper capital gains rate, Mr. Norquist? Should we make
it 10 percent? 5 percent? Or should it be zero?
They won't say. Because if they did, they would be laughed out of
town.
The Wall Street Journal says we are ``oppressive and demagogic.''
No. In America, You are free to leave. But if you leave to purposely
avoid paying your fair share, then we will attach a consequence to that
dodge.
Right wing blog after blog--from the American Thinker to the Daily
Caller--echoes that, ``punishing Saverin for tax dodging is un-
American.''
Really? Silly me. I thought that renouncing one's citizenship was un-
American.
While on right wing radio they ask:

If it's a more favorable tax haven than you can find
elsewhere, why is it automatic that you are unpatriotic? Why
is it automatic that you are a coward?

Because, my fellow Americans, when you renounce your nation to fatten
your bank account, you are--by definition--being greedy and
unpatriotic.
Grover Norquist: says our bill is like fascist Nazi Germany or
apartheid South Africa or communist Soviet Union, while in American
Thinker we of erecting a ``Berlin Wall.'' And In the Examiner they are
accused say we are ``totalitarian.''
The comparisons are absurd on their face and burden on the odious.
The law Mr. Norquist references in Nazi Germany was purely;
discriminatory. It targeted a particular race of people--the Jewish
people--and--punished them for nothing other than being Jewish and
exercising freedom of movement. It was meant to constrain that freedom
by forcing Jews to reside inside Germany.
Our proposal targets no single race, creed or class. It doesn't
punish you for factors beyond your control, like who your parents were.
It applies based on actions you take--namely, disowning the United
States to avoid taxes. Our law is not triggered by a wish to travel
beyond America's borders, or even reside permanently in a foreign
country. It is the act of renouncing one's U.S. citizenship--for the
purpose of avoiding taxes--that triggers our bill.
Another right wing opinion piece asks: ``If you leave to protest
heavy taxation why must you pay a penalty?''
I am sorry, gentlemen, but Mr. Saverin is not protesting anything If
he was protesting, he would stay here, and fight for a lower tax rate--
not simply exempt himself and leave others like him to continue paying
a rate he considers too high. What he is doing is free-riding on
America, dodging paying his fair share, and pocketing the billions from
an IPO windfall.
Yet another right wing blog says we are engaged in ``class warfare to
vilify people that create wealth-just like the Nazi's did with the
Jews.''--I know a thing or two about what Nazi's did--some of my
relatives were killed by them--and saying that a person who made their
fortune specifically because of the positive elements of American
society, in turn, has a responsibility to do right by America is not
even on the same planet as comparing to what the Nazis did to the Jews.
That comparison is odious, but it is in a bunch of these right-wing
blogs.
On and on it goes. The whole torrent of vitriol is absurd. Just
absurd.
Mr. Saverin is, in essence, an economic tax dodger.
And once upon a time, the right wing castigated draft dodgers for
failing to heed their nation's call. Those who fled the country were
vilified by the right wing as cowards, as self-absorbed, as traitors.
Yet, in this case, the exact same kind of unpatriotic, un-American
behavior is actually being defended by the extreme right wing.
It is off the deep end.
And when a view this irrational has overtaken one end of the
political spectrum, it has serious, negative consequences for our
ability to solve our nation's problems.
If those on the other side of the negotiating table are this
obsessive on taxes--that they consider their minimization a higher
priority than preserving our national identity--then it is no wonder a
grand bargain on taxes and spending has been so out of reach.
In the last several years, the far right has disregarded one
historically conservative priority after another in favor of an all-
consuming obsession with protecting low tax rates for the wealthiest
Americans.
First, it was the deficit. The Republicans have for years claimed
that deficit reduction was their top priority. But that has since been
exposed as a myth.
Every independent economist will tell you that the deficit problem
cannot be solved except through both spending cuts and revenue
increases. In fact, preserving tax cuts for the very wealthy is
counterproductive to the goal of reducing our annual deficits.
Yet the far right marches on in defense of tax cuts for millionaires,
deficits be damned.
Last August, our Nation's creditworthiness became a second casualty
of the far right's insistence on low taxes for the wealthy. The right
wing was so dug in against any reasonable fiscal

[[Page S3550]]

compromise that they forced a manufactured crisis over raising the
Nation's debt limit. This caused the first-ever downgrade of our
Nation's credit rating.
Unbelievably, the far right prioritized millionaire tax breaks over
our Nation's full faith and credit.
Despite that unreasonableness, we thought we had finally figured out
a way to force the far right to come to grips with the need to deal
with revenues. We come up with a mechanism called the sequester that
would trigger harsh defense cuts if the Republicans continued to refuse
any new revenues.
Surely, if there was one thing conservatives prized as much as tax
cuts, it was defense spending, right?
Wrong. As we speak, the far right remains unwilling to cede an inch
on revenues, no matter what it means for the Pentagon. The deficit; the
Nation's creditworthiness; National security--all of these have taken a
backseat to the far right's idolatry on taxes. Now they have gone so
far, they have taken this idolatry all the way to its extreme end point
by making Eduardo Saverin into their patron saint.
In the name of low taxes for the wealthy, they have lionized an
inherently unpatriotic person.
The hero worship of Saverin is Norquist's extreme right wing anti-tax
agenda being carried to its logical conclusion. And it is a scary,
absurd place where even a tax dodger who renounces America for his own
30 pieces of silver is celebrated as a patriot and an American hero.
It is perverse.
Reasonable Republicans rightly seem wary to embrace taking things
this far. House Speaker John Boehner labeled Saverin's move
``absolutely outrageous'' and said he would support legislation to stop
wealthy ex-pats relocating to avoid taxes.
Others have been quiet, perhaps cowed by fears of being the next
target of the right wing echo chamber.
Shouldn't loyalty to America--and the broader responsibilities and
duty of citizenship--trump base, non-essential financial self-interest?
Sadly, the answer of the extreme right is no.
The Wall Street Journal attacked the thrust of our proposed
legislation as an example of the ``age of envy.'' Well, it is not envy.
In fact, I am happy those who intended and invested in Facebook got
very rich. Having an idea and succeeding and maybe getting rich off
this great idea is the American way. More power to them.
However, what is not the American way is taking a free ride on all
the exceptional aspects of American society. What is not the American
way is deriving massive advantage from various publicly supported
elements of that society and then skipping town when you hit the
jackpot. Yes, you are free to leave. You have a right to be selfish--
even greedy--when renouncing this Nation.
I understand this will make you more money and there is a rational,
simplistic argument to be made in favor of doing it--if the only factor
that mattered was always getting richer and all other values were
irrelevant. But we Americans have other values too.
America is special for many reasons. It is secure, it offers freedom
of expression, it is diverse and tolerant, it is entrepreneurial, and
it is economically and culturally dynamic. Looking out for the common
good is in our blood. It is a part of our shared history and vision of
our Founding Fathers.
We provide for the common defense. We promote the general welfare. We
are not just out for ourselves. No. We look to secure the blessings of
liberty not just for ourselves but for our posterity. It is this, and
so much more, that makes America an exceptional society.
I am appalled by the reaction. I am not appalled by a debate on tax
policy. I am appalled by making heroic a man who renounces his
citizenship to escape a tax rate, capital gains of 15 percent.
Too often I think every action and dilemma we face is now reduced to
a question of whether this means bigger government or smaller
government. Since those on the extreme right believe we must have
smaller government at all costs, they vehemently oppose all taxes. But
sometimes, as with this case and others like it, it is not just about
the size of government. It is about doing what is fair and right and
just based on your responsibilities as a citizen.
Citizenship is not simply a business decision, it is not just a
transaction. Those on the right, such as Grover Norquist, defending
this economic draft dodger are saying something very different. They
are saying the social contract somehow excludes the accumulation of
money. We know we give up certain rights and freedoms to live in a
place like America, but we cannot just carry out vigilantism to pursue
justice.
So in conclusion, being an American is not a one-way street. There
are enormous benefits to being a citizen of our Nation and a member of
the amazing society that has spawns. But there are also
responsibilities and duties, such as patriotism, service, contributing
your fair share, and commitment to community and family.
As we approach critical debates on the matters of taxation and
fairness and job creation so critical to keeping America, the greatest
Nation on the face of the Earth, I certainly hope it is these values,
not glorified self-interest, that drowns out all other values that
guide our actions.
Thank you. I yield the floor.
The PRESIDING OFFICER. The senior Senator from Wyoming.
Mr. ENZI. Mr. President, while I agree with much of what the Senator
has said, I hope this doesn't encourage other partisan diatribes to
come to the floor when we are on a bipartisan bill and trying to solve
getting necessary pharmaceuticals to the market as soon as possible. We
have a limited time of debate, and we need to stay on the subject. So I
hope others are not encouraged to come down to counter anything they
may have heard or to make different charges.
We have some time left on Bingaman and some others, but I hope we can
move forward on the bill.
I yield the floor to the Chair.
The PRESIDING OFFICER. The Senator from Iowa.
Mr. HARKIN. Mr. President, I concur with Senator Enzi on that, to
stick to the bill.
I ask unanimous consent, notwithstanding the previous order, the
Senate proceed to votes in relation to the following amendments at 12
noon with all other provisions of the previous order remaining in
effect: Bingaman amendment No. 2111, Murkowski amendment No. 2108, and
Paul amendment No. 2143.
The PRESIDING OFFICER. Is there objection?
Mr. VITTER addressed the Chair.
The PRESIDING OFFICER. The Senator from Louisiana.
Mr. VITTER. Mr. President, reserving the right to object, I will not
object. I want to ensure that I will have 10 minutes in support of the
Bingaman-Vitter amendment prior to the vote as was promised to me.
The PRESIDING OFFICER. The Senator from Louisiana is notified that
there is not 10 minutes remaining in support of that amendment.
Mr. VITTER. Mr. President, may I inquire to the Chair how much time
is remaining.
The PRESIDING OFFICER. There are 3 minutes left in support of the
Bingaman-Vitter amendment.
Mr. VITTER. Mr. President, I ask unanimous consent that as part of
this agreement that I be given 7 minutes before the vote.
The PRESIDING OFFICER. Is there objection?
Mr. HARKIN. Mr. President, I would modify my unanimous consent
request to have the vote start at 12:05.
The PRESIDING OFFICER. Is there objection? Without objection, it is
so ordered.
The assistant majority leader is recognized.
Mr. DURBIN. Mr. President, I think that accommodation was to allow
the Senator from Louisiana for 7 minutes, and I would ask for 5 minutes
before the votes begin.
The PRESIDING OFFICER. Without objection, the Senator from Louisiana
will be given 7 minutes and the assistant majority leader will be given
5 minutes and the vote will begin at 12:05. Is there objection? Without
objection, it is so ordered.
The assistant majority leader.

Amendment No. 2127

Mr. DURBIN. Mr. President, today we are considering a bill that will
improve the FDA's ability to assure the

[[Page S3551]]

safety of drugs in our medicine cabinets and medical devices in our
hospitals. The FDA is an essential guardian of the public's health and
safety. In the past few years, FDA has faced obstacles that call on the
agency to adapt and respond to the evolving nature of reviewing,
manufacturing, and distributing drugs and devices.
Some of those obstacles and challenges are addressed in the
reauthorizations of the Prescription Drug User Fee Act and the Medical
Device User Fee Act, which are set to expire at the end of September
2012.
Last fall, I visited Cook Medical's medical device plant in Canton,
Illinois, and representatives expressed concern about the amount of
time it takes medical devices to be reviewed. The FDA needs sufficient
time to review medical devices, in order to ensure their safety and
effectiveness. However, inefficiencies and insufficient resources can
result in longer review times, which mean patients have to wait longer
to benefit from new medical devices.
This bill makes key changes to maintain the safety of devices and
preserve our country's leadership in biomedical innovation. The bill
will authorize the FDA to collect almost $600 million in user fees over
5 years. The FDA can use these additional resources to help hire and
train staff.
Furthermore, the bill makes important improvements by streamlining
the review process for devices and increasing communication between the
FDA and device manufacturers throughout the review process. These
changes to the review of medical devices will not only help innovative
device companies get their product to market faster, but will prevent
patients from having to wait extra weeks and months to benefit from a
new device.
In addition to reauthorizing the Prescription Drug and Medical Device
User Fee Acts, this bill also establishes the Drug User Fee Act and
Biosimilar User Fee Act, which gives the FAA new authority to collect
user fees for generic and biosimilar drugs. Currently the FDA does not
collect user fees to support the review of generic drugs, and it takes
about 30 months for the agency to review generic drug applications.
This extra time reduces access to safe, affordable generic drugs and
leaves patients and taxpayers paying the tab for brand-name drugs that
lack competition from generics.
Since the first Prescription Drug User Fee Act was enacted in 1992,
the FDA began collecting user fees to support the review of
applications. The FDA has cut the review time for new drugs by 60%,
from 2 years to a little over 1 year. Similarly, the Generic Drug User
Fee Act will give the FDA the support it needs to cut the current 30-
month review time for generic drugs down to 10 months. This improvement
will promote competition in the marketplace and save money by reducing
the amount of time patients have to wait for less expensive generic
alternatives to brand name drugs. The process of negotiating and
drafting this legislation started 18 months ago and the result is a
comprehensive bill that improves the safety and quality of drugs and
medical devices.
Chairman Harkin and Senator Enzi have put together a bill that
responds to many of these challenges, including one that is of
particular interest to me----the national shortage of critical drugs.
Between 2006 and 2010 the drug shortage increased 200 percent from 56
to 178 drugs. Currently the drug shortage includes over 200 drugs, like
intravenous nutrition supplements, cancer treating drugs, and
anesthesia.
Over the past few months, I have held three roundtable discussions at
hospitals across Illinois to learn about the drug shortage and how it
is affecting providers and patients. From these discussions it is clear
that the drug shortage is being felt at most hospitals and those
Illinois hospitals, providers, and pharmacists are working around the
clock to ensure patients maintain access to drugs and safe treatments.
At Advocate Hospital in Libertyville, a doctor shared that he learned
just days before starting a patient on chemotherapy that the drug was
not available. Unfortunately, this is a common scenario across the
country as doctors learn days before starting a treatment or even once
the patient is on the hospital bed that a drug is not available.
Pharmacists now spend part of each day scrambling to find drugs or an
alternative treatment.
Recently I learned that a young woman on my staff here in D.C. is all
too familiar with the drug shortage. She is a smart and hard-working
woman who has been taking Concerta to treat her ADD since she was 14.
Like most people with severe ADD, she must take her medicine at a
certain time every day in order to keep her ADD symptoms from impeding
basic life and work responsibilities. And while there are several ADD
drugs on the market, each drug works differently and can have different
side effects, so switching to a new prescription is not without risk.
Last year, the local CVS where she usually had her prescription
filled started telling her they didn't have her drug in stock. She
didn't think much of it as she would wake up early and walk to another
CVS in the morning where she was usually able to get the prescription.
Over time, she grew accustomed to going between these two CVS
pharmacies to fill her prescription.
Until one month, when she carried her prescription with her for 3
days and was unable to find a pharmacy with enough Concerta to fill her
30-day prescription.
By the end of day 3, she was out of her supply. She woke up early and
rode her bike to four or five CVS pharmacies until she was able to find
a pharmacy that could fill her prescription. But by then it was 12
o'clock and past the prescribed time to take the drug.
The shortage of ADD drugs impacts children, adults, parents, and
employees across the country. Congress needs to take action to address
the drug shortage.

The FDA Safety and Innovation Act builds on Senator Klobuchar's bill
with key provisions to curb the national drug shortage. First, the bill
requires drug manufacturers to notify the FDA 6 months in advance for
certain drug shortages. With this much notice, the FDA can work with
manufacturers to try to avoid a shortage and, when necessary, identify
alternative sources of the drug to ensure we maintain a supply for
patients.
This winter, thanks to open communication between the FDA and drug
companies, the FDA successfully avoided a shortage of methotrexate, a
vital drug to treat leukemia in children. The FDA collaborated with
Illinois-based generic drug manufacturer, Hospira, to increase
production of this live-saving drug when another company halted
production. Requiring 6 months advance notice of a drug shortage will
help the FDA to work with companies to avoid shortages of critical
drugs.
Furthermore, the bill requires FDA to enhance the agency's response
to shortages and will improve reporting of shortages by allowing third-
parties to report drug shortages to the FDA.
This bill also takes steps to improve the safety of drugs and the
drug supply chain.
In 2008, serious injuries and 81 deaths were linked to contamination
of the crucial blood thinning drug heparin. The source of the
contamination was a facility in China that intentionally adulterated
the drug. This was a horrible illustration of what happens when
adulterated and counterfeit drugs make their way into the drug supply
chain and ultimately to patients. This case has also raised serious
questions about the global manufacturing practices of drugs and drug
ingredients and the FDA's responsibility to protect the drug supply
chain.
Since the heparin incident, the global nature of the drug supply
chain has only grown. Today 80 percent of active pharmaceutical
ingredients are manufactured outside of the United States. This bill
improves the safety of our supply chain, both domestically and
internationally by requiring foreign manufacturers to register their
facilities with the FDA. The bill also places greater responsibility on
U.S. drug manufacturers to know their international suppliers and
increases penalties for intentionally contaminating or counterfeiting
drug. Counterfeit and adulterated drugs can have deadly consequences,
yet the penalty for committing these crimes is less than the penalty
for selling a counterfeit designer purse.
Currently, the penalty for intentionally counterfeiting or
adulterating a drug is no more than 3 years in prison or a $10,000 fine
or both.

[[Page S3552]]

This bill raises the penalty for intentionally adulterating a drug to
no more than 20 years in prison or a $1 million fine or both.
And the penalty for intentionally counterfeiting drugs is raised to
no more than 20 years in prison or a $4 million fine or both.
This bill addresses the drug shortage, reduces the review time for
medical devices and drugs, improves the pipeline for antibiotics and
pediatric drugs, and helps secure the supply chain for prescription
drugs.
I would like to thank Chairman Harkin and Senator Enzi for their
extraordinary leadership and hard work on this bill.
The amendment we will face this afternoon is one I am offering
relative to dietary supplements. I want to make it clear what this is
about.
If someone walked into their neighborhood drugstore and looked at
everything on the shelf, here is what they can say: All the
prescription drugs the pharmacy has access to have been reviewed by the
Food and Drug Administration that they are safe and effective. All of
the over-the-counter drugs have been reviewed and registered with the
Food and Drug Administration to make certain they are safe and have
been precleared before they can be sold. Now when they move back to the
vitamin counter, all bets are off. Those are called dietary
supplements. They are not subject to the same level of scrutiny,
inspection, testing or regulation. It is an entirely different world.
It is understandable that there are those of us who want to be able
to walk in and buy vitamins, for example, without a prescription. That
is our right as Americans. But we also want to make sure that whatever
is on the shelf at the pharmacy is not dangerous or at least we know it
is there.
There are between 55,000 and 75,000 dietary supplements in America.
We don't know the exact number. They include the obvious, vitamins and
minerals, but they also go further. They include energy drinks. Ever
heard of the 5-Hour Energy Drink, Monster Energy Drink? Those are not
sold as colas, sodas, or beverages. They are sold as dietary
supplements. Why? Because there is no regulation in terms of their
contents.
We had a sad story I told on the Senate floor 2 days ago, with the
family in the gallery, about a 16-year-old girl from Hagerstown, MD,
who drank two Monster Energy Drinks within a 24-hour period and went
into cardiac arrest. It was too much for her heart. She died. That was
a dietary supplement.
My amendment says if they want to sell a dietary supplement in the
United States, they have to do one basic thing: They have to go to the
Food and Drug Administration and say: This is the name of my company.
This is the name of my product and the ingredients in it. And here is a
copy of the label. That is it.
So is it important that we know this? There will be 1,000 new
products bought and sold in the United States as dietary supplements
every year. Just in case we think knowing the dietary supplement
facility company has been registered is enough, hang on tight. These
dietary supplements are coming from all over the world. Sadly, a lot of
them turn out to be dangerous.
In 2009 the FDA announced that Super Slim, a dietary supplement
manufactured in China, contained the pharmaceutical ingredient
sibutramine, which is no longer available in the United States and
found to increase the risk of heart attack or stroke. If the
manufacturers had registered this dietary supplement so we knew the
ingredient, we could protect American consumers.
The same thing was true in 2001. Another Chinese-based weight-loss
ingredient, aristolochic acid, was found to cause kidney damage and to
be a potent carcinogen. Isn't it important for us to know this? Is it
too much to ask the dietary supplement companies to go to the FDA and
at least register their products before they put them on the shelves
across America? Don't American families have the right to scrutiny and
at least some basic knowledge of the sale of these products?
The industry is against this. They don't want to report it. They
basically say: It is none of your business. We will sell what we want
to sell, and that is the way it will be. If we want to volunteer the
information, so be it. But we don't want to be required to disclose the
information.
There are groups that see it differently. I ask unanimous consent to
have printed in the Record letters that support my amendment. The
Center for Science and Public Interest and the Consumers Union are in
support of this amendment.
There being no objection, the material was ordered to be printed in
the Record, as follows:

Center for Science in

the Public Interest,

Washington, DC, May 24, 2012.
Senator Dick Durbin,
Attn.: Binta Beard, U.S. Senate, Washington, DC.
Dear Senator Durbin: The Center for Science in the Public
Interest is pleased that you are introducing an amendment to
the Food, Drug, and Cosmetic Act that would help improve
public confidence in dietary supplements. Supplements are
poorly tested, may be contaminated, can sometimes interact
with pharmaceuticals, and are marketed with more hype than
just about any other consumer product. Your amendment would
do the minimum to protect both consumers and conscientious
companies: require disclosure to the Food and Drug
Administration of all ingredients, build a repository of
labels, and require registration with the FDA. Much more
really should be done to assure safety and efficacy, but we
hope your amendment will receive widespread support.
Sincerely,
Michael F. Jacobson,
Ph.D., Executive Director.
____

May 21, 2012.
Senator Richard J. Durbin,
U.S. Senate, Hart Senate Office Building, Washington, DC.
Dear Senator Durbin: Consumers Union applauds your efforts
to strengthen dietary supplement safety by requiring
manufacturers to register their products with the Food and
Drug Administration (FDA). Specifically, your proposed
amendment to the Food and Drug Administration Safety and
Innovation Act (S. 3187) would require manufacturers to
provide the FDA with accurate and up-to-date information
regarding each dietary supplement product they manufacture, a
list of ingredients included in those products, and a copy of
the product labels.
Although many dietary supplements on the market may be safe
and healthful, there are numerous ingredients that may pose
significant dangers to consumers. Some supplement ingredients
could, for example, interact with prescription drugs to
produce dangerous side effects. Others can change the
effectiveness of prescription drugs. Still others could be
generally safe for most consumers, but have hazardous health
effects for certain population subgroups, such as pregnant
women or children.
Dietary supplement manufacturers are currently subject to
limited registration requirements as food-processing
facilities. However, these entities are not required to
register their products with the FDA, in order to facilitate
timely action in the event of a safety alert. As noted by the
U.S. Government Accountability Office (GAO) in its 2009
report, FDA ``lacks complete information on the names and
location of dietary supplement firms within the agency's
jurisdiction,'' and does not have a comprehensive database of
products currently being sold in the marketplace, and the
ingredients they contain. This leaves the FDA without
adequate marketplace information, should it need to take
prompt or immediate action regarding supplement ingredients
that are dangerous or found to be adulterated.
Requiring manufacturers to submit a list of products sold,
product ingredients, and product labels to FDA on a regular
basis would ensure that the agency can appropriately assess
potential safety issues and quickly respond as they arise.
The FDA's post-marketing surveillance of dietary supplements
will be much more effective if the FDA has accurate, timely
information about supplement products currently available in
the U.S. marketplace.
Consumers Union believes this amendment will advance the
safety of dietary supplements for consumers. We thank you for
taking on this critically important issue, and look forward
to working with you to support the amendment.
Sincerely,
Chuck Bell,
Programs Director Consumers Union.
Ioana Rusu,
Regulatory Counsel Consumers Union.

Mr. DURBIN. I ask my colleagues when this vote comes before us,
before we have another death in America from a dietary supplement from
China, India, Mexico, or even in the United States, shouldn't we
require the most basic information so we know the name of the company,
the ingredients in the product, and what the label looks like?
The FDA has asked for this information. They asked expressly for this
information. To say it is a burden on them, they already asked for it.

[[Page S3553]]

I ask my colleagues when this amendment comes up later this afternoon
that they support this in the best interest of protecting American
families and consumers.
I yield the floor.
The PRESIDING OFFICER (Mrs. Hagan). The Senator from Louisiana.

Amendment No. 211

Mr. VITTER. Madam President, I rise to strongly support the upcoming
Bingaman-Vitter amendment, which is basically an amendment form that
Bingaman-Vitter Fair Generics Act would stop an escalating trend in the
drug industry which has pay-for-delay deals between a generic
manufacturer and a big pharmaceutical manufacturer.
Over the last several years we have seen a huge increase, and we have
seen this trend grow from modest to a raging trend, and it is
anticompetitive. It is pay-for-delay deals in which the brand-name drug
dealer pays off or settles with the first-to-file generic drugmaker,
often restricting generic market entry for years into the future.
As prescription drug prices explode, they put real pressure and
burdens on many Americans' budgets because they are making medications
that should be more affordable in terms of coming onto the market. They
are postponing those drugs, paying for the delay, and holding them off
the market longer and longer.
The FTC has compiled data and made clear that this trend is
happening, and the FTC, an official government agency, said:

The continued trends of record numbers of brands and
generics resolving patent litigation prior to a final court
decision [yields] significant numbers of such settlements
potentially involving pay-for-delay.

Those were the FTC's words.
In 2004 the FTC had identified zero of those sorts of pay-for-delay
deals. In 2006 it was up to 14. In 2011 it doubled to 28. Clearly it is
a big trend. That is ``28 final settlements (that) contain both
compensation to the generic manufacturer and a restriction on the
generic manufacturer's ability to market its product.''
This fair generics bill, through this amendment, fixes the problem.
That was the intent of the original Hatch-Waxman language, but there
was a loophole that has been exploited in this pay-for-delay deal
because the first filer is granted exclusivity even if the first filer
is paid off and settles and doesn't pursue its ability to enter the
market.
The Fair Generics Act would fix that, and it would basically outlaw
that sort of marketing of generics. It would realign and reaffirm the
incentive and reward not just for filing first but for successfully
challenging and invalidating a patent. So we would move the first
filing exclusivity to a reward for filing and also successfully
invalidating a patent.
It is a realistic proposal. It would allow the first filer to follow
through on that filing. It would encourage it, but also if that is not
going to happen, it would allow subsequent filers to litigate and
validate the patent and thereby gain ability to enter the
marketplace. I really think this was the intent of Hatch-Waxman.

Unfortunately, there is a loophole that has been exploited in Hatch-
Waxman that has led to these serious pay-for delay cases. Again, this
is an escalating trend that is still growing. I have no doubt that when
we get the number for 2012, it is going to be significantly above the
2011 number of 28.
So to simplify it, if the first filer does not enter into a
settlement with the restricted and delayed market entry date and if it
does diligently challenge and invalidate a patent, nothing changes
under present law. The current 6-month market exclusivity reward
remains. So that incentive, that reward absolutely remains. However, if
that doesn't happen and the first filer just wants to settle or park
its filing and is generic, a subsequent filer would have the ability to
step up and challenge the patent and, if it won, it would have market
access.
This solution provides more litigation certainty. We propose
basically a use-it-or-lose-it statute for the brand name to sue the
generic within the 45-day window. Current law provides a brand
manufacturer a 30-month stay if they sue the generic within the 45-day
window but still allows a suit after.
So, again, I believe this is a reasonable and measured approach. This
is not as Draconian or dramatic an approach as other proposals in the
Senate. I believe this is the middle ground, and I believe this honors
and gets us back to the original intent on this subject of Hatch-
Waxman. But it is a measured response to this escalating trend that we
clearly see, that the FTC has objectively identified and measured--a
so-called pay-for-delay arrangement.
In conclusion, the goal of Hatch-Waxman was to bring generics to the
market more quickly. This approach, the FAIR Generics Act, will do
that. There are anticompetitive deals that are being struck more and
more often--pay for delay--and they are becoming much more prevalent,
and they are hurting American families.
The mega-lobbyist pharmaceutical industry, of course, opposes this
reform because, quite frankly, those pay-for-delay deals are a way to
buy more exclusivity and keep generics off the market longer. But that
is not in the interests of the consumer. It is time to stand up to
them. It is time to have some courage, to stand up to Big Pharma and
say: We are going to preserve your exclusivity for developing a drug,
but we are not going to let you buy off generics and unfairly extend
that time period. We are going to let generics come to market in a
reasonable time. We are going to create incentives to make sure that
happens.
I urge all of my colleagues to support that proposal, which is
embodied in the Bingaman-Vitter amendment, the FAIR Generics Act.
I yield the floor.
The PRESIDING OFFICER. There is now 2 minutes of debate equally
divided on the Bingaman amendment.
Mr. HARKIN. Madam President, first I ask for the yeas and nays.
The PRESIDING OFFICER. Is there a sufficient second?
There appears to be a sufficient second.
The yeas and nays are ordered.
The Senator from New Mexico.
Mr. BINGAMAN. Madam President, I thank Senator Vitter for his
comments and for his strong support of this amendment. I thank all of
the other cosponsors of the legislation.
If we are interested in promoting competition in the health care
field so that we can keep prices down, then we need to support this
amendment. That is exactly what this does.
Under our law in this country, we provide exclusive rights to a
company that develops a drug to sell that drug during the time the
patent is in effect. But what we are concerned with here is that after
that patent is no longer valid, companies are still extending their
exclusivity, extending their time when they don't have any competition
by entering into these agreements. So we think they can settle their
disputes--we don't have a problem there--but they cannot keep other
generic manufacturers from coming to the market who also have
demonstrated the invalidity of a patent.
If we are worried about the cost of health care to the Federal
Government--the Federal Government is paying too much for prescription
drugs because of this flaw in the Hatch-Waxman Act that we are trying
to correct. If we are worried about keeping prices down for hospitals,
insurance companies, and consumers, this amendment will help to do
that.
I urge my colleagues to support the amendment.
The PRESIDING OFFICER. The Senator from Wyoming.
Mr. ENZI. Madam President, I rise today to oppose the amendment
addressing the patent settlements for generic claims.
I am sympathetic to the intent of the sponsors of this amendment. I
believe that some drug patent settlements may be improper and could be
unfairly increasing drug prices for consumers. If that is in fact
happening, we should stop the bad settlements and encourage the ones
that work.
The problem with this amendment, however, is that its scope is much
broader and could lead to unintended consequences that could harm
consumers and increase costs. That is why I must oppose it. The
amendment uses a machete when a scalpel might solve the problem. Not
all patent settlements are abusive. They do not all lead to higher
costs. In fact, some settlements can actually expedite generic drugs
coming to market. According to

[[Page S3554]]

one recent study by RBC Capital Markets, patent settlements helped
expedite 24 of the 37 most recent generic drug approvals.
The amendment would allow competing generic manufacturers, in certain
cases, to share the 180 days of exclusivity provided under the drug
patent law known as Hatch-Waxman. This period of exclusivity was
intended to create a market incentive for generic manufacturers to be
the first to file a generic drug application with FDA.
The amendment is intended to discourage generic manufacturers from
reaching settlements with brand manufacturers to delay generic
competition. Unfortunately, it may also have the unintended consequence
of discouraging generic competition generally.
The Hatch-Waxman statute, which first established our current system
of brand and generic drug approvals, was a careful compromise of
competing interests. It struck a balance between encouraging research
and development of new cures and promoting competition to lower costs.
By all accounts, this law has been a success. Our Nation leads the
world in the creation of new drugs and therapies that improve the lives
of countless patients across the world. At the same time, generic drugs
have promoted competition and lowered costs to American patients.
According to one recent estimate, generic drugs have saved the American
health care system over $930 billion over the last decade.
This amendment would disrupt that system and reduce the incentives
that currently encourage manufacturers to file generic drug
applications with the FDA. Allowing competitors to share the 180 days
of exclusivity will undermine the market incentives for manufacturers
to make such filings. It will also create uncertainty about whether
generic manufacturers will ultimately be able to recoup their
investments and could mean that there will be fewer generic drugs.
That is why the generic drug manufacturers oppose this amendment.
While I genuinely appreciate the desire to prevent abusive settlements,
I believe that we must be very careful in disrupting a system that has
worked so well for patients and consumers.
We should hold hearings in the HELP Committee to hear from all of the
stakeholders who have a role in this system. We need to learn how any
proposal will impact the incentives to encourage competition. We also
need to learn how any proposed solutions will affect settlements and
patent litigation.
This is clearly an important and very complex issue, but this
amendment could have serious and detrimental consequences for patients.
This is why I would urge my colleagues to oppose this amendment.
I yield the floor.
The PRESIDING OFFICER. The question is on agreeing to the amendment.
The yeas and nays have been ordered.
This is a 60-vote threshold vote.
The clerk will call the roll.
The assistant bill clerk called the roll.
Mr. DURBIN. I announce that the Senator from Connecticut (Mr.
Blumenthal) and the Senator from Maryland (Ms. Mikulski) are
necessarily absent.
Mr. KYL. The following Senators are necessarily absent: the Senator
from Idaho (Mr. Crapo), the Senator from Texas (Mrs. Hutchison), and
the Senator from Illinois (Mr. Kirk).
The PRESIDING OFFICER. Are there any other Senators in the Chamber
desiring to vote?
The result was announced--yeas 28, nays 67, as follows:

[Rollcall Vote No. 105 Leg.]

YEAS--28

Akaka
Bingaman
Boxer
Brown (OH)
Cardin
Conrad
Durbin
Feinstein
Franken
Gillibrand
Inouye
Johnson (SD)
Klobuchar
Kohl
Levin
McCain
Merkley
Pryor
Reed
Sanders
Schumer
Shaheen
Snowe
Udall (CO)
Udall (NM)
Vitter
Webb
Whitehouse

NAYS--67

Alexander
Ayotte
Barrasso
Baucus
Begich
Bennet
Blunt
Boozman
Brown (MA)
Burr
Cantwell
Carper
Casey
Chambliss
Coats
Coburn
Cochran
Collins
Coons
Corker
Cornyn
DeMint
Enzi
Graham
Grassley
Hagan
Harkin
Hatch
Heller
Hoeven
Inhofe
Isakson
Johanns
Johnson (WI)
Kerry
Kyl
Landrieu
Lautenberg
Leahy
Lee
Lieberman
Lugar
Manchin
McCaskill
McConnell
Menendez
Moran
Murkowski
Murray
Nelson (NE)
Nelson (FL)
Paul
Portman
Reid
Risch
Roberts
Rockefeller
Rubio
Sessions
Shelby
Stabenow
Tester
Thune
Toomey
Warner
Wicker
Wyden

NOT VOTING--5

Blumenthal
Crapo
Hutchison
Kirk
Mikulski
The PRESIDING OFFICER. Under the previous order requiring 60 votes
for the adoption of this amendment, the amendment is rejected.

Amendment No. 2108

Mr. HARKIN. Madam President, I inquire what the next vote would be
on?
The PRESIDING OFFICER. The Murkowski amendment No. 2108.
Mr. HARKIN. Madam President, I ask that that vote be a 10-minute
vote.
The PRESIDING OFFICER. That is already the order.
There are now 2 minutes equally divided.
Ms. MURKOWSKI. Madam President, I ask for support of the amendment
that is before us. This is an amendment that will actually strengthen
the role of NOAA as the Federal agency that has oversight over our
fisheries.
Currently the FDA is considering an application for a genetically
engineered fish, a fish that takes DNA from one salmon and an ell pout
to accelerate the growth unnaturally. The FDA is not looking at
labeling this fish. The FDA is not considering the environmental impact
of escapement on this fish into the marine environment.
What we are asking for with this amendment is as the FDA proceeds in
its process that the agency that has oversight of our fisheries be
allowed to participate and weigh in as to whether there are any
environmental consequences that may come about as a consequence of a
release into a marine environment.
This is a situation where people have a right to know about the
quality of their fish, where it comes from, what it is made of. What I
am asking is for the agency that has oversight of our fisheries to have
a role in this process. I urge Members to support the amendment.
The PRESIDING OFFICER. The majority leader.
Mr. REID. Madam President, the time, as usual, did not run as quickly
as we wanted. I ask unanimous consent that we only have two votes prior
to lunch today, and that the next vote start at 5 minutes until 2 today
after we complete this vote.
The PRESIDING OFFICER. Without objection, it is so ordered.
The Senator from Kansas.
Mr. HARKIN. Regular order, please.
The PRESIDING OFFICER. For what purpose does the Senator seek
recognition?
Mr. ROBERTS. Madam President, I rise in opposition to speak for 1
minute.
The PRESIDING OFFICER. There is 1 minute in opposition. The Senator
is recognized.
Mr. ROBERTS. Madam President, I fear this legislation would insert
Congress in the scientific process of approving applications that we
have entrusted to the FDA. This application has been pending at FDA for
over 15 years. We should allow the FDA to complete their scientific
review of the product and not interfere with the ongoing reviews.
We have a science-based system that allows for complete review. We
should allow that process to continue. This amendment sets up a two-
tiered, two-agency approval system. That is not good. We know the FDA
has already conferred with NOAA regarding the pending application.
Basically, Members of the Senate should not put on lab coats and tell
the FDA to approve or deny the pending application. We should allow
them to act on the statutory authority that is given to them. I
reluctantly oppose the amendment of my colleague from Alaska.
The PRESIDING OFFICER. The Senator from Massachusetts.
Mr. KERRY. Madam President, this would be the first time Congress has
ever interfered in an FDA-based, science-based approval process. If we
open that, we would be opening an extraordinary can of worms.

[[Page S3555]]

I urge my colleagues to oppose this amendment.
The PRESIDING OFFICER. The question is on agreeing to the amendment.
Mr. MERKLEY. Madam President, I ask for the yeas and nays.
The PRESIDING OFFICER. Is there a sufficient second?
There is a sufficient second.
The clerk will call the roll.
The bill clerk called the roll.
Mr. DURBIN. I announce the Senator from Connecticut (Mr. Blumenthal)
is necessarily absent.
Mr. KYL. The following Senators are necessarily absent: the Senator
from Idaho (Mr. Crapo), the Senator from Texas (Mrs. Hutchison), and
the Senator from Illinois (Mr. Kirk).
The PRESIDING OFFICER. Are there any other Senators in the Chamber
desiring to vote?
The result was announced--yeas 46, nays 50, as follows:

[Rollcall Vote No. 106 Leg.]

YEAS--46

Akaka
Ayotte
Baucus
Begich
Bennet
Bingaman
Boxer
Cantwell
Cardin
Coburn
Cochran
Collins
Conrad
Durbin
Feinstein
Gillibrand
Graham
Johnson (SD)
Landrieu
Lautenberg
Leahy
Levin
Lieberman
Manchin
Menendez
Merkley
Mikulski
Murkowski
Murray
Nelson (FL)
Portman
Reed
Reid
Rockefeller
Sanders
Schumer
Shaheen
Snowe
Stabenow
Tester
Udall (CO)
Udall (NM)
Warner
Whitehouse
Wicker
Wyden

NAYS--50

Alexander
Barrasso
Blunt
Boozman
Brown (MA)
Brown (OH)
Burr
Carper
Casey
Chambliss
Coats
Coons
Corker
Cornyn
DeMint
Enzi
Franken
Grassley
Hagan
Harkin
Hatch
Heller
Hoeven
Inhofe
Inouye
Isakson
Johanns
Johnson (WI)
Kerry
Klobuchar
Kohl
Kyl
Lee
Lugar
McCain
McCaskill
McConnell
Moran
Nelson (NE)
Paul
Pryor
Risch
Roberts
Rubio
Sessions
Shelby
Thune
Toomey
Vitter
Webb

NOT VOTING--4

Blumenthal
Crapo
Hutchison
Kirk
The amendment (No. 2108) was rejected.
The PRESIDING OFFICER. Under the previous order requiring 60 votes
for the adoption of the amendment, the amendment is rejected.
The Senator from Tennessee.
Mr. CORKER. Madam President, I understand I have 3 or 4 minutes to
speak about the GAIN Act.
The PRESIDING OFFICER. How much time does the Senator wish to speak?
Mr. CORKER. About 3 or 4 minutes.
The PRESIDING OFFICER. On an amendment or on the bill?
Mr. CORKER. On the bill.
Mr. HARKIN. Madam President, parliamentary inquiry.
The PRESIDING OFFICER. The Senator from Iowa.
Mr. HARKIN. There is a lot of commotion going on. I want to know
where the time is coming from for the Senator from Tennessee.
The PRESIDING OFFICER. The Senator said he was speaking on the bill.
Mr. HARKIN. Madam President, how much time is left on the bill?
The PRESIDING OFFICER. The Senator from Iowa controls 15 minutes, and
the Senator from Wyoming controls 22 minutes.
Mr. HARKIN. How much time does the Senator from Tennessee need?
Mr. CORKER. Three minutes.
Mr. HARKIN. OK, that is fine.
Mr. ENZI. Madam President, I yield 3 minutes to the Senator from
Tennessee.
Mr. HARKIN. I will, too, if he needs it.
Mr. CORKER. Madam President, I rise to thank both the majority and
minority leaders of the bill for their great effort. I am pleased to
speak about a provision in the FDA Safety Innovation Act that addresses
a growing public threat in Tennessee and Connecticut and across the
Nation.
Several months ago, Senator Blumenthal and I introduced the GAIN Act,
which is a bipartisan provision that provides a meaningful market
incentive and reduces regulatory burdens to encourage development of
new antibiotics that will help save lives and reduce health care costs.
Drug-resistant bacteria, or ``superbugs'' as we call them, are
becoming harder to treat because we lack new antibiotics capable of
combating these infections. Not only do these infections take a toll on
patients and their families, but they also run up health care spending
to the tune of $35 billion to $45 billion annually.
It is crucial that these new antibiotics are discovered in order to
stay ahead of the growing trend of drug resistance. Drug discoveries do
not happen overnight, so we must act now to ensure that we have
lifesaving medications when we need them.
The GAIN Act is a straightforward, commonsense bill that provides
market incentives to encourage innovation without putting Federal
dollars at stake, and it is included in this FDA reauthorization.
Antibiotic resistance is a growing issue that we need to address now to
properly prepare for the future.
Dr. William Evans, director and CEO of St. Jude's Hospital in
Tennessee, wrote a letter supporting this bill, which says:

We don't want to find ourselves in a situation in which we
have been able to save a child's life after a cancer
diagnosis only to lose them to an untreatable multi-drug
resistant infection.

I thank Senator Blumenthal from Connecticut for his leadership on
this bill. I especially thank Senators Harkin and Enzi for working with
us the way they have to include this provision in the FDA Safety and
Innovation Act.
I think I have stayed within my time limit.
I yield the floor.
The PRESIDING OFFICER. Who yields time?
The Senator from Wyoming.
Mr. ENZI. Madam President, I yield 5 minutes to the Senator from
Ohio.
The PRESIDING OFFICER. The Senator from Ohio.

Amendments Nos. 2145 and 2146

Mr. PORTMAN. Madam President, I thank the ranking member and
congratulate him for the good work today on this legislation.
There are a couple of amendments that are part of the bill I want to
speak about. First is on prescription drug abuse--a problem we all face
as representatives of our States. I particularly thank Senator
Whitehouse for his partnership on this important bill.
In the last decade, unfortunately, prescription drug abuse has
reached epidemic proportions in States such as Ohio, and in so many
other States around the country. In doing so, it has devastated the
lives of so many individuals but also the well-being of our
communities, and of course affected their families, affected our
economy, and it has caused a big spike in crimes, including theft, as
addicts look for ways to support their addictions. This crime, of
course, has doubly strained law enforcement, which has already had to
contend with the increase in drug trafficking with constrained budgets.
It has also served as a gateway to other drug use, including heroin
use, which tends to be less expensive and causes additional public
health challenges.
Amazingly, since 2007, drug overdoses have now moved ahead of car
accidents as the leading cause of accidental death in my home State of
Ohio. Again, we have seen this, unfortunately, too often around the
country. We have had record levels of hepatitis C infection from needle
sharing. In one county on the Ohio River, in southern Ohio, 10 percent
of the babies born in 2010 had drugs in their system.
The good news is progress is being made in places such as Scioto
County and around the country thanks to the good work of health
professionals, law enforcement, local, State, and Federal officials,
along with community groups, families, schools, churches, and others.
But they need some help. More work needs to be done, and one critical
tool they are looking for in the fight against prescription drug abuse
is a better way to monitor prescription drug use. There are databases
around the country called prescription drug monitoring programs. They
allow States to monitor and track the dispensing of prescription drug
medications by health care providers to be able to identify and stop
the abuse of people getting prescriptions for these drugs in various
different doctors' offices and in what have been called pill mills.
Preliminary research has shown monitoring programs are highly effective
in stemming the tide of abuse. That is why 48 States and 1 territory

[[Page S3556]]

now have them, with 41 of them operational.
There is a problem, however. Different States' monitoring programs
can't communicate with one another, so one State doesn't know what the
other State is doing, and drug trafficking is an interstate problem.
This is especially true in places such as Scioto County in southern
Ohio, right across the river from Kentucky and bordering West Virginia.
We want these States to be able to work together, and that is why
Senator Whitehouse and I have offered this amendment, No. 2145, as a
Federal solution to providing a framework for monitoring programs to
participate in data sharing across State lines.
This amendment also supports collaboration between the Department of
Health and Human Services and the Bureau of Justice Assistance in order
to further their research to assess challenges that have an impact on
States' interoperability.
Some have called for a national monitoring program--one Federal
program. I don't think that is necessary. I don't think it will work as
well. A lot of States have programs that are working extremely well and
they have put a lot of money into them. There are differing protected
health standards State by State. So rather than trying to federalize
it, our amendment gets these disparate programs to work together
securely, reliably, and efficiently without undermining or jeopardizing
the State's autonomy in this area. States should remain free to
establish laws that determine user eligibility and reporting
requirements. So this amendment is to help, again, give these
communities the tools they need to fight this prescription drug abuse.
Finally, I would say that our amendment has no effect on direct
spending or revenues over the 10-year period.
The other amendment I want to mention also has to do with substance
abuse--about the dangers of what we unfortunately all here in this
Chamber have heard about--and that is synthetic drug abuse, including
K2 Spice, bath salts, and herbal incense. Today we have an opportunity
to do something about this problem. Let's prohibit these drugs from
getting into the hands of our children, our service men and women, and
others.
This amendment addresses the growing use and misuse of synthetic
drugs by placing 15 cannabinoids, 2 stimulants, and 9 hallucinogens in
Schedule I to expose those who manufacture, distribute, possess,
import, and export synthetic drugs without proper authority to the full
spectrum of criminal, civil, and administrative penalties, sanctions,
and regulatory controls.
I want to give special thanks to the people who led this effort over
the years--Senators Grassley, Schumer, and Klobuchar. They have worked
hard on this issue, and we are all pleased this is part of the
underlying legislation. It was Senator Grassley, as well as the folks
from the Community Anti-Drug Coalition, who originally introduced me to
the prevalence of designer drugs. I was told of the story of David
Mitchell Rozga and many others who have suffered, and of some of the
deaths that have occurred around the country.
This amendment, again, would have no significant effect on direct
spending or revenues over a 10-year period and is a good, commonsense
approach to trying to get our hands around this issue and help the
constituents we represent and help our communities fight to stem this
particular substance abuse that is affecting us all.
Madam President, I yield the remainder of my time, and I yield the
floor.
Mr. HARKIN. Madam President, if I may inquire of the Senator how much
time she wishes.
Mrs. HAGAN. I would request 6 minutes.
Mr. HARKIN. I yield 6 minutes off the bill.
The PRESIDING OFFICER (Mrs. McCaskill). The Senator from North
Carolina.
Mrs. HAGAN. First, Madam President, I do want to applaud the hard
work of the Senate HELP Committee chairman Tom Harkin and the ranking
member Senator Mike Enzi. This bill is truly one of the most bipartisan
efforts I have had the opportunity to be a part of in the 3 years I
have served in the Senate. It ought to be a reminder that, yes, when we
work together across the aisle, the Senate can get things done.
I am particularly proud to support this bill because of what it will
mean for patients who are suffering with diseases, who do not have
access to adequate treatments, or who do not have access to any
treatment at all. This bill we are voting on includes key provisions of
the TREAT Act--the Transforming the Regulatory Environment to
Accelerate Access to Treatments Act--which I introduced in February.
These important provisions will expedite the review of treatments for
serious or life-threatening diseases without compromising the FDA's
already high standards for safety and effectiveness.
I introduced the TREAT Act after meeting with a family whose child
suffered from spinal muscular atrophy or SMA. This is an incurable
neuromuscular disease and is the leading genetic cause of infant
deaths. Of course, that family was not alone. There are 30 million
Americans suffering from rare diseases, and I have had the honor to
meet a number of them. Their stories are both heartbreaking and
inspiring.
When I visited the North Carolina Children's Hospital last month, I
met with Megan and Jarrod Hendren of Lumberton, NC, whose 13-month-old
twins Logan and Lucas suffer from Gaucher's disease. This disease is a
painful and potentially debilitating metabolic disorder for which
currently there is no cure.
I also met with 8-year-old Ashley Burnette from Raleigh, who is
resilient and wise beyond her years, but who is suffering from
neuroblastoma.
For the families and patients like these, suffering from these rare
diseases for which there are no approved medications, medical advances
cannot come fast enough. There are so many rare diseases, but fewer
than 250 have FDA-approved therapies. The provisions of the TREAT Act
that have been included in this bill take great steps toward resolving
the problem.
There is currently a pathway at the FDA to expedite the review of
drugs for illnesses that are serious or life-threatening and for which
there is no adequate treatment. This is called the Accelerated approval
pathway. Since the early 1990s, it has been successfully used to
advance treatments for patients with HIV and cancer by leaps and
bounds. However, it has not been applied regularly or consistently to
the review of drugs to treat other diseases.
This inconsistency is why I introduced the TREAT Act. My bill will
broaden the application of the accelerated approval pathway beyond HIV/
AIDS and cancer to a wider range of diseases, with a particular focus
on rare diseases. That is why my proposal enjoys broad support from
patient advocates, including the National Organization of Rare
Diseases, Us Against Alzheimers, Parkinson's Action Network, the
Huntington's Disease Society of America, and many more.
By providing for consistent application, we will help the FDA
implement these provisions, assist drug sponsors to navigate the
approval process, and, hopefully, bring safe and effective treatments
more rapidly to the patients who need them.
I am also proud to have played a critical role in the legislation
that led to the negotiations of the first biosimilars user fee
agreement, which is also included in the bill before us. Last Congress,
we passed the Biologics Price Competition and Innovation Act to
facilitate the introduction of lower cost alternatives to biologic
drugs, while ensuring continued research and development into
innovative biologics which can save or improve the lives of millions of
Americans.
The user fees negotiated by the industry and the FDA will provide the
necessary funding for the review of these critical therapies. The
biosimilars industry is in the earliest stages of development, and the
biosimilars user fee agreement will help facilitate this industry's
growth.
In addition, the FDA Safety and Innovation Act provides the necessary
regulatory updates to keep pace with the rapid innovations of the
biopharmaceutical industry. This is imperative for creating jobs in
States such as mine--in North Carolina--and maintaining America's
competitive edge in the global economy.
Companies with footprints in North Carolina are partnering with our
world-class universities to improve the health of people all across the
globe

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every day by researching, discovering, and developing lifesaving
treatments for those suffering from these devastating diseases.
Passing the FDA Safety and Innovation Act for States such as North
Carolina, and for our Nation, to remain global leaders is important. It
is especially important if we are to help attract the jobs of the
future.
The American public also expects the FDA to be the world's gold
standard when it comes to ensuring the supply, the safety, and the
integrity of our drug supply. By sending the FDA Safety and Innovation
Act to the President's desk, we will establish a clear and effective
pathway for turning ideas into cures and cures into treatments. And we
will have shown the foresight and flexibility required to maintain our
country's position at the top of the medical treatment and device
industries.
I thank the Chair and I urge my colleagues to join in supporting the
FDA Safety and Innovation Act.
I yield the floor.
Ms. MIKULSKI. Madam President, I rise in opposition to the McCain
amendment No. 2107. I appreciate the intent of Senator McCain to make
lower cost drugs available to the American people, but I have many
flashing lights about this amendment. I bring this from knowledge of
being both on the Intelligence Committee and also in working with the
FBI as the chair of the Subcommittee on Commerce, Justice, and Science.
This amendment allows individuals to import FDA approved drugs from
Canada. It sounds great, but we don't know if the drug was made in
Canada. No HHS Secretary has been able to demonstrate that importation
will be safe. It is ironic that some faux populists who oppose a public
option, who oppose allowing Medicare to negotiate drug prices, support
importing price controls from Canada. This amendment doesn't guarantee
cost savings for consumers, Medicare, Medicaid, or insurers.
I oppose this amendment for four reasons. First, it is a budget
buster. Enforcing this will take enormous amounts of resources, and the
amendment doesn't give the FDA the human resources, the financial
resources, or the technological resources to ensure the safety of these
drugs for U.S. consumers. It doesn't give FDA the resources to inspect
and certify the brick-and-mortar and Internet-based Canadian
pharmacies, nor does it give FDA the resources to verify that these
pharmacies comply with Canada's laws. We all know that FDA needs more
money to carry out its existing responsibilities overseas and
domestically. The agency doesn't need another unfunded mandate.
The second reason I oppose this amendment is because I am concerned
about organized crime and counterfeiting. We have a history of phony
drugs coming from rogue Web sites. We cannot be sure that the drugs
coming from Canada are not a counterfeit, lethal drug. There is no
guarantee that these drugs originate from the legitimate supply chain.
Where there is compelling, compassionate human need, there is greed.
Where there is greed, there are scams and schemes. In this case, the
scams and schemes can be lethal.
The third reason I oppose this amendment is that it doesn't exempt
biologics. Biologics are different from chemical drugs. There is no way
to ensure that the supply chain remains intact and that the product
that reaches your doorstep will be effective. Because biologics tend to
be more expensive than chemical drugs, criminals will make more money
by counterfeiting them.
The final reason I oppose this amendment is because it doesn't
guarantee that the drug you buy will be bioequivalent to the FDA-
approved drug. How will consumers be assured that the drug they buy
online is metabolized the same way? Also, what guarantee is there that
the packaging and labeling will be identical?
We have examples of awful things that have happened. Interpol and the
United States have seized millions of counterfeit pills. These drugs
were made in unsanitary conditions and were deadly and ineffective.
Remember the contaminated Heparin from China that killed over 150
people. Then there was cough syrup made from antifreeze instead of
glycerin. Seventy-eight people died. There are also the ineffective
drugs that may not kill you but certainly won't improve your health. I
could list more, but I urge my colleagues to go talk to the FDA, FBI,
and Customs and Border Protection and hear firsthand what they have
experienced.
Counterfeiting is a real threat. It is a matter of life and death. We
have to make affordable drugs in our own country, and we did so by
closing the doughnut hole in health reform. Today we are doing so
again. The FDA user fee reauthorization before us creates the first
ever generic drug user fee program. It will speed generic drug entry
into the U.S. market so that consumers get safe FDA approved drugs more
quickly and cheaply.
If you want safety, then defeat the McCain amendment.
Mr. BENNET. Mr. President, I come to the floor today to support the
goal of my friend and colleague from New Mexico of delivering lower
cost medicines to Americans. But, unfortunately, I cannot support his
underlying amendment, No. 2111 to S. 3187. I agree that we should
increase access to generic drugs wherever we can, and I agree that the
path to market for generic products is fraught with legal challenges.
But I have several concerns about the amendment. First, as convoluted
as it seems, the Hatch-Waxman law that created the pathway to bring
generic drugs to market has been a tremendous success in doing just
that. Eighty percent of the drugs on the market now are generic, and
over the last decade consumers have saved $931 billion on their drug
costs as a result. There is clearly a balance in the system, and
mechanisms within that system are working to bring generics to market.
As I understand it, a key element of generic entry into the market is
the incentive to challenge brand-name patents. The underlying amendment
changes the key incentive for generic manufacturers--the 180 days of
market exclusivity. The amendment allows late filers to now share in
the exclusivity, significantly reducing the incentive for companies to
file early and ensuring that products get to market as quickly as
possible. Generic manufacturers have a limited window for market
advantage, and it is the revenues gained during this incentive period
that fuel additional product development. There is a balance here. If
we need to adjust that balance, I think it needs to be done in a
broader context. We need to be sure that any changes that we might make
do not disrupt the balance and inadvertently harm consumers.
While other aspects of the amendment are well-meaning, they may also
have unintended consequences. I look forward to continuing the dialog
on this issue with my colleague and others as we all work collectively
to provide lower cost medicines to our constituents while maintaining
an appropriate incentive for companies to innovate and develop the
therapies that patients need.
Mr. HARKIN. I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. HARKIN. Madam President, I ask unanimous consent that the order
for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. HARKIN. Madam President, I suggest the absence of a quorum, and I
ask unanimous consent that the time during the quorum call be taken off
of the Burr amendment and be equally divided on both sides.
The PRESIDING OFFICER. Without objection, it is so ordered.
The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. CARPER. Madam President, I ask unanimous consent that the order
for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. CARPER. I ask unanimous consent to be recognized for 10 minutes
and that the time be taken from the Burr amendment and equally divided.
The PRESIDING OFFICER. Without objection, it is so ordered.

Amendment No. 2131

Mr. CARPER. Madam President, we have three counties in Delaware. The

[[Page S3558]]

southernmost county is called Sussex County. Several years ago, I was
privileged to visit a Methodist Church there and speak as a lay speaker
to try to encourage people to become mentors.
The minister that day was a great old guy, Reverend Reynolds. He is
now deceased, but he said to me that day these words, and I have never
forgotten them. He said, ``The main thing is to keep the main thing the
main thing.''
That is what he said. ``The main thing is to keep the main thing the
main thing.''
At first I wasn't sure what he was talking about, but the more I
thought about it I thought: Boy, this guy is smart. And if I am smart,
I will keep the main thing the main thing.
For us in the Senate and in Congress, the main thing for the voters
of this country is they want us to work together--well, maybe the two
main things are they want us to work together--they want Democrats and
Republicans to work together--and they want us to get things done. One
of the things they want us to get done is to create what I call a
nurturing environment for job creation and job preservation. They want
us to do things that are going to help encourage the creation of jobs
and the preservation of jobs.
Little known to a lot of folks across the country, we actually have
been doing some of that in the Senate for much of this year, and we
have worked productively across party lines to pass a series of bills
that I think do help create a more nurturing environment for job
preservation and job creation.
Just a couple examples, if I could: One, the reauthorization of the
Federal Aviation Administration to establish a new source of additional
revenues to modernize and update airports across the country, to bring
the air traffic control system of our country into the 21st century
where we had kind of an analogue system, and to bring it into the
digital age.
Patent reform was another significant step forward earlier this year,
where we said enough of this patent patrol--people who come in after
someone has filed for a patent and say: Oh, no, that was my idea, and
just botch things up and drag things out in the courts. Under patent
reform legislation, if you are first to file, you are first to file,
and that is your patent. Also provided in the same legislation are the
resources needed in the Patent Office to more expeditiously process
patent applicants.
Free-trade agreements. One of our roles as the government is to try
to make sure we have access to foreign markets. If our goods and
services are being closed out in those foreign markets, then we have to
open them up. We agreed by a broad bipartisan proposal this year--three
of them, actually, three free-trade agreements--one with South Korea,
one with Colombia, one with Panama negotiated originally by the George
W. Bush administration and embraced by the Obama administration, which
is now the law of the land, to make sure when businesses have the
opportunity to export, the barriers that have maybe kept them out in
the past are knocked down or eliminated, and to make sure if American
businesses need financing and help to finance their exports, that they
have that kind of help through the Export-Import Bank, which we have
reauthorized and extended into the future.
Another one that we worked on this year together, a bipartisan bill
and supported by the President, is something called the JOBS Act. What
it is all about is trying to make sure companies have better access to
capital, and if a small or medium privately held company wants to go
public, to make sure they can do it through something called an IPO
onramp as opposed to just trying to jump into it and get it done all at
once. Or for companies that want to stay privately held, for them to be
capped at 1964 levels, 500 shareholders, to say they can go up to
1,000, 2,000 shareholders to enable them to have that access to capital
to continue to grow and to create jobs.
Other examples of bipartisan legislation we worked on, in one case
the Transportation bill--land transportation: roads, highways, bridges,
and transit--we passed a good bill in the Senate, paid for, to help
over the next couple of years to meet our transportation needs and make
sure the 3 million people who are working on transportation and transit
projects across the country don't basically get laid off in a month or
two. We passed a good bill. I give a lot of credit to Senators Boxer
and Inhofe for helping to lead the bipartisan approach.
Also, 7 or 8 million jobs depend on the Postal Service. The Postal
Service is in tough straits, running out of money and losing $125
million a day. We are hoping that the House of Representatives will
pass the bill--they need to--so we can go to conference and help fix
that problem. But there is good bipartisan legislation here to effect
positively 7 or 8 million jobs that depend on the Postal Service. All
that stuff, in terms of the American people wanting us to work
together, and we have been. Those are just a couple examples.

In terms of actually doing things that help create jobs and preserve
jobs, every one of the items I just mentioned does create a more
nurturing environment for job creation and job preservation. In the
coming weeks, we also want to work on agricultural legislation--a
bipartisan bill, again, out of the Agriculture Committee that will save
billions of dollars on the deficit side. It will also help to
strengthen our agricultural economy.
We need to get to work on a national flood insurance update, and that
legislation helps to bolster the home building industry in this country
which is struggling, as we know, and we have the opportunity for those
things that are on our to-do list, to get them done.
Today the Senate is considering another bipartisan piece of
legislation, as we know, the Food and Drug Administration Safety and
Innovation Act, affectionately known by its acronym. I don't like
acronyms, but I love this one. It is called PDUFA. So it is the FDA and
how we make sure the FDA has the resources they need to do their job.
As the other bills passed by the Senate I just talked about, this bill
helps create a more nurturing environment for those businesses to
thrive. Those businesses include the pharmaceutical business and
businesses that make and sell medical devices. But just as important,
this bill helps to ensure that Americans get access to lifesaving
medications and medical devices that are developed in this country as
soon and as safely as possible.
This bill reflects a strong bipartisan, bicameral effort, for which
Chairman Harkin and ranking member Mike Enzi deserve enormous praise,
and I praise them even though they are not in the Chamber right now.
They have done great work, and I thank them and their staffs for
bringing it to this point today.
The legislation builds upon the successful current user fee programs.
For a number of years, the companies have paid a user fee if they want
the FDA to approve a drug or medical device, and we are making progress
to actually have more resources for the FDA to do this than we used to.
But they need some additional help, and this legislation would do that,
paid for by the industries that are seeking the consideration of their
new pharmaceuticals and their new medical devices.
The legislation also adds important new user fees for generic and
biological drugs. The user fees are paid, again, by the prescription
drug and medical device industries to help cover the FDA's costs for
reviewing new drugs and medical devices.
What this means is safer drugs and a speedier process to bring new
and less expensive drugs and medical devices to markets for consumers,
and I think it is a win-win for just about everybody.
As a result of the FDA legislation affectionately known as PDUFA, the
FDA's drug review times have already been cut in half. That is good. If
these user fees, these user programs are not reauthorized, though, the
FDA would have to lay off, I am told, about 2,000 employees, which
would put them back in the ditch, if you will, and begin to delay
approval of new drugs. We don't want to see that happen. That would
threaten patent access to new therapies, as well as pharmaceutical and
medical device industry jobs, and America's global leadership in
biomedical innovation.
This bill also makes medicines safer for millions of children,
improves the FDA's tools to police the global drug supply chain, and
reduces the risk of drug shortages. There are a number of amendments
that are being offered to the bill--we have voted on a couple of

[[Page S3559]]

those--and one of the amendments that we will be voting on, I believe,
a little later this afternoon is legislation that would, in my view,
weaken or contaminate our country's supply of prescription drugs and
put our patients and our health care system at risk.
Some of my colleagues have proposed to include a measure in this bill
that ostensibly would lower prescription drug prices. This amendment,
in my view, however, is not without unintended consequences, and we
always have to be careful of those.
The PRESIDING OFFICER. The Senator's time has expired.
Mr. CARPER. I ask unanimous consent for 3 more minutes equally
divided.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. CARPER. Unfortunately, it would open our borders to increased
numbers of contaminated and adulterated drugs.
The proposal to import drugs from Canada would allow drugs to be
imported wholesale, often from illegal Internet pharmacies with no
protection against abuse or contamination.
Also, though this measure is supposed to be about importing drugs
from Canada, in truth it would allow drugs to come from countries that
don't have the kind of strong inspection and policing of prescription
drugs that we have in the United States.
Instead of going down that road, we should work to increase the FDA's
abilities to protect and regulate our drug supply. While doing so, we
should reject any proposals to import drugs from Canada that undermine
our ability to ensure that prescription drugs are safe and effective.
One last thing I want to mention is there is an amendment that is
going to be offered today--or maybe already has been, but I am going to
mention this anyway--that deals with generic drugs and concern about
the ability for larger pharmaceutical companies to work with and pay
off, buy out the generic drug companies so they don't bring their
generic version of the name-brand drug to market. I just want to say
that we need to be careful what we are doing here.
I came out of the Navy and came to this Congress in 1983 as a
freshman Congressman. In 1982, 20 percent of the prescriptions being
filled in this country were generic drugs. This year, 80 percent of the
medicines or prescriptions that are being filled are generic. One of
the well-intentioned amendments to have been offered today is one that
says we are not making enough progress toward allowing the generics to
grow. Say that again?
We have gone from 20 percent generic penetration in 1982 to, today,
80 percent. I would suggest that we should declare victory, and as time
goes by, even that 80 percent will become 85 percent or 90 percent. But
we have come a long way. As a result of that, people who need to buy
medicine can find a generic version of almost any medicine that is
being sold in this country. I think the system is working just fine,
and we ought to allow it to continue to work.
In closing, the main thing is the main thing. The main thing is to
keep the main thing the main thing.
For us, the main thing is to work together. We are in a whole host of
ways--including under the great leadership of Senator Harkin and
Senator Enzi--working to make sure our pharmaceutical industry is
vibrantly strong, the medical device industry is vitally strong, but
also that patients are not disadvantaged, that they are actually
advantaged by all of that.
So responding to folks in Delaware and Iowa and across the country,
we are working together. We are not just working together on a couple
of things but on a whole host of things, a whole litany of provisions
and laws and proposals that do what: help us to create a more nurturing
environment for job creation and job preservation. That is a good
thing. That is a very good thing.
I thank Senator Harkin for giving me a chance to say a few words and
for the great work that he and Senator Enzi have done. I am happy to
follow their leadership here today.
The PRESIDING OFFICER. The Senator from Iowa.
Mr. HARKIN. Madam President, I appreciate the remarks made by my good
friend from Delaware. I thank him and his staff for their input on this
bill. Again, this bill is the work of a lot of different people, and I
want to thank the Senator from Delaware for helping us get to the point
where we have a good consensus bill.
Madam President, is there any time remaining on the Burr amendment?
The PRESIDING OFFICER. There is no time remaining on the Burr
amendment.
Mr. HARKIN. Madam President, I yield 6 minutes off of the McCain
amendment, on our side, to the Senator from New Jersey.
The PRESIDING OFFICER. Without objection, it is so ordered.

Amendment No. 2107

Mr. LAUTENBERG. Madam President, I rise to speak against amendment
No. 2107, the one that talks about pharmaceutical products, medicines.
We know how important the prescription medicines are in improving
health in this country and the need to make sure those drugs are safe
and affordable. Prescription drugs have brought great advances in
health outcomes. Just look at how much longer people are living. Over
the past century, life expectancy increased from 49 years to 77 years.
We know that beneficial drugs need to be more affordable and more
readily available. But allowing drugs to enter into the United States
from other countries is not the answer.
The Department of Health and Human Services found that importing
prescription drugs might save 1 to 2 percent on their prescription
drugs--and I am not describing that as insignificant--but these are
modest savings compared to what the outcome might be.
Importing risky prescription drugs from other countries could cause
more health problems, more suffering, and in the final analysis, more
expensive treatments. Americans buy medicine to lower their
cholesterol, fight cancer, prevent heart disease. Some of these have
had remarkable effects. Heart disease is much less threatening. It is
still a dangerous disease but much less than it was years ago. Imagine
what would happen to a mother or a child if they were relying on
imported drugs only to find out that the drugs were unsafe. We need to
be absolutely certain that we are not putting Americans' lives at risk.
That is why I am opposing amendment No. 2107, the McCain amendment,
which would allow potentially unsafe prescription drugs to be shipped
across our border, directly into the medicine cabinets of homes
throughout America. Instead of safeguarding American patients, this
amendment could bring potentially dangerous and ineffective drugs from
Canada. I say that because, though Canadian drugs may seem safe, we
already know that drugs that claim to be from Canada are not always
reliable. They are not worth the risk. An FDA investigation found that
85 percent of drugs imported from Canadian Internet pharmacies were
actually from 27 other countries. Many of these were pure counterfeit.
The Senate already recognized the danger that imported drugs pose to
Americans. On five previous occasions, this Chamber has asked the
Department of Health and Human Services to certify that importation
will not put people at risk. The Secretary still has not been able to
confirm that imported drugs would be safe.
I wish to make another observation. I find it kind of amusing to
watch Republican colleagues talk about how wonderful the Canadian
health system is. Last I checked, Canada's health care system is
socialized medicine. During the health care reform debate these same
colleagues were decrying the Canadian system as a horrible socialist
experiment. My colleagues need to make up their minds. Do they prefer
socialized medicine? If so, it comes with some risks.
I am proud that many of our country's drugs originate in the State of
New Jersey, commonly known as the Medicine Chest State. In fact, there
are over 46,000 highly skilled people in my home State working to
produce lifesaving drugs. It would be wrong to undercut the hard work
of these trained New Jerseyans, only to put Americans in danger.
Right now the drugs in our country are safe and effective, as we have
seen by the results. Thanks to Senator Harkin and Senator Enzi, this
bill will even make our drugs more safe. Americans deserve real peace
of mind. When

[[Page S3560]]

they open the pill bottle and swallow their medicine, they have to know
the product is safe and effective.
I urge my colleagues to support keeping medicine in our country safe
and affordable. I urge the drug companies, the medicine companies, to
do whatever they can to make drugs, medicines, more available at
cheaper prices. I urge my colleagues to vote against amendment No.
2107.
I yield the floor.
Mr. HARKIN. Madam President, I yield 6 minutes to the Senator from
West Virginia, again off the opposition to the McCain amendment time.
The PRESIDING OFFICER. The Senator from West Virginia is recognized.
Mr. MANCHIN. Madam President, I wish to say to the chairman that I
appreciate his hard work on this bill, a very important piece of
legislation.
I would like to address an issue that touches all of us: Democrats
and Republicans, rich and poor, young and old, West Virginians and New
Yorkers.
As you know, the prescription drug epidemic is destroying communities
across this nation, wreaking havoc on our education system, devastating
our workforce and our economy, and tearing our families apart.
Prescription drug abuse is the fastest growing drug problem in the
United States, and it is claiming the lives of thousands of Americans
every year. According to a report issued by the Centers for Disease
Control in November, the death toll from overdoses of prescription
painkillers has more than tripled in the past decade. More than 40
people die every day--every single day--from overdoses involving
narcotic pain relievers. These prescription painkillers kill more
Americans than heroin and cocaine combined.
It's especially tough in my home state of West Virginia, which has
the highest rate of drug overdose deaths in the country. Nearly 90
percent of those deaths are linked to prescription drug abuse.
For months now, I have been going out and listening to the stories of
so many people in my State--law enforcement, business owners, school
teachers, pastors, and especially the children who ask for help getting
their parents off the stuff. So I worked with all of them to offer an
amendment to this bill that would make it harder for anyone to abuse
prescription drugs. That bipartisan amendment was submitted on behalf
of the countless West Virginians and Americans whose lives have been
cut short by drug abuse and the families who are picking up the pieces,
and it is on their behalf that I thank my colleagues in the Senate for
passing it unanimously.
Last night I was so moved and encouraged to see the Members of the
U.S. Senate come together across party lines and unanimously approve
that measure, to take a serious step to fight this prescription drug
epidemic. I strongly urge our friends in the House to do the same, and
the President to sign this important bill.

This measure is not the work of just one person, however. I would
like to thank the cosponsors of this bill, who all believe so strongly
in it: Senator Mark Kirk of Illinois, Senator Kirsten Gillibrand of New
York, Senator Chuck Schumer of New York and, of course, Senator Jay
Rockefeller of my home State of West Virginia.
I also thank Governor Earl Ray Tomblin and Congressman Nick Rahall
for their tireless work on this issue, along with Congressman Vern
Buchanan of Florida, who is doing excellent work to end pill mills. As
we all know, last night's vote gives this amendment a solid step
forward, but there is much work remaining to give our communities the
right tools to fight this epidemic.
That's because all too often, we all hear stories like this one,
which the Ohio County Substance Abuse Prevention Coalition in my State
shared with me.

A young boy was injured and was prescribed prescription
pain killers containing hydrocodone. After the injury he
began using the opiates with the other teens in school. They
began by taking pills and eventually by graduation, snorting
the pills on a daily basis. One day he was convinced by a
friend to try IV use. He was married and was able to hold
down a job until he began using IV. His wife was addicted to
pain killers and their child was born addicted to drugs. He
wanted more than anything to be a hard-working father and
husband. He wanted to live and to amend his past behaviors.
He completed treatment but eventually began using pain
killers again. This man in his mid-twenties overdosed and
died.

Think about it. This young man was snorting pills by high school
graduation and dead in his mid-20s. Unfortunately, that story is more
common than we would all like to believe.
A 2012 study by the National Institute on Drug Abuse found that 8
percent of high school seniors had admitted to abusing Vicodin in the
past year. The Centers for Disease Control has found that about
12 million Americans have reported non-medical use of prescription
painkillers in the past year.

Unlike many illegal drugs, prescription drugs are not produced in
basement labs or smuggled across the border--they are found in our own
medicine cabinets and are often prescribed for medically necessary
reasons. And that makes it much easier for people to become addicted or
abuse these medications.
In 2010 alone, pharmacies dispensed the equivalent of 42 tons of pure
hydrocodone--that is enough to give every man, woman and child in the
United States 24 Vicodin pills.
The fact is, that number is just too high. People are getting these
pills because it is just too easy.
That is why this amendment would make it harder to get addictive
prescription drugs, by moving them to a more restrictive category in
our official drug classification system.
Practically, this means that patients would need an original
prescription for refills and pills would have to be stored more
securely.
Let me me close by sharing a few more personal stories about this
problem--stories that show on a human level the urgency we need to put
a stop to prescription drug abuse and why I am committed to this fight.
This is a problem that hits very close to home in my office. A member
of my staff, a very bright young girl from Wyoming County who is doing
very good work has lost three friends to drug abuse, all in their 20s.
Theirs were lives full of promise, but they were tragically cut short
by drug abuse.
In the past 7 years, more than 120 people have died from drug
overdoses in Wyoming County alone, including 41 in 2011 and 12 just
this year.
I visited Wyoming County in October to speak with a group of students
at Oceana Middle School who are working very hard to take on the drug
abuse crisis in their community.
These students were part of a letter writing campaign, organized by
the faith-based group ``One Voice,'' which works to help addicts and
their families. I want to share with you a few excerpts from some of
these letters:

``My town, Oceana, has an issue about drugs. I write this
letter to you because I hope that you can do something about
it. In 2006, my godmother died of an overdose. She was the
only person I could talk to. Drugs make people act in bad
ways and if something doesn't happen about them then our town
will be in worse shape.

I will give just one more example:

I am 13 years old and I am a student at Oceana Middle
School. I have witnessed drug deals, prostitution and
homeless people in our town. I have medicine I take for ADHD
and here recently some of my meds were stolen. I will
graduate high school in 7 years. If nothing is done about
these issues it'll be worse in the future.

I visited with these students in person. They want a better life for
their parents, their siblings, their friends, their communities--and
themselves. They are willing to fight, and they are asking for our
help.
The amendment that passed last night with unanimous bipartisan
support is a good step toward reaching their dream, and I offer my
heartfelt thanks to my colleagues on behalf of all the people in West
Virginia who have been affected by prescription drug abuse. And I urge
my colleagues in the House to support this measure and the President to
sign it--for the good of all the 12-year-old girls who are asking us to
help get their daddies off this stuff.
The PRESIDING OFFICER. The time of the Senator has expired.
Mr. MANCHIN. I would like to say to both chairmen on both sides of
the aisle, thank you for legislation that is much needed. Thank you for
an amendment agreed upon, voted on unanimously, and accepted last
night. This will go a long way to fight drug abuse in America and save
countless children's lives. I thank both Senators so much.
The PRESIDING OFFICER. The Senator from Iowa.

[[Page S3561]]

Mr. HARKIN. Madam President, how much time remains on the McCain
opposition?
The PRESIDING OFFICER. There is 3 minutes.
Mr. HARKIN. Madam President, I yield myself that time and a couple of
minutes off the bill.
The PRESIDING OFFICER. The Senator is recognized.
Mr. HARKIN. Madam President, I wish Senators to know that we will
start voting here in 9 or 10 minutes, and these will be 10-minute
votes.
The first vote will be on the amendment offered by the Senator from
Kentucky, Mr. Paul, followed by Senator McCain's amendment, Senator
Sanders' amendment, Senator Durbin's amendment, and then final passage.
By an earlier consent, all of those votes will be 10-minute votes. I
wanted to make sure that people knew what the lay of the land was here.
We are rapidly approaching the final passage of this bill. We have
had great cooperation from all Senators on both sides in moving this
legislation forward here on the floor. We have had good debates. They
have not been drawn out endlessly, but we have had good debates and a
good airing of the amendments on the bill. I thank all Senators for
that, and hopefully we can move rapidly to wrap up this bill and move
on.
This bill is the product of 18 months of very hard work by Senator
Enzi and all of the Senators on our committee on both sides of the
aisle. It is a true compromise and bipartisan bill. As I mentioned
earlier, it has the support of a broad spectrum of stakeholders, from
the pharmaceutical companies to pharmacists to consumer organizations,
across the broad spectrum who support this bill, and it is necessary
that we get it done. That is why we have urged everyone to
expeditiously get this done before the break period coming up for
Memorial Day so the Food and Drug Administration won't have to start
sending pink slips out to people this summer, and so there will not be
any disruptions. It will allow them to get on with the business of
making sure we get drugs and devices to patients expeditiously but
safely, making sure our drugs and our devices are safe.
It is a good bill, and it is the result of a lot of hard work by a
lot of people, so I hope we can move these amendments rapidly and move
to final passage this afternoon.
I yield the floor.
The PRESIDING OFFICER. The Senator from Wyoming.
Mr. ENZI. Madam President, I ask unanimous consent that when we begin
the next vote, Senator Paul, who has 7 minutes left on his item, be
given 2 minutes so he may explain his bill in exchange for those 7
minutes.
The PRESIDING OFFICER. Is there objection?
Without objection, it is so ordered.
The Senator from Iowa.
Mr. HARKIN. Madam President, I yield myself as much time as I may
consume off the bill.
The PRESIDING OFFICER. Without objection, it is so ordered.

Amendment No. 2143

Mr. HARKIN. Madam President, we are rapidly approaching a vote on the
Paul amendment, and I know the Senator wants to have a couple of
minutes to speak on that.
I rise in opposition to the Paul amendment. I oppose it for several
reasons. Perhaps the most important reason is that this is a drug bill.
This bill deals with drugs and devices. It does not deal with food. We
dealt with dietary supplements and vitamins and things such as that in
the food safety bill that we passed 2 years ago and that bill, again,
was a consensus bill that has been through the committee structure. We
brought it to the floor and had a lot of debate on it. We made
modifications at that time to the whole area of vitamins, minerals, and
supplements, and that is the proper place to address it, not on a bill
such as this. This bill is a bill on drugs, not on supplements and
food, so that is the most important reason.
I will make that same argument on the Durbin amendment. That should
not be here because this is a drug bill.
On substance, I would say this bill kind of turns food law on its
head. It would allow supplements to be sold with claims to cure any
disease, such as AIDS or cancer, without any kind of FDA review
whatsoever. I take a backseat to no one in terms of my support for the
vitamin, mineral, and supplement industry and their products. Senator
Hatch and I were the two people who put through the DSHEA bill, the
Dietary Supplementary Health and Education Act in 1994. If I might say,
we have sort of been protectors of it in working to make sure it has
been implemented correctly since that time.
But the Paul amendment would go way too far. It is not consensus
policy. In fact, it is strongly opposed by even the dietary supplement
industry. I would note that the Natural Products Association, United
Natural Products Alliance, and the Council on Responsible Nutrition,
all three are big umbrella groups that oppose the Paul amendment. This
would open this industry to snake oil salesmen.
Again, those of us who want to make sure people have unfettered
access to safe products and to good, nutritious vitamins, minerals, and
supplements, the last thing we want to see is people in their garages
mixing it up and selling it as snake oil. This is not good for America,
it is not good for people who want to take vitamins and supplements and
minerals for their own health. It would throw this thing open and turn
the clock back 50 years or more where anybody could make any claim they
want and the FDA would have no way of reviewing it whatsoever.
I will move to table the amendment at the appropriate time, but I
urge all Senators to oppose the Paul amendment.
I yield the floor.
The PRESIDING OFFICER. Who yields time?
Mr. ENZI. Madam President, I yield the Senator from Kentucky the time
he is already entitled to.
The PRESIDING OFFICER. The Senator from Kentucky is recognized for 2
minutes under the previous order.
Mr. PAUL. My amendment is to rein in the FDA. I believe they have
gotten overzealous in their duties. They do have important duties, but
I think they have gotten overblown. My amendment has three parts.
First, it attempts to stop the FDA's overzealous regulation of
vitamins, foods, and supplements by codifying the first amendment
prohibition on prior restraint. What this means is the first amendment
says we cannot restrain speech before it happens. This amendment also
helps to make explicit that commercial speech is speech and should be
protected.
Under current rules, the FDA prevents even the manufacturer of prune
juice from saying that prune juice relieves constipation. I think that
is an FDA that has gotten a little bit out of hand. I think that
vitamin supplement manufacturers and distributors should be allowed to
give us information and that the buyers should be allowed to review
that information in making decisions about the product and that this
speech should not be restricted.
Second, my amendment says the FDA doesn't need to be carrying
weapons. I don't need to see bureaucrats carrying automatic weapons. If
there are police officers necessary in the operation of their duties, I
would rather have the FBI. The FDA does not need to be sending armed
agents to the Amish farms to arrest a farmer for selling milk from the
cow.
Third, my amendment fixes what needs to be fixed in a lot of
regulatory crimes. We need to add in the component of mens rea. Mens
rea means that when a person commits a crime and they put that person
in jail, they have to prove that person had a guilty mind and had
intent to commit a crime. So we add two words. If they are going to
accuse a person of a crime, it has to be knowing and willful. These are
very simple words, but they change the burden of the government. If the
government is going to accuse a person of the crime, they need to know
this. If Congress is going to criminalize conduct at a Federal level,
as it does in the FDA Act, then the least we can do is add in the mens
rea requirement.
Thank you. I urge support for my amendment.
The PRESIDING OFFICER. The Senator from Iowa.
Mr. HARKIN. Madam President, I move to table the amendment by the
Senator from Kentucky and ask for the yeas and nays.
The PRESIDING OFFICER. Is there a sufficient second?
There appears to be a sufficient second.
The question is agreeing to the motion.

[[Page S3562]]

The clerk will call the roll.
The assistant legislative clerk called the roll.
Mr. DURBIN. I announce that the Senator from Hawaii (Mr. Akaka), the
Senator from Connecticut (Mr. Blumenthal), the Senator from California
(Mrs. Boxer), and the Senator from Michigan (Ms. Stabenow) are
necessarily absent.
Mr. KYL. The following Senators are necessarily absent: the Senator
from Nevada (Mr. Heller), the Senator from Texas (Mrs. Hutchison), and
the Senator from Illinois (Mr. Kirk).
The PRESIDING OFFICER (Mr. Sanders). Are there any other Senators in
the Chamber desiring to vote?
The result was announced--yeas 78, nays 15, as follows:

[Rollcall Vote No. 107 Leg.]

YEAS--78

Alexander
Barrasso
Baucus
Begich
Bennet
Bingaman
Blunt
Brown (MA)
Brown (OH)
Burr
Cantwell
Cardin
Carper
Casey
Chambliss
Coats
Cochran
Collins
Conrad
Coons
Corker
Durbin
Enzi
Feinstein
Franken
Gillibrand
Graham
Grassley
Hagan
Harkin
Hatch
Hoeven
Inhofe
Inouye
Isakson
Johnson (SD)
Kerry
Klobuchar
Kohl
Kyl
Landrieu
Lautenberg
Leahy
Levin
Lieberman
Lugar
Manchin
McCain
McCaskill
McConnell
Menendez
Merkley
Mikulski
Moran
Murkowski
Murray
Nelson (NE)
Nelson (FL)
Portman
Pryor
Reed
Reid
Roberts
Rockefeller
Rubio
Sanders
Schumer
Sessions
Shaheen
Shelby
Snowe
Tester
Udall (CO)
Udall (NM)
Warner
Webb
Whitehouse
Wyden

NAYS--15

Ayotte
Boozman
Coburn
Cornyn
Crapo
DeMint
Johanns
Johnson (WI)
Lee
Paul
Risch
Thune
Toomey
Vitter
Wicker

NOT VOTING--7

Akaka
Blumenthal
Boxer
Heller
Hutchison
Kirk
Stabenow
The motion was agreed to.

Amendment No. 2107

The PRESIDING OFFICER. Under the previous order, there will now be 2
minutes of debate equally divided prior to a vote in relation to
amendment No. 2107, offered by the Senator from Arizona, Mr. McCain.
Who wishes the floor?
The Senator from Arizona.
Mr. McCAIN. Mr. President, this amendment is a simple one. It creates
a safe individual drug importation program only from approved Canadian
pharmacies, overseen by the Secretary of Health and Human Services.
In a normal world, this would probably require a voice vote. But what
we are about to see is the incredible influence of the special
interests, particularly PhRMA, here in Washington, where people who
cannot afford it will have to make a choice between eating and
medicine. They will not be allowed to purchase a medication at less
than half the price, many times, than they will in American pharmacies
in Canada.
So what you are about to see is the reason for the cynicism the
American people have about the way we do business in Washington.
PhRMA--one of the most powerful lobbies in Washington--will exert its
influence again at the expense of average low-income Americans who
will, again, have to choose between medication and eating.
The PRESIDING OFFICER. The Senator from New Jersey.
Mr. MENENDEZ. Mr. President, it is not the special interests that
have caused the Senate countless times to reject this policy. It is an
amendment that puts Americans at risk, undermines the FDA's authority,
and would have a devastating ripple effect throughout the country's
drug supply by allowing foreign pharmaceuticals into the country.
It is not simply about Canada. The Canadians themselves have said
they cannot be expected to monitor all the drugs coming through Canada
and into our country, and all the Web-based opportunities would allow
untraceable drugs to come through Canada into the United States.
This is about the health and security of the American people. That is
why time after time the Senate has rejected it. It is why it should be
rejected once again.
The PRESIDING OFFICER. The majority leader.
Mr. REID. Mr. President, I have had, during this short period of
time, four different Senators come to me and say: Please hold the votes
to 10 minutes, with the 5-minute penalty. So we are going to do that. A
number of Senators already missed votes today. We are going to cut
those votes off. If you are not here, there is no excuse. These votes
have been scheduled since yesterday. So we are going to turn in these
votes exactly at 15 minutes. The clerks understand that. If a Senator
is late, they are late.
The PRESIDING OFFICER. Under the previous order, this amendment is
subject to a 60-vote threshold. The question is on agreeing to the
amendment.
The yeas and nays have been ordered.
The clerk will call the roll.
The bill clerk called the roll.
Mr. DURBIN. I announce that the Senator from Connecticut (Mr.
Blumenthal) is necessarily absent.
Mr. KYL. The following Senators are necessarily absent: the Senator
from Texas (Mrs. Hutchison) and the Senator from Illinois (Mr. Kirk).
The PRESIDING OFFICER (Mr. Wyden). Are there any other Senators in
the Chamber desiring to vote?
The result was announced--yeas 43, nays 54, as follows:

[Rollcall Vote No. 108 Leg.]

YEAS--43

Begich
Bingaman
Boozman
Boxer
Brown (OH)
Cardin
Collins
Conrad
DeMint
Feinstein
Franken
Graham
Grassley
Heller
Johnson (SD)
Klobuchar
Kohl
Leahy
Lee
Levin
McCain
McCaskill
Merkley
Murkowski
Nelson (NE)
Nelson (FL)
Paul
Pryor
Reed
Rockefeller
Sanders
Sessions
Shaheen
Shelby
Snowe
Stabenow
Thune
Toomey
Udall (NM)
Vitter
Webb
Whitehouse
Wyden

NAYS--54

Akaka
Alexander
Ayotte
Barrasso
Baucus
Bennet
Blunt
Brown (MA)
Burr
Cantwell
Carper
Casey
Chambliss
Coats
Coburn
Cochran
Coons
Corker
Cornyn
Crapo
Durbin
Enzi
Gillibrand
Hagan
Harkin
Hatch
Hoeven
Inhofe
Inouye
Isakson
Johanns
Johnson (WI)
Kerry
Kyl
Landrieu
Lautenberg
Lieberman
Lugar
Manchin
McConnell
Menendez
Mikulski
Moran
Murray
Portman
Reid
Risch
Roberts
Rubio
Schumer
Tester
Udall (CO)
Warner
Wicker

NOT VOTING--3

Blumenthal
Hutchison
Kirk
The PRESIDING OFFICER. Under the previous order requiring 60 votes
for the adoption of this amendment, the amendment is rejected.

Amendment No. 2109

Under the previous order, there will now be 2 minutes of debate
equally divided prior to a vote in relation to amendment No. 2109,
offered by the Senator from Vermont, Mr. Sanders.
Mr. SANDERS. Mr. President, this amendment is supported by Public
Citizen, U.S. PIRG, the National Committee to Preserve Social Security
and Medicare, and the National Women's Health Network.
In the United States, we pay by far the highest prices in the world
for prescription drugs--much higher than Canada, much higher than
Europe. There are a number of reasons for that. One of the reasons is
the widespread fraud, systemic fraud being perpetrated on the American
people by virtually every major drug company in this country.
In the last few years, companies such as Abbott, Pfizer, Johnson &
Johnson, Merck, GlaxoSmithKline, and many others combined have paid
billions of dollars in fines because they are ripping off Medicare,
they are ripping off Medicaid, and they are ripping off the American
consumer. It is high time we said that fraud cannot be perpetrated as a
business model by some of the major corporations in this country.
I ask for a ``yes'' vote.
The PRESIDING OFFICER. The Senator from Wyoming
Mr. ENZI. Mr. President, I would oppose this amendment. We do need to
combat health care fraud, but this amendment goes too far in several
aspects. First and most important, it would discourage any settlement
agreements. People would fight it to the death if they are going to
lose their exclusivity.

[[Page S3563]]

Second, as drafted, the amendment would require companies to forfeit
exclusivity anytime there is a civil or criminal liability under the
Federal Food, Drug, and Cosmetic Act. It is disproportionate. This
could be triggered by a misdemeanor. In addition, such liability may
not reflect fraud. The amendment would discourage the development of
new cures for patients. If manufactures know they could lose
exclusivity for even minor infractions, they will not invest the
millions of dollars necessary to create new lifesaving therapies for
patients.
I ask that the Senate oppose the amendment.
I yield the floor.
The PRESIDING OFFICER. All time has expired.
Under the previous order, this amendment is subject to a 60-vote
threshold for adoption.
The question is on agreeing to the amendment.
Mr. HARKIN. I ask for the yeas and nays.
The PRESIDING OFFICER. Is there a sufficient second?
There is a sufficient second.
The clerk will call the roll.
The assistant bill clerk called the roll.
Mr. DURBIN. I announce that the Senator from Connecticut (Mr.
Blumenthal) is necessarily absent.
Mr. KYL. The following Senators are necessarily absent: the Senator
from Texas (Mrs. Hutchison) and the Senator from Illinois (Mr. Kirk).
The PRESIDING OFFICER (Mr. Sanders). Are there any other Senators in
the Chamber desiring to vote?
The result was announced--yeas 9, nays 88, as follows:

[Rollcall Vote No. 109 Leg.]

YEAS--9

Bennet
Brown (OH)
Durbin
Franken
Levin
McCain
Sanders
Schumer
Whitehouse

NAYS--88

Akaka
Alexander
Ayotte
Barrasso
Baucus
Begich
Bingaman
Blunt
Boozman
Boxer
Brown (MA)
Burr
Cantwell
Cardin
Carper
Casey
Chambliss
Coats
Coburn
Cochran
Collins
Conrad
Coons
Corker
Cornyn
Crapo
DeMint
Enzi
Feinstein
Gillibrand
Graham
Grassley
Hagan
Harkin
Hatch
Heller
Hoeven
Inhofe
Inouye
Isakson
Johanns
Johnson (SD)
Johnson (WI)
Kerry
Klobuchar
Kohl
Kyl
Landrieu
Lautenberg
Leahy
Lee
Lieberman
Lugar
Manchin
McCaskill
McConnell
Menendez
Merkley
Mikulski
Moran
Murkowski
Murray
Nelson (NE)
Nelson (FL)
Paul
Portman
Pryor
Reed
Reid
Risch
Roberts
Rockefeller
Rubio
Sessions
Shaheen
Shelby
Snowe
Stabenow
Tester
Thune
Toomey
Udall (CO)
Udall (NM)
Vitter
Warner
Webb
Wicker
Wyden

NOT VOTING--3

Blumenthal
Hutchison
Kirk
The PRESIDING OFFICER. Under the previous order requiring 60 votes
for the adoption of the amendment, the amendment is rejected.
The Senator from North Carolina.

Amendment No. 2130 Withdrawn

Mr. BURR. Mr. President, I ask unanimous consent to withdraw the Burr
amendment No. 2130.
The PRESIDING OFFICER. Is there objection? Without objection, it is
so ordered.
Mr. BURR. I thank the Chair.

Amendment No. 2127

The PRESIDING OFFICER. Under the previous order, there will now be 2
minutes of debate equally divided prior to a vote in relation to
amendment No. 2127, offered by the Senator from Illinois, Mr. Durbin.
Mr. DURBIN. Mr. President, this is a very simple amendment. If you go
into the drugstore and look at the prescription drugs, every one of
them has been registered with the FDA. The over-the-counter drugs have
all been registered. When you go to the dietary supplement section,
there is no requirement under the law for the company selling those
products to register the name of the product, the ingredients of it, or
a copy of the label.
The GAO did a study in 2009, and the FDA said we need this
information to protect American consumers. From what? One of them is an
example on this chart. This is a Chinese product that was imported into
the United States, put up for sale, and then we discovered that one of
the ingredients was life-threatening. It was never registered with the
FDA, and there was no disclosure of its ingredients.
If you want to sell from the counters in America, shouldn't you be
required, whether you are from China, India, Mexico, or anywhere in the
United States, to register your product, the ingredients in it, and a
copy of the label? The FDA says they need this information to keep
America safe.
The PRESIDING OFFICER. The Senator from Iowa.
Mr. HARKIN. Mr. President, first of all, this is a drug and device
bill, not a food bill. We addressed food issues in the food safety bill
2 years ago. That doesn't solve the problem Senator Durbin talked
about. This bill is a very delicate balance. We have worked on this for
18 months. Stakeholders all over the country, consumers, the
pharmaceutical industry, and pharmacists all support this bill. This
would upset that delicate balance.
I say to the Senator that every supplement has a label, the
ingredients, and the potency, by law, on every single item sold as a
supplement. This is a drug bill, not a food bill.
The PRESIDING OFFICER. The Senator from Utah.
Mr. HATCH. Mr. President, I strongly oppose this amendment. I will be
voting to table it, and I encourage my colleagues to do the same. It
would impose another layer of regulations on an industry that already
has a workable regulatory framework. It is totally unnecessary, and it
will only increase costs for those who use dietary supplements.
I wish to make a few points clear.
First, HHS already has authority to impose an immediate ban on any
dietary supplement that poses imminent hazard to public health.
Second, four previous FDA Commissioners and a former Deputy
Commissioner agree that DSHEA already provides sufficient oversight of
this industry. This amendment would strap the FDA with a huge burden at
a time when the agency is already struggling to perform its current
core responsibilities.
Third, it unnecessarily expands registration requirements without
adding any additional consumer protections.
All this amendment does is penalize good companies, while doing
nothing to go after the bad.
In the end, as a result of this amendment, consumers will suffer by
paying higher prices for their supplements.
This amendment is bad for the FDA and bad for consumers. The Senate
should reject it.
We already have a regulatory framework under DSHEA that works. A new
intrusive regulatory regime is totally unnecessary. I urge my
colleagues to vote with me to table this amendment.
Mr. DURBIN. Mr. President, I ask unanimous consent to have the same
amount of time given on the other side.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. DURBIN. Mr. President, the FDA asked for this knowledge and
information. What am I asking them to disclose? The name of the
product, the ingredients of it, and a copy of the label. If a Chinese
manufacturer wants to sell a dietary supplement in Des Moines, IA,
shouldn't they have to report to the FDA the name of the product and
its ingredients? It is not required by law now. Let's give the FDA this
extra information to keep Americans safe.
Mr. HARKIN. Madam President, I move to table the Durbin amendment,
and I ask for the yeas and nays.
The PRESIDING OFFICER (Mrs. Hagan). Is there a sufficient second?
There is a sufficient second.
The question is on agreeing to the motion.
The clerk will call the roll.
The bill clerk called the roll.
Mr. DURBIN. I announce that the Senator from Connecticut (Mr.
Blumenthal) is necessarily absent.
Mr. KYL. The following Senators are necessarily absent: the Senator
from Texas (Mrs. Hutchison) and the Senator from Illinois (Mr. Kirk).
The PRESIDING OFFICER. Are there any other Senators in the Chamber
desiring to vote?
The result was announced--yeas 77, nays 20, as follows:

[Rollcall Vote No. 110 Leg.]

YEAS--77

Akaka
Alexander
Ayotte
Barrasso
Begich
Bennet
Blunt
Boozman
Brown (MA)

[[Page S3564]]

Brown (OH)
Burr
Cantwell
Carper
Casey
Chambliss
Coats
Coburn
Cochran
Collins
Coons
Corker
Cornyn
Crapo
DeMint
Enzi
Graham
Grassley
Hagan
Harkin
Hatch
Heller
Hoeven
Inhofe
Inouye
Isakson
Johanns
Johnson (SD)
Johnson (WI)
Kerry
Kohl
Kyl
Landrieu
Lee
Levin
Lieberman
Lugar
Manchin
McCain
McConnell
Menendez
Merkley
Mikulski
Moran
Murkowski
Murray
Nelson (NE)
Nelson (FL)
Paul
Portman
Risch
Roberts
Rubio
Sessions
Shaheen
Shelby
Snowe
Stabenow
Tester
Thune
Toomey
Udall (CO)
Udall (NM)
Vitter
Warner
Whitehouse
Wicker
Wyden

NAYS--20

Baucus
Bingaman
Boxer
Cardin
Conrad
Durbin
Feinstein
Franken
Gillibrand
Klobuchar
Lautenberg
Leahy
McCaskill
Pryor
Reed
Reid
Rockefeller
Sanders
Schumer
Webb

NOT VOTING--3

Blumenthal
Hutchison
Kirk
The motion was agreed to.
Mr. HARKIN. Madam President, I move to reconsider the vote and to lay
that motion on the table.
The motion to lay on the table was agreed to.

Prescription Drug Information

Mrs. GILLIBRAND. Madam President, earlier this week I introduced the
Cody Miller Initiative for Safe Prescriptions Act. The legislation
would require the Food and Drug Administration to issue regulations to
ensure patients receive timely, consistent, and accurate information
with their prescription drugs. The legislation would ensure patient
medication information is regularly updated as new information becomes
available and ensure that common information is applied consistently
across similar products. Most importantly, the legislation would ensure
patients are kept up to date about potential adverse side effects and
dangerous drug interactions.
Mr. HARKIN. I applaud the work of the Senator from New York on this
legislation and share her commitment to ensuring patients receive
standardized and accurate information about their prescription drugs.
While verbal counseling by a pharmacist is still critical, the patient
medication information is also an important resource to help patients
use medications safely.
Mrs. GILLIBRAND. I appreciate the Chairman's support and hope to work
with him to advance this legislation. I also hope he will join me in
calling on the FDA to use its existing authority to ensure patient
medication information is uniform, accurate, and up-to-date. The FDA is
currently engaged in efforts to revise the patient education materials
that are distributed to patients. However, the FDA's current plan falls
short of ensuring that consumers will receive unbiased and accurate
information about their prescription drugs. It also fails to ensure
that patient medication information is consistent for identical or
similar products.
Mr. HARKIN. I agree we need to take steps to improve the information
patients receive and look forward to working with the Senator on this
issue.

ACCELERATED PATIENT ACCESS

Mrs. HAGAN. Section 901 of the managers' amendment to S. 3187,
Enhancement of Accelerated Patient Access to New Medical Treatments
states that an accelerated approval under section 506(b) of the Federal
Food, Drug, and Cosmetic Act is subject to certain limitations,
including the requirement that the sponsor conduct appropriate post-
approval studies to verify and describe the predicted effect on
irreversible morbidity or mortality or other clinical benefit. Does the
lack of an explicit reference to postapproval validation of surrogate
endpoints, as described in current law, in any way restrict the
Secretary's existing authority to require such validation postapproval?
Mr. HARKIN. The managers' amendment to 3187 revises section 506(b),
removing the explicit language in current law requiring postapproval
validation of surrogate endpoints. However, this is not intended to
restrict the Secretary's current ability to require such validation
postapproval, if appropriate. Equally important, the change likewise is
not intended to suggest that any such validation should now occur prior
to approval under section 506(b). Rather, in keeping with current
practice, the bill's new language continues to permit the Secretary to
require postapproval studies to verify the effect on the surrogate
endpoint or predicted clinical outcome, i.e., verification of the
predicted clinical benefit. In addition, it continues to allow the
Secretary to withdraw an accelerated approval if the required studies
fail to verify and describe the predicted effect.
Mr. ENZI. To receive accelerated approval, the managers' amendment
requires that FDA determine that a surrogate or clinical endpoint is
reasonably likely to be predictive of an effect on clinical benefit or
on a clinical endpoint that can be measured earlier than irreversible
morbidity or mortality as of the time of granting accelerated approval
and the standards under section 505(c) of the FDCA or section 351(a) of
the Public Health Service Act are met. In meeting such a requirement,
it is appropriate for the Secretary to seek data and information to
show that the surrogate or clinical endpoint is reasonably likely to
predict an effect on irreversible morbidity or mortality or other
clinical benefit.
I would just like to reiterate that nothing in these amendments to
section 506(b) is intended to alter the FDA's historical practice of
utilizing unvalidated surrogates to grant accelerated approval in
appropriate cases or its practice of granting traditional approval
under section 505(b) based on validated surrogates in appropriate
cases.
Mr. LEAHY. Madam President, Senator Manchin's amendment, amendment
2151 to the Food and Drug Administration Safety and Innovation Act,
seeks to address the problem of prescription opiate drugs by tightening
restrictions on hydrocodone. Opiate prescription drugs like hydrocodone
have been a tremendous and growing problem in Vermont, as they have in
West Virginia. I thank Senator Manchin for working with me to make the
amendment better.
The scourge of prescription drug abuse has had a devastating effect
in communities across the country. I heard about the lives destroyed by
this epidemic and the violence and other ills it has brought with it in
several hearings in Vermont in recent years. Senator Manchin's
amendment seeks to make it more difficult for prescription drugs to get
into the hands of those who would abuse them by requiring prescriptions
more comprehensively and by restricting storage and transportation. I
hope these steps will be helpful.
I am glad Senator Manchin was willing to work with me to modify the
amendment so that it did not cause as many sentencing increases, and
particularly to eliminate what would have been a new mandatory minimum
sentence. Those who work on the problem of prescription drugs every day
have not identified a lack of adequate criminal sentences to be part of
the problem, so a significant change in the sentencing scheme was not
needed or intended.
Indeed, the proliferation of severe sentences for drug offenses and
of mandatory minimum sentences in particular is a large part of what
has led to the serious problem we face now in having too many people in
prison for too long. These sentences have contributed to the runaway
prison costs that are so crippling to Federal and State budgets.
Overwhelming prison costs take resources away from programs focusing
on drug prevention, drug treatment, and strong law enforcement, all of
which are more effective in helping communities take on prescription
drug problems than are lengthy sentences. I am glad that we could work
to ensure that this amendment would help to address our prescription
drug problem without contributing to the overincarceration of drug
offenders.
I know some doctors in Vermont and elsewhere continue to have
concerns about the effect this amendment will have on getting
prescriptions to those who need them. I hope we can continue working
together to ensure that we tackle the difficult problem of prescription
drug addiction without hindering crucial medical care.
I thank Senator Manchin for his leadership on this issue.
Mr. REED. Madam President, I am pleased that last night, my
amendment, No. 2126, which would ensure that there are no future delays
on the

[[Page S3565]]

implementation of new sunscreen labeling and testing standards, was
adopted as part of the Food and Drug Administration Safety and
Innovation Act.
Because sunscreens have been considered a cosmetic, they have largely
avoided government oversight and the FDA hasn't changed its
recommendations for sunscreen standards in over 30 years.
However, last June, after years of prodding by our former colleague
Senator Dodd, me, and others, the FDA finally acted.
The agency finalized comprehensive new sunscreen regulations that
were scheduled to go into effect on June 18, just a few weeks from now
and in time for summer. Indeed, this was considered a victory for
families across the country that spend more time outdoors and under the
sun's harmful UVA and UVB rays during the summer months.
But just 2 weeks ago, the FDA announced it is now giving the industry
an extra 6 months to make changes, meaning the standards will take
effect in mid-December instead of this summer.
For too long the FDA has allowed manufacturers to get away with
inaccurate claims about sun protection. My amendment will protect
against any future delays and ensure the new sunscreen safety and
labeling standards go into effect no later than the end of this year.
I am pleased that the Environmental Working Group supports this
amendment, and the Consumer Health Care Products Association, which
represents sunscreen manufacturers, has agreed to the amendment's
inclusion in this bill. Finally, the Congressional Budget Office has
informed me that my amendment would not result in any additional cost
to the Federal government.
I thank Chairman Harkin and Senator Enzi for reviewing this amendment
and including it in this FDA reauthorization bill.
Mr. LEVIN. Madam President, I will support final passage of the Food
and Drug Administration Safety and Innovation Act which will
reauthorize the user fee agreements that govern the fees paid by the
pharmaceutical and medical device industries to the Food and Drug
Administration, FDA, to expedite the drug and device approval process.
These fees are an important funding source that provides the FDA with
resources necessary to ensure potentially lifesaving drugs and medical
devices can be reviewed and ultimately brought to market quickly and
safely. I understand this legislation is the product of a tremendous
amount of work by the chairman and ranking member of the HELP
Committee, in conjunction with various stakeholders, and enjoys broad
support from industry, the FDA, and consumer groups.
For the first time, this bill will also create new user fee
agreements for generic drug manufacturers; manufacturers of biologics;
and would make permanent the Best Pharmaceuticals for Children Act and
the Pediatric Research Equity Act. These two laws together help improve
the safety and efficacy of pharmaceuticals for children.
Of particular interest, the bill aims to address drug shortages by
requiring all manufactures of certain drugs to provide advance
notification of possible supply disruptions and any permanent
discontinuance of these products to the Health and Human Services
Secretary. In addition, it will also require HHS to establish a task
force to address possible drug shortages and will grant the secretary
the authority to expedite the inspection and review process of
substitute products that could mitigate a shortage.
The bill will allow the FDA to continue to collect fees from
pharmaceutical manufacturers and medical device manufacturers through
2017. I am pleased to join with colleagues from both sides of the aisle
in voting in favor of this important legislation.
Ms. MIKULSKI. Madam President, I applaud the effort underway between
the FDA and industry to develop a transitional pathway for the
regulation of emerging diagnostic tests. In addition, I am pleased that
the FDA expressed its commitment to work with industry on this
important initiative in the MDUFA III commitment letter.
Many new diagnostic tests serve as the missing link to improved
health care through better detection, treatment, and monitoring of
disease. Thus, it is critical for public health that FDA's premarket
review system for diagnostics be modernized in a manner that supports
advances in the sciences and promotes patient access.
I look forward to developments with respect to the agency's plans to
develop a transitional in vitro diagnostics pathway and steps taken
related to its implementation.
I also wish to talk about two massively important laws that work to
ensure that medications used in children are tested and labeled
correctly--the Best Pharmaceuticals for Children Act, known as BPCA,
and the Pediatric Research Equity Act, known as PREA.
Taken together, these two laws encourage and require drug companies
to study their products in children. They have been hugely successful
in ensuring that physicians and parents have information needed to best
treat our Nation's children.
Most drugs on the market have never been tested in children, largely
because manufacturers face economic, mechanical, ethical, and legal
obstacles that work to discourage pediatric testing.
With respect to economic obstacles, the pediatric drug marketplace is
generally small, with little economic incentive for manufacturers to
commit resources to testing in children when they could just test in
the much larger adult population.
With respect to mechanical obstacles, young children often cannot
swallow pills. This presents a challenge for drug manufacturers, who
often then have to develop alternate formulations, such as liquids or
chewable tablets. Finally, even for adults, ethical and legal
requirements for participation in a clinical trial are incredibly
complex and challenging. Trying to recruit children for trials is even
more difficult. Parents don't want their kids used in experiments, and
drug companies face added liability concerns.
We understand these challenges, but doctors still must treat
children--many with serious and life-threatening conditions. And, too
often, doctors are forced to prescribe drugs that have never been
studied in kids. So in 2002 and 2003 Congress passed laws that serve as
a carrot and stick to generate more pediatric drug information. We
passed the Pediatric Research Equity Act, which requires safety and
efficacy studies in children for all new drugs. For drugs that were on
the market before PREA was enacted, the law allows FDA to go back and
mandate child studies where appropriate.
We also passed the Best Pharmaceuticals for Children Act, which
rewards drug companies with 6 months additional exclusivity if they
complete additional pediatric testing requested by FDA.
As a result of BPCA and PREA, over 425 drug labels have been revised
with important pediatric information. Before BPCA and PREA, more than
80 percent of drugs used in kids were used off-label without data on
safety and efficacy. Today, that number has been reduced to
approximately 50 percent. New pediatric studies conducted as result of
BPCA and PREA have resulted in new dosing information, new indications
of use, new safety information, and new data on effectiveness in
children.
The Food and Drug Administration Safety and Innovation Act removes
the 5-year sunsets for BPCA and PREA, giving biopharmaceutical
companies a more predictable regulatory path and providing certainty
that these programs will still be up and running when companies
complete their pediatric trials.
This bill also makes important pediatric information publicly
available. The last reauthorization of BPCA and PREA ensured that
certain pediatric studies were made publicly available but did not
ensure the availability of pre-2007 studies. This bill ensures that
pediatric studies conducted between 2002 and 2007, which resulted in a
labeling change, are made publicly available for physicians,
researchers, and parents.
Finally, this bill gives FDA new tools to ensure that studies
required by PREA are completed on time, unless there is an appropriate
reason for delay.
Children are not small adults. They have different medical needs. The
only way to improve the health of current and future generations of
children is to

[[Page S3566]]

better understand how drugs work in pediatric populations. We need to
help doctors by getting them more information so that treatment of
pediatric diseases is less of a guessing game and more of an informed
practice. I believe these two pediatric programs have been incredibly
successful, and I am very encouraged by the improvements we make in the
bill before us today.
Finally Madam President, I wish to talk about the safety of our
Nation's prescription drug supply. Today, there are many challenges and
obstacles facing our families--from trying to find or keep a job, to
figuring out how to pay off crushing student loans, to obtaining
affordable health insurance. One thing that our families shouldn't have
to worry about is whether the drug they are taking or whether the drug
their loved one is taking to cure or treat an illness is going to harm
them instead of help them.
When the modern FDA was first established in 1938, most of our
medical products were developed and manufactured within our own
borders. That is no longer the case. Nearly 40 percent of drugs
Americans rely upon are made outside our borders. About 80 percent of
the active ingredients used in drugs made in the United States come
from 150 other countries. The increased globalization of our drug
industry, coupled with the fact that we have not given our Federal
agencies additional authorities to keep pace, has created great
challenges for FDA and industry and great danger to patients in need.
Where there is need, there is greed. Where there is greed, there is
scam and schemes. In this case, we know that increased globalization
and insufficient authorities to regulate at a Federal level has created
a dangerous opportunity for bad actors to take advantage. And they have
taken advantage--from adulteration, to counterfeiting, to cargo theft,
to manufacturing drugs in unsanitary conditions, to mislabeled
products. We have seen it all in recent years and the consequences have
been deadly.
In recent years, a highly toxic solvent, known as DEG, added to fever
medicine, cough syrup, and teething products resulted in the deaths of
children and adults in Panama, Haiti, and Nigeria.
In 2007, pet food adulterated with melamine and acid sickened several
thousand pets in the United States. Melamine and acid was added to
infant formula in China, poisoning and killing six babies and sickening
300,000 others.
In 2008, contaminated Heparin from China killed and sickened hundreds
across the United States.
In 2003, more than $20 million in illegally imported and counterfeit
Lipitor was sold throughout the United States.
In 2009, an estimated 46 drug cargo thefts occurred, valued at $184
million.
Many stolen drugs are then improperly stored or handled before being
sold back to consumers, putting patients at risk. For instance, stolen
insulin was reintroduced into the drug supply and caused adverse events
in patients because it had not been refrigerated. I could go on and on
with examples of how counterfeit, adulterated, and stolen drugs have
sickened and killed people and animals worldwide.
But, I am encouraged by the bill before us today. The FDA Safety and
Innovation Act takes a number of important steps to improve the safety
of our Nation's drug supply. For instance, this legislation requires
every foreign establishment engaged in the manufacture of a drug or
device imported into the United States, to electronically register with
the FDA.
Under current law, there are no requirements governing how often FDA
must inspect foreign facilities. The bill before us requires FDA to set
up a risk-based inspection frequency to ensure that we are getting in
there and inspecting facilities that pose the greatest risks.
This legislation gives the Secretary of Homeland Security the
authority to refuse admission into the United States any drug or
ingredient if it was manufactured, processed, packed, or held at an
establishment that has refused or delayed inspection by FDA.
This bill requires drug manufacturers and wholesalers to notify the
FDA if they become aware that their drug has been counterfeited or has
been stolen or lost in substantial quantities.
Finally, this bill increases penalties for bad actors who knowingly
adulterate or counterfeit drugs.
In developing this legislation, the question we had to ask was this:
Does the Federal agency tasked with ensuring the safety of our Nation's
drugs have the resources and authorities necessary to do their job and
protect the public health? The answer was no. But I believe the new
authorities contained in the FDA Safety and Innovation Act--which we
developed on a bipartisan basis in the Senate HELP committee--will help
us ensure that the next time we ask this question, the answer will be
yes.
Mr. DURBIN. Madam President, today, we are considering a bill that
will improve the FDA's ability to assure the safety of drugs in our
medicine cabinets and medical devices in our hospitals.
The FDA is an essential guardian of the public's health and safety.
In the past few years, FDA has faced obstacles that call on the
agency to adapt and respond to the evolving nature of reviewing,
manufacturing, and distributing drugs and devices.
Some of those obstacles and challenges are addressed in the
reauthorizations of the Prescription Drug User Fee Act and the Medical
Device User Fee Act, which are set to expire at the end of September
2012.
Last fall, I visited Cook Medical's medical device plant in Canton,
IL, and representatives expressed concern about the amount of time it
takes medical devices to be reviewed.
FDA needs sufficient time to review medical devices in order to
ensure their safety and effectiveness. However, inefficiencies and
insufficient resources can result in longer review times, which means
patients have to wait longer to benefit from new medical devices.
This bill makes key changes to maintain the safety of devices and
preserve our country's leadership in biomedical innovation.
The bill will authorize the FDA to collect almost $600 million in
user fees over 5 years. FDA can use these additional resources to help
hire and train staff.
Furthermore, the bill makes important improvements by streamlining
the review process for devices and increasing communication between the
FDA and device manufacturers throughout the review process.
These changes to the review of medical devices will not only help
innovative device companies get their product to market faster but will
prevent patients from having to wait extra weeks and months to benefit
from a new device.
In addition to reauthorizing the Prescription Drug and Medical Device
User Fee Acts, this bill also establishes the Generic Drug User Fee Act
and Biosimilar User Fee Act, which give FDA new authority to collect
user fees for generic and biosimilar drugs.
Currently the FDA does not collect user fees to support the review of
generic drugs, and it takes about 30 months for the agency to review
generic drug applications. This extra time reduces access to safe,
affordable generic drugs and leaves patients and taxpayers paying the
tab for brand-name drugs that lack competition from generics.
Since the first Prescription Drug User Fee Act was enacted in 1992,
the FDA began collecting user fees to support the review of
applications.
FDA has cut the review time for new drugs by 60 percent, from 2 years
to a little over 1 year.
Similarly, the Generic Drug User Fee Act will give FDA the support it
needs to cut the current 30-month review time for generic drugs down to
10 months.
This improvement will promote competition in the marketplace and save
money by reducing the amount of time patients have to wait for less
expensive generic alternatives to brand-name drugs.
The process of negotiating and drafting this legislation started 18
months ago, and the result is a comprehensive bill that improves the
safety and quality of drugs and medical devices.
Chairman Harkin and Senator Enzi have put together a bill that
responds to many of these challenges, including one that is of
particular interest to me--the national shortage of critical drugs.
Between 2006 and 2010 the drug shortage increased 200 percent--from
56 to

[[Page S3567]]

178 drugs. Currently the drug shortage includes over 200 drugs, such as
intravenous nutrition supplements, cancer treating drugs, and
anesthesia.
Over the past few months, I have held three roundtable discussions at
hospitals across Illinois to learn about the drug shortage and how it
is affecting providers and patients. From these discussions it is clear
that the drug shortage is being felt at most hospitals, and those
Illinois hospitals, providers, and pharmacists are working around the
clock to ensure patients maintain access to drugs and safe treatments.
At Advocate Hospital in Libertyville, a doctor shared that he learned
just days before starting a patient on chemotherapy that the drug was
not available. Unfortunately, this is a common scenario across the
country as doctors learn days before starting a treatment or even once
the patient is on the hospital bed that a drug is not available.
Pharmacists now spend part of each day scrambling to find drugs or an
alternative treatment.
I recently learned that a young woman on my staff here in DC is all
too familiar with the drug shortage. She is a smart and hardworking
woman who has been taking Concerta to treat her ADD since she was 14.
Like most people with severe ADD, she must take her medicine at a
certain time every day in order to keep their ADD symptoms from
impeding basic life and work responsibilities. And while there are
several ADD drugs on the market, each drug works differently and can
have different side effects, so switching to a new prescription is not
without risk.
Last year, the local CVS where she usually had her prescription
filled started telling her they didn't have her drug in stock. She
didn't think much of it, as she would wake up early and walk to another
CVS in the morning where she was usually able to get the prescription.
Over time, she grew accustomed to going between these two CVS
pharmacies to fill her prescription until one month when she carried
her prescription with her for 3 days and was unable to find a pharmacy
with enough Concerta to fill her 30-day prescription. By the end of day
3, she was out of her supply. She woke up early and rode her bike to
four or five CVS pharmacies until she was able to find a pharmacy that
could fill her prescription. But by then it was 12 o'clock and past the
prescribed time to take the drug.
The shortage of ADD drugs impacts children, adults, parents, and
employees across the country.
Congress must take action to address the drug shortage.
The FDA Safety and Innovation Act builds on Senator Klobuchar's bill,
with key provisions to curb the national drug shortage.
First, the bill requires drug manufacturers to notify the FDA 6
months in advance for certain drug shortages.
With this much notice, the FDA can work with manufacturers to try to
avoid a shortage and, when necessary, identify alternative sources of
the drug to ensure we maintain a supply for patients.
This winter, thanks to open communication between the FDA and drug
companies, the FDA successfully avoided a shortage of methotrexate, a
vital drug to treat leukemia with children.
FDA collaborated with Illinois-based generic drug manufacturer
Hospira to increase production of this lifesaving drug when another
company halted production.
Requiring 6 months' advance notice of a drug shortage will help the
FDA to work with companies to avoid shortages of critical drugs.
Furthermore, the bill requires FDA to enhance the agency's response
to shortages and will improve reporting of shortages by allowing third
parties to report drug shortages to the FDA.
This bill also takes steps to improve the safety of drugs and the
drug supply chain.
In 2008, serious injuries and 81 deaths were linked to contamination
of the crucial blood thinning drug heparin. The source of the
contamination was a facility in China that intentionally adulterated
the drug. This was a horrible illustration of what happens when
adulterated and counterfeit drugs make their way into the drug supply
chain and ultimately to patients.
This case has also raised serious questions about the global
manufacturing practices of drugs and drug ingredients and the FDA's
responsibility to protect the drug supply chain. Since the heparin
incident, the global nature of the drug supply chain has only grown.
Today, 80 percent of active pharmaceutical ingredients are manufactured
outside of the United States.
This bill improves the safety of our supply chain both domestically
and internationally by requiring foreign manufacturers to register
their facilities with the FDA.
The bill also places greater responsibility on U.S. drug
manufacturers to know their international suppliers and increases
penalties for intentionally contaminating or counterfeiting drugs.
Counterfeit and adulterated drugs can have deadly consequences, yet
the penalty for committing these crimes is less than the penalty for
selling a counterfeit designer purse. Currently, the penalty for
intentionally counterfeiting or adulterating a drug is no more than 3
ears in prison or a $10,000 fine or both. This bill raises the penalty
for intentionally adulterating a drug to no more than 20 years in
prison or a $1 million fine or both. And the penalty for intentionally
counterfeiting drugs is raised to no more than 20 years in prison or a
$4 million fine or both.
This bill addresses the drug shortage, reduces the review time for
medical devices and drugs, improves the pipeline for antibiotics and
pediatric drugs, and helps secure the supply chain for prescription
drugs.
I thank Chairman Harkin and Senator Enzi for their extraordinary
leadership and hard work on this bill.
The PRESIDING OFFICER. The question is on the engrossment and the
third reading of the bill.
The bill was ordered to be engrossed for a third reading and was read
the third time.
The PRESIDING OFFICER. Under the previous order, there will now be 2
minutes of debate equally divided prior to a vote on passage of the
bill, as amended.
The Senator from Iowa.
Mr. HARKIN. Madam President, we have all put in a lot of work and
benefited greatly by the constructive ideas and efforts of all the
Members of this body. I sincerely thank all my colleagues, especially
Senator Enzi, for their hard work on this must-pass legislation.
This excellent bill is a shining example of what we can achieve when
we all work together. Now we must keep our promise to patients and the
biomedical industry and pass this critical bill.
Today, with one vote, we can reauthorize the essential FDA's user fee
agreements, systematically modernize FDA's medical product authority,
and help to boost American innovation and ensure that patients have
access to the therapies they need.
So I urge my colleagues to join in this bipartisan spirit of
cooperation and pass this important legislation, the FDA Safety and
Innovation Act.
The PRESIDING OFFICER. The Senator from Wyoming.
Mr. ENZI. Madam President, the chairman has said it well. We
appreciate the bipartisan spirit in which people have participated,
especially in committee for a year and a half, working out amendments,
working out ideas, and coming up with a bill that had a good consensus.
I appreciate the action on the Senate floor, the people who were
willing to do time limits on their amendments, and how quickly we have
gotten through the votes.
I particularly want to thank the chairman for the way he has handled
this in committee and the process since then. We had a couple of issues
that were outstanding and those got worked out.
I also want to thank the staffs on both sides. Their dedication for a
year and a half is what made this happen, and we have some outstanding
staff on both sides. Every member of the committee and every committee
member's staff helped on this one, and that makes a difference. So I
ask everyone to support the bill.
I yield the floor.
The PRESIDING OFFICER. The question is, Shall the bill pass?
Mr. HARKIN. Madam President, I ask for the yeas and nays.
The PRESIDING OFFICER. Is there a sufficient second?
There appears to be a sufficient second.

[[Page S3568]]

The clerk will call the roll.
The assistant bill clerk called the roll.
Mr. DURBIN. I announce that the Senator from Connecticut (Mr.
Blumenthal) is necessarily absent.
Mr. KYL. The following Senators are necessarily absent: the Senator
from Texas (Mrs. Hutchison) and the Senator from Illinois (Mr. Kirk).
The PRESIDING OFFICER. Are there any other Senators in the Chamber
desiring to vote?
The result was announced--yeas 96, nays 1, as follows:

[Rollcall Vote No. 111 Leg.]

YEAS--96

Akaka
Alexander
Ayotte
Barrasso
Baucus
Begich
Bennet
Bingaman
Blunt
Boozman
Boxer
Brown (MA)
Brown (OH)
Burr
Cantwell
Cardin
Carper
Casey
Chambliss
Coats
Coburn
Cochran
Collins
Conrad
Coons
Corker
Cornyn
Crapo
DeMint
Durbin
Enzi
Feinstein
Franken
Gillibrand
Graham
Grassley
Hagan
Harkin
Hatch
Heller
Hoeven
Inhofe
Inouye
Isakson
Johanns
Johnson (SD)
Johnson (WI)
Kerry
Klobuchar
Kohl
Kyl
Landrieu
Lautenberg
Leahy
Lee
Levin
Lieberman
Lugar
Manchin
McCain
McCaskill
McConnell
Menendez
Merkley
Mikulski
Moran
Murkowski
Murray
Nelson (NE)
Nelson (FL)
Paul
Portman
Pryor
Reed
Reid
Risch
Roberts
Rockefeller
Rubio
Schumer
Sessions
Shaheen
Shelby
Snowe
Stabenow
Tester
Thune
Toomey
Udall (CO)
Udall (NM)
Vitter
Warner
Webb
Whitehouse
Wicker
Wyden

NAYS--1

Sanders

NOT VOTING--3

Blumenthal
Hutchison
Kirk
The bill (S. 3187), as amended, was passed, as follows:

S. 3187

Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Food and Drug Administration
Safety and Innovation Act''.

SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT.

(a) Table of Contents.--The table of contents of this Act
is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents; references in Act.

TITLE I--FEES RELATING TO DRUGS

Sec. 101. Short title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Reauthorization; reporting requirements.
Sec. 105. Sunset dates.
Sec. 106. Effective date.
Sec. 107. Savings clause.

TITLE II--FEES RELATING TO DEVICES

Sec. 201. Short title; findings.
Sec. 202. Definitions.
Sec. 203. Authority to assess and use device fees.
Sec. 204. Reauthorization; reporting requirements.
Sec. 205. Savings clause.
Sec. 206. Effective date.
Sec. 207. Sunset dates.
Sec. 208. Streamlined hiring authority to support activities related to
the process for the review of device applications.

TITLE III--FEES RELATING TO GENERIC DRUGS

Sec. 301. Short title.
Sec. 302. Authority to assess and use human generic drug fees.
Sec. 303. Reauthorization; reporting requirements.
Sec. 304. Sunset dates.
Sec. 305. Effective date.
Sec. 306. Amendment with respect to misbranding.
Sec. 307. Streamlined hiring authority of the Food and Drug
Administration to support activities related to human
generic drugs.

TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

Sec. 401. Short title; finding.
Sec. 402. Fees relating to biosimilar biological products.
Sec. 403. Reauthorization; reporting requirements.
Sec. 404. Sunset dates.
Sec. 405. Effective date.
Sec. 406. Savings clause.
Sec. 407. Conforming amendment.

TITLE V--PEDIATRIC DRUGS AND DEVICES

Sec. 501. Permanence.
Sec. 502. Written requests.
Sec. 503. Communication with Pediatric Review Committee.
Sec. 504. Access to data.
Sec. 505. Ensuring the completion of pediatric studies.
Sec. 506. Pediatric study plans.
Sec. 507. Reauthorizations.
Sec. 508. Report.
Sec. 509. Technical amendments.
Sec. 510. Relationship between pediatric labeling and new clinical
investigation exclusivity.
Sec. 511. Pediatric rare diseases.

TITLE VI--MEDICAL DEVICE REGULATORY IMPROVEMENTS

Sec. 601. Reclassification procedures.
Sec. 602. Condition of approval studies.
Sec. 603. Postmarket surveillance.
Sec. 604. Sentinel.
Sec. 605. Recalls.
Sec. 606. Clinical holds on investigational device exemptions.
Sec. 607. Unique device identifier.
Sec. 608. Clarification of least burdensome standard.
Sec. 609. Custom devices.
Sec. 610. Agency documentation and review of certain decisions
regarding devices.
Sec. 611. Good guidance practices relating to devices.
Sec. 612. Modification of de novo application process.
Sec. 613. Humanitarian device exemptions.
Sec. 614. Reauthorization of third-party review and inspections.
Sec. 615. 510(k) device modifications.
Sec. 616. Health information technology.

TITLE VII--DRUG SUPPLY CHAIN

Subtitle A--Drug Supply Chain

Sec. 701. Registration of domestic drug establishments.
Sec. 702. Registration of foreign establishments.
Sec. 703. Identification of drug excipient information with product
listing.
Sec. 704. Electronic system for registration and listing.
Sec. 705. Risk-based inspection frequency.
Sec. 706. Records for inspection.
Sec. 707. Failure to allow foreign inspection.
Sec. 708. Exchange of information.
Sec. 709. Enhancing the safety and quality of the drug supply.
Sec. 710. Accreditation of third-party auditors for drug
establishments.
Sec. 711. Standards for admission of imported drugs.
Sec. 712. Notification.
Sec. 713. Protection against intentional adulteration.
Sec. 714. Enhanced criminal penalty for counterfeiting drugs.
Sec. 715. Extraterritorial jurisdiction.
Sec. 716. Compliance with international agreements.

Subtitle B--Pharmaceutical Distribution Integrity

Sec. 721. Short title.
Sec. 722. Securing the pharmaceutical distribution supply chain.
Sec. 723. Independent assessment.

TITLE VIII--GENERATING ANTIBIOTIC INCENTIVES NOW

Sec. 801. Extension of exclusivity period for drugs.
Sec. 802. Priority review.
Sec. 803. Fast track product.
Sec. 804. GAO study.
Sec. 805. Clinical trials.
Sec. 806. Regulatory certainty and predictability.

TITLE IX--DRUG APPROVAL AND PATIENT ACCESS

Sec. 901. Enhancement of accelerated patient access to new medical
treatments.
Sec. 902. Breakthrough therapies.
Sec. 903. Consultation with external experts on rare diseases, targeted
therapies, and genetic targeting of treatments.
Sec. 904. Accessibility of information on prescription drug container
labels by visually-impaired and blind consumers.
Sec. 905. Risk-benefit framework.
Sec. 906. Independent study on medical innovation inducement model.
Sec. 907. Orphan product grants program.
Sec. 908. Reporting of inclusion of demographic subgroups in clinical
trials and data analysis in applications for drugs,
biologics, and devices.

TITLE X--DRUG SHORTAGES

Sec. 1001. Drug shortages.

TITLE XI--OTHER PROVISIONS

Subtitle A--Reauthorizations

Sec. 1101. Reauthorization of provision relating to exclusivity of
certain drugs containing single enantiomers.
Sec. 1102. Reauthorization of the Critical Path Public-Private
Partnerships.

Subtitle B--Medical Gas Product Regulation

Sec. 1111. Regulation of medical gas products.
Sec. 1112. Regulations.
Sec. 1113. Applicability.

Subtitle C--Miscellaneous Provisions

Sec. 1121. Advisory committee conflicts of interest.
Sec. 1122. Guidance document regarding product promotion using the
Internet.
Sec. 1123. Electronic submission of applications.
Sec. 1124. Combating prescription drug abuse.
Sec. 1125. Tanning bed labeling.

[[Page S3569]]

Sec. 1126. Optimizing global clinical trials.
Sec. 1127. Advancing regulatory science to promote public health
innovation.
Sec. 1128. Information technology.
Sec. 1129. Reporting requirements.
Sec. 1130. Strategic integrated management plan.
Sec. 1131. Drug development and testing.
Sec. 1132. Patient participation in medical product discussions.
Sec. 1133. Nanotechnology regulatory science program.
Sec. 1134. Online pharmacy report to Congress.
Sec. 1135. Medication and device errors.
Sec. 1136. Compliance provision.
Sec. 1137. Ensuring adequate information regarding pharmaceuticals for
all populations, particularly underrepresented
subpopulations, including racial subgroups.
Sec. 1138. Report on small businesses.
Sec. 1139. Protections for the commissioned corps of the public health
service act.
Sec. 1140. Regulations on clinical trial registration; GAO Study of
clinical trial registration and reporting requirements.
Sec. 1141. Hydrocodone amendment.
Sec. 1142. Compliance date for rule relating to sunscreen drug products
for over-the-counter human use.
Sec. 1143. Recommendations on interoperability standards.

Subtitle D--Synthetic Drugs

Sec. 1151. Short title.
Sec. 1152. Addition of synthetic drugs to schedule I of the Controlled
Substances Act.
Sec. 1153. Temporary scheduling to avoid imminent hazards to public
safety expansion.
Sec. 1154. Prohibition on imposing mandatory minimum sentences.
(b) References in Act.--Except as otherwise specified,
amendments made by this Act to a section or other provision
of law are amendments to such section or other provision of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.).

TITLE I--FEES RELATING TO DRUGS

SEC. 101. SHORT TITLE; FINDING.

(a) Short Title.--This title may be cited as the
``Prescription Drug User Fee Amendments of 2012''.
(b) Finding.--The Congress finds that the fees authorized
by the amendments made in this title will be dedicated toward
expediting the drug development process and the process for
the review of human drug applications, including postmarket
drug safety activities, as set forth in the goals identified
for purposes of part 2 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act, in the letters from the
Secretary of Health and Human Services to the Chairman of the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Chairman of the Committee on Energy and
Commerce of the House of Representatives, as set forth in the
Congressional Record.

SEC. 102. DEFINITIONS.

Paragraph (7) of section 735 (21 U.S.C. 379g) is amended,
in the matter preceding subparagraph (A), by striking
``incurred''.

SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.

Section 736 (21 U.S.C. 379h) is amended--
(1) in subsection (a)--
(A) in the matter preceding paragraph (1), by striking
``fiscal year 2008'' and inserting ``fiscal year 2013'';
(B) in paragraph (1), in clauses (i) and (ii) of
subparagraph (A), by striking ``subsection (c)(5)'' each
place such term appears and inserting ``subsection (c)(4)'';
(C) in the matter following clause (ii) in paragraph
(2)(A)--
(i) by striking ``subsection (c)(5)'' and inserting
``subsection (c)(4)''; and
(ii) by striking ``payable on or before October 1 of each
year'' and inserting ``due on the later of the first business
day on or after October 1 of each fiscal year or the first
business day after the enactment of an appropriations Act
providing for the collection and obligation of fees for such
fiscal year under this section''; and
(D) in paragraph (3)--
(i) in subparagraph (A)--

(I) by striking ``subsection (c)(5)'' and inserting
``subsection (c)(4)''; and
(II) by striking ``payable on or before October 1 of each
year.'' and inserting ``due on the later of the first
business day on or after October 1 of each fiscal year or the
first business day after the enactment of an appropriations
Act providing for the collection and obligation of fees for
such fiscal year under this section.''; and

(ii) by amending subparagraph (B) to read as follows:
``(B) Exception.--A prescription drug product shall not be
assessed a fee under subparagraph (A) if such product is--
``(i) identified on the list compiled under section
505(j)(7) with a potency described in terms of per 100 mL;
``(ii) the same product as another product that--

``(I) was approved under an application filed under section
505(b) or 505(j); and
``(II) is not in the list of discontinued products compiled
under section 505(j)(7);

``(iii) the same product as another product that was
approved under an abbreviated application filed under section
507 (as in effect on the day before the date of enactment of
the Food and Drug Administration Modernization Act of 1997);
or
``(iv) the same product as another product that was
approved under an abbreviated new drug application pursuant
to regulations in effect prior to the implementation of the
Drug Price Competition and Patent Term Restoration Act of
1984.'';
(2) in subsection (b)--
(A) in paragraph (1)--
(i) in the matter preceding subparagraph (A), by striking
``fiscal years 2008 through 2012'' and inserting ``fiscal
years 2013 through 2017'';
(ii) in subparagraph (A), by striking ``$392,783,000; and''
and inserting ``$693,099,000;''; and
(iii) by striking subparagraph (B) and inserting the
following:
``(B) the dollar amount equal to the inflation adjustment
for fiscal year 2013 (as determined under paragraph (3)(A));
and
``(C) the dollar amount equal to the workload adjustment
for fiscal year 2013 (as determined under paragraph
(3)(B)).''; and
(B) by striking paragraphs (3) and (4) and inserting the
following:
``(3) Fiscal year 2013 inflation and workload
adjustments.--For purposes of paragraph (1), the dollar
amount of the inflation and workload adjustments for fiscal
year 2013 shall be determined as follows:
``(A) Inflation adjustment.--The inflation adjustment for
fiscal year 2013 shall be the sum of--
``(i) $652,709,000 multiplied by the result of an inflation
adjustment calculation determined using the methodology
described in subsection (c)(1)(B); and
``(ii) $652,709,000 multiplied by the result of an
inflation adjustment calculation determined using the
methodology described in subsection (c)(1)(C).
``(B) Workload adjustment.--Subject to subparagraph (C),
the workload adjustment for fiscal 2013 shall be--
``(i) $652,709,000 plus the amount of the inflation
adjustment calculated under subparagraph (A); multiplied by
``(ii) the amount (if any) by which a percentage workload
adjustment for fiscal year 2013, as determined using the
methodology described in subsection (c)(2)(A), would exceed
the percentage workload adjustment (as so determined) for
fiscal year 2012, if both such adjustment percentages were
calculated using the 5-year base period consisting of fiscal
years 2003 through 2007.
``(C) Limitation.--Under no circumstances shall the
adjustment under subparagraph (B) result in fee revenues for
fiscal year 2013 that are less than the sum of the amount
under paragraph (1)(A) and the amount under paragraph
(1)(B).'';
(3) by striking subsection (c) and inserting the following:
``(c) Adjustments.--
``(1) Inflation adjustment.--For fiscal year 2014 and
subsequent fiscal years, the revenues established in
subsection (b) shall be adjusted by the Secretary by notice,
published in the Federal Register, for a fiscal year by the
amount equal to the sum of--
``(A) one;
``(B) the average annual percent change in the cost, per
full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and benefits
paid with respect to such positions for the first 3 years of
the preceding 4 fiscal years, multiplied by the proportion of
personnel compensation and benefits costs to total costs of
the process for the review of human drug applications (as
defined in section 735(6)) for the first 3 years of the
preceding 4 fiscal years; and
``(C) the average annual percent change that occurred in
the Consumer Price Index for urban consumers (Washington-
Baltimore, DC MD VA WV; Not Seasonally Adjusted; All items;
Annual Index) for the first 3 years of the preceding 4 years
of available data, multiplied by the proportion of all costs
other than personnel compensation and benefits costs to total
costs of the process for the review of human drug
applications (as defined in section 735(6)) for the first 3
years of the preceding 4 fiscal years.

The adjustment made each fiscal year under this paragraph
shall be added on a compounded basis to the sum of all
adjustments made each fiscal year after fiscal year 2013
under this paragraph.
``(2) Workload adjustment.--For fiscal year 2014 and
subsequent fiscal years, after the fee revenues established
in subsection (b) are adjusted for a fiscal year for
inflation in accordance with paragraph (1), the fee revenues
shall be adjusted further for such fiscal year to reflect
changes in the workload of the Secretary for the process for
the review of human drug applications. With respect to such
adjustment:
``(A) The adjustment shall be determined by the Secretary
based on a weighted average of the change in the total number
of human drug applications (adjusted for changes in review
activities, as described in the notice that the Secretary is
required to publish in the Federal Register under this
subparagraph), efficacy supplements, and manufacturing
supplements submitted to the Secretary, and the change in the
total number of active commercial investigational new drug
applications (adjusted for changes in review activities, as
so described) during the most recent 12-month period for
which data on such submissions is available. The Secretary
shall publish in the Federal Register

[[Page S3570]]

the fee revenues and fees resulting from the adjustment and
the supporting methodologies.
``(B) Under no circumstances shall the adjustment result in
fee revenues for a fiscal year that are less than the sum of
the amount under subsection (b)(1)(A) and the amount under
subsection (b)(1)(B), as adjusted for inflation under
paragraph (1).
``(C) The Secretary shall contract with an independent
accounting or consulting firm to periodically review the
adequacy of the adjustment and publish the results of those
reviews. The first review shall be conducted and published by
the end of fiscal year 2013 (to examine the performance of
the adjustment since fiscal year 2009), and the second review
shall be conducted and published by the end of fiscal year
2015 (to examine the continued performance of the
adjustment). The reports shall evaluate whether the
adjustment reasonably represents actual changes in workload
volume and complexity and present options to discontinue,
retain, or modify any elements of the adjustment. The reports
shall be published for public comment. After review of the
reports and receipt of public comments, the Secretary shall,
if warranted, adopt appropriate changes to the methodology.
If the Secretary adopts changes to the methodology based on
the first report, the changes shall be effective for the
first fiscal year for which fees are set after the Secretary
adopts such changes and each subsequent fiscal year.
``(3) Final year adjustment.--For fiscal year 2017, the
Secretary may, in addition to adjustments under this
paragraph and paragraphs (1) and (2), further increase the
fee revenues and fees established in subsection (b) if such
an adjustment is necessary to provide for not more than 3
months of operating reserves of carryover user fees for the
process for the review of human drug applications for the
first 3 months of fiscal year 2018. If such an adjustment is
necessary, the rationale for the amount of the increase shall
be contained in the annual notice establishing fee revenues
and fees for fiscal year 2017. If the Secretary has carryover
balances for such process in excess of 3 months of such
operating reserves, the adjustment under this paragraph shall
not be made.
``(4) Annual fee setting.--The Secretary shall, not later
than 60 days before the start of each fiscal year that begins
after September 30, 2012, establish, for the next fiscal
year, application, product, and establishment fees under
subsection (a), based on the revenue amounts established
under subsection (b) and the adjustments provided under this
subsection.
``(5) Limit.--The total amount of fees charged, as adjusted
under this subsection, for a fiscal year may not exceed the
total costs for such fiscal year for the resources allocated
for the process for the review of human drug applications.'';
and
(4) in subsection (g)--
(A) in paragraph (1), by striking ``Fees authorized'' and
inserting ``Subject to paragraph (2)(C), fees authorized'';
(B) in paragraph (2)--
(i) in subparagraph (A)--

(I) in clause (i), by striking ``shall be retained'' and
inserting ``subject to subparagraph (C), shall be collected
and available''; and
(II) in clause (ii), by striking ``shall only be collected
and available'' and inserting ``shall be available''; and

(ii) by adding at the end the following new subparagraph:
``(C) Provision for early payments.--Payment of fees
authorized under this section for a fiscal year, prior to the
due date for such fees, may be accepted by the Secretary in
accordance with authority provided in advance in a prior year
appropriations Act.'';
(C) in paragraph (3), by striking ``fiscal years 2008
through 2012'' and inserting ``fiscal years 2013 through
2017''; and
(D) in paragraph (4)--
(i) by striking ``fiscal years 2008 through 2010'' and
inserting ``fiscal years 2013 through 2015'';
(ii) by striking ``fiscal year 2011'' and inserting
``fiscal year 2016'';
(iii) by striking ``fiscal years 2008 though 2011'' and
inserting ``fiscal years 2013 through 2016''; and
(iv) by striking ``fiscal year 2012'' and inserting
``fiscal year 2017''.

SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.

Section 736B (21 U.S.C. 379h 2) is amended--
(1) by amending subsection (a) to read as follows:
``(a) Performance Report.--Beginning with fiscal year 2013,
not later than 120 days after the end of each fiscal year for
which fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report
concerning the progress of the Food and Drug Administration
in achieving the goals identified in the letters described in
section 101(b) of the Prescription Drug User Fee Amendments
of 2012 during such fiscal year and the future plans of the
Food and Drug Administration for meeting the goals. The
report under this subsection for a fiscal year shall include
information on all previous cohorts for which the Secretary
has not given a complete response on all human drug
applications and supplements in the cohort.'';
(2) in subsection (b), by striking ``2008'' and inserting
``2013''; and
(3) in subsection (d), by striking ``2012'' each place it
appears and inserting ``2017''.

SEC. 105. SUNSET DATES.

(a) Authorization.--Sections 735 and 736 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall
cease to be effective October 1, 2017.
(b) Reporting Requirements.--Section 736B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379h 2) shall cease
to be effective January 31, 2018.
(c) Previous Sunset Provision.--Section 106 of the
Prescription Drug User Fee Amendments of 2007 (Title I of
Public Law 110 85) is repealed.
(d) Technical Clarifications.--
(1) Effective September 30, 2007, section 509 of the
Prescription Drug User Fee Amendments Act of 2002 (Title V of
Public Law 107 188) is repealed.
(2) Effective September 30, 2002, section 107 of the Food
and Drug Administration Modernization Act of 1997 (Public Law
105 115) is repealed.
(3) Effective September 30, 1997, section 105 of the
Prescription Drug User Fee Act of 1992 (Public Law 102 571)
is repealed.

SEC. 106. EFFECTIVE DATE.

The amendments made by this title shall take effect on
October 1, 2012, or the date of the enactment of this Act,
whichever is later, except that fees under part 2 of
subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act shall be assessed for all human drug
applications received on or after October 1, 2012, regardless
of the date of the enactment of this Act.

SEC. 107. SAVINGS CLAUSE.

Notwithstanding the amendments made by this title, part 2
of subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act, as in effect on the day before the date of the
enactment of this title, shall continue to be in effect with
respect to human drug applications and supplements (as
defined in such part as of such day) that on or after October
1, 2007, but before October 1, 2012, were accepted by the
Food and Drug Administration for filing with respect to
assessing and collecting any fee required by such part for a
fiscal year prior to fiscal year 2012.

TITLE II--FEES RELATING TO DEVICES

SEC. 201. SHORT TITLE; FINDINGS.

(a) Short Title.--This title may be cited as the ``Medical
Device User Fee Amendments of 2012''.
(b) Findings.--The Congress finds that the fees authorized
under the amendments made by this title will be dedicated
toward expediting the process for the review of device
applications and for assuring the safety and effectiveness of
devices, as set forth in the goals identified for purposes of
part 3 of subchapter C of chapter VII of the Federal Food,
Drug, and Cosmetic Act in the letters from the Secretary of
Health and Human Services to the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Chairman of the Committee on Energy and Commerce of the House
of Representatives, as set forth in the Congressional Record.

SEC. 202. DEFINITIONS.

Section 737 (21 U.S.C. 379i) is amended--
(1) in paragraph (9), by striking ``incurred'' after
``expenses'';
(2) in paragraph (10), by striking ``October 2001'' and
inserting ``October 2011''; and
(3) in paragraph (13), by striking ``is required to
register'' and all that follows through the end of paragraph
(13) and inserting the following: ``is registered (or is
required to register) with the Secretary under section 510
because such establishment is engaged in the manufacture,
preparation, propagation, compounding, or processing of a
device.''.

SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.

(a) Types of Fees.--Section 738(a) (21 U.S.C. 379j(a)) is
amended--
(1) in paragraph (1), by striking ``fiscal year 2008'' and
inserting ``fiscal year 2013'';
(2) in paragraph (2)(A)--
(A) in the matter preceding clause (i)--
(i) by striking ``subsections (d) and (e)'' and inserting
``subsections (d), (e), and (f)'';
(ii) by striking ``October 1, 2002'' and inserting
``October 1, 2012''; and
(iii) by striking ``subsection (c)(1)'' and inserting
``subsection (c)''; and
(B) in clause (viii), by striking ``1.84'' and inserting
``2''; and
(3) in paragraph (3)--
(A) in subparagraph (A)--
(i) by inserting ``and subsection (f)'' after
``subparagraph (B)''; and
(ii) by striking ``2008'' and inserting ``2013''; and
(B) in subparagraph (C), by striking ``initial
registration'' and all that follows through ``section 510.''
and inserting ``later of--
``(i) the initial or annual registration (as applicable) of
the establishment under section 510; or
``(ii) the first business day after the date of enactment
of an appropriations Act providing for the collection and
obligation of fees for such year under this section.''.
(b) Fee Amounts.--Section 738(b) (21 U.S.C. 379j(b)) is
amended to read as follows:
``(b) Fee Amounts.--
``(1) In general.--Subject to subsections (c), (d), (e),
(f), and (i), for each of fiscal years 2013 through 2017,
fees under subsection (a) shall be derived from the base fee
amounts specified in paragraph (2), to generate the total
revenue amounts specified in paragraph (3).

[[Page S3571]]

``(2) Base fee amounts.--For purposes of paragraph (1), the
base fee amounts specified in this paragraph are as follows:

----------------------------------------------------------------------------------------------------------------
Fiscal Year Fiscal Year Fiscal Year Fiscal Year Fiscal Year
``Fee Type 2013 2014 2015 2016 2017
----------------------------------------------------------------------------------------------------------------
Premarket Application.......................... $248,000 $252,960 $258,019 $263,180 $268,443
Establishment Registration..................... $2,575 $3,200 $3,750 $3,872 $3,872
----------------------------------------------------------------------------------------------------------------

``(3) Total revenue amounts.--For purposes of paragraph
(1), the total revenue amounts specified in this paragraph
are as follows:
``(A) $97,722,301 for fiscal year 2013.
``(B) $112,580,497 for fiscal year 2014.
``(C) $125,767,107 for fiscal year 2015.
``(D) $129,339,949 for fiscal year 2016.
``(E) $130,184,348 for fiscal year 2017.''.
(c) Annual Fee Setting; Adjustments.--Section 738(c) (21
U.S.C. 379j(c)) is amended--
(1) in the subsection heading, by inserting ``;
Adjustments'' after ``setting'';
(2) by striking paragraphs (1) and (2);
(3) by redesignating paragraphs (3) and (4) as paragraphs
(4) and (5), respectively; and
(4) by inserting before paragraph (4), as so redesignated,
the following:
``(1) In general.--The Secretary shall, 60 days before the
start of each fiscal year after September 30, 2012, establish
fees under subsection (a), based on amounts specified under
subsection (b) and the adjustments provided under this
subsection, and publish such fees, and the rationale for any
adjustments to such fees, in the Federal Register.
``(2) Inflation adjustments.--
``(A) Adjustment to total revenue amounts.--For fiscal year
2014 and each subsequent fiscal year, the Secretary shall
adjust the total revenue amount specified in subsection
(b)(3) for such fiscal year by multiplying such amount by the
applicable inflation adjustment under subparagraph (B) for
such year.
``(B) Applicable inflation adjustment to total revenue
amounts.--The applicable inflation adjustment for a fiscal
year is--
``(i) for fiscal year 2014, the base inflation adjustment
under subparagraph (C) for such fiscal year; and
``(ii) for fiscal year 2015 and each subsequent fiscal
year, the product of--

``(I) the base inflation adjustment under subparagraph (C)
for such fiscal year; and
``(II) the product of the base inflation adjustment under
subparagraph (C) for each of the fiscal years preceding such
fiscal year, beginning with fiscal year 2014.

``(C) Base inflation adjustment to total revenue amounts.--
``(i) In general.--Subject to further adjustment under
clause (ii), the base inflation adjustment for a fiscal year
is the sum of one plus--

``(I) the average annual percent change in the cost, per
full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and benefits
paid with respect to such positions for the first 3 years of
the preceding 4 fiscal years, multiplied by 0.60; and
``(II) the average annual percent change that occurred in
the Consumer Price Index for urban consumers (Washington-
Baltimore, DC MD VA WV; Not Seasonally Adjusted; All items;
Annual Index) for the first 3 years of the preceding 4 years
of available data multiplied by 0.40.

``(ii) Limitations.--For purposes of subparagraph (B), if
the base inflation adjustment for a fiscal year under clause
(i)--

``(I) is less than 1, such adjustment shall be considered
to be equal to 1; or
``(II) is greater than 1.04, such adjustment shall be
considered to be equal to 1.04.

``(D) Adjustment to base fee amounts.--For each of fiscal
years 2014 through 2017, the base fee amounts specified in
subsection (b)(2) shall be adjusted as needed, on a uniform
proportionate basis, to generate the total revenue amounts
under subsection (b)(3), as adjusted for inflation under
subparagraph (A).
``(3) Volume-based adjustments to establishment
registration base fees.--For each of fiscal years 2014
through 2017, after the base fee amounts specified in
subsection (b)(2) are adjusted under paragraph (2)(D), the
base establishment registration fee amounts specified in such
subsection shall be further adjusted, as the Secretary
estimates is necessary in order for total fee collections for
such fiscal year to generate the total revenue amounts, as
adjusted under paragraph (2).''.
(d) Fee Waiver or Reduction.--Section 738 (21 U.S.C. 379j)
is amended by--
(1) redesignating subsections (f) through (k) as
subsections (g) through (l), respectively; and
(2) by inserting after subsection (e) the following new
subsection:
``(f) Fee Waiver or Reduction.--
``(1) In general.--The Secretary may, at the Secretary's
sole discretion, grant a waiver or reduction of fees under
subsection (a)(2) or (a)(3) if the Secretary finds that such
waiver or reduction is in the interest of public health.
``(2) Limitation.--The sum of all fee waivers or reductions
granted by the Secretary in any fiscal year under paragraph
(1) shall not exceed 2 percent of the total fee revenue
amounts established for such year under subsection (c).
``(3) Duration.--The authority provided by this subsection
terminates October 1, 2017.''.
(e) Conditions.--Section 738(h)(1)(A) (21 U.S.C.
379j(h)(1)(A)), as redesignated by subsection (d)(1), is
amended by striking ``$205,720,000'' and inserting
``$280,587,000''.
(f) Crediting and Availability of Fees.--Section 738(i) (21
U.S.C. 379j(i)), as redesignated by subsection (d)(1), is
amended--
(1) in paragraph (1), by striking ``Fees authorized'' and
inserting ``Subject to paragraph (2)(C), fees authorized'';
(2) in paragraph (2)--
(A) in subparagraph (A)--
(i) in clause (i), by striking ``shall be retained'' and
inserting ``subject to subparagraph (C), shall be collected
and available''; and
(ii) in clause (ii)--

(I) by striking ``collected and'' after ``shall only be'';
and
(II) by striking ``fiscal year 2002'' and inserting
``fiscal year 2009''; and

(B) by adding at the end, the following:
``(C) Provision for early payments.--Payment of fees
authorized under this section for a fiscal year, prior to the
due date for such fees, may be accepted by the Secretary in
accordance with authority provided in advance in a prior year
appropriations Act.'';
(3) by amending paragraph (3) to read as follows:
``(3) Authorizations of appropriations.--For each of the
fiscal years 2013 through 2017, there is authorized to be
appropriated for fees under this section an amount equal to
the total revenue amount specified under subsection (b)(3)
for the fiscal year, as adjusted under subsection (c) and,
for fiscal year 2017 only, as further adjusted under
paragraph (4).''; and
(4) in paragraph (4)--
(A) by striking ``fiscal years 2008, 2009, and 2010'' and
inserting ``fiscal years 2013, 2014, and 2015'';
(B) by striking ``fiscal year 2011'' and inserting ``fiscal
year 2016'';
(C) by striking ``June 30, 2011'' and inserting ``June 30,
2016'';
(D) by striking ``the amount of fees specified in aggregate
in'' and inserting ``the cumulative amount appropriated
pursuant to'';
(E) by striking ``aggregate amount in'' before ``excess
shall be credited''; and
(F) by striking ``fiscal year 2012'' and inserting ``fiscal
year 2017''.
(g) Conforming Amendment.--Section 515(c)(4)(A) (21 U.S.C.
360e(c)(4)(A)) is amended by striking ``738(g)'' and
inserting ``738(h)''.

SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.

(a) Reauthorization.--Section 738A(b) (21 U.S.C. 379j 1(b))
is amended--
(1) in paragraph (1), by striking ``2012'' and inserting
``2017''; and
(2) in paragraph (5), by striking ``2012'' and inserting
``2017''.
(b) Reports.--Section 738A(a) (21 U.S.C. 379j 1(a)) is
amended--
(1) by striking ``2008 through 2012'' each place it appears
and inserting ``2013 through 2017''; and
(2) by striking ``section 201(c) of the Food and Drug
Administration Amendments Act of 2007'' and inserting
``section 201(b) of the Medical Device User Fee Amendments of
2012''.

SEC. 205. SAVINGS CLAUSE.

Notwithstanding the amendments made by this title, part 3
of subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the
day before the date of the enactment of this title, shall
continue to be in effect with respect to submissions
described in section 738(a)(2)(A) of the Federal Food, Drug,
and Cosmetic Act (as in effect as of such day) that on or
after October 1, 2007, but before October 1, 2012, were
accepted by the Food and Drug Administration for filing with
respect to assessing and collecting any fee required by such
part for a fiscal year prior to fiscal year 2013.

SEC. 206. EFFECTIVE DATE.

The amendments made by this title shall take effect on
October 1, 2012, or the date of the enactment of this Act,
whichever is later, except that fees under part 3 of
subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act shall be assessed for submissions described in
section 738(a)(2)(A) of the Federal Food, Drug, and Cosmetic
Act received on or after October 1, 2012, regardless of the
date of the enactment of this Act.

SEC. 207. SUNSET DATES.

(a) Authorizations.--Sections 737 and 738 (21 U.S.C. 739i;
739j) shall cease to be effective October 1, 2017.
(b) Reporting Requirements.--Section 738A (21 U.S.C. 739j
1) shall cease to be effective January 31, 2018.

[[Page S3572]]

(c) Previous Sunset Provision.--Section 217 of the Medical
Device User Fee Amendments of 2007 (Title II of Public Law
110 85) is repealed.
(d) Technical Clarification.--Effective September 30, 2007,
section 107 of the Medical Device User Fee and Modernization
Act of 2002 (Public Law 107 250) is repealed.

SEC. 208. STREAMLINED HIRING AUTHORITY TO SUPPORT ACTIVITIES
RELATED TO THE PROCESS FOR THE REVIEW OF DEVICE
APPLICATIONS.

Subchapter A of chapter VII (21 U.S.C. 371 et seq.) is
amended by inserting after section 713 the following new
section:

``SEC. 714. STREAMLINED HIRING AUTHORITY.

``(a) In General.--In addition to any other personnel
authorities under other provisions of law, the Secretary may,
without regard to the provisions of title 5, United States
Code, governing appointments in the competitive service,
appoint employees to positions in the Food and Drug
Administration to perform, administer, or support activities
described in subsection (b), if the Secretary determines that
such appointments are needed to achieve the objectives
specified in subsection (c).
``(b) Activities Described.--The activities described in
this subsection are activities under this Act related to the
process for the review of device applications (as defined in
section 737(8)).
``(c) Objectives Specified.--The objectives specified in
this subsection are with respect to the activities under
subsection (b), the goals referred to in section 738A(a)(1).
``(d) Internal Controls.--The Secretary shall institute
appropriate internal controls for appointments under this
section.
``(e) Sunset.--The authority to appoint employees under
this section shall terminate on the date that is three years
after the date of enactment of this section.''.

TITLE III--FEES RELATING TO GENERIC DRUGS

SEC. 301. SHORT TITLE.

(a) Short Title.--This title may be cited as the ``Generic
Drug User Fee Amendments of 2012''.
(b) Finding.--The Congress finds that the fees authorized
by the amendments made in this title will be dedicated to
human generic drug activities, as set forth in the goals
identified for purposes of part 7 of subchapter C of chapter
VII of the Federal Food, Drug, and Cosmetic Act, in the
letters from the Secretary of Health and Human Services to
the Chairman of the Committee on Health, Education, Labor,
and Pensions of the Senate and the Chairman of the Committee
on Energy and Commerce of the House of Representatives, as
set forth in the Congressional Record.

SEC. 302. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG
FEES.

Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is
amended by adding at the end the following:

``PART 7--FEES RELATING TO GENERIC DRUGS

``SEC. 744A. DEFINITIONS.

``For purposes of this part:
``(1) The term `abbreviated new drug application'--
``(A) means an application submitted under section 505(j),
an abbreviated application submitted under section 507 (as in
effect on the day before the date of enactment of the Food
and Drug Administration Modernization Act of 1997), or an
abbreviated new drug application submitted pursuant to
regulations in effect prior to the implementation of the Drug
Price Competition and Patent Term Restoration Act of 1984;
and
``(B) does not include an application for a positron
emission tomography drug.
``(2) The term `active pharmaceutical ingredient' means--
``(A) a substance, or a mixture when the substance is
unstable or cannot be transported on its own, intended--
``(i) to be used as a component of a drug; and
``(ii) to furnish pharmacological activity or other direct
effect in the diagnosis, cure, mitigation, treatment, or
prevention of disease, or to affect the structure or any
function of the human body; or
``(B) a substance intended for final crystallization,
purification, or salt formation, or any combination of those
activities, to become a substance or mixture described in
subparagraph (A).
``(3) The term `adjustment factor' means a factor
applicable to a fiscal year that is the Consumer Price Index
for all urban consumers (all items; United States city
average) for October of the preceding fiscal year divided by
such Index for October 2011.
``(4) The term `affiliate' means a business entity that has
a relationship with a second business entity if, directly or
indirectly--
``(A) one business entity controls, or has the power to
control, the other business entity; or
``(B) a third party controls, or has power to control, both
of the business entities.
``(5)(A) The term `facility'--
``(i) means a business or other entity--
``(I) under one management, either direct or indirect; and
``(II) at one geographic location or address engaged in
manufacturing or processing an active pharmaceutical
ingredient or a finished dosage form; and
``(ii) does not include a business or other entity whose
only manufacturing or processing activities are one or more
of the following: repackaging, relabeling, or testing.
``(B) For purposes of subparagraph (A), separate buildings
within close proximity are considered to be at one geographic
location or address if the activities in them are--
``(i) closely related to the same business enterprise;
``(ii) under the supervision of the same local management;
and
``(iii) capable of being inspected by the Food and Drug
Administration during a single inspection.
``(C) If a business or other entity would meet the
definition of a facility under this paragraph but for being
under multiple management, the business or other entity is
deemed to constitute multiple facilities, one per management
entity, for purposes of this paragraph.
``(6) The term `finished dosage form' means--
``(A) a drug product in the form in which it will be
administered to a patient, such as a tablet, capsule,
solution, or topical application;
``(B) a drug product in a form in which reconstitution is
necessary prior to administration to a patient, such as oral
suspensions or lyophilized powders; or
``(C) any combination of an active pharmaceutical
ingredient with another component of a drug product for
purposes of production of a drug product described in
subparagraph (A) or (B).
``(7) The term `generic drug submission' means an
abbreviated new drug application, an amendment to an
abbreviated new drug application, or a prior approval
supplement to an abbreviated new drug application.
``(8) The term `human generic drug activities' means the
following activities of the Secretary associated with generic
drugs and inspection of facilities associated with generic
drugs:
``(A) The activities necessary for the review of generic
drug submissions, including review of drug master files
referenced in such submissions.
``(B) The issuance of--
``(i) approval letters which approve abbreviated new drug
applications or supplements to such applications; or
``(ii) complete response letters which set forth in detail
the specific deficiencies in such applications and, where
appropriate, the actions necessary to place such applications
in condition for approval.
``(C) The issuance of letters related to Type II active
pharmaceutical drug master files which--
``(i) set forth in detail the specific deficiencies in such
submissions, and where appropriate, the actions necessary to
resolve those deficiencies; or
``(ii) document that no deficiencies need to be addressed.
``(D) Inspections related to generic drugs.
``(E) Monitoring of research conducted in connection with
the review of generic drug submissions and drug master files.
``(F) Postmarket safety activities with respect to drugs
approved under abbreviated new drug applications or
supplements, including the following activities:
``(i) Collecting, developing, and reviewing safety
information on approved drugs, including adverse event
reports.
``(ii) Developing and using improved adverse-event data-
collection systems, including information technology systems.
``(iii) Developing and using improved analytical tools to
assess potential safety problems, including access to
external data bases.
``(iv) Implementing and enforcing section 505(o) (relating
to postapproval studies and clinical trials and labeling
changes) and section 505(p) (relating to risk evaluation and
mitigation strategies) insofar as those activities relate to
abbreviated new drug applications.
``(v) Carrying out section 505(k)(5) (relating to adverse-
event reports and postmarket safety activities).
``(G) Regulatory science activities related to generic
drugs.
``(9) The term `positron emission tomography drug' has the
meaning given to the term `compounded positron emission
tomography drug' in section 201(ii), except that paragraph
(1)(B) of such section shall not apply.
``(10) The term `prior approval supplement' means a request
to the Secretary to approve a change in the drug substance,
drug product, production process, quality controls,
equipment, or facilities covered by an approved abbreviated
new drug application when that change has a substantial
potential to have an adverse effect on the identity,
strength, quality, purity, or potency of the drug product as
these factors may relate to the safety or effectiveness of
the drug product.
``(11) The term `resources allocated for human generic drug
activities' means the expenses for--
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees, and costs related to
such officers and employees and to contracts with such
contractors;
``(B) management of information, and the acquisition,
maintenance, and repair of computer resources;
``(C) leasing, maintenance, renovation, and repair of
facilities and acquisition, maintenance, and repair of
fixtures, furniture, scientific equipment, and other
necessary materials and supplies; and
``(D) collecting fees under subsection (a) and accounting
for resources allocated for

[[Page S3573]]

the review of abbreviated new drug applications and
supplements and inspection related to generic drugs.
``(12) The term `Type II active pharmaceutical ingredient
drug master file' means a submission of information to the
Secretary by a person that intends to authorize the Food and
Drug Administration to reference the information to support
approval of a generic drug submission without the submitter
having to disclose the information to the generic drug
submission applicant.

``SEC. 744B. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG
FEES.

``(a) Types of Fees.--Beginning in fiscal year 2013, the
Secretary shall assess and collect fees in accordance with
this section as follows:
``(1) One-time backlog fee for abbreviated new drug
applications pending on october 1, 2012.--
``(A) In general.--Each person that owns an abbreviated new
drug application that is pending on October 1, 2012, and that
has not received a tentative approval prior to that date,
shall be subject to a fee for each such application, as
calculated under subparagraph (B).
``(B) Method of fee amount calculation.--The amount of each
one-time backlog fee shall be calculated by dividing
$50,000,000 by the total number of abbreviated new drug
applications pending on October 1, 2012, that have not
received a tentative approval as of that date.
``(C) Notice.--Not later than October 31, 2012, the
Secretary shall publish in the Federal Register a notice
announcing the amount of the fee required by subparagraph
(A).
``(D) Fee due date.--The fee required by subparagraph (A)
shall be due no later than 30 calendar days after the date of
the publication of the notice specified in subparagraph (C).
``(2) Drug master file fee.--
``(A) In general.--Each person that owns a Type II active
pharmaceutical ingredient drug master file that is referenced
on or after October 1, 2012, in a generic drug submission by
any initial letter of authorization shall be subject to a
drug master file fee.
``(B) One-time payment.--If a person has paid a drug master
file fee for a Type II active pharmaceutical ingredient drug
master file, the person shall not be required to pay a
subsequent drug master file fee when that Type II active
pharmaceutical ingredient drug master file is subsequently
referenced in generic drug submissions.
``(C) Notice.--
``(i) Fiscal year 2013.--Not later than October 31, 2012,
the Secretary shall publish in the Federal Register a notice
announcing the amount of the drug master file fee for fiscal
year 2013.
``(ii) Fiscal year 2014 through 2017.--Not later than 60
days before the start of each of fiscal years 2014 through
2017, the Secretary shall publish in the Federal Register the
amount of the drug master file fee established by this
paragraph for such fiscal year.
``(D) Availability for reference.--
``(i) In general.--Subject to subsection (g)(2)(C), for a
generic drug submission to reference a Type II active
pharmaceutical ingredient drug master file, the drug master
file must be deemed available for reference by the Secretary.
``(ii) Conditions.--A drug master file shall be deemed
available for reference by the Secretary if--

``(I) the person that owns a Type II active pharmaceutical
ingredient drug master file has paid the fee required under
subparagraph (A) within 20 calendar days after the applicable
due date under subparagraph (E); and
``(II) the drug master file has not failed an initial
completeness assessment by the Secretary, in accordance with
criteria to be published by the Secretary.

``(iii) List.--The Secretary shall make publicly available
on the Internet Web site of the Food and Drug Administration
a list of the drug master file numbers that correspond to
drug master files that have successfully undergone an initial
completeness assessment, in accordance with criteria to be
published by the Secretary, and are available for reference.
``(E) Fee due date.--
``(i) In general.--Subject to clause (ii), a drug master
file fee shall be due no later than the date on which the
first generic drug submission is submitted that references
the associated Type II active pharmaceutical ingredient drug
master file.
``(ii) Limitation.--No fee shall be due under subparagraph
(A) for a fiscal year until the later of--

``(I) 30 calendar days after publication of the notice
provided for in clause (i) or (ii) of subparagraph (C), as
applicable; or
``(II) 30 calendar days after the date of enactment of an
appropriations Act providing for the collection and
obligation of fees under this section.

``(3) Abbreviated new drug application and prior approval
supplement filing fee.--
``(A) In general.--Each applicant that submits, on or after
October 1, 2012, an abbreviated new drug application or a
prior approval supplement to an abbreviated new drug
application shall be subject to a fee for each such
submission in the amount established under subsection (d).
``(B) Notice.--
``(i) Fiscal year 2013.--Not later than October 31, 2012,
the Secretary shall publish in the Federal Register a notice
announcing the amount of the fees under subparagraph (A) for
fiscal year 2013.
``(ii) Fiscal years 2014 through 2017.--Not later than 60
days before the start of each of fiscal years 2014 through
2017, the Secretary shall publish in the Federal Register the
amount of the fees under subparagraph (A) for such fiscal
year.
``(C) Fee due date.--
``(i) In general.--Except as provided in clause (ii), the
fees required by subparagraphs (A) and (F) shall be due no
later than the date of submission of the abbreviated new drug
application or prior approval supplement for which such fee
applies.
``(ii) Special rule for 2013.--For fiscal year 2013, such
fees shall be due on the later of--

``(I) the date on which the fee is due under clause (i);
``(II) 30 calendar days after publication of the notice
referred to in subparagraph (B)(i); or
``(III) if an appropriations Act is not enacted providing
for the collection and obligation of fees under this section
by the date of submission of the application or prior
approval supplement for which the fees under subparagraphs
(A) and (F) apply, 30 calendar days after the date that such
an appropriations Act is enacted.

``(D) Refund of fee if abbreviated new drug application is
not considered to have been received.--The Secretary shall
refund 75 percent of the fee paid under subparagraph (A) for
any abbreviated new drug application or prior approval
supplement to an abbreviated new drug application that the
Secretary considers not to have been received within the
meaning of section 505(j)(5)(A) for a cause other than
failure to pay fees.
``(E) Fee for an application the secretary considers not to
have been received, or that has been withdrawn.--An
abbreviated new drug application or prior approval supplement
that was submitted on or after October 1, 2012, and that the
Secretary considers not to have been received, or that has
been withdrawn, shall, upon resubmission of the application
or a subsequent new submission following the applicant's
withdrawal of the application, be subject to a full fee under
subparagraph (A).
``(F) Additional fee for active pharmaceutical ingredient
information not included by reference to type ii active
pharmaceutical ingredient drug master file.--An applicant
that submits a generic drug submission on or after October 1,
2012, shall pay a fee, in the amount determined under
subsection (d)(3), in addition to the fee required under
subparagraph (A), if--
``(i) such submission contains information concerning the
manufacture of an active pharmaceutical ingredient at a
facility by means other than reference by a letter of
authorization to a Type II active pharmaceutical drug master
file; and
``(ii) a fee in the amount equal to the drug master file
fee established in paragraph (2) has not been previously paid
with respect to such information.
``(4) Generic drug facility fee and active pharmaceutical
ingredient facility fee.--
``(A) In general.--Facilities identified, or intended to be
identified, in at least one generic drug submission that is
pending or approved to produce a finished dosage form of a
human generic drug or an active pharmaceutical ingredient
contained in a human generic drug shall be subject to fees as
follows:
``(i) Generic drug facility.--Each person that owns a
facility which is identified or intended to be identified in
at least one generic drug submission that is pending or
approved to produce one or more finished dosage forms of a
human generic drug shall be assessed an annual fee for each
such facility.
``(ii) Active pharmaceutical ingredient facility.--Each
person that owns a facility which produces, or which is
pending review to produce, one or more active pharmaceutical
ingredients identified, or intended to be identified, in at
least one generic drug submission that is pending or approved
or in a Type II active pharmaceutical ingredient drug master
file referenced in such a generic drug submission, shall be
assessed an annual fee for each such facility.
``(iii) Facilities producing both active pharmaceutical
ingredients and finished dosage forms.--Each person that owns
a facility identified, or intended to be identified, in at
least one generic drug submission that is pending or approved
to produce both one or more finished dosage forms subject to
clause (i) and one or more active pharmaceutical ingredients
subject to clause (ii) shall be subject to fees under both
such clauses for that facility.
``(B) Amount.--The amount of fees established under
subparagraph (A) shall be established under subsection (d).
``(C) Notice.--
``(i) Fiscal year 2013.--For fiscal year 2013, the
Secretary shall publish in the Federal Register a notice
announcing the amount of the fees provided for in
subparagraph (A) within the timeframe specified in subsection
(d)(1)(B).
``(ii) Fiscal years 2014 through 2017.--Within the
timeframe specified in subsection (d)(2), the Secretary shall
publish in the Federal Register the amount of the fees under
subparagraph (A) for such fiscal year.
``(D) Fee due date.--
``(i) Fiscal year 2013.--For fiscal year 2013, the fees
under subparagraph (A) shall be due on the later of--

``(I) not later than 45 days after the publication of the
notice under subparagraph (B); or

[[Page S3574]]

``(II) if an appropriations Act is not enacted providing
for the collection and obligation of fees under this section
by the date of the publication of such notice, 30 days after
the date that such an appropriations Act is enacted.

``(ii) Fiscal years 2014 through 2017.--For each of fiscal
years 2014 through 2017, the fees under subparagraph (A) for
such fiscal year shall be due on the later of--

``(I) the first business day on or after October 1 of each
such year; or
``(II) the first business day after the enactment of an
appropriations Act providing for the collection and
obligation of fees under this section for such year.

``(5) Date of submission.--For purposes of this Act, a
generic drug submission or Type II pharmaceutical master file
is deemed to be `submitted' to the Food and Drug
Administration--
``(A) if it is submitted via a Food and Drug Administration
electronic gateway, on the day when transmission to that
electronic gateway is completed, except that a submission or
master file that arrives on a weekend, Federal holiday, or
day when the Food and Drug Administration office that will
review that submission is not otherwise open for business
shall be deemed to be submitted on the next day when that
office is open for business; or
``(B) if it is submitted in physical media form, on the day
it arrives at the appropriate designated document room of the
Food and Drug Administration.
``(b) Fee Revenue Amounts.--
``(1) In general.--
``(A) Fiscal year 2013.--For fiscal year 2013, fees under
subsection (a) shall be established to generate a total
estimated revenue amount under such subsection of
$299,000,000. Of that amount--
``(i) $50,000,000 shall be generated by the one-time
backlog fee for generic drug applications pending on October
1, 2012, established in subsection (a)(1); and
``(ii) $249,000,000 shall be generated by the fees under
paragraphs (2) through (4) of subsection (a).
``(B) Fiscal years 2014 through 2017.--For each of the
fiscal years 2014 through 2017, fees under paragraphs (2)
through (4) of subsection (a) shall be established to
generate a total estimated revenue amount under such
subsection that is equal to $299,000,000, as adjusted
pursuant to subsection (c).
``(2) Types of fees.--In establishing fees under paragraph
(1) to generate the revenue amounts specified in paragraph
(1)(A)(ii) for fiscal year 2013 and paragraph (1)(B) for each
of fiscal years 2014 through 2017, such fees shall be derived
from the fees under paragraphs (2) through (4) of subsection
(a) as follows:
``(A) 6 percent shall be derived from fees under subsection
(a)(2) (relating to drug master files).
``(B) 24 percent shall be derived from fees under
subsection (a)(3) (relating to abbreviated new drug
applications and supplements). The amount of a fee for a
prior approval supplement shall be half the amount of the fee
for an abbreviated new drug application.
``(C) 56 percent shall be derived from fees under
subsection (a)(4)(A)(i) (relating to generic drug
facilities). The amount of the fee for a facility located
outside the United States and its territories and possessions
shall be not less than $15,000 and not more than $30,000
higher than the amount of the fee for a facility located in
the United States and its territories and possessions, as
determined by the Secretary on the basis of data concerning
the difference in cost between inspections of facilities
located in the United States, including its territories and
possessions, and those located outside of the United States
and its territories and possessions.
``(D) 14 percent shall be derived from fees under
subsection (a)(4)(A)(ii) (relating to active pharmaceutical
ingredient facilities). The amount of the fee for a facility
located outside the United States and its territories and
possessions shall be not less than $15,000 and not more than
$30,000 higher than the amount of the fee for a facility
located in the United States, including its territories and
possessions, as determined by the Secretary on the basis of
data concerning the difference in cost between inspections of
facilities located in the United States and its territories
and possessions and those located outside of the United
States and its territories and possessions.
``(c) Adjustments.--
``(1) Inflation adjustment.--For fiscal year 2014 and
subsequent fiscal years, the revenues established in
subsection (b) shall be adjusted by the Secretary by notice,
published in the Federal Register, for a fiscal year, by an
amount equal to the sum of--
``(A) one;
``(B) the average annual percent change in the cost, per
full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and benefits
paid with respect to such positions for the first 3 years of
the preceding 4 fiscal years multiplied by the proportion of
personnel compensation and benefits costs to total costs of
human generic drug activities for the first 3 years of the
preceding 4 fiscal years; and
``(C) the average annual percent change that occurred in
the Consumer Price Index for urban consumers (Washington-
Baltimore, DC MD VA WV; Not Seasonally Adjusted; All items;
Annual Index) for the first 3 years of the preceding 4 years
of available data multiplied by the proportion of all costs
other than personnel compensation and benefits costs to total
costs of human generic drug activities for the first 3 years
of the preceding 4 fiscal years.

The adjustment made each fiscal year under this subsection
shall be added on a compounded basis to the sum of all
adjustments made each fiscal year after fiscal year 2013
under this subsection.
``(2) Final year adjustment.--For fiscal year 2017, the
Secretary may, in addition to adjustments under paragraph
(1), further increase the fee revenues and fees established
in subsection (b) if such an adjustment is necessary to
provide for not more than 3 months of operating reserves of
carryover user fees for human generic drug activities for the
first 3 months of fiscal year 2018. Such fees may only be
used in fiscal year 2018. If such an adjustment is necessary,
the rationale for the amount of the increase shall be
contained in the annual notice establishing fee revenues and
fees for fiscal year 2017. If the Secretary has carryover
balances for such activities in excess of 3 months of such
operating reserves, the adjustment under this subparagraph
shall not be made.
``(d) Annual Fee Setting.--
``(1) Fiscal year 2013.--For fiscal year 2013--
``(A) the Secretary shall establish, by October 31, 2012,
the one-time generic drug backlog fee for generic drug
applications pending on October 1, 2012, the drug master file
fee, the abbreviated new drug application fee, and the prior
approval supplement fee under subsection (a), based on the
revenue amounts established under subsection (b); and
``(B) the Secretary shall establish, not later than 45 days
after the date to comply with the requirement for
identification of facilities in subsection (f)(2), the
generic drug facility fee and active pharmaceutical
ingredient facility fee under subsection (a) based on the
revenue amounts established under subsection (b).
``(2) Fiscal years 2014 through 2017.--Not more than 60
days before the first day of each of fiscal years 2014
through 2017, the Secretary shall establish the drug master
file fee, the abbreviated new drug application fee, the prior
approval supplement fee, the generic drug facility fee, and
the active pharmaceutical ingredient facility fee under
subsection (a) for such fiscal year, based on the revenue
amounts established under subsection (b) and the adjustments
provided under subsection (c).
``(3) Fee for active pharmaceutical ingredient information
not included by reference to type ii active pharmaceutical
ingredient drug master file.--In establishing the fees under
paragraphs (1) and (2), the amount of the fee under
subsection (a)(3)(F) shall be determined by multiplying--
``(A) the sum of--
``(i) the total number of such active pharmaceutical
ingredients in such submission; and
``(ii) for each such ingredient that is manufactured at
more than one such facility, the total number of such
additional facilities; and
``(B) the amount equal to the drug master file fee
established in subsection (a)(2) for such submission.
``(e) Limit.--The total amount of fees charged, as adjusted
under subsection (c), for a fiscal year may not exceed the
total costs for such fiscal year for the resources allocated
for human generic drug activities.
``(f) Identification of Facilities.--
``(1) Publication of notice; deadline for compliance.--Not
later than October 1, 2012, the Secretary shall publish in
the Federal Register a notice requiring each person that owns
a facility described in subsection (a)(4)(A), or a site or
organization required to be identified by paragraph (4), to
submit to the Secretary information on the identity of each
such facility, site, or organization. The notice required by
this paragraph shall specify the type of information to be
submitted and the means and format for submission of such
information.
``(2) Required submission of facility identification.--Each
person that owns a facility described in subsection (a)(4)(A)
or a site or organization required to be identified by
paragraph (4) shall submit to the Secretary the information
required under this subsection each year. Such information
shall--
``(A) for fiscal year 2013, be submitted not later than 60
days after the publication of the notice under paragraph (1);
and
``(B) for each subsequent fiscal year, be submitted,
updated, or reconfirmed on or before June 1 of the previous
year.
``(3) Contents of notice.--At a minimum, the submission
required by paragraph (2) shall include for each such
facility--
``(A) identification of a facility identified or intended
to be identified in an approved or pending generic drug
submission;
``(B) whether the facility manufactures active
pharmaceutical ingredients or finished dosage forms, or both;
``(C) whether or not the facility is located within the
United States and its territories and possessions;
``(D) whether the facility manufactures positron emission
tomography drugs solely, or in addition to other drugs; and
``(E) whether the facility manufactures drugs that are not
generic drugs.
``(4) Certain sites and organizations.--
``(A) In general.--Any person that owns or operates a site
or organization described in

[[Page S3575]]

subparagraph (B) shall submit to the Secretary information
concerning the ownership, name, and address of the site or
organization.
``(B) Sites and organizations.--A site or organization is
described in this subparagraph if it is identified in a
generic drug submission and is--
``(i) a site in which a bioanalytical study is conducted;
``(ii) a clinical research organization;
``(iii) a contract analytical testing site; or
``(iv) a contract repackager site.
``(C) Notice.--The Secretary may, by notice published in
the Federal Register, specify the means and format for
submission of the information under subparagraph (A) and may
specify, as necessary for purposes of this section, any
additional information to be submitted.
``(D) Inspection authority.--The Secretary's inspection
authority under section 704(a)(1) shall extend to all such
sites and organizations.
``(g) Effect of Failure To Pay Fees.--
``(1) Generic drug backlog fee.--Failure to pay the fee
under subsection (a)(1) shall result in the Secretary placing
the person that owns the abbreviated new drug application
subject to that fee on an arrears list, such that no new
abbreviated new drug applications or supplement submitted on
or after October 1, 2012, from that person, or any affiliate
of that person, will be received within the meaning of
section 505(j)(5)(A) until such outstanding fee is paid.
``(2) Drug master file fee.--
``(A) Failure to pay the fee under subsection (a)(2) within
20 calendar days after the applicable due date under
subparagraph (E) of such subsection (as described in
subsection (a)(2)(D)(ii)(I)) shall result in the Type II
active pharmaceutical ingredient drug master file not being
deemed available for reference.
``(B)(i) Any generic drug submission submitted on or after
October 1, 2012, that references, by a letter of
authorization, a Type II active pharmaceutical ingredient
drug master file that has not been deemed available for
reference shall not be received within the meaning of section
505(j)(5)(A) unless the condition specified in clause (ii) is
met.
``(ii) The condition specified in this clause is that the
fee established under subsection (a)(2) has been paid within
20 calendar days of the Secretary providing the notification
to the sponsor of the abbreviated new drug application or
supplement of the failure of the owner of the Type II active
pharmaceutical ingredient drug master file to pay the drug
master file fee as specified in subparagraph (C).
``(C)(i) If an abbreviated new drug application or
supplement to an abbreviated new drug application references
a Type II active pharmaceutical ingredient drug master file
for which a fee under subsection (a)(2)(A) has not been paid
by the applicable date under subsection (a)(2)(E), the
Secretary shall notify the sponsor of the abbreviated new
drug application or supplement of the failure of the owner of
the Type II active pharmaceutical ingredient drug master file
to pay the applicable fee.
``(ii) If such fee is not paid within 20 calendar days of
the Secretary providing the notification, the abbreviated new
drug application or supplement to an abbreviated new drug
application shall not be received within the meaning of
505(j)(5)(A).
``(3) Abbreviated new drug application fee and prior
approval supplement fee.--Failure to pay a fee under
subparagraph (A) or (F) of subsection (a)(3) within 20
calendar days of the applicable due date under subparagraph
(C) of such subsection shall result in the abbreviated new
drug application or the prior approval supplement to an
abbreviated new drug application not being received within
the meaning of section 505(j)(5)(A) until such outstanding
fee is paid.
``(4) Generic drug facility fee and active pharmaceutical
ingredient facility fee.--
``(A) In general.--Failure to pay the fee under subsection
(a)(4) within 20 calendar days of the due date as specified
in subparagraph (D) of such subsection shall result in the
following:
``(i) The Secretary shall place the facility on a publicly
available arrears list, such that no new abbreviated new drug
application or supplement submitted on or after October 1,
2012, from the person that is responsible for paying such
fee, or any affiliate of that person, will be received within
the meaning of section 505(j)(5)(A).
``(ii) Any new generic drug submission submitted on or
after October 1, 2012, that references such a facility shall
not be received, within the meaning of section 505(j)(5)(A)
if the outstanding facility fee is not paid within 20
calendar days of the Secretary providing the notification to
the sponsor of the failure of the owner of the facility to
pay the facility fee under subsection (a)(4)(C).
``(iii) All drugs or active pharmaceutical ingredients
manufactured in such a facility or containing an ingredient
manufactured in such a facility shall be deemed misbranded
under section 502(aa).
``(B) Application of penalties.--The penalties under this
paragraph shall apply until the fee established by subsection
(a)(4) is paid or the facility is removed from all generic
drug submissions that refer to the facility.
``(C) Nonreceival for nonpayment.--
``(i) Notice.--If an abbreviated new drug application or
supplement to an abbreviated new drug application submitted
on or after October 1, 2012, references a facility for which
a facility fee has not been paid by the applicable date under
subsection (a)(4)(C), the Secretary shall notify the sponsor
of the generic drug submission of the failure of the owner of
the facility to pay the facility fee.
``(ii) Nonreceival.--If the facility fee is not paid within
20 calendar days of the Secretary providing the notification
under clause (i), the abbreviated new drug application or
supplement to an abbreviated new drug application shall not
be received within the meaning of section 505(j)(5)(A).
``(h) Limitations.--
``(1) In general.--Fees under subsection (a) shall be
refunded for a fiscal year beginning after fiscal year 2012,
unless appropriations for salaries and expenses of the Food
and Drug Administration for such fiscal year (excluding the
amount of fees appropriated for such fiscal year) are equal
to or greater than the amount of appropriations for the
salaries and expenses of the Food and Drug Administration for
the fiscal year 2009 (excluding the amount of fees
appropriated for such fiscal year) multiplied by the
adjustment factor (as defined in section 744A) applicable to
the fiscal year involved.
``(2) Authority.--If the Secretary does not assess fees
under subsection (a) during any portion of a fiscal year and
if at a later date in such fiscal year the Secretary may
assess such fees, the Secretary may assess and collect such
fees, without any modification in the rate, for Type II
active pharmaceutical ingredient drug master files,
abbreviated new drug applications and prior approval
supplements, and generic drug facilities and active
pharmaceutical ingredient facilities at any time in such
fiscal year notwithstanding the provisions of subsection (a)
relating to the date fees are to be paid.
``(i) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in
appropriations Acts, subject to paragraph (2). Such fees are
authorized to remain available until expended. Such sums as
may be necessary may be transferred from the Food and Drug
Administration salaries and expenses appropriation account
without fiscal year limitation to such appropriation account
for salaries and expenses with such fiscal year limitation.
The sums transferred shall be available solely for human
generic drug activities.
``(2) Collections and appropriation acts.--
``(A) In general.--The fees authorized by this section--
``(i) subject to subparagraphs (C) and (D), shall be
collected and available in each fiscal year in an amount not
to exceed the amount specified in appropriation Acts, or
otherwise made available for obligation for such fiscal year;
and
``(ii) shall be available for a fiscal year beginning after
fiscal year 2012 to defray the costs of human generic drug
activities (including such costs for an additional number of
full-time equivalent positions in the Department of Health
and Human Services to be engaged in such activities), only if
the Secretary allocates for such purpose an amount for such
fiscal year (excluding amounts from fees collected under this
section) no less than $97,000,000 multiplied by the
adjustment factor, as defined in section 744A(3), applicable
to the fiscal year involved.
``(B) Compliance.--The Secretary shall be considered to
have met the requirements of subparagraph (A)(ii) in any
fiscal year if the costs funded by appropriations and
allocated for human generic activities are not more than 10
percent below the level specified in such subparagraph.
``(C) Fee collection during first program year.--Until the
date of enactment of an Act making appropriations through
September 30, 2013 for the salaries and expenses account of
the Food and Drug Administration, fees authorized by this
section for fiscal year 2013, may be collected and shall be
credited to such account and remain available until expended.
``(D) Provision for early payments in subsequent years.--
Payment of fees authorized under this section for a fiscal
year (after fiscal year 2013), prior to the due date for such
fees, may be accepted by the Secretary in accordance with
authority provided in advance in a prior year appropriations
Act.
``(3) Authorization of appropriations.--For each of the
fiscal years 2013 through 2017, there is authorized to be
appropriated for fees under this section an amount equivalent
to the total revenue amount determined under subsection (b)
for the fiscal year, as adjusted under subsection (c), if
applicable, or as otherwise affected under paragraph (2) of
this subsection.
``(j) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 calendar days after it is due, such
fee shall be treated as a claim of the United States
Government subject to subchapter II of chapter 37 of title
31, United States Code.
``(k) Construction.--This section may not be construed to
require that the number of full-time equivalent positions in
the Department of Health and Human Services, for officers,
employees, and advisory committees not engaged in human
generic drug activities, be reduced to offset the number of
officers, employees, and advisory committees so engaged.

[[Page S3576]]

``(l) Positron Emission Tomography Drugs.--
``(1) Exemption from fees.--Submission of an application
for a positron emission tomography drug or active
pharmaceutical ingredient for a positron emission tomography
drug shall not require the payment of any fee under this
section. Facilities that solely produce positron emission
tomography drugs shall not be required to pay a facility fee
as established in subsection (a)(4).
``(2) Identification requirement.--Facilities that produce
positron emission tomography drugs or active pharmaceutical
ingredients of such drugs are required to be identified
pursuant to subsection (f).
``(m) Disputes Concerning Fees.--To qualify for the return
of a fee claimed to have been paid in error under this
section, a person shall submit to the Secretary a written
request justifying such return within 180 calendar days after
such fee was paid.
``(n) Substantially Complete Applications.--An abbreviated
new drug application that is not considered to be received
within the meaning of section 505(j)(5)(A) because of failure
to pay an applicable fee under this provision within the time
period specified in subsection (g) shall be deemed not to
have been `substantially complete' on the date of its
submission within the meaning of section
505(j)(5)(B)(iv)(II)(cc). An abbreviated new drug application
that is not substantially complete on the date of its
submission solely because of failure to pay an applicable fee
under the preceding sentence shall be deemed substantially
complete and received within the meaning of section
505(j)(5)(A) as of the date such applicable fee is
received.''.

SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS.

Part 7 of subchapter C of chapter VII, as added by section
302 of this Act, is amended by inserting after section 744B
the following:

``SEC. 744C. REAUTHORIZATION; REPORTING REQUIREMENTS.

``(a) Performance Report.--Beginning with fiscal year 2013,
not later than 120 days after the end of each fiscal year for
which fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report
concerning the progress of the Food and Drug Administration
in achieving the goals identified in the letters described in
section 301(b) of the Generic Drug User Fee Amendments of
2012 during such fiscal year and the future plans of the Food
and Drug Administration for meeting the goals.
``(b) Fiscal Report.--Beginning with fiscal year 2013, not
later than 120 days after the end of each fiscal year for
which fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report on the
implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected for such fiscal year.
``(c) Public Availability.--The Secretary shall make the
reports required under subsections (a) and (b) available to
the public on the Internet Web site of the Food and Drug
Administration.
``(d) Reauthorization.--
``(1) Consultation.--In developing recommendations to
present to the Congress with respect to the goals, and plans
for meeting the goals, for human generic drug activities for
the first 5 fiscal years after fiscal year 2017, and for the
reauthorization of this part for such fiscal years, the
Secretary shall consult with--
``(A) the Committee on Energy and Commerce of the House of
Representatives;
``(B) the Committee on Health, Education, Labor, and
Pensions of the Senate;
``(C) scientific and academic experts;
``(D) health care professionals;
``(E) representatives of patient and consumer advocacy
groups; and
``(F) the generic drug industry.
``(2) Prior public input.--Prior to beginning negotiations
with the generic drug industry on the reauthorization of this
part, the Secretary shall--
``(A) publish a notice in the Federal Register requesting
public input on the reauthorization;
``(B) hold a public meeting at which the public may present
its views on the reauthorization, including specific
suggestions for changes to the goals referred to in
subsection (a);
``(C) provide a period of 30 days after the public meeting
to obtain written comments from the public suggesting changes
to this part; and
``(D) publish the comments on the Food and Drug
Administration's Internet Web site.
``(3) Periodic consultation.--Not less frequently than once
every month during negotiations with the generic drug
industry, the Secretary shall hold discussions with
representatives of patient and consumer advocacy groups to
continue discussions of their views on the reauthorization
and their suggestions for changes to this part as expressed
under paragraph (2).
``(4) Public review of recommendations.--After negotiations
with the generic drug industry, the Secretary shall--
``(A) present the recommendations developed under paragraph
(1) to the congressional committees specified in such
paragraph;
``(B) publish such recommendations in the Federal Register;
``(C) provide for a period of 30 days for the public to
provide written comments on such recommendations;
``(D) hold a meeting at which the public may present its
views on such recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(5) Transmittal of recommendations.--Not later than
January 15, 2017, the Secretary shall transmit to the
Congress the revised recommendations under paragraph (4), a
summary of the views and comments received under such
paragraph, and any changes made to the recommendations in
response to such views and comments.
``(6) Minutes of negotiation meetings.--
``(A) Public availability.--Before presenting the
recommendations developed under paragraphs (1) through (5) to
the Congress, the Secretary shall make publicly available, on
the Internet Web site of the Food and Drug Administration,
minutes of all negotiation meetings conducted under this
subsection between the Food and Drug Administration and the
generic drug industry.
``(B) Content.--The minutes described under subparagraph
(A) shall summarize any substantive proposal made by any
party to the negotiations as well as significant
controversies or differences of opinion during the
negotiations and their resolution.''.

SEC. 304. SUNSET DATES.

(a) Authorization.--The amendments made by section 302
cease to be effective October 1, 2017.
(b) Reporting Requirements.--The amendments made by section
303 cease to be effective January 31, 2018.

SEC. 305. EFFECTIVE DATE.

The amendments made by this title shall take effect on
October 1, 2012, or the date of the enactment of this title,
whichever is later, except that fees under section 302 shall
be assessed for all human generic drug submissions and Type
II active pharmaceutical drug master files received on or
after October 1, 2012, regardless of the date of enactment of
this title.

SEC. 306. AMENDMENT WITH RESPECT TO MISBRANDING.

Section 502 (21 U.S.C. 352) is amended by adding at the end
the following:
``(aa) If it is a drug, or an active pharmaceutical
ingredient, and it was manufactured, prepared, propagated,
compounded, or processed in a facility for which fees have
not been paid as required by section 744A(a)(4) or for which
identifying information required by section 744B(f) has not
been submitted, or it contains an active pharmaceutical
ingredient that was manufactured, prepared, propagated,
compounded, or processed in such a facility.''.

SEC. 307. STREAMLINED HIRING AUTHORITY OF THE FOOD AND DRUG
ADMINISTRATION TO SUPPORT ACTIVITIES RELATED TO
HUMAN GENERIC DRUGS.

Section 714 of the Federal Food, Drug, and Cosmetic Act, as
added by section 208, is amended--
(1) in subsection (b)--
(A) by striking ``are activities'' and inserting ``are--
``(1) activities'';
(B) by striking the period at the end and inserting ``;
and''; and
(C) by adding at the end the following:
``(2) activities under this Act related to human generic
drug activities (as defined in section 744A).''; and
(2) by amending subsection (c) to read as follows:
``(c) Objectives Specified.--The objectives specified in
this subsection are--
``(1) with respect to the activities under subsection
(b)(1), the goals referred to in section 738A(a)(1); and
``(2) with respect to the activities under subsection
(b)(2), the performance goals with respect to section 744A
(regarding assessment and use of human generic drug fees), as
set forth in the letters described in section 301(b) of the
Generic Drug User Fee Amendments of 2012.''.

TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

SEC. 401. SHORT TITLE; FINDING.

(a) Short Title.--This title may be cited as the
``Biosimilar User Fee Act of 2012''.
(b) Finding.--The Congress finds that the fees authorized
by the amendments made in this title will be dedicated to
expediting the process for the review of biosimilar
biological product applications, including postmarket safety
activities, as set forth in the goals identified for purposes
of part 8 of subchapter C of chapter VII of the Federal Food,
Drug, and Cosmetic Act, in the letters from the Secretary of
Health and Human Services to the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Chairman of the Committee on Energy and Commerce of the House
of Representatives, as set forth in the Congressional Record.

SEC. 402. FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS.

Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is
amended by inserting after part 7, as added by title III of
this Act, the following:

[[Page S3577]]

``PART 8--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

``SEC. 744G. DEFINITIONS.

``For purposes of this part:
``(1) The term `adjustment factor' applicable to a fiscal
year that is the Consumer Price Index for all urban consumers
(Washington-Baltimore, DC MD VA WV; Not Seasonally Adjusted;
All items) of the preceding fiscal year divided by such Index
for September 2011.
``(2) The term `affiliate' means a business entity that has
a relationship with a second business entity if, directly or
indirectly--
``(A) one business entity controls, or has the power to
control, the other business entity; or
``(B) a third party controls, or has power to control, both
of the business entities.
``(3) The term `biosimilar biological product' means a
product for which a biosimilar biological product application
has been approved.
``(4)(A) Subject to subparagraph (B), the term `biosimilar
biological product application' means an application for
licensure of a biological product under section 351(k) of the
Public Health Service Act.
``(B) Such term does not include--
``(i) a supplement to such an application;
``(ii) an application filed under section 351(k) of the
Public Health Service Act that cites as the reference product
a bovine blood product for topical application licensed
before September 1, 1992, or a large volume parenteral drug
product approved before such date;
``(iii) an application filed under section 351(k) of the
Public Health Service Act with respect to--
``(I) whole blood or a blood component for transfusion;
``(II) an allergenic extract product;
``(III) an in vitro diagnostic biological product; or
``(IV) a biological product for further manufacturing use
only; or
``(iv) an application for licensure under section 351(k) of
the Public Health Service Act that is submitted by a State or
Federal Government entity for a product that is not
distributed commercially.
``(5) The term `biosimilar biological product development
meeting' means any meeting, other than a biosimilar initial
advisory meeting, regarding the content of a development
program, including a proposed design for, or data from, a
study intended to support a biosimilar biological product
application.
``(6) The term `biosimilar biological product development
program' means the program under this part for expediting the
process for the review of submissions in connection with
biosimilar biological product development.
``(7)(A) The term `biosimilar biological product
establishment' means a foreign or domestic place of
business--
``(i) that is at one general physical location consisting
of one or more buildings, all of which are within five miles
of each other; and
``(ii) at which one or more biosimilar biological products
are manufactured in final dosage form.
``(B) For purposes of subparagraph (A)(ii), the term
`manufactured' does not include packaging.
``(8) The term `biosimilar initial advisory meeting'--
``(A) means a meeting, if requested, that is limited to--
``(i) a general discussion regarding whether licensure
under section 351(k) of the Public Health Service Act may be
feasible for a particular product; and
``(ii) if so, general advice on the expected content of the
development program; and
``(B) does not include any meeting that involves
substantive review of summary data or full study reports.
``(9) The term `costs of resources allocated for the
process for the review of biosimilar biological product
applications' means the expenses in connection with the
process for the review of biosimilar biological product
applications for--
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees, and costs related to
such officers employees and committees and to contracts with
such contractors;
``(B) management of information, and the acquisition,
maintenance, and repair of computer resources;
``(C) leasing, maintenance, renovation, and repair of
facilities and acquisition, maintenance, and repair of
fixtures, furniture, scientific equipment, and other
necessary materials and supplies; and
``(D) collecting fees under section 744H and accounting for
resources allocated for the review of submissions in
connection with biosimilar biological product development,
biosimilar biological product applications, and supplements.
``(10) The term `final dosage form' means, with respect to
a biosimilar biological product, a finished dosage form which
is approved for administration to a patient without
substantial further manufacturing (such as lyophilized
products before reconstitution).
``(11) The term `financial hold'--
``(A) means an order issued by the Secretary to prohibit
the sponsor of a clinical investigation from continuing the
investigation if the Secretary determines that the
investigation is intended to support a biosimilar biological
product application and the sponsor has failed to pay any fee
for the product required under subparagraph (A), (B), or (D)
of section 744H(a)(1); and
``(B) does not mean that any of the bases for a `clinical
hold' under section 505(i)(3) have been determined by the
Secretary to exist concerning the investigation.
``(12) The term `person' includes an affiliate of such
person.
``(13) The term `process for the review of biosimilar
biological product applications' means the following
activities of the Secretary with respect to the review of
submissions in connection with biosimilar biological product
development, biosimilar biological product applications, and
supplements:
``(A) The activities necessary for the review of
submissions in connection with biosimilar biological product
development, biosimilar biological product applications, and
supplements.
``(B) Actions related to submissions in connection with
biosimilar biological product development, the issuance of
action letters which approve biosimilar biological product
applications or which set forth in detail the specific
deficiencies in such applications, and where appropriate, the
actions necessary to place such applications in condition for
approval.
``(C) The inspection of biosimilar biological product
establishments and other facilities undertaken as part of the
Secretary's review of pending biosimilar biological product
applications and supplements.
``(D) Activities necessary for the release of lots of
biosimilar biological products under section 351(k) of the
Public Health Service Act.
``(E) Monitoring of research conducted in connection with
the review of biosimilar biological product applications.
``(F) Postmarket safety activities with respect to
biologics approved under biosimilar biological product
applications or supplements, including the following
activities:
``(i) Collecting, developing, and reviewing safety
information on biosimilar biological products, including
adverse-event reports.
``(ii) Developing and using improved adverse-event data-
collection systems, including information technology systems.
``(iii) Developing and using improved analytical tools to
assess potential safety problems, including access to
external data bases.
``(iv) Implementing and enforcing section 505(o) (relating
to postapproval studies and clinical trials and labeling
changes) and section 505(p) (relating to risk evaluation and
mitigation strategies).
``(v) Carrying out section 505(k)(5) (relating to adverse-
event reports and postmarket safety activities).
``(14) The term `supplement' means a request to the
Secretary to approve a change in a biosimilar biological
product application which has been approved, including a
supplement requesting that the Secretary determine that the
biosimilar biological product meets the standards for
interchangeability described in section 351(k)(4) of the
Public Health Service Act.

``SEC. 744H. AUTHORITY TO ASSESS AND USE BIOSIMILAR
BIOLOGICAL PRODUCT FEES.

``(a) Types of Fees.--Beginning in fiscal year 2013, the
Secretary shall assess and collect fees in accordance with
this section as follows:
``(1) Biosimilar development program fees.--
``(A) Initial biosimilar biological product development
fee.--
``(i) In general.--Each person that submits to the
Secretary a meeting request described under clause (ii) or a
clinical protocol for an investigational new drug protocol
described under clause (iii) shall pay for the product named
in the meeting request or the investigational new drug
application the initial biosimilar biological product
development fee established under subsection (b)(1)(A).
``(ii) Meeting request.--The meeting request described in
this clause is a request for a biosimilar biological product
development meeting for a product.
``(iii) Clinical protocol for ind.--A clinical protocol for
an investigational new drug protocol described in this clause
is a clinical protocol consistent with the provisions of
section 505(i), including any regulations promulgated under
section 505(i), (referred to in this section as
`investigational new drug application') describing an
investigation that the Secretary determines is intended to
support a biosimilar biological product application for a
product.
``(iv) Due date.--The initial biosimilar biological product
development fee shall be due by the earlier of the following:

``(I) Not later than 5 days after the Secretary grants a
request for a biosimilar biological product development
meeting.
``(II) The date of submission of an investigational new
drug application describing an investigation that the
Secretary determines is intended to support a biosimilar
biological product application.

``(v) Transition rule.--Each person that has submitted an
investigational new drug application prior to the date of
enactment of the Biosimilars User Fee Act of 2012 shall pay
the initial biosimilar biological product development fee by
the earlier of the following:

``(I) Not later than 60 days after the date of the
enactment of the Biosimilars User Fee Act of 2012, if the
Secretary determines that the investigational new drug
application describes an investigation that is intended to

[[Page S3578]]

support a biosimilar biological product application.
``(II) Not later than 5 days after the Secretary grants a
request for a biosimilar biological product development
meeting.

``(B) Annual biosimilar biological product development
fee.--
``(i) In general.--A person that pays an initial biosimilar
biological product development fee for a product shall pay
for such product, beginning in the fiscal year following the
fiscal year in which the initial biosimilar biological
product development fee was paid, an annual fee established
under subsection (b)(1)(B) for biosimilar biological product
development (referred to in this section as `annual
biosimilar biological product development fee').
``(ii) Due date.--The annual biosimilar biological product
development program fee for each fiscal year will be due on
the later of--

``(iii) Exception.--The annual biosimilar development
program fee for each fiscal year will be due on the date
specified in clause (ii), unless the person has--

``(I) submitted a marketing application for the biological
product that was accepted for filing; or
``(II) discontinued participation in the biosimilar
biological product development program for the product under
subparagraph (C).

``(C) Discontinuation of fee obligation.--A person may
discontinue participation in the biosimilar biological
product development program for a product effective October 1
of a fiscal year by, not later than August 1 of the preceding
fiscal year--
``(i) if no investigational new drug application concerning
the product has been submitted, submitting to the Secretary a
written declaration that the person has no present intention
of further developing the product as a biosimilar biological
product; or
``(ii) if an investigational new drug application
concerning the product has been submitted, by withdrawing the
investigational new drug application in accordance with part
312 of title 21, Code of Federal Regulations (or any
successor regulations).
``(D) Reactivation fee.--
``(i) In general.--A person that has discontinued
participation in the biosimilar biological product
development program for a product under subparagraph (C)
shall pay a fee (referred to in this section as `reactivation
fee') by the earlier of the following:

``(I) Not later than 5 days after the Secretary grants a
request for a biosimilar biological product development
meeting for the product (after the date on which such
participation was discontinued).
``(II) Upon the date of submission (after the date on which
such participation was discontinued) of an investigational
new drug application describing an investigation that the
Secretary determines is intended to support a biosimilar
biological product application for that product.

``(ii) Application of annual fee.--A person that pays a
reactivation fee for a product shall pay for such product,
beginning in the next fiscal year, the annual biosimilar
biological product development fee under subparagraph (B).
``(E) Effect of failure to pay biosimilar development
program fees.--
``(i) No biosimilar biological product development
meetings.--If a person has failed to pay an initial or annual
biosimilar biological product development fee as required
under subparagraph (A) or (B), or a reactivation fee as
required under subparagraph (D), the Secretary shall not
provide a biosimilar biological product development meeting
relating to the product for which fees are owed.
``(ii) No receipt of investigational new drug
applications.--Except in extraordinary circumstances, the
Secretary shall not consider an investigational new drug
application to have been received under section 505(i)(2)
if--

``(I) the Secretary determines that the investigation is
intended to support a biosimilar biological product
application; and
``(II) the sponsor has failed to pay an initial or annual
biosimilar biological product development fee for the product
as required under subparagraph (A) or (B), or a reactivation
fee as required under subparagraph (D).

``(iii) Financial hold.--Notwithstanding section 505(i)(2),
except in extraordinary circumstances, the Secretary shall
prohibit the sponsor of a clinical investigation from
continuing the investigation if--

``(iv) No acceptance of biosimilar biological product
applications or supplements.--If a person has failed to pay
an initial or annual biosimilar biological product
development fee as required under subparagraph (A) or (B), or
a reactivation fee as required under subparagraph (D), any
biosimilar biological product application or supplement
submitted by that person shall be considered incomplete and
shall not be accepted for filing by the Secretary until all
such fees owed by such person have been paid.
``(F) Limits regarding biosimilar development program
fees.--
``(i) No refunds.--The Secretary shall not refund any
initial or annual biosimilar biological product development
fee paid under subparagraph (A) or (B), or any reactivation
fee paid under subparagraph (D).
``(ii) No waivers, exemptions, or reductions.--The
Secretary shall not grant a waiver, exemption, or reduction
of any initial or annual biosimilar biological product
development fee due or payable under subparagraph (A) or (B),
or any reactivation fee due or payable under subparagraph
(D).
``(2) Biosimilar biological product application and
supplement fee.--
``(A) In general.--Each person that submits, on or after
October 1, 2012, a biosimilar biological product application
or a supplement shall be subject to the following fees:
``(i) A fee for a biosimilar biological product application
that is equal to--

``(I) the amount of the fee established under subsection
(b)(1)(D) for a biosimilar biological product application;
minus
``(II) the cumulative amount of fees paid, if any, under
subparagraphs (A), (B), and (D) of paragraph (1) for the
product that is the subject of the application.

``(ii) A fee for a biosimilar biological product
application for which clinical data (other than comparative
bioavailability studies) with respect to safety or
effectiveness are not required, that is equal to--

``(I) half of the amount of the fee established under
subsection (b)(1)(D) for a biosimilar biological product
application; minus
``(II) the cumulative amount of fees paid, if any, under
subparagraphs (A), (B), and (D) of paragraph (1) for that
product.

``(iii) A fee for a supplement for which clinical data
(other than comparative bioavailability studies) with respect
to safety or effectiveness are required, that is equal to
half of the amount of the fee established under subsection
(b)(1)(D) for a biosimilar biological product application.
``(B) Reduction in fees.--Notwithstanding section 404 of
the Biosimilars User Fee Act of 2012, any person who pays a
fee under subparagraph (A), (B), or (D) of paragraph (1) for
a product before October 1, 2017, but submits a biosimilar
biological product application for that product after such
date, shall be entitled to the reduction of any biosimilar
biological product application fees that may be assessed at
the time when such biosimilar biological product application
is submitted, by the cumulative amount of fees paid under
subparagraphs (A), (B), and (D) of paragraph (1) for that
product.
``(C) Payment due date.--Any fee required by subparagraph
(A) shall be due upon submission of the application or
supplement for which such fee applies.
``(D) Exception for previously filed application or
supplement.--If a biosimilar biological product application
or supplement was submitted by a person that paid the fee for
such application or supplement, was accepted for filing, and
was not approved or was withdrawn (without a waiver), the
submission of a biosimilar biological product application or
a supplement for the same product by the same person (or the
person's licensee, assignee, or successor) shall not be
subject to a fee under subparagraph (A).
``(E) Refund of application fee if application refused for
filing or withdrawn before filing.--The Secretary shall
refund 75 percent of the fee paid under this paragraph for
any application or supplement which is refused for filing or
withdrawn without a waiver before filing.
``(F) Fees for applications previously refused for filing
or withdrawn before filing.--A biosimilar biological product
application or supplement that was submitted but was refused
for filing, or was withdrawn before being accepted or refused
for filing, shall be subject to the full fee under
subparagraph (A) upon being resubmitted or filed over
protest, unless the fee is waived under subsection (c).
``(3) Biosimilar biological product establishment fee.--
``(A) In general.--Except as provided in subparagraph (E),
each person that is named as the applicant in a biosimilar
biological product application shall be assessed an annual
fee established under subsection (b)(1)(E) for each
biosimilar biological product establishment that is listed in
the approved biosimilar biological product application as an
establishment that manufactures the biosimilar biological
product named in such application.
``(B) Assessment in fiscal years.--The establishment fee
shall be assessed in each fiscal year for which the
biosimilar biological product named in the application is
assessed a fee under paragraph (4) unless the biosimilar
biological product establishment listed in the application
does not engage in the manufacture of the biosimilar
biological product during such fiscal year.
``(C) Due date.--The establishment fee for a fiscal year
shall be due on the later of--
``(i) the first business day on or after October 1 of such
fiscal year; or
``(ii) the first business day after the enactment of an
appropriations Act providing for the collection and
obligation of fees for such fiscal year under this section.
``(D) Application to establishment.--
``(i) Each biosimilar biological product establishment
shall be assessed only one fee

[[Page S3579]]

per biosimilar biological product establishment,
notwithstanding the number of biosimilar biological products
manufactured at the establishment, subject to clause (ii).
``(ii) In the event an establishment is listed in a
biosimilar biological product application by more than one
applicant, the establishment fee for the fiscal year shall be
divided equally and assessed among the applicants whose
biosimilar biological products are manufactured by the
establishment during the fiscal year and assessed biosimilar
biological product fees under paragraph (4).
``(E) Exception for new products.--If, during the fiscal
year, an applicant initiates or causes to be initiated the
manufacture of a biosimilar biological product at an
establishment listed in its biosimilar biological product
application--
``(i) that did not manufacture the biosimilar biological
product in the previous fiscal year; and
``(ii) for which the full biosimilar biological product
establishment fee has been assessed in the fiscal year at a
time before manufacture of the biosimilar biological product
was begun,
the applicant shall not be assessed a share of the biosimilar
biological product establishment fee for the fiscal year in
which the manufacture of the product began.
``(4) Biosimilar biological product fee.--
``(A) In general.--Each person who is named as the
applicant in a biosimilar biological product application
shall pay for each such biosimilar biological product the
annual fee established under subsection (b)(1)(F).
``(B) Due date.--The biosimilar biological product fee for
a fiscal year shall be due on the later of--
``(i) the first business day on or after October 1 of each
such year; or
``(ii) the first business day after the enactment of an
appropriations Act providing for the collection and
obligation of fees for such year under this section.
``(C) One fee per product per year.--The biosimilar
biological product fee shall be paid only once for each
product for each fiscal year.
``(b) Fee Setting and Amounts.--
``(1) In general.--Subject to paragraph (2), the Secretary
shall, 60 days before the start of each fiscal year that
begins after September 30, 2012, establish, for the next
fiscal year, the fees under subsection (a). Except as
provided in subsection (c), such fees shall be in the
following amounts:
``(A) Initial biosimilar biological product development
fee.--The initial biosimilar biological product development
fee under subsection (a)(1)(A) for a fiscal year shall be
equal to 10 percent of the amount established under section
736(c)(4) for a human drug application described in section
736(a)(1)(A)(i) for that fiscal year.
``(B) Annual biosimilar biological product development
fee.--The annual biosimilar biological product development
fee under subsection (a)(1)(B) for a fiscal year shall be
equal to 10 percent of the amount established under section
736(c)(4) for a human drug application described in section
736(a)(1)(A)(i) for that fiscal year.
``(C) Reactivation fee.--The reactivation fee under
subsection (a)(1)(D) for a fiscal year shall be equal to 20
percent of the amount of the fee established under section
736(c)(4) for a human drug application described in section
736(a)(1)(A)(i) for that fiscal year.
``(D) Biosimilar biological product application fee.--The
biosimilar biological product application fee under
subsection (a)(2) for a fiscal year shall be equal to the
amount established under section 736(c)(4) for a human drug
application described in section 736(a)(1)(A)(i) for that
fiscal year.
``(E) Biosimilar biological product establishment fee.--The
biosimilar biological product establishment fee under
subsection (a)(3) for a fiscal year shall be equal to the
amount established under section 736(c)(4) for a prescription
drug establishment for that fiscal year.
``(F) Biosimilar biological product fee.--The biosimilar
biological product fee under subsection (a)(4) for a fiscal
year shall be equal to the amount established under section
736(c)(4) for a prescription drug product for that fiscal
year.
``(2) Limit.--The total amount of fees charged for a fiscal
year under this section may not exceed the total amount for
such fiscal year of the costs of resources allocated for the
process for the review of biosimilar biological product
applications.
``(c) Application Fee Waiver for Small Business.--
``(1) Waiver of application fee.--The Secretary shall grant
to a person who is named in a biosimilar biological product
application a waiver from the application fee assessed to
that person under subsection (a)(2)(A) for the first
biosimilar biological product application that a small
business or its affiliate submits to the Secretary for
review. After a small business or its affiliate is granted
such a waiver, the small business or its affiliate shall
pay--
``(A) application fees for all subsequent biosimilar
biological product applications submitted to the Secretary
for review in the same manner as an entity that is not a
small business; and
``(B) all supplement fees for all supplements to biosimilar
biological product applications submitted to the Secretary
for review in the same manner as an entity that is not a
small business.
``(2) Considerations.--In determining whether to grant a
waiver of a fee under paragraph (1), the Secretary shall
consider only the circumstances and assets of the applicant
involved and any affiliate of the applicant.
``(3) Small business defined.--In this subsection, the term
`small business' means an entity that has fewer than 500
employees, including employees of affiliates, and does not
have a drug product that has been approved under a human drug
application (as defined in section 735) or a biosimilar
biological product application (as defined in section
744G(4)) and introduced or delivered for introduction into
interstate commerce.
``(d) Effect of Failure To Pay Fees.--A biosimilar
biological product application or supplement submitted by a
person subject to fees under subsection (a) shall be
considered incomplete and shall not be accepted for filing by
the Secretary until all fees owed by such person have been
paid.
``(e) Crediting and Availability of Fees.--
``(1) In general.--Subject to paragraph (2), fees
authorized under subsection (a) shall be collected and
available for obligation only to the extent and in the amount
provided in advance in appropriations Acts. Such fees are
authorized to remain available until expended. Such sums as
may be necessary may be transferred from the Food and Drug
Administration salaries and expenses appropriation account
without fiscal year limitation to such appropriation account
for salaries and expenses with such fiscal year limitation.
The sums transferred shall be available solely for the
process for the review of biosimilar biological product
applications.
``(2) Collections and appropriation acts.--
``(A) In general.--Subject to subparagraphs (C) and (D),
the fees authorized by this section shall be collected and
available in each fiscal year in an amount not to exceed the
amount specified in appropriation Acts, or otherwise made
available for obligation for such fiscal year.
``(B) Use of fees and limitation.--The fees authorized by
this section shall be available for a fiscal year beginning
after fiscal year 2012 to defray the costs of the process for
the review of biosimilar biological product applications
(including such costs for an additional number of full-time
equivalent positions in the Department of Health and Human
Services to be engaged in such process), only if the
Secretary allocates for such purpose an amount for such
fiscal year (excluding amounts from fees collected under this
section) no less than $20,000,000, multiplied by the
adjustment factor applicable to the fiscal year involved.
``(C) Fee collection during first program year.--Until the
date of enactment of an Act making appropriations through
September 30, 2013, for the salaries and expenses account of
the Food and Drug Administration, fees authorized by this
section for fiscal year 2013 may be collected and shall be
credited to such account and remain available until expended.
``(D) Provision for early payments in subsequent years.--
Payment of fees authorized under this section for a fiscal
year (after fiscal year 2013), prior to the due date for such
fees, may be accepted by the Secretary in accordance with
authority provided in advance in a prior year appropriations
Act.
``(3) Authorization of appropriations.--For each of fiscal
years 2013 through 2017, there is authorized to be
appropriated for fees under this section an amount equivalent
to the total amount of fees assessed for such fiscal year
under this section.
``(f) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 days after it is due, such fee shall
be treated as a claim of the United States Government subject
to subchapter II of chapter 37 of title 31, United States
Code.
``(g) Written Requests for Waivers and Refunds.--To qualify
for consideration for a waiver under subsection (c), or for a
refund of any fee collected in accordance with subsection
(a)(2)(A), a person shall submit to the Secretary a written
request for such waiver or refund not later than 180 days
after such fee is due.
``(h) Construction.--This section may not be construed to
require that the number of full-time equivalent positions in
the Department of Health and Human Services, for officers,
employers, and advisory committees not engaged in the process
of the review of biosimilar biological product applications,
be reduced to offset the number of officers, employees, and
advisory committees so engaged.''.

SEC. 403. REAUTHORIZATION; REPORTING REQUIREMENTS.

Part 8 of subchapter C of chapter VII, as added by section
402, is further amended by inserting after section 744H the
following:

``SEC. 744I. REAUTHORIZATION; REPORTING REQUIREMENTS.

[[Page S3580]]

and the future plans of the Food and Drug Administration for
meeting such goals. The report for a fiscal year shall
include information on all previous cohorts for which the
Secretary has not given a complete response on all biosimilar
biological product applications and supplements in the
cohort.
``(b) Fiscal Report.--Not later than 120 days after the end
of fiscal year 2013 and each subsequent fiscal year for which
fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report on the
implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected for such fiscal year.
``(c) Public Availability.--The Secretary shall make the
reports required under subsections (a) and (b) available to
the public on the Internet Web site of the Food and Drug
Administration.
``(d) Study.--
``(1) In general.--The Secretary shall contract with an
independent accounting or consulting firm to study the
workload volume and full costs associated with the process
for the review of biosimilar biological product applications.
``(2) Interim results.--Not later than June 1, 2015, the
Secretary shall publish, for public comment, interim results
of the study described under paragraph (1).
``(3) Final results.--Not later than September 30, 2016,
the Secretary shall publish, for public comment, the final
results of the study described under paragraph (1).
``(e) Reauthorization.--
``(1) Consultation.--In developing recommendations to
present to the Congress with respect to the goals described
in subsection (a), and plans for meeting the goals, for the
process for the review of biosimilar biological product
applications for the first 5 fiscal years after fiscal year
2017, and for the reauthorization of this part for such
fiscal years, the Secretary shall consult with--
``(A) the Committee on Energy and Commerce of the House of
Representatives;
``(B) the Committee on Health, Education, Labor, and
Pensions of the Senate;
``(C) scientific and academic experts;
``(D) health care professionals;
``(E) representatives of patient and consumer advocacy
groups; and
``(F) the regulated industry.
``(2) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
``(A) present the recommendations developed under paragraph
(1) to the congressional committees specified in such
paragraph;
``(B) publish such recommendations in the Federal Register;
``(C) provide for a period of 30 days for the public to
provide written comments on such recommendations;
``(D) hold a meeting at which the public may present its
views on such recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(3) Transmittal of recommendations.--Not later than
January 15, 2017, the Secretary shall transmit to the
Congress the revised recommendations under paragraph (2), a
summary of the views and comments received under such
paragraph, and any changes made to the recommendations in
response to such views and comments.''.

SEC. 404. SUNSET DATES.

(a) Authorization.--The amendment made by section 402 shall
cease to be effective October 1, 2017.
(b) Reporting Requirements.--The amendment made by section
403 shall cease to be effective January 31, 2018.

SEC. 405. EFFECTIVE DATE.

(a) In General.--Except as provided under subsection (b),
the amendments made by this title shall take effect on the
later of--
(1) October 1, 2012; or
(2) the date of the enactment of this title.
(b) Exception.--Fees under part 8 of subchapter C of
chapter VII of the Federal Food, Drug, and Cosmetic Act, as
added by this title, shall be assessed for all biosimilar
biological product applications received on or after October
1, 2012, regardless of the date of the enactment of this
title.

SEC. 406. SAVINGS CLAUSE.

Notwithstanding the amendments made by this title, part 2
of subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act, as in effect on the day before the date of the
enactment of this title, shall continue to be in effect with
respect to human drug applications and supplements (as
defined in such part as of such day) that were accepted by
the Food and Drug Administration for filing on or after
October 1, 2007, but before October 1, 2012, with respect to
assessing and collecting any fee required by such part for a
fiscal year prior to fiscal year 2013.

SEC. 407. CONFORMING AMENDMENT.

Section 735(1)(B) (21 U.S.C. 379g(1)(B)) is amended by
striking ``or (k)''.

TITLE V--PEDIATRIC DRUGS AND DEVICES

SEC. 501. PERMANENCE.

(a) Pediatric Studies of Drugs.--Subsection (q) of section
505A (21 U.S.C. 355a) is amended--
(1) in the subsection heading, by striking ``Sunset'' and
inserting ``Permanence'';
(2) in paragraph (1), by striking ``on or before October 1,
2012,''; and
(3) in paragraph (2), by striking ``on or before October 1,
2012,''.
(b) Research Into Pediatric Uses for Drugs and Biological
Products.--Section 505B (21 U.S.C. 355c) is amended--
(1) by striking subsection (m); and
(2) by redesignating subsection (n) as subsection (m).

SEC. 502. WRITTEN REQUESTS.

(a) Federal Food, Drug, and Cosmetic Act.--Subsection (h)
of section 505A (21 U.S.C. 355a) is amended to read as
follows:
``(h) Relationship to Pediatric Research Requirements.--
Exclusivity under this section shall only be granted for the
completion of a study or studies that are the subject of a
written request and for which reports are submitted and
accepted in accordance with subsection (d)(3). Written
requests under this section may consist of a study or studies
required under section 505B.''.
(b) Public Health Service Act.--Section 351(m)(1) of the
Public Health Service Act (42 U.S.C. 262(m)(1)) is amended by
striking ``(f), (i), (j), (k), (l), (p), and (q)'' and
inserting ``(f), (h), (i), (j), (k), (l), (n), and (p)''.

SEC. 503. COMMUNICATION WITH PEDIATRIC REVIEW COMMITTEE.

Not later than 1 year after the date of enactment of this
Act, the Secretary of Health and Human Services (referred to
in this title as the ``Secretary'') shall issue internal
standard operating procedures that provide for the review by
the internal review committee established under section 505C
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355d)
of any significant modifications to initial pediatric study
plans, agreed initial pediatric study plans, and written
requests under sections 505A and 505B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355c). Such internal
standard operating procedures shall be made publicly
available on the Internet website of the Food and Drug
Administration.

SEC. 504. ACCESS TO DATA.

Not later than 3 years after the date of enactment of this
Act, the Secretary shall make available to the public,
including through posting on the Internet website of the Food
and Drug Administration, the medical, statistical, and
clinical pharmacology reviews of, and corresponding written
requests issued to an applicant, sponsor, or holder for,
pediatric studies submitted between January 4, 2002 and
September 27, 2007 under subsection (b) or (c) of section
505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a) for which 6 months of market exclusivity was granted
and that resulted in a labeling change. The Secretary shall
make public the information described in the preceding
sentence in a manner consistent with how the Secretary
releases information under section 505A(k) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355a(k)).

SEC. 505. ENSURING THE COMPLETION OF PEDIATRIC STUDIES.

(a) Extension of Deadline for Deferred Studies.--Section
505B (21 U.S.C. 355c) is amended--
(1) in subsection (a)(3)--
(A) by redesignating subparagraph (B) as subparagraph (C);
(B) by inserting after subparagraph (A) the following:
``(B) Deferral extension.--
``(i) In general.--On the initiative of the Secretary or at
the request of the applicant, the Secretary may grant an
extension of a deferral approved under subparagraph (A) for
submission of some or all assessments required under
paragraph (1) if--

``(I) the Secretary determines that the conditions
described in subclause (II) or (III) of subparagraph (A)(i)
continue to be met; and
``(II) the applicant submits a new timeline under
subparagraph (A)(ii)(IV) and any significant updates to the
information required under subparagraph (A)(ii).

``(ii) Timing and information.--If the deferral extension
under this subparagraph is requested by the applicant, the
applicant shall submit the deferral extension request
containing the information described in this subparagraph not
less than 90 days prior to the date that the deferral would
expire. The Secretary shall respond to such request not later
than 45 days after the receipt of such letter. If the
Secretary grants such an extension, the specified date shall
be the extended date. The sponsor of the required assessment
under paragraph (1) shall not be issued a letter described in
subsection (d) unless the specified or extended date of
submission for such required studies has passed or if the
request for an extension is pending. For a deferral that has
expired prior to the date of enactment of the Food and Drug
Administration Safety and Innovation Act or that will expire
prior to 270 days after the date of enactment of such Act, a
deferral extension shall be requested by an applicant not
later than 180 days after the date of enactment of such Act.
The Secretary shall respond to any such request as soon as
practicable, but not later than 1 year after the date of
enactment of such Act. Nothing in this clause shall prevent
the Secretary from updating the status of a study or studies
publicly if components of such study or studies are late or
delayed.''; and
(C) in subparagraph (C), as so redesignated--
(i) in clause (i), by adding at the end the following:

[[Page S3581]]

``(III) Projected completion date for pediatric studies.
``(IV) The reason or reasons why a deferral or deferral
extension continues to be necessary.''; and

(ii) in clause (ii)--

(I) by inserting ``, as well as the date of each deferral
or deferral extension, as applicable,'' after ``clause (i)'';
and
(II) by inserting ``not later than 90 days after submission
to the Secretary or with the next routine quarterly update''
after ``Administration''; and

(2) in subsection (f)--
(A) in the subsection heading, by inserting ``Deferral
Extensions,'' after ``Deferrals,'';
(B) in paragraph (1), by inserting ``, deferral
extension,'' after ``deferral''; and
(C) in paragraph (4)--
(i) in the paragraph heading, by inserting ``deferral
extensions,'' after ``deferrals,''; and
(ii) by inserting ``, deferral extensions,'' after
``deferrals''.
(b) Tracking of Extensions; Annual Information.--Section
505B(f)(6)(D) (21 U.S.C. 355c(f)(6)(D)) is amended to read as
follows:
``(D) aggregated on an annual basis--
``(i) the total number of deferrals and deferral extensions
requested and granted under this section and, if granted, the
reasons for each such deferral or deferral extension;
``(ii) the timeline for completion of the assessments; and
``(iii) the number of assessments completed and pending;''.
(c) Action on Failure To Complete Studies.--
(1) Issuance of letter.--Subsection (d) of section 505B (21
U.S.C. 355c) is amended to read as follows:
``(d) Submission of Assessments.--If a person fails to
submit a required assessment described in subsection (a)(2),
fails to meet the applicable requirements in subsection
(a)(3), or fails to submit a request for approval of a
pediatric formulation described in subsection (a) or (b), in
accordance with applicable provisions of subsections (a) and
(b), the following shall apply:
``(1) Beginning 270 days after the date of enactment of the
Food and Drug Administration Safety and Innovation Act, the
Secretary shall issue a non-compliance letter to such person
informing them of such failure to submit or meet the
requirements of the applicable subsection. Such letter shall
require the person to respond in writing within 45 calendar
days of issuance of such letter. Such response may include
the person's request for a deferral extension if applicable.
Such letter and the person's written response to such letter
shall be made publicly available on the Internet Web site of
the Food and Drug Administration 60 calendar days after
issuance, with redactions for any trade secrets and
confidential commercial information. If the Secretary
determines that the letter was issued in error, the
requirements of this paragraph shall not apply.
``(2) The drug or biological product that is the subject of
an assessment described in subsection (a)(2), applicable
requirements in subsection (a)(3), or request for approval of
a pediatric formulation, may be considered misbranded solely
because of that failure and subject to relevant enforcement
action (except that the drug or biological product shall not
be subject to action under section 303), but such failure
shall not be the basis for a proceeding--
``(A) to withdraw approval for a drug under section 505(e);
or
``(B) to revoke the license for a biological product under
section 351 of the Public Health Service Act.''.
(2) Tracking of letters issued.--Subparagraph (D) of
section 505B(f)(6) (21 U.S.C. 355c(f)(6)), as amended by
subsection (b), is further amended--
(A) in clause (ii), by striking ``; and'' and inserting a
semicolon;
(B) in clause (iii), by adding ``and'' at the end; and
(C) by adding at the end the following:
``(iv) the number of postmarket non-compliance letters
issued pursuant to subsection (d), and the recipients of such
letters;''.

SEC. 506. PEDIATRIC STUDY PLANS.

(a) In General.--Subsection (e) of section 505B (21 U.S.C.
355c) is amended to read as follows:
``(e) Pediatric Study Plans.--
``(1) In general.--An applicant subject to subsection (a)
shall submit to the Secretary an initial pediatric study plan
prior to the submission of the assessments described under
subsection (a)(2).
``(2) Timing; content; meeting.--
``(A) Timing.--An applicant shall submit an initial
pediatric study plan to the Secretary not later than 60
calendar days after the date of the end of phase II meeting
or such other equivalent time agreed upon between the
Secretary and the applicant. Nothing in this paragraph shall
preclude the Secretary from accepting the submission of an
initial pediatric study plan earlier than the date described
under the preceding sentence.
``(B) Content of initial plan.--The initial pediatric study
plan shall include--
``(i) an outline of the pediatric study or studies that the
applicant plans to conduct (including, to the extent
practicable study objectives and design, age groups, relevant
endpoints, and statistical approach);
``(ii) any request for a deferral, partial waiver, or
waiver under this section, if applicable, along with any
supporting information; and
``(iii) other information specified in the regulations
promulgated under paragraph (4).
``(C) Meeting.--The Secretary--
``(i) shall meet with the applicant to discuss the initial
pediatric study plan as soon as practicable, but not later
than 90 calendar days after the receipt of such plan under
subparagraph (A);
``(ii) may determine that a written response to the initial
pediatric study plan is sufficient to communicate comments on
the initial pediatric study plan, and that no meeting is
necessary; and
``(iii) if the Secretary determines that no meeting is
necessary, shall so notify the applicant and provide written
comments of the Secretary as soon as practicable, but not
later than 90 calendar days after the receipt of the initial
pediatric study plan.
``(3) Agreed initial pediatric study plan.--Not later than
90 calendar days following the meeting under paragraph
(2)(C)(i) or the receipt of a written response from the
Secretary under paragraph (2)(C)(iii), the applicant shall
document agreement on the initial pediatric study plan in a
submission to the Secretary marked `Agreed Initial Pediatric
Study Plan', and the Secretary shall confirm such agreement
to the applicant in writing not later than 30 calendar days
of receipt of such agreed initial pediatric study plan.
``(4) Deferral and waiver.--If the agreed initial pediatric
study plan contains a request from the applicant for a
deferral, partial waiver, or waiver under this section, the
written confirmation under paragraph (3) shall include a
recommendation from the Secretary as to whether such request
meets the standards under paragraphs (3) or (4) of subsection
(a).
``(5) Amendments to the plan.--At the initiative of the
Secretary or the applicant, the agreed initial pediatric
study plan may be amended at any time. The requirements of
paragraph (2)(C) shall apply to any such proposed amendment
in the same manner and to the same extent as such
requirements apply to an initial pediatric study plan under
paragraph (1). The requirements of paragraphs (3) and (4)
shall apply to any agreement resulting from such proposed
amendment in the same manner and to the same extent as such
requirements apply to an agreed initial pediatric study plan.
``(6) Internal committee.--The Secretary shall consult the
internal committee under section 505C on the review of the
initial pediatric study plan, agreed initial pediatric plan,
and any significant amendments to such plans.
``(7) Required rulemaking.--Not later than 1 year after the
date of enactment of the Food and Drug Administration Safety
and Innovation Act, the Secretary shall promulgate proposed
regulations and issue proposed guidance to implement the
provisions of this subsection.''.
(b) Conforming Amendments.--Section 505B (21 U.S.C. 355c)is
amended--
(1) by amending subclause (II) of subsection (a)(3)(A)(ii)
to read as follows:

``(II) a pediatric study plan as described in subsection
(e);''; and

(2) in subsection (f)--
(A) in the subsection heading, by striking ``pediatric
Plans,'' and inserting ``pediatric Study Plans,'';
(B) in paragraph (1), by striking ``all pediatric plans''
and inserting ``initial pediatric study plans, agreed initial
pediatric study plans,''; and
(C) in paragraph (4)--
(i) in the paragraph heading, by striking ``pediatric
Plans,'' and inserting ``pediatric Study Plans,''; and
(ii) by striking ``pediatric plans'' and inserting
``initial pediatric study plans, agreed initial pediatric
study plans,''.
(c) Effective Dates.--
(1) Pediatric study plans.--Subsection (e) of section 505B
of the Federal Food, Drug, and Cosmetic Act (other than
paragraph (4) of such subsection), as amended by subsection
(a), shall take effect 180 days after the date of enactment
of this Act, without regard to whether the Secretary has
promulgated final regulations under paragraph (4) of such
subsection by such date.
(2) Conforming amendments.--The amendments made by
subsection (b) shall take effect 180 days after the date of
enactment of this Act.

SEC. 507. REAUTHORIZATIONS.

(a) Pediatric Advisory Committee.--Section 14(d) of the
Best Pharmaceuticals for Children Act (42 U.S.C. 284m note)
is amended by striking ``Notwithstanding section 14 of the
Federal Advisory Committee Act, the advisory committee shall
continue to operate during the five-year period beginning on
the date of the enactment of the Best Pharmaceuticals for
Children Act of 2007'' and inserting ``Section 14 of the
Federal Advisory Committee Act shall not apply to the
advisory committee''.
(b) Pediatric Subcommittee of the Oncologic Drugs Advisory
Committee.--Section 15(a)(3) of the Best Pharmaceuticals for
Children Act (42 U.S.C. 284m note) is amended by striking
``during the five-year period beginning on the date of the
enactment of the Best Pharmaceuticals for Children Act of
2007'' and inserting ``for the duration of the operation of
the Oncologic Drugs Advisory Committee''.
(c) Humanitarian Device Exemption Extension.--Section
520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking ``2012''
and inserting ``2017''.

[[Page S3582]]

(d) Demonstration Grants To Improve Pediatric Device
Availability.--Section 305(e) of Pediatric Medical Device
Safety and Improvement Act (Public Law 110 85; 42 U.S.C. 282
note)) is amended by striking ``$6,000,000 for each of fiscal
years 2008 through 2012'' and inserting ``$4,500,000 for each
of fiscal years 2013 through 2017''.
(e) Program for Pediatric Study of Drugs in PHSA.--Section
409I(e)(1) of the Public Health Service Act (42 U.S.C.
284m(e)(1)) is amended by striking ``to carry out this
section'' and all that follows through the end of paragraph
(1) and inserting ``to carry out this section $25,000,000 for
each of fiscal years 2012 through 2017.''.

SEC. 508. REPORT.

(a) In General.--Not later than October 31, 2016, and at
the end of each subsequent 5-year period, the Secretary shall
submit to Congress a report that evaluates the effectiveness
of sections 505A and 505B of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355a, 355c) and section 409I of the
Public Health Service Act (42 U.S.C. 284m) in ensuring that
medicines used by children are tested in pediatric
populations and properly labeled for use in children.
(b) Contents.--The report under subsection (a) shall
include--
(1) the number and importance of drugs and biological
products for children for which studies have been requested
or required (as of the date of such report) under 505A and
505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a, 355c) and section 409I of the Public Health Service Act
(42 U.S.C. 284m), including--
(A) the number of labeling changes made to drugs and
biological products pursuant to such sections since the date
of enactment of this Act; and
(B) the importance of such drugs and biological products in
the improvement of the health of children;
(2) the number of required studies under such section 505B
that have not met the initial deadline provided under such
section, including--
(A) the number of deferrals and deferral extensions granted
and the reasons such extensions were granted;
(B) the number of waivers and partial waivers granted; and
(C) the number of letters issued under subsection (d) of
such section 505B;
(3) the number of written requests issued, declined, and
referred to the National Institutes of Health under such
section 505A since the date of enactment of this Act
(including the reasons for such declination), and a
description and status of referrals made under subsection (n)
of such section 505A;
(4) the number of proposed pediatric study plans submitted
and agreed to as identified in the marketing application
under such section 505B;
(5) any labeling changes recommended by the Pediatric
Advisory Committee as a result of the review by such
Committee of adverse events reports;
(6) the number and current status of pediatric
postmarketing requirements;
(7) the number and importance of drugs and biological
products for children that are not being tested for use in
pediatric populations, notwithstanding the existence of the
programs under such sections 505A and 505B and section 409I
of the Public Health Service Act;
(8) the possible reasons for the lack of testing reported
under paragraph (7);
(9) the number of drugs and biological products for which
testing is being done (as of the date of the report) and for
which a labeling change is required under the programs
described in paragraph (7), including--
(A) the date labeling changes are made;
(B) which labeling changes required the use of the dispute
resolution process; and
(C) for labeling changes that required such dispute
resolution process, a description of--
(i) the disputes;
(ii) the recommendations of the Pediatric Advisory
Committee; and
(iii) the outcomes of such process; and
(D) an assessment of the effectiveness in improving
information about pediatric uses of drugs and biological
products;
(10)(A) the efforts made by the Secretary to increase the
number of studies conducted in the neonatal population
(including efforts made to encourage the conduct of
appropriate studies in neonates by companies with products
that have sufficient safety and other information to make the
conduct of the studies ethical and safe); and
(B) the results of such efforts;
(11)(A) the number and importance of drugs and biological
products for children with cancer that are being tested as a
result of the programs described in paragraph (7); and
(B) any recommendations for modifications to such programs
that would lead to new and better therapies for children with
cancer, including a detailed rationale for each
recommendation;
(12) an assessment of progress made in addressing the
recommendations and findings of any prior report issued by
the Comptroller General, the Institute of Medicine, or the
Secretary regarding the topics addressed in the report under
this section, including with respect to--
(A) improving public access to information from pediatric
studies conducted under such sections 505A and 505B; and
(B) improving the timeliness of pediatric studies and
pediatric study planning under such sections 505A and 505B;
(13) any recommendations for modification to the programs
that would improve pediatric drug research and increase
pediatric labeling of drugs and biological products; and
(14) an assessment of the successes of and limitations to
studying drugs for rare diseases under such sections 505A and
505B.
(c) Consultation on Recommendations.--At least 180 days
before the report is due under subsection (a), and no sooner
than 4 years after the date of enactment of this Act, the
Secretary shall consult with representatives of patient
groups, including pediatric patient groups, consumer groups,
regulated industry, scientific and medical communities,
academia, and other interested parties to obtain any
recommendations or information relevant to the effectiveness
of the programs described in subsection (b)(7), including
suggestions for modifications to such programs.

SEC. 509. TECHNICAL AMENDMENTS.

(a) Pediatric Studies of Drugs in FFDCA.--Section 505A (21
U.S.C. 355a) is amended--
(1) in subsection (k)(2), by striking ``subsection
(f)(3)(F)'' and inserting ``subsection (f)(6)(F)'';
(2) in subsection (n)--
(A) in the subsection heading, by striking ``completed''
and inserting ``submitted''; and
(B) in paragraph (1)--
(i) in the matter preceding subparagraph (A), by striking
``have not been completed'' and inserting ``have not been
submitted by the date specified in the written request issued
or if the applicant or holder does not agree to the
request'';
(ii) in subparagraph (A)--

(I) in the first sentence, by inserting ``, or for which a
period of exclusivity eligible for extension under subsection
(b)(1) or (c)(1) of this section or under subsection (m)(2)
or (m)(3) of section 351 of the Public Health Service Act has
not ended'' after ``expired''; and
(II) by striking ``Prior to'' and all that follows through
the period at the end; and

(iii) in subparagraph (B), by striking ``no listed patents
or has 1 or more listed patents that have expired,'' and
inserting ``no unexpired listed patents and for which no
unexpired periods of exclusivity eligible for extension under
subsection (b)(1) or (c)(1) of this section or under
subsection (m)(2) or (m)(3) of section 351 of the Public
Health Service Act apply,''; and
(3) in subsection (o)(2), by amendment subparagraph (B) to
read as follows:
``(B) a statement of any appropriate pediatric
contraindications, warnings, precautions, or other
information that the Secretary considers necessary to assure
safe use.''.
(b) Research Into Pediatric Uses for Drugs and Biological
Projects in FFDCA.--Section 505B (21 U.S.C. 355c) is
amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) in the matter preceding subparagraph (A), by inserting
``for a drug'' after ``(or supplement to an application)'';
(ii) in subparagraph (A), by striking ``for a'' and
inserting ``, including, with respect to a drug, an
application (or supplement to an application) for a'';
(iii) in subparagraph (B), by striking ``for a'' and
inserting ``, including, with respect to a drug, an
application (or supplement to an application) for a''; and
(iv) in the matter following subparagraph (B), by inserting
``(or supplement)'' after ``application''; and
(B) in paragraph (4)(C)--
(i) in the first sentence, by inserting ``partial'' before
``waiver is granted''; and
(ii) in the second sentence, by striking ``either a full
or'' and inserting ``such a'';
(2) in subsection (b)(1), in the matter preceding
subparagraph (A), by striking ``After providing notice'' and
all that follows through ``studies), the'' and inserting
``The'';
(3) in subsection (g)--
(A) in paragraph (1)(A), by inserting ``that receives a
priority review or 330 days after the date of the submission
of an application or supplement that receives a standard
review'' after ``after the date of the submission of the
application or supplement''; and
(B) in paragraph (2), by striking ``the label of such
product'' and inserting ``the labeling of such product''; and
(4) in subsection (h)(1)--
(A) by inserting ``an application (or supplement to an
application) that contains'' after ``date of submission of'';
and
(B) by inserting ``, if the application (or supplement)
receives a priority review, or not later than 330 days after
the date of submission of an application (or supplement to an
application) that contains a pediatric assessment under this
section, if the application (or supplement) receives a
standard review,'' after ``under this section,''.
(c) Internal Review Committee.--The heading of section 505C
(21 U.S.C. 355d) is amended by inserting ``AND DEFERRAL
EXTENSIONS'' after ``DEFERRALS''.
(d) Program for Pediatric Studies of Drugs.--Section
409I(c) of the Public Health Service Act (42 U.S.C. 284m(c))
is amended--
(1) in paragraph (1)--
(A) in the matter preceding subparagraph (A), by inserting
``or section 351(m) of this Act,'' after ``Cosmetic Act,'';
(B) in subparagraph (A)(i), by inserting ``or section
351(k) of this Act'' after ``Cosmetic Act''; and
(C) by amending subparagraph (B) to read as follows:

[[Page S3583]]

``(B) there remains no patent listed pursuant to section
505(b)(1) of the Federal Food, Drug, and Cosmetic Act, and
every three-year and five-year period referred to in
subsection (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv),
(j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) of section
505 of the Federal Food, Drug, and Cosmetic Act, or
applicable twelve-year period referred to in section
351(k)(7) of this Act, and any seven-year period referred to
in section 527 of the Federal Food, Drug, and Cosmetic Act
has ended for at least one form of the drug; and''; and
(2) in paragraph (2)--
(A) in the paragraph heading, by striking ``for drugs
lacking exclusivity''; and
(B) by striking ``under section 505 of the Federal Food,
Drug, and Cosmetic Act''; and
(C) by striking ``505A of such Act'' and inserting ``505A
of the Federal Food, Drug, and Cosmetic Act or section 351(m)
of this Act''.
(e) Pediatric Subcommittee of the Oncologic Advisory
Committee.--Section 15(a) of the Best Pharmaceuticals for
Children Act (Public Law 107 109), as amended by section
502(e) of the Food and Drug Administration Amendments Act of
2007 (Public Law 110 85), is amended in paragraph (1)(D), by
striking ``section 505B(f)'' and inserting `` `section 505C'
''.
(f) Foundation of National Institutes of Health.--Section
499(c)(1)(C) of the Public Health Service Act (42 U.S.C.
290b(c)(1)(C)) is amended by striking ``for which the
Secretary issues a certification in the affirmative under
section 505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic
Act''.
(g) Application.--Notwithstanding any provision of section
505A and 505B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355a, 355c) stating that a provision applies beginning
on the date of the enactment of the Best Pharmaceuticals for
Children Act of 2007 or the date of the enactment of the
Pediatric Research Equity Act of 2007, any amendment made by
this title to such a provision applies beginning on the date
of the enactment of this Act.

SEC. 510. RELATIONSHIP BETWEEN PEDIATRIC LABELING AND NEW
CLINICAL INVESTIGATION EXCLUSIVITY.

(a) In General.--Section 505 (21 U.S.C. 351) is amended by
adding at the end the following:
``(w) Relationship Between Pediatric Labeling and New
Clinical Investigation Exclusivity.--The period of market
exclusivity described in clauses (iii) and (iv) of subsection
(c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F)
shall not apply to a pediatric study conducted under section
505A or 505B that results, pursuant to section 505B(g)(2), in
the inclusion in the labeling of the product a determination
that the product is not indicated for use in pediatric
populations or subpopulations or information indicating that
the results of a study were inconclusive or did not
demonstrate that the product is safe or effective in
pediatric populations or subpopulations.''.
(b) Pediatric Studies of Drugs.--Section 505A(m) (21 U.S.C.
355a(m)) is amended--
(1) by striking ``(m) Clarification of Interaction of
Market Exclusivity Under This Section and Market Exclusivity
Awarded to an Applicant for Approval of A Drug Under Section
505(j).--If a'' and all that follows through the end of the
matter that precedes paragraph (1) and inserting the
following:
``(m) Clarification of Interaction of Market Exclusivity
Under This Section and Market Exclusivity Awarded to an
Application or Supplement Under Subsection (c) or (j) of
Section 505.--
``(1) 180-day exclusivity period.--If a 180-day period
under section 505(j)(5)(B)(iv) overlaps with a 6-month
exclusivity period under this section, so that the applicant
for approval of a drug under section 505(j) entitled to the
180-day period under that section loses a portion of the 180-
day period to which the applicant is entitled for the drug,
the 180-day period shall be extended from--'';
(2) by redesignating paragraphs (1) and (2) as
subparagraphs (A) and (B) and moving such subparagraphs, as
so redesignated, 2 ems to the right; and
(3) by adding at the end the following:
``(2) 3-year exclusivity period.--The 3-year period of
exclusivity under clauses (iii) and (iv) of subsection
505(c)(3)(E) and clauses (iii) and (iv) of subsection
505(j)(5)(F) are not available for approval of applications
or supplements to applications based on reports of pediatric
studies conducted under sections 505A or 505B that resulted,
pursuant to section 505A(j) or 505B(g)(2), in the inclusion
in the labeling of the product a determination that the
product is not indicated for use in pediatric populations or
subpopulations or information indicating that the results of
an assessment were inconclusive or did not demonstrate that
the product is safe or effective in pediatric populations or
subpopulation.''.
(c) Prompt Approval of Drugs.--Section 505A(o) (21 U.S.C.
355a(o)) is amended--
(1) in the heading, by striking ``section 505(j)'' and
inserting ``subsections (c) and (j) of Section 505'';
(2) in paragraph (1), by striking ``under section 505(j)''
and inserting ``under subsection (b)(2), (c), or (j) of
section 505'';
(3) in paragraph (2), in the matter preceding subparagraph
(A), by inserting ``clauses (iii) and (iv) of section
505(c)(3)(E) or'' after ``Notwithstanding''; and
(4) in paragraph (3)--
(A) in subparagraph (B), by inserting ``that differ from
adult formulations'' before the semicolon at the end; and
(B) in subparagraph (C)--
(i) by striking ``under section 505(j)'' and inserting
``under subsection (c) or (j) of section 505''; and
(ii) by inserting ``clauses (iii) or (iv) of section
505(c)(3)(E) or'' after ``exclusivity under''.

SEC. 511. PEDIATRIC RARE DISEASES.

(a) Public Meeting.--Not later than 18 months after the
date of enactment of this Act, the Secretary shall hold a
public meeting to discuss ways to encourage and accelerate
the development of new therapies for pediatric rare diseases.
(b) Report.--Not later than 180 days after the date of the
public meeting under subsection (a), the Secretary shall
issue a report that includes a strategic plan for encouraging
and accelerating the development of new therapies for
treating pediatric rare diseases.

TITLE VI--MEDICAL DEVICE REGULATORY IMPROVEMENTS

SEC. 601. RECLASSIFICATION PROCEDURES.

(a) Classification Changes.--
(1) In general.--Section 513(e)(1) (21 U.S.C. 360c(e)(1))
is amended to read as follows:
``(e)(1)(A) Based on new information respecting a device,
the Secretary may, upon the initiative of the Secretary or
upon petition of an interested person, change the
classification of such device, and revoke, on account of the
change in classification, any regulation or requirement in
effect under section 514 or 515 with respect to such device,
by administrative order published in the Federal Register
following publication of a proposed reclassification order in
the Federal Register, a meeting of a device classification
panel described in subsection (b), and consideration of
comments to a public docket, notwithstanding subchapter II of
Chapter 5 of title 5 of the United States Code. An order
under this subsection changing the classification of a device
from class III to class II may provide that such
classification shall not take effect until the effective date
of a performance standard established under section 514 for
such device.
``(B) Authority to issue such administrative order shall
not be delegated below the Commissioner. The Commissioner
shall issue such an order as proposed by the Director of the
Center for Devices and Radiological Health unless the
Commissioner, in consultation with the Office of the
Secretary of Health and Human Services, concludes that the
order exceeds the legal authority of the Food and Drug
Administration or that the order would be lawful, but
unlikely to advance the public health.''.
(2) Technical and conforming amendments.--
(A) Section 513(e)(2) (21 U.S.C. 360c(e)(2)) is amended by
striking ``regulation promulgated'' and inserting ``an order
issued''.
(B) Section 514(a)(1) (21 U.S.C. 360d(a)(1)) is amended by
striking ``under a regulation under section 513(e) but such
regulation'' and inserting ``under an administrative order
under section 513(e) (or a regulation promulgated under such
section prior to the date of enactment of the Food and Drug
Administration Safety and Innovation Act) but such order (or
regulation)'';
(C) Section 517(a)(1) (21 U.S.C. 360g(a)(1)) is amended by
striking ``or changing the classification of a device to
class I'' and inserting ``, an administrative order changing
the classification of a device to class I,''.
(3) Devices reclassified prior to the date of enactment of
this act.--
(A) In general.--The amendments made by this subsection
shall have no effect on a regulation promulgated with respect
to the classification of a device under section 513(e) of the
Federal Food, Drug, and Cosmetic Act prior to the date of
enactment of this Act.
(B) Applicability of other provisions.--In the case of a
device reclassified under section 513(e) of the Federal Food,
Drug, and Cosmetic Act by regulation prior to the date of
enactment of this Act, section 517(a)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360g(a)(1)) shall apply to
such regulation promulgated under section 513(e) of such Act
with respect to such device in the same manner such section
517(a)(1) applies to an administrative order issued with
respect to a device reclassified after the date of enactment
of this Act.
(b) Devices Marketed Before May 28, 1976.--
(1) Premarket approval.--Section 515 (21 U.S.C. 360e) is
amended--
(A) in subsection (a), by striking ``regulation promulgated
under subsection (b)'' and inserting ``an order issued under
subsection (b) (or a regulation promulgated under such
subsection prior to the date of enactment of the Food and
Drug Administration Safety and Innovation Act)'';
(B) in subsection (b)--
(i) in paragraph (1)--

(I) in the heading, by striking ``Regulation'' and
inserting ``Order''; and
(II) in the matter following subparagraph (B)--

(aa) by striking ``by regulation, promulgated in accordance
with this subsection'' and inserting ``by administrative
order following publication of a proposed order in the
Federal Register, a meeting of a device classification panel
described in section 513(b), and consideration of comments
from all affected stakeholders, including patients, payors,
and providers, notwithstanding subchapter II of chapter 5 of
title 5, United States Code''; and
(bb) by adding at the end the following:

[[Page S3584]]

``Authority to issue such administrative order shall not be
delegated below the Commissioner. Before publishing such
administrative order, the Commissioner shall consult with the
Office of the Secretary. The Commissioner shall issue such an
order as proposed by the Director of the Center for Devices
and Radiological Health unless the Commissioner, in
consultation with the Office of the Secretary, concludes that
the order exceeds the legal authority of the Food and Drug
Administration or that the order would be lawful, but
unlikely to advance the public health.'';
(ii) in paragraph (2)--

(I) by striking subparagraph (B); and
(II) in subparagraph (A)--

(aa) by striking ``(2)(A) A proceeding for the promulgation
of a regulation under paragraph (1) respecting a device shall
be initiated by the publication in the Federal Register of a
notice of proposed rulemaking. Such notice shall contain--''
and inserting ``(2) A proposed order required under paragraph
(1) shall contain--'';
(bb) by redesignating clauses (i) through (iv) as
subparagraphs (A) through (D), respectively;
(cc) in subparagraph (A), as so redesignated, by striking
``regulation'' and inserting ``order''; and
(dd) in subparagraph (C), as so redesignated, by striking
``regulation'' and inserting ``order'';
(iii) in paragraph (3)--

(I) by striking ``proposed regulation'' each place such
term appears and inserting ``proposed order'';
(II) by striking ``paragraph (2) and after'' and inserting
``paragraph (2),'';
(III) by inserting ``and a meeting of a device
classification panel described in section 513(b),'' after
``such proposed regulation and findings,'';
(IV) by striking ``(A) promulgate such regulation'' and
inserting ``(A) issue an administrative order under paragraph
(1)'';
(V) by striking ``paragraph (2)(A)(ii)'' and inserting
``paragraph (2)(B)''; and
(VI) by striking ``promulgation of the regulation'' and
inserting ``issuance of the administrative order''; and

(iv) by striking paragraph (4); and
(C) in subsection (i)--
(i) in paragraph (2)--

(I) in the matter preceding subparagraph (A)--

(aa) by striking ``December 1, 1995'' and inserting ``the
date that is 2 years after the date of enactment of the Food
and Drug Administration Safety and Innovation Act''; and
(bb) by striking ``publish a regulation in the Federal
Register'' and inserting ``issue an administrative order
following publication of a proposed order in the Federal
Register, a meeting of a device classification panel
described in section 513(b), and consideration of comments
from all affected stakeholders, including patients, payors,
and providers, notwithstanding subchapter II of chapter 5 of
title 5, United States Code,'';

(II) in subparagraph (B), by striking ``final regulation
has been promulgated under section 515(b)'' and inserting
``administrative order has been issued under subsection (b)
(or no regulation has been promulgated under such subsection
prior to the date of enactment of the Food and Drug
Administration Safety and Innovation Act)'';
(III) in the matter following subparagraph (B), by striking
``regulation requires'' and inserting ``administrative order
issued under this paragraph requires''; and
(IV) by striking the third and fourth sentences; and

(ii) in paragraph (3)--

(I) by striking ``regulation requiring'' each place such
term appears and inserting ``order requiring''; and
(II) by striking ``promulgation of a section 515(b)
regulation'' and inserting ``issuance of an administrative
order under subsection (b)''.

(2) Technical and conforming amendments.--Section 501(f)
(21 U.S.C. 351(f)) is amended--
(A) in subparagraph (1)(A)--
(i) in subclause (i), by striking ``a regulation
promulgated'' and inserting ``an order issued''; and
(ii) in subclause (ii), by striking ``promulgation of such
regulation'' and inserting ``issuance of such order'';
(B) in subparagraph (2)(B)--
(i) by striking ``a regulation promulgated'' and inserting
``an order issued''; and
(ii) by striking ``promulgation of such regulation'' and
inserting ``issuance of such order''; and
(C) by adding at the end the following:
``(3) In the case of a device with respect to which a
regulation was promulgated under section 515(b) prior to the
date of enactment of the Food and Drug Administration Safety
and Innovation Act, a reference in this subsection to an
order issued under section 515(b) shall be deemed to include
such regulation.''.
(3) Approval by regulation prior to the date of enactment
of this act.--The amendments made by this subsection shall
have no effect on a regulation that was promulgated prior to
the date of enactment of this Act requiring that a device
have an approval under section 515 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360e) of an application for
premarket approval.
(c) Reporting.--The Secretary of Health and Human Services
shall annually post on the Internet website of the Food and
Drug Administration--
(1) the number and type of class I and class II devices
reclassified as class II or class III in the previous
calendar year under section 513(e)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360c(e)(1));
(2) the number and type of class II and class III devices
reclassified as class I or class II in the previous calendar
year under such section 513(e)(1); and
(3) the number and type of devices reclassified in the
previous calendar year under section 515 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360e).

SEC. 602. CONDITION OF APPROVAL STUDIES.

Section 515(d)(1)(B)(ii) (21 U.S.C. 360e(d)(1)(B)(ii)) is
amended--
(1) by striking ``(ii)'' and inserting ``(ii)(I)''; and
(2) by adding at the end the following:
``(II) An order approving an application for a device may
require as a condition to such approval that the applicant
conduct a postmarket study regarding the device.''.

SEC. 603. POSTMARKET SURVEILLANCE.

Section 522 (21 U.S.C. 360l) is amended--
(1) in subsection (a)(1)(A), in the matter preceding clause
(i), by inserting ``, at the time of approval or clearance of
a device or at any time thereafter,'' after ``by order''; and
(2) in subsection (b)(1), by inserting ``The manufacturer
shall commence surveillance under this section not later than
15 months after the day on which the Secretary issues an
order under this section.'' after the second sentence.

SEC. 604. SENTINEL.

Section 519 (21 U.S.C. 360i) is amended by adding at the
end the following:
``(h) Inclusion of Devices in the Postmarket Risk
Identification and Analysis System.--
``(1) In general.--
``(A) Application to devices.--The Secretary shall amend
the procedures established and maintained under clauses (i),
(ii), (iii), and (v) of section 505(k)(3)(C) in order to
expand the postmarket risk identification and analysis system
established under such section to include and apply to
devices.
``(B) Exception.--Subclause (II) of clause (i) of section
505(k)(3)(C) shall not apply to devices.
``(C) Clarification.--With respect to devices, the private
sector health-related electronic data provided under section
505(k)(3)(C)(i)(III)(bb) may include medical device
utilization data, health insurance claims data, and procedure
and device registries.
``(2) Data.--In expanding the system as described in
paragraph (1)(A), the Secretary shall use relevant data with
respect to devices cleared under section 510(k) or approved
under section 515, including claims data, patient survey
data, and any other data deemed appropriate by the Secretary.
``(3) Stakeholder input.--To help ensure effective
implementation of the system described in paragraph (1)(A),
the Secretary shall engage outside stakeholders in
development of the system through a public hearing, advisory
committee meeting, public docket, or other like public
measures, as appropriate.
``(4) Voluntary surveys.--Chapter 35 of title 44, United
States Code, shall not apply to the collection of voluntary
information from health care providers, such as voluntary
surveys or questionnaires, initiated by the Secretary for
purposes of postmarket risk identification for devices.''.

SEC. 605. RECALLS.

(a) Assessment of Device Recall Information.--
(1) In general.--
(A) Assessment program.--The Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall enhance the Food and Drug Administration's recall
program to routinely and systematically assess--
(i) information submitted to the Secretary pursuant to a
device recall order under section 518(e) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360h(e)); and
(ii) information required to be reported to the Secretary
regarding a correction or removal of a device under section
519(g) of such Act (21 U.S.C. 360i(g)).
(B) Use.--The Secretary shall use the assessment of
information described under subparagraph (A) to proactively
identify strategies for mitigating health risks presented by
defective or unsafe devices.
(2) Design.--The program under paragraph (1) shall, at a
minimum, identify--
(A) trends in the numbers and types of device recalls;
(B) the types of devices in each device class that are most
frequently recalled;
(C) the causes of device recalls; and
(D) any other information as the Secretary determines
appropriate.
(b) Audit Check Procedures.--The Secretary shall clarify
procedures for conducting device recall audit checks to
improve the ability of investigators to perform these checks
in a consistent manner.
(c) Assessment Criteria.--The Secretary shall develop
explicit criteria for assessing whether a person subject to a
recall order under section 518(e) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360h(e)) or to a requirement
under section 519(g) of such Act (21 U.S.C. 360i(g)) has
performed an effective recall under such section 518(e) or an
effective correction or removal action under such section
519(g), respectively.

[[Page S3585]]

(d) Termination of Recalls.--The Secretary shall document
the basis for the termination by the Food and Drug
Administration of--
(1) an individual device recall ordered under section
518(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360h(e)); and
(2) any correction or removal action for which a report is
required to be submitted to the Secretary under section
519(g) of such Act (21 U.S.C. 360i(g)).

SEC. 606. CLINICAL HOLDS ON INVESTIGATIONAL DEVICE
EXEMPTIONS.

Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at
the end the following:
``(8)(A) At any time, the Secretary may prohibit the
sponsor of an investigation from conducting the investigation
(referred to in this paragraph as a `clinical hold') if the
Secretary makes a determination described in subparagraph
(B). The Secretary shall specify the basis for the clinical
hold, including the specific information available to the
Secretary which served as the basis for such clinical hold,
and confirm such determination in writing.
``(B) For purposes of subparagraph (A), a determination
described in this subparagraph with respect to a clinical
hold is a determination that--
``(i) the device involved represents an unreasonable risk
to the safety of the persons who are the subjects of the
clinical investigation, taking into account the
qualifications of the clinical investigators, information
about the device, the design of the clinical investigation,
the condition for which the device is to be investigated, and
the health status of the subjects involved; or
``(ii) the clinical hold should be issued for such other
reasons as the Secretary may by regulation establish.
``(C) Any written request to the Secretary from the sponsor
of an investigation that a clinical hold be removed shall
receive a decision, in writing and specifying the reasons
therefor, within 30 days after receipt of such request. Any
such request shall include sufficient information to support
the removal of such clinical hold.''.

SEC. 607. UNIQUE DEVICE IDENTIFIER.

Section 519(f) (21 U.S.C. 360i(f)) is amended--
(1) by striking ``The Secretary shall promulgate'' and
inserting ``Not later than December 31, 2012, the Secretary
shall issue proposed''; and
(2) by adding at the end the following: ``The Secretary
shall finalize the proposed regulations not later than 6
months after the close of the comment period and shall
implement the final regulations with respect to devices that
are implantable, life-saving, and life sustaining not later
than 2 years after the regulations are finalized.''.

SEC. 608. CLARIFICATION OF LEAST BURDENSOME STANDARD.

(a) Premarket Approval.--Section 513(a)(3)(D) (21 U.S.C.
360c(a)(3)(D)) is amended--
(1) by redesignating clause (iii) as clause (v); and
(2) by inserting after clause (ii) the following:
``(iii) For purposes of clause (ii), the term `necessary'
means the minimum required information that would support a
determination by the Secretary that an application provides
reasonable assurance of the effectiveness of the device.
``(iv) Nothing in this subparagraph shall alter the
criteria for evaluating an application for premarket approval
of a device.''.
(b) Premarket Notification Under Section 510(k).--Section
513(i)(1)(D) (21 U.S.C. 360c(i)(1)(D)) is amended--
(1) by striking ``(D) Whenever'' and inserting ``(D)(i)
Whenever''; and
(2) by adding at the end the following:
``(ii) For purposes of clause (i), the term `necessary'
means the minimum required information that would support a
determination of substantial equivalence between a new device
and a predicate device.
``(iii) Nothing in this subparagraph shall alter the
standard for determining substantial equivalence between a
new device and a predicate device.''.

SEC. 609. CUSTOM DEVICES.

Section 520(b) (21 U.S.C. 360j(b)) is amended to read as
follows:
``(b) Custom Devices.--
``(1) In general.--The requirements of sections 514 and 515
shall not apply to a device that--
``(A) is created or modified in order to comply with the
order of an individual physician or dentist (or any other
specially qualified person designated under regulations
promulgated by the Secretary after an opportunity for an oral
hearing);
``(B) in order to comply with an order described in
subparagraph (A), necessarily deviates from an otherwise
applicable performance standard under section 514 or
requirement under section 515;
``(C) is not generally available in the United States in
finished form through labeling or advertising by the
manufacturer, importer, or distributor for commercial
distribution;
``(D) is designed to treat a unique pathology or
physiological condition that no other device is domestically
available to treat;
``(E)(i) is intended to meet the special needs of such
physician or dentist (or other specially qualified person so
designated) in the course of the professional practice of
such physician or dentist (or other specially qualified
person so designated); or
``(ii) is intended for use by an individual patient named
in such order of such physician or dentist (or other
specially qualified person so designated);
``(F) is assembled from components or manufactured and
finished on a case-by-case basis to accommodate the unique
needs described in clause (i) or (ii) of subparagraph (E);
and
``(G) may have common, standardized design characteristics,
chemical and material compositions, and manufacturing
processes as commercially distributed devices.
``(2) Limitations.--Paragraph (1) shall apply to a device
only if--
``(A) such device is for the purpose of treating a
sufficiently rare condition, such that conducting clinical
investigations on such device would be impractical;
``(B) production of such device under paragraph (1) is
limited to no more than 5 units per year of a particular
device type, provided that such replication otherwise
complies with this section; and
``(C) the manufacturer of such device created or modified
as described in paragraph (1) notifies the Secretary on an
annual basis, in a manner prescribed by the Secretary, of the
manufacture of such device.
``(3) Exception.--Paragraph (1) shall not apply to oral
facial devices.
``(4) Guidance.--Not later than 2 years after the date of
enactment of this section, the Secretary shall issue final
guidance on replication of multiple devices described in
paragraph (2)(B).''.

SEC. 610. AGENCY DOCUMENTATION AND REVIEW OF CERTAIN
DECISIONS REGARDING DEVICES.

Chapter V (21 U.S.C. 351 et seq.) is amended by inserting
after section 517 the following:

``SEC. 517A. AGENCY DOCUMENTATION AND REVIEW OF CERTAIN
DECISIONS REGARDING DEVICES.

``(a) Documentation of Rationale for Denial.--If the
Secretary renders a final decision to deny clearance of a
premarket notification under section 510(k) or approval of a
premarket application under section 515, or when the
Secretary disapproves an application for an investigational
exemption under 520(g), the written correspondence to the
applicant communicating that decision shall provide a
substantive summary of the scientific and regulatory
rationale for the decision.
``(b) Review of Denial.--
``(1) In general.--A person who has submitted a report
under section 510(k), an application under section 515, or an
application for an exemption under section 520(g) and for
whom clearance of the report or approval of the application
is denied may request a supervisory review of the decision to
deny such clearance or approval. Such review shall be
conducted by an individual at the organizational level above
the organization level at which the decision to deny the
clearance of the report or approval of the application is
made.
``(2) Submission of request.--A person requesting a
supervisory review under paragraph (1) shall submit such
request to the Secretary not later than 30 days after such
denial and shall indicate in the request whether such person
seeks an in-person meeting or a teleconference review.
``(3) Timeframe.--
``(A) In general.--Except as provided in subparagraph (B),
the Secretary shall schedule an in-person or teleconference
review, if so requested, not later than 30 days after such
request is made. The Secretary shall issue a decision to the
person requesting a review under this subsection not later
than 45 days after the request is made under paragraph (1),
or, in the case of a person who requests an in-person meeting
or teleconference, 30 days after such meeting or
teleconference.
``(B) Exception.--Subparagraph (A) shall not apply in cases
that involve consultation with experts outside of the Food
and Drug Administration, or in cases in which the sponsor
seeks to introduce evidence not already in the administrative
record at the time the denial decision was made.''.

SEC. 611. GOOD GUIDANCE PRACTICES RELATING TO DEVICES.

Subparagraph (C) of section 701(h)(1) (21 U.S.C. 371(h)(1))
is amended--
(1) by striking ``(C) For guidance documents'' and
inserting ``(C)(i) For guidance documents''; and
(2) by adding at the end the following:
``(ii) With respect to devices, if a notice to industry
guidance letter, a notice to industry advisory letter, or any
similar notice sets forth initial interpretations of a
regulation or policy or sets forth changes in interpretation
or policy, such notice shall be treated as a guidance
document for purposes of this subparagraph.''.

SEC. 612. MODIFICATION OF DE NOVO APPLICATION PROCESS.

(a) In General.--Section 513(f)(2) (21 U.S.C. 360c(f)(2))
is amended--
(1) by redesignating subparagraphs (B) and (C) as
subparagraphs (C) and (D), respectively;
(2) by amending subparagraph (A) to read as follows:
``(A) In the case of a type of device that has not
previously been classified under this Act, a person may do
one of the following:
``(i) Submit a report under section 510(k), and, if the
device is classified into class III under paragraph (1), such
person may request, not later than 30 days after receiving

[[Page S3586]]

written notice of such a classification, the Secretary to
classify the device under the criteria set forth in
subparagraphs (A) through (C) of subsection (a)(1). The
person may, in the request, recommend to the Secretary a
classification for the device. Any such request shall
describe the device and provide detailed information and
reasons for the recommended classification.
``(ii) Submit a request for initial classification of the
device under this subparagraph, if the person declares that
there is no legally marketed device upon which to base a
substantial equivalence determination as that term is defined
in subsection (i). Subject to subparagraph (B), the Secretary
shall classify the device under the criteria set forth in
subparagraphs (A) through (C) of subsection (a)(1). The
person submitting the request for classification under this
subparagraph may recommend to the Secretary a classification
for the device and shall, if recommending classification in
class II, include in the request an initial draft proposal
for applicable special controls, as described in subsection
(a)(1)(B), that are necessary, in conjunction with general
controls, to provide reasonable assurance of safety and
effectiveness and a description of how the special controls
provide such assurance. Requests under this clause shall be
subject to the electronic copy requirements of section
745A(b).'';
(3) by inserting after subparagraph (A) the following:
``(B) The Secretary may decline to undertake a
classification request submitted under clause (2)(A)(ii) if
the Secretary identifies a legally marketed device that could
provide a reasonable basis for review of substantial
equivalence under paragraph (1), or when the Secretary
determines that the device submitted is not of low-moderate
risk or that general controls would be inadequate to control
the risks and special controls to mitigate the risks cannot
be developed.''; and
(4) in subparagraph (C), as so redesignated--
(A) in clause (i), by striking ``Not later than 60 days
after the date of the submission of the request under
subparagraph (A),'' and inserting ``Not later than 120 days
after the date of the submission of the request under
subparagraph (A)(i) or 150 days after the date of the
submission of the request under subparagraph (A)(ii),''; and
(B) in clause (ii), by inserting ``or is classified in''
after ``remains in''.
(b) GAO Report.--Not later than 2 years after the date of
enactment of this Act, the Comptroller General of the United
States shall complete a study and submit to Congress a report
on the effectiveness of the review pathway under section
513(f)(2)(A) of the Federal Food, Drug, and Cosmetic Act, as
amended by this Act.
(c) Conforming Amendment.--Section 513(f)(1)(B) (21 U.S.C.
360c(f)(1)(B)) is amended by inserting ``a request under
paragraph (2) or'' after ``response to''.

SEC. 613. HUMANITARIAN DEVICE EXEMPTIONS.

(a) In General.--Section 520(m) (21 U.S.C. 360j(m)) is
amended--
(1) in paragraph (6)--
(A) in subparagraph (A)--
(i) by striking clause (i) and inserting the following:
``(i) The device with respect to which the exemption is
granted--
``(I) is intended for the treatment or diagnosis of a
disease or condition that occurs in pediatric patients or in
a pediatric subpopulation, and such device is labeled for use
in pediatric patients or in a pediatric subpopulation in
which the disease or condition occurs; or
``(II) is intended for the treatment or diagnosis of a
disease or condition that does not occur in pediatric
patients or that occurs in pediatric patients in such numbers
that the development of the device for such patients is
impossible, highly impracticable, or unsafe.''; and
(ii) by striking clause (ii) and inserting the following:
``(ii) During any calendar year, the number of such devices
distributed during that year under each exemption granted
under this subsection does not exceed the annual distribution
number for such device. In this paragraph, the term `annual
distribution number' means the number of such devices
reasonably needed to treat, diagnose, or cure a population of
4,000 individuals in the United States. The Secretary shall
determine the annual distribution number when the Secretary
grants such exemption.''; and
(B) by amending subparagraph (C) to read as follows:
``(C) A person may petition the Secretary to modify the
annual distribution number determined by the Secretary under
subparagraph (A)(ii) with respect to a device if additional
information arises, and the Secretary may modify such annual
distribution number.'';
(2) in paragraph (7), by striking ``regarding a device''
and inserting ``regarding a device described in paragraph
(6)(A)(i)(I)''; and
(3) in paragraph (8), by striking ``of all devices
described in paragraph (6)'' and inserting ``of all devices
described in paragraph (6)(A)(i)(I)''.
(b) Applicability To Existing Devices.--A sponsor of a
device for which an exemption was approved under paragraph
(2) of section 520(m) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360j(m)) before the date of enactment of this
Act may seek a determination under subclause (I) or (II) of
section 520(m)(6)(A)(i) (as amended by subsection (a)). If
the Secretary of Health and Human Services determines that
such subclause (I) or (II) applies with respect to a device,
clauses (ii), (iii), and (iv) of subparagraph (A) and
subparagraphs (B), (C), (D), and (E) of paragraph (6) of such
section 520(m) shall apply to such device, and the Secretary
shall determine the annual distribution number for purposes
of clause (ii) of such subparagraph (A) when making the
determination under this subsection.
(c) Report.--Not later than January 1, 2017, the
Comptroller General of the United States shall submit to
Congress a report that evaluates and describes--
(1) the effectiveness of the amendments made by subsection
(a) in stimulating innovation with respect to medical
devices, including any favorable or adverse impact on
pediatric device development;
(2) the impact of such amendments on pediatric device
approvals for devices that received a humanitarian use
designation under section 520(m) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360j(m)) prior to the date of
enactment of this Act;
(3) the status of public and private insurance coverage of
devices granted an exemption under paragraph (2) of such
section 520(m) (as amended by subsection (a)) and costs to
patients of such devices;
(4) the impact that paragraph (4) of such section 520(m)
has had on access to and insurance coverage of devices
granted an exemption under paragraph (2) of such section
520(m); and
(5) the effect of the amendments made by subsection (a) on
patients described in such section 520(m).

SEC. 614. REAUTHORIZATION OF THIRD-PARTY REVIEW AND
INSPECTIONS.

(a) Third Party Review.--Section 523(c) (21 U.S.C. 360m(c))
is amended by striking ``2012'' and inserting ``2017''.
(b) Third Party Inspections.--Section 704(g)(11) (21 U.S.C.
374(g)(11)) is amended by striking ``2012'' and inserting
``2017''.

SEC. 615. 510(K) DEVICE MODIFICATIONS.

Having acknowledged to Congress potential unintended
consequences that may result from the implementation of the
Food and Drug Administration guidance entitled ``Guidance for
Industry and FDA Staff--510(k) Device Modifications: Deciding
When to Submit a 510(k) for a Change to an Existing Device'',
the Secretary of Health and Human Services shall withdraw
such guidance promptly and ensure that, before any future
guidance document on this issue is made final, affected
stakeholders are provided with an opportunity to comment.

SEC. 616. HEALTH INFORMATION TECHNOLOGY.

(a) Limitation.--Notwithstanding any other provision of
law, the Secretary of Health and Human Services (referred to
in this section as the ``Secretary'') may issue final
guidance on medical mobile applications only after the
requirements under subsections (b) and (c) are met.
(b) Report.--Not later than 18 months after the date of
enactment of this Act, the Secretary, in consultation with
the Commissioner of Food and Drugs, the National Coordinator
for Health Information Technology, and the Chairman of the
Federal Communications Commission, shall submit to the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House
of Representatives a report that contains a proposed strategy
and recommendations on an appropriate, risk-based regulatory
framework pertaining to medical device regulation and health
information technology software, including mobile
applications, that promotes innovation and protects patient
safety.
(c) Working Group.--
(1) In general.--In carrying out subsection (b), the
Secretary shall convene a working group of external
stakeholders and experts to provide appropriate input on the
strategy and recommendations required for the report under
subsection (b).
(2) Representatives.--The Secretary shall determine the
number of representatives participating in the working group,
and shall ensure that the working group is geographically
diverse and includes representatives of patients, consumers,
health care providers, startup companies, health plans or
other third-party payers, venture capital investors,
information technology vendors, small businesses, purchasers,
employers, and other stakeholders with relevant expertise, as
determined by the Secretary.
(3) Other requirements.--
(A) FACA.--The Federal Advisory Committee Act (5 U.S.C.
App.) shall apply to the working group under this section.
(B) FFDCA advisory committees.--The requirements for
advisory committees under section 712 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379d 1), as amended by
section 1121, shall not apply to the working group under this
section.

TITLE VII--DRUG SUPPLY CHAIN

Subtitle A--Drug Supply Chain

SEC. 701. REGISTRATION OF DOMESTIC DRUG ESTABLISHMENTS.

Section 510 (21 U.S.C. 360) is amended--
(1) in subsection (b)--
(A) in paragraph (1), by striking ``On or before'' and all
that follows through the period at the end and inserting the
following: ``During the period beginning on October 1 and
ending on December 31 of each year, every person who owns or
operates any establishment in any State engaged in the
manufacture, preparation, propagation, compounding, or
processing of a drug or drugs shall register with the
Secretary--

[[Page S3587]]

``(A) the name of such person, places of business of such
person, all such establishments, the unique facility
identifier of each such establishment, and a point of contact
e-mail address; and
``(B) the name and place of business of each importer that
takes physical possession of and supplies a drug (other than
an excipient) to such person, including all establishments of
each such drug importer, the unique facility identifier of
each such drug importer establishment, and a point of contact
e-mail address for each such drug importer.''; and
(B) by adding at the end the following:
``(3) The Secretary may specify the unique facility
identifier system that shall be used by registrants under
paragraph (1).''; and
(2) in subsection (c), by striking ``with the Secretary his
name, place of business, and such establishment'' and
inserting ``with the Secretary--
``(1) with respect to drugs, the information described
under subsection (b)(1); and
``(2) with respect to devices, the information described
under subsection (b)(2).''.

SEC. 702. REGISTRATION OF FOREIGN ESTABLISHMENTS.

(a) Enforcement of Registration of Foreign
Establishments.--Section 502(o) (21 U.S.C. 352(o)) is amended
by striking ``in any State''.
(b) Registration of Foreign Drug Establishments.--Section
510(i) (U.S.C. 360(i)) is amended--
(1) in paragraph (1)--
(A) by amending the matter preceding subparagraph (A) to
read as follows: ``Every person who owns or operates any
establishment within any foreign country engaged in the
manufacture, preparation, propagation, compounding, or
processing of a drug or device that is imported or offered
for import into the United States shall, through electronic
means in accordance with the criteria of the Secretary--'';
(B) by amending subparagraph (A) to read as follows:
``(A) upon first engaging in any such activity, immediately
submit a registration to the Secretary that includes--
``(i) with respect to drugs, the name and place of business
of such person, all such establishments, the unique facility
identifier of each such establishment, a point of contact e-
mail address, the name of the United States agent of each
such establishment, the name and place of business of each
drug importer with which such person conducts business to
import or offer to import drugs into the United States,
including all establishments of each such drug importer, the
unique facility identifier of each such establishment, and a
point of contact e-mail address for each such drug importer;
and
``(ii) with respect to devices, the name and place of
business of the establishment, the name of the United States
agent for the establishment, the name of each importer of
such device in the United States that is known to the
establishment, and the name of each person who imports or
offers for import such device to the United States for
purposes of importation; and''; and
(C) by amending subparagraph (B) to read as follows:
``(B) each establishment subject to the requirements of
subparagraph (A) shall thereafter register with the Secretary
during the period beginning on October 1 and ending on
December 31 of each year.''; and
(2) by adding at the end the following:
``(4) The Secretary may specify the unique facility
identifier system that shall be used by registrants under
paragraph (1) with respect to drugs.''.

SEC. 703. IDENTIFICATION OF DRUG EXCIPIENT INFORMATION WITH
PRODUCT LISTING.

Section 510(j)(1) (21 U.S.C. 360(j)(1)) is amended--
(1) in subparagraph (C), by striking ``; and'' and
inserting a semicolon;
(2) in subparagraph (D), by striking the period at the end
and inserting ``; and''; and
(3) by adding at the end the following:
``(E) in the case of a drug contained in the applicable
list, the name and place of business of each manufacturer of
an excipient of the listed drug with which the person listing
the drug conducts business, including all establishments used
in the production of such excipient, the unique facility
identifier of each such establishment, and a point of contact
e-mail address for each such excipient manufacturer.''.

SEC. 704. ELECTRONIC SYSTEM FOR REGISTRATION AND LISTING.

Section 510(p) (21 U.S.C. 360(p)) is amended--
(1) by striking ``(p) Registrations and listings'' and
inserting the following:
``(p) Electronic Registration and Listing.--
``(1) In general.--Registration and listing''; and
(2) by adding at the end the following:
``(2) Electronic database.--Not later than 2 years after
the Secretary specifies a unique facility identifier system
under subsections (b) and (i), the Secretary shall maintain
an electronic database, which shall not be subject to
inspection under subsection (f), populated with the
information submitted as described under paragraph (1) that--
``(A) enables personnel of the Food and Drug Administration
to search the database by any field of information submitted
in a registration described under paragraph (1), or
combination of such fields; and
``(B) uses the unique facility identifier system to link
with other relevant databases within the Food and Drug
Administration, including the database for submission of
information under section 801(r).
``(3) Risk-based information and coordination.--The
Secretary shall ensure the accuracy and coordination of
relevant Food and Drug Administration databases in order to
identify and inform risk-based inspections under section
510(h).''.

SEC. 705. RISK-BASED INSPECTION FREQUENCY.

Section 510(h) (21 U.S.C. 360(h)) is amended to read as
follows:
``(h) Inspections.--
``(1) In general.--Every establishment that is required to
be registered with the Secretary under this section shall be
subject to inspection pursuant to section 704.
``(2) Biennial inspections for devices.--Every
establishment described in paragraph (1), in any State, that
is engaged in the manufacture, propagation, compounding, or
processing of a device or devices classified in class II or
III shall be so inspected by one or more officers or
employees duly designated by the Secretary, or by persons
accredited to conduct inspections under section 704(g), at
least once in the 2-year period beginning with the date of
registration of such establishment pursuant to this section
and at least once in every successive 2-year period
thereafter.
``(3) Risk-based schedule for drugs.--The Secretary, acting
through one or more officers or employees duly designated by
the Secretary, shall inspect establishments described in
paragraph (1) that are engaged in the manufacture,
preparation, propagation, compounding, or processing of a
drug or drugs (referred to in this subsection as `drug
establishments') in accordance with a risk-based schedule
established by the Secretary.
``(4) Risk factors.--In establishing the risk-based
scheduled under paragraph (3), the Secretary shall inspect
establishments according to the known safety risks of such
establishments, which shall be based on the following
factors:
``(A) The compliance history of the establishment.
``(B) The record, history, and nature of recalls linked to
the establishment.
``(C) The inherent risk of the drug manufactured, prepared,
propagated, compounded, or processed at the establishment.
``(D) The certifications described under sections 801(r)
and 809 for the establishment.
``(E) Whether the establishment has been inspected in the
preceding 4-year period.
``(F) Any other criteria deemed necessary and appropriate
by the Secretary for purposes of allocating inspection
resources.
``(5) Effect of status.--In determining the risk associated
with an establishment for purposes of establishing a risk-
based schedule under paragraph (3), the Secretary shall not
consider whether the drugs manufactured, prepared,
propagated, compounded, or processed by such establishment
are drugs described in section 503(b).
``(6) Annual report on inspections of establishments.--Not
later than February 1 of each year, the Secretary shall
submit a report to Congress regarding--
``(A)(i) the number of domestic and foreign establishments
registered pursuant to this section in the previous fiscal
year; and
``(ii) the number of such domestic establishments and the
number of such foreign establishments that the Secretary
inspected in the previous fiscal year;
``(B) with respect to establishments that manufacture,
prepare, propagate, compound, or process an active ingredient
of a drug, a finished drug product, or an excipient of a
drug, the number of each such type of establishment; and
``(C) the percentage of the budget of the Food and Drug
Administration used to fund the inspections described under
subparagraph (A).
``(7) Public availability of annual reports.--The Secretary
shall make the report required under paragraph (6) available
to the public on the Internet Web site of the Food and Drug
Administration.''.

SEC. 706. RECORDS FOR INSPECTION.

Section 704(a) (21 U.S.C. 374(a)) is amended by adding at
the end the following:
``(4)(A) Any records or other information that the
Secretary is entitled to inspect under this section from a
person that owns or operates an establishment that is engaged
in the manufacture, preparation, propagation, compounding, or
processing of a drug shall, upon the request of the
Secretary, be provided to the Secretary by such person within
a reasonable time frame, within reasonable limits and in a
reasonable manner, and in electronic form, at the expense of
such person. The Secretary's request shall include a clear
description of the records requested.
``(B) Upon receipt of the records requested under
subparagraph (A), the Secretary shall provide to the person
confirmation of the receipt of such records.
``(C) Nothing in this paragraph supplants the authority of
the Secretary to conduct inspections otherwise permitted
under this Act in order to ensure compliance by an
establishment with this Act.''.

SEC. 707. FAILURE TO ALLOW FOREIGN INSPECTION.

Section 801(a) (21 U.S.C. 381(a)) is amended by adding at
the end the following: ``Notwithstanding any other provision
of this subsection, the Secretary of Homeland Security shall,
upon request from the Secretary of

[[Page S3588]]

Health and Human Services refuse to admit into the United
States any article if the article was manufactured, prepared,
propagated, compounded, processed, or held at an
establishment that has refused to permit the Secretary of
Health and Human Services to enter or inspect the
establishment in the same manner and to the same extent as
the Secretary may inspect establishments under section
704.''.

SEC. 708. EXCHANGE OF INFORMATION.

Section 708 (21 U.S.C. 379) is amended--
(1) by striking ``confidential information'' and all that
follows through ``The Secretary'' and inserting
``CONFIDENTIAL INFORMATION.
``(a) Contractors.--The Secretary''; and
(2) by adding at the end the following:
``(b) Ability To Receive and Protect Confidential
Information Obtained From Foreign Governments.--
``(1) In general.--The Secretary shall not be required to
disclose under section 552 of title 5, United States Code
(commonly referred to as the Freedom of Information Act), or
any other provision of law, any information described in
subsection (c)(3) obtained from a foreign government agency,
if--
``(A) the information is provided or made available to the
United States Government voluntarily and on the condition
that the information not be released to the public; and
``(B) the information is covered by, and subject to, a
certification and written agreement under subsections (c)(1)
and (c)(2).
``(2) Time limitations.--The written agreement described in
subsection (c)(2) shall specify the time period for which the
non-disclosure requirements under paragraph (1) shall apply
to the voluntarily disclosed information. The non-disclosure
requirements under paragraph (1) shall not apply after the
date specified, but all other applicable legal protections,
including section 552 of title 5, United States Code and
section 319L(e)(1) of the Public Health Service Act, shall
continue to apply to such information, as appropriate. If no
date is specified in the written agreement, the non-
disclosure protections described in paragraph (1) shall not
exceed 3 years.
``(3) Disclosures not affected.--Nothing in this section
authorizes any official to withhold, or to authorize the
withholding of, information from Congress or information
required to be disclosed pursuant to an order of a court of
the United States.
``(4) Public information.--For purposes of section 552 of
title 5, United States Code, this subsection shall be
considered a statute described in section 552(b)(3)(B).
``(c) Authority To Enter Into Memoranda of Understanding
for Purposes of Information Exchange.--The Secretary may
enter into written agreements regarding the exchange of
information referenced in section 301(j) subject to the
following criteria:
``(1) Certification.--The Secretary may only enter into
written agreements under this subsection with foreign
governments that the Secretary has certified as having the
authority and demonstrated ability to protect trade secret
information from disclosure. Responsibility for this
certification shall not be delegated to any officer or
employee other than the Commissioner.
``(2) Written agreement.--The written agreement under this
subsection shall include a commitment by the foreign
government to protect information exchanged under this
subsection from disclosure unless and until the sponsor gives
written permission for disclosure or the Secretary makes a
declaration of a public health emergency pursuant to section
319 of the Public Health Service Act that is relevant to the
information.
``(3) Information exchange.--The Secretary may provide to a
foreign government that has been certified under paragraph
(1) and that has executed a written agreement under paragraph
(2) information referenced in section 301(j) in the following
circumstances:
``(A) Information concerning the inspection of a facility
may be provided if--
``(i) the Secretary reasonably believes, or that the
written agreement described in paragraph (2) establishes,
that the government has authority to otherwise obtain such
information; and
``(ii) the written agreement executed under paragraph (2)
limits the recipient's use of the information to the
recipient's civil regulatory purposes.
``(B) Information not described in subparagraph (A) may be
provided as part of an investigation, or to alert the foreign
government to the potential need for an investigation, if the
Secretary has reasonable grounds to believe that a drug has a
reasonable probability of causing serious adverse health
consequences or death to humans or animals.
``(4) Effect of subsection.--Nothing in this subsection
affects the ability of the Secretary to enter into any
written agreement authorized by other provisions of law to
share confidential information.''.

SEC. 709. ENHANCING THE SAFETY AND QUALITY OF THE DRUG
SUPPLY.

Section 501 (21 U.S.C. 351) is amended by adding at the end
the following flush text:
``For purposes of subsection (a)(2)(B), the term `current
good manufacturing practice' includes the implementation of
oversight and controls over the manufacture of drugs to
ensure quality, including managing the risk of and
establishing the safety of raw materials, materials used in
the manufacturing of drugs, and finished drug products.''.

SEC. 710. ACCREDITATION OF THIRD-PARTY AUDITORS FOR DRUG
ESTABLISHMENTS.

(a) In General.--Chapter VIII (21 U.S.C. 381 et seq.) is
amended by adding at the end the following:

``SEC. 809. ACCREDITATION OF THIRD-PARTY AUDITORS FOR DRUG
ESTABLISHMENTS.

``(a) Definitions.--In this section:
``(1) Accreditation body.--The term `accreditation body'
means an authority that performs accreditation of third-party
auditors.
``(2) Accredited third-party auditor.--The term `accredited
third-party auditor' means a third-party auditor (which may
be an individual) accredited by an accreditation body to
conduct drug safety and quality audits.
``(3) Audit agent.--The term `audit agent' means an
individual who is an employee or agent of an accredited
third-party auditor and, although not individually
accredited, is qualified to conduct drug safety and quality
audits on behalf of an accredited third-party auditor.
``(4) Consultative audit.--The term `consultative audit'
means an audit of an eligible entity intended for internal
purposes only to determine whether an establishment is in
compliance with the provisions of this Act and applicable
industry practices, or any other such service.
``(5) Drug safety and quality audit.--The term `drug safety
and quality audit'--
``(A) means an audit of an eligible entity to certify that
the eligible entity meets the requirements of this Act
applicable to drugs, including the requirements of section
501 with respect to drugs; and
``(B) is not a consultative audit.
``(6) Eligible entity.--The term `eligible entity' means an
entity, including a foreign drug establishment registered
under section 510(c), in the drug supply chain that chooses
to be audited by an accredited third-party auditor or the
audit agent of such accredited third-party auditor.
``(7) Third-party auditor.--The term `third-party auditor'
means a foreign government, agency of a foreign government or
any other third party (which may be an individual), as the
Secretary determines appropriate in accordance with the
criteria described in subsection (c)(1), that is eligible to
be considered for accreditation to conduct drug safety and
quality audits.
``(b) Accreditation System.--
``(1) Recognition of accreditation bodies.--
``(A) In general.--Not later than 2 years after date of
enactment of the Food and Drug Administration Safety and
Innovation Act, the Secretary shall establish a system for
the recognition of accreditation bodies that accredit third-
party auditors to conduct drug safety and quality audits.
``(B) Direct accreditation.--
``(i) In general.--If, by the date that is 2 years after
the date of establishment of the system described in
subparagraph (A), the Secretary has not identified and
recognized an accreditation body to meet the requirements of
this section, the Secretary may directly accredit third-party
auditors.
``(ii) Certain direct accreditations.--Notwithstanding
subparagraph (A) or clause (i), the Secretary may directly
accredit any foreign government or any agency of a foreign
government as a third-party auditor at any time after the
date of enactment of the Food and Drug Administration Safety
and Innovation Act.
``(2) Notification.--Each accreditation body recognized by
the Secretary shall submit to the Secretary--
``(A) a list of all accredited third-party auditors
accredited by such body (including the name, contact
information, and scope and duration of accreditation for each
such auditor), and the audit agents of such auditors; and
``(B) updated lists as needed to ensure the list held by
the Secretary is accurate.
``(3) Revocation of recognition as an accreditation body.--
The Secretary shall promptly revoke, after the opportunity
for an informal hearing, the recognition of any accreditation
body found not to be in compliance with the requirements of
this section.
``(4) Reinstatement.--The Secretary shall establish
procedures to reinstate recognition of an accreditation body
if the Secretary determines, based on evidence presented by
such accreditation body, that revocation was inappropriate or
that the body meets the requirements for recognition under
this section.
``(5) Model accreditation standards.--
``(A) In general.--Not later than 18 months after the date
of enactment of the Food and Drug Administration Safety and
Innovation Act, the Secretary shall develop model standards,
including standards for drug safety and quality audit
results, reports, and certifications, and each recognized
accreditation body shall ensure that third-party auditors and
audit agents of such auditors meet such standards in order to
qualify such third-party auditors as accredited third-party
auditors under this section.
``(B) Content.--The standards developed under subparagraph
(A) may--
``(i) include a description of required standards relating
to the training procedures, competency, management
responsibilities, quality control, and conflict of interest
requirements of accredited third-party auditors; and

[[Page S3589]]

``(ii) set forth procedures for the periodic renewal of the
accreditation of accredited third-party auditors.
``(C) Requirement to provide results and reports to the
secretary.--An accreditation body (or, in the case of direct
accreditation under subsection (b)(1)(B), the Secretary) may
not accredit a third-party auditor unless such third-party
auditor agrees to provide to the Secretary, upon request, the
results and reports of any drug safety and quality audit
conducted pursuant to the accreditation provided under this
section.
``(6) Disclosure.--The Secretary shall maintain on the
Internet Web site of the Food and Drug Administration a list
of recognized accreditation bodies and accredited third-party
auditors under this section.
``(c) Accredited Third-party Auditors.--
``(1) Requirements for accreditation as a third-party
auditor.--
``(A) Foreign governments.--Prior to accrediting a foreign
government or an agency of a foreign government as an
accredited third-party auditor, the accreditation body (or,
in the case of direct accreditation under subsection
(b)(1)(B), the Secretary) shall perform such reviews and
audits of drug safety programs, systems, and standards of the
government or agency of the government as the Secretary deems
necessary, including requirements under the standards
developed under subsection (b)(5), to determine that the
foreign government or agency of the foreign government is
capable of adequately ensuring that eligible entities or
drugs certified by such government or agency meet the
requirements of this Act.
``(B) Other third parties.--Prior to accrediting any other
third party to be an accredited third-party auditor, the
accreditation body (or, in the case of direct accreditation
under subsection (b)(1)(B), the Secretary) shall perform such
reviews and audits of the training and qualifications of
audit agents used by that party and conduct such reviews of
internal systems and such other investigation of the party as
the Secretary deems necessary, including requirements under
the standards developed under subsection (b)(5), to determine
that the third-party auditor is capable of adequately
ensuring that an eligible entity or drug certified by such
third-party auditor meets the requirements of this Act.
``(2) Use of audit agents.--An accredited third-party
auditor may conduct drug safety and quality audits and may
employ or use audit agents to conduct drug safety and quality
audits, but must ensure that such audit agents comply with
all requirements the Secretary deems necessary, including
requirements under paragraph (1) and subsection (b)(5).
``(3) Revocation of accreditation.--
``(A) In general.--The Secretary shall promptly revoke,
after the opportunity for an informal hearing, the
accreditation of an accredited third-party auditor--
``(i) if, following an evaluation, the Secretary finds that
the accredited third-party auditor is not in compliance with
the requirements of this section; or
``(ii) following a refusal to allow United States officials
to conduct such audits and investigations as may be necessary
to determine compliance with the requirements set forth in
this section.
``(B) Additional basis for revocation of accreditation.--
The Secretary may revoke accreditation from an accredited
third-party auditor in the case that such third-party auditor
is accredited by an accreditation body for which recognition
as an accreditation body under subsection (b)(3) is revoked,
if the Secretary determines that there is good cause for the
revocation of accreditation.
``(4) Reaccreditation.--The Secretary shall establish
procedures to reinstate the accreditation of a third-party
auditor for which accreditation has been revoked under
paragraph (3)--
``(A) if the Secretary determines, based on evidence
presented, that--
``(i) the third-party auditor satisfies the requirements of
this section; and
``(ii) adequate grounds for revocation no longer exist; and
``(B) in the case of a third-party auditor accredited by an
accreditation body for which recognition as an accreditation
body is revoked under subsection (b)(3)--
``(i) if the third-party auditor becomes accredited not
later than 1 year after revocation of accreditation under
paragraph (3), through direct accreditation under subsection
(b)(1)(B), or by an accreditation body in good standing; or
``(ii) under such other conditions as the Secretary may
require.
``(5) Requirement to issue certification of eligible
entities for compliance with current good manufacturing
practice.--
``(A) In general.--An accreditation body (or, in the case
of direct accreditation under subsection (b)(1)(B), the
Secretary) may not accredit a third-party auditor unless such
third-party auditor agrees to issue a written and, as
appropriate, electronic, document or certification, as the
Secretary may require under this Act, regarding compliance
with section 501. The Secretary may consider any such
document or certification to satisfy requirements under
section 801(r) and to target inspection resources under
section 510(h).
``(B) Requirements for issuing certification.--
``(i) In general.--An accredited third-party auditor shall
issue a drug certification described in subparagraph (A) only
after conducting a drug safety and quality audit and such
other activities that may be necessary to establish
compliance with the provisions of section 501.
``(ii) Provision of certification.--Only an accredited
third-party auditor or the Secretary may provide a drug
certification described in subparagraph (A).
``(C) Records.--Following any accreditation of a third-
party auditor, the Secretary may, at any time, require the
accredited third-party auditor or any audit agent of such
auditor to submit to the Secretary a drug safety and quality
audit report and such other reports or documents required as
part of the drug safety and quality audit process, for any
eligible entity for which the accredited third-party auditor
or audit agent of such auditor performed a drug safety and
quality audit. The Secretary may require documentation that
the eligible entity is in compliance with any applicable
registration requirements.
``(D) Limitation.--The requirement under subparagraph (C)
shall not include any report or other documents resulting
from a consultative audit, except that the Secretary may
access the results of a consultative audit in accordance with
section 704.
``(E) Declaration of audit type.--Before an accredited
third-party auditor begins any audit or provides any
consultative service to an eligible entity, both the
accredited third-party auditor and eligible entity shall
establish in writing whether the audit is intended to be a
drug safety and quality audit. Any audit, inspection, or
consultative service of any type provided by an accredited
third-party auditor on behalf of an eligible entity shall be
presumed to be a drug safety and quality audit in the absence
of such a written agreement. Once a drug safety and quality
audit is initiated, it shall be subject to the requirements
of this section, and no person may withhold from the
Secretary any document subject to subparagraph (C) on the
grounds that the audit was a consultative audit or otherwise
not a drug safety and quality audit.
``(F) Rule of construction.--Nothing in this section shall
be construed to limit the authority of the Secretary under
section 704.
``(6) Requirements regarding serious risks to the public
health.--If, at any time during a drug safety and quality
audit, an accredited third-party auditor or an audit agent of
such auditor discovers a condition that could cause or
contribute to a serious risk to the public health, such
auditor shall immediately notify the Secretary of--
``(A) the identity and location of the eligible entity
subject to the drug safety and quality audit; and
``(B) such condition.
``(7) Limitations.--
``(A) In general.--An audit agent of an accredited third-
party auditor may not perform a drug safety and quality audit
of an eligible entity if such audit agent has performed a
drug safety and quality audit or consultative audit of such
eligible entity during the previous 13-month period.
``(B) Waiver.--The Secretary may waive the application of
subparagraph (A) if the Secretary determines that there is
insufficient access to accredited third-party auditors in a
country or region or that the use of the same audit agent or
accredited third-party auditor is otherwise necessary.
``(8) Conflicts of interest.--
``(A) Accreditation bodies.--A recognized accreditation
body shall--
``(i) not be owned, managed, or controlled by any person
that owns or operates a third-party auditor to be accredited
by such body;
``(ii) in carrying out accreditation of third-party
auditors under this section, have procedures to ensure
against the use of any officer or employee of such body that
has a financial conflict of interest regarding a third-party
auditor to be accredited by such body; and
``(iii) annually make available to the Secretary
disclosures of the extent to which such body and the officers
and employees of such body have maintained compliance with
clauses (i) and (ii) relating to financial conflicts of
interest.
``(B) Accredited third-party auditors.--An accredited
third-party auditor shall--
``(i) not be owned, managed, or controlled by any person
that owns or operates an eligible entity to be certified by
such auditor;
``(ii) in carrying out drug safety and quality audits of
eligible entities under this section, have procedures to
ensure against the use of any officer or employee of such
auditor that has a financial conflict of interest regarding
an eligible entity to be certified by such auditor; and
``(iii) annually make available to the Secretary
disclosures of the extent to which such auditor and the
officers and employees of such auditor have maintained
compliance with clauses (i) and (ii) relating to financial
conflicts of interest.
``(C) Audit agents.--An audit agent shall--
``(i) not own or operate an eligible entity to be audited
by such agent;
``(ii) in carrying out audits of eligible entities under
this section, have procedures to ensure that such agent does
not have a financial conflict of interest regarding an
eligible entity to be audited by such agent; and
``(iii) annually make available to the Secretary
disclosures of the extent to which such agent has maintained
compliance with clauses (i) and (ii) relating to financial
conflicts of interest.
``(d) False Statements.--Any statement or representation
made--

[[Page S3590]]

``(1) by an employee or agent of an eligible entity to an
accredited third-party auditor or audit agent; or
``(2) by an accreditation body, accredited third-party
auditor, or audit agent of such auditor to the Secretary,
shall be subject to section 1001 of title 18, United States
Code.
``(e) Monitoring.--To ensure compliance with the
requirements of this section, the Secretary--
``(1) shall periodically, or at least once every 4 years,
reevaluate the accreditation bodies described in subsection
(b)(1);
``(2) shall periodically, or at least once every 4 years,
evaluate the performance of each accredited third-party
auditor, through the review of regulatory audit reports by
such auditors, the compliance history as available of
eligible entities certified by such auditors, and any other
measures deemed necessary by the Secretary;
``(3) may at any time, conduct an onsite audit of any
eligible entity certified by an accredited third-party
auditor, with or without the auditor present; and
``(4) shall take any other measures deemed necessary by the
Secretary.
``(f) Effect of Audit.--The results of a drug safety and
quality audit by an accredited third-party auditor under this
section--
``(1) may be used by the eligible entity--
``(A) as documentation of compliance with section
501(a)(2)(B) or section 801(r); and
``(B) for other purposes as determined appropriate by the
Secretary; and
``(2) shall be used by the Secretary in establishing the
risk-based inspection schedules under section 510(h).
``(g) Costs.--
``(1) Authorized fees of secretary.--The Secretary may
assess fees on accreditation bodies and accredited third-
party auditors in such an amount necessary to establish and
administer the recognition and accreditation program under
this section. The Secretary may require accredited third-
party auditors and audit agents to reimburse the Food and
Drug Administration for the work performed to carry out this
section. The Secretary shall not generate surplus revenue
from such a reimbursement mechanism. Fees authorized under
this paragraph shall be collected and available for
obligation only to the extent and in the amount provided in
advance in appropriation Acts. Such fees are authorized to
remain available until expended.
``(2) Authorized fees for recognized accreditation
bodies.--An accreditation body recognized by the Secretary
under subsection (b) may assess a reasonable fee to accredit
third-party auditors.
``(h) Limitations.--
``(1) No effect on section 704 inspections.--The drug
safety and quality audits performed under this section shall
not be considered inspections under section 704.
``(2) No effect on inspection authority.--Nothing in this
section affects the authority of the Secretary to inspect any
eligible entity pursuant to this Act.
``(i) Regulations.--
``(1) In general.--Not later than 18 months after the date
of enactment of the Food and Drug Administration Safety and
Innovation Act, the Secretary shall adopt final regulations
implementing this section.
``(2) Procedure.--In promulgating the regulations
implementing this section, the Secretary shall--
``(A) issue a notice of proposed rulemaking that includes
the proposed regulation;
``(B) provide a period of not less than 60 days for
comments on the proposed regulation; and
``(C) publish the final regulation not less than 30 days
before the effective date of the regulation.
``(3) Content.--Such regulations shall include--
``(A) requirements that, to the extent practicable, drug
safety and quality audits performed under this section be
unannounced;
``(B) a structure to decrease the potential for conflicts
of interest, including timing and public disclosure, for fees
paid by eligible entities to accredited third-party auditors;
and
``(C) appropriate limits on financial affiliations between
an accredited third-party auditor or audit agents of such
auditor and any person that owns or operates an eligible
entity to be audited by such auditor, as described in
subparagraphs (A) and (B).
``(4) Restrictions.--Notwithstanding any other provision of
law, the Secretary shall promulgate regulations implementing
this section only as described in paragraph (2).''.
(b) Report on Accredited Third-party Auditors.--Not later
than January 20, 2017, the Comptroller General of the United
States shall submit to Congress a report that addresses the
following, with respect to the period beginning on the date
of implementation of section 809 of the Federal Food, Drug,
and Cosmetic Act (as added by subsection (a)) and ending on
the date of such report:
(1) The extent to which drug safety and quality audits
completed by accredited third-party auditors under such
section 809 are being used by the Secretary of Health and
Human Services (referred to in this subsection as the
``Secretary'') in establishing or applying the risk-based
inspection schedules under section 510(h) of such Act (as
amended by section 705).
(2) The extent to which drug safety and quality audits
completed by accredited third-party auditors or agents are
assisting the Food and Drug Administration in evaluating
compliance with sections 501(a)(2)(B) of such Act (21 U.S.C.
351(a)(2)(B)) and 801(r) of such Act (as added by section
711).
(3) Whether the Secretary has been able to access drug
safety and quality audit reports completed by accredited
third-party auditors under such section 809.
(4) Whether accredited third-party auditors accredited
under such section 809 have adhered to the conflict of
interest provisions set forth in such section.
(5) The extent to which the Secretary has audited
recognized accreditation bodies or accredited third-party
auditors to ensure compliance with the requirements of such
section 809.
(6) The number of waivers under subsection (c)(7)(B) of
such section 809 issued during the most recent 12-month
period and the official justification by the Secretary for
each determination that there was insufficient access to an
accredited third-party auditor.
(7) The number of times a manufacturer has used the same
accredited third-party auditor for 2 or more consecutive drug
safety and quality audits under such section 809.
(8) Recommendations to Congress regarding the accreditation
program under such section 809, including whether Congress
should continue, modify, or terminate the program.

SEC. 711. STANDARDS FOR ADMISSION OF IMPORTED DRUGS.

Section 801 (21 U.S.C. 381) is amended--
(1) in subsection (o), by striking ``drug or''; and
(2) by adding at the end the following:
``(r)(1) The Secretary may require, as a condition of
granting admission to a drug imported or offered for import
into the United States, that the importer electronically
submit information demonstrating that the drug complies with
applicable requirements of this Act.
``(2) The information described under paragraph (1) may
include--
``(A) information demonstrating the regulatory status of
the drug, such as the new drug application, abbreviated new
drug application, or investigational new drug or drug master
file number;
``(B) facility information, such as proof of registration
and the unique facility identifier;
``(C) indication of compliance with current good
manufacturing practice, testing results, certifications
relating to satisfactory inspections, and compliance with the
country of export regulations; and
``(D) any other information deemed necessary and
appropriate by the Secretary to assess compliance of the
article being offered for import.
``(3) Information requirements referred to in paragraph
(2)(C) may, at the discretion of the Secretary, be
satisfied--
``(A) by certifications from accredited third parties, as
described under section 809;
``(B) through representation by a foreign government, if
such inspection is conducted using standards and practices as
determined appropriate by the Secretary; or
``(C) other appropriate documentation or evidence as
described by the Secretary.
``(4)(A) Not later than 18 months after the date of
enactment of the Food and Drug Administration Safety and
Innovation Act, the Secretary shall adopt final regulations
implementing this subsection. Such requirements shall be
appropriate for the type of import, such as whether the drug
is for import into the United States for use in preclinical
research or in a clinical investigation under an
investigational new drug exemption under 505(i).
``(B) In promulgating the regulations implementing this
subsection, the Secretary shall--
``(i) issue a notice of proposed rulemaking that includes
the proposed regulation;
``(ii) provide a period of not less than 60 days for
comments on the proposed regulation; and
``(iii) publish the final regulation not less than 30 days
before the effective date of the regulation.
``(C) Notwithstanding any other provision of law, the
Secretary shall promulgate regulations implementing this
subsection only as described in subparagraph (B).''.

SEC. 712. NOTIFICATION.

(a) Prohibited Acts.--Section 301 (21 U.S.C. 331) is
amended by adding at the end the following:
``(aaa) The failure to notify the Secretary in violation of
section 568.''.
(b) Notification.--
(1) In general.--Subchapter E of chapter V (21 U.S.C.
360bbb et seq.) is amended by adding at the end the
following:

``SEC. 568. NOTIFICATION.

``(a) Notification to Secretary.--With respect to a drug,
the Secretary may require notification to the Secretary by a
covered person if the covered person knows--
``(1) of a substantial loss or theft of such drug; or
``(2) that such drug--
``(A) has been or is being counterfeited; and
``(B)(i) is a counterfeit product in commerce in the United
States; or
``(ii) is offered for import into the United States.
``(b) Manner of Notification.--Notification under this
section shall be made in a reasonable time, in such
reasonable manner, and by such reasonable means as the
Secretary may require by regulation or specify in guidance.
``(c) Definition.--In this section, the term `covered
person' means--

[[Page S3591]]

``(1) a person who is required to register under section
510 with respect to an establishment engaged in the
manufacture, preparation, propagation, compounding, or
processing of a drug; or
``(2) a person engaged in the wholesale distribution (as
defined in section 503(e)(3)(B)) of a drug.''.
(2) Applicability.--Notifications under section 568 of the
Federal Food, Drug, and Cosmetic Act (as added by paragraph
(1)) apply to losses, thefts, or counterfeiting, as described
in subsection (a) of such section 568, that occur on or after
the date of enactment of this Act.

SEC. 713. PROTECTION AGAINST INTENTIONAL ADULTERATION.

Section 303(b) (21 U.S.C. 333(b)) is amended by adding at
the end the following:
``(7) Notwithstanding subsection (a)(2), any person that
knowingly and intentionally adulterates a drug such that the
drug is adulterated under subsection (a)(1), (b), (c), or (d)
of section 501 and has a reasonable probability of causing
serious adverse health consequences or death to humans or
animals shall be imprisoned for not more than 20 years or
fined not more than $1,000,000, or both.''.

SEC. 714. ENHANCED CRIMINAL PENALTY FOR COUNTERFEITING DRUGS.

(a) FFDCA.--Section 303(b) (21 U.S.C. 333(b)), as amended
by section 713, is further amended by adding at the end the
following:
``(8) Notwithstanding subsection (a)(2), any person who
knowingly and intentionally violates section 301(i) shall be
imprisoned for not more than 20 years or fined not more than
$4,000,000 or both.''.
(b) Title 18.--Section 2320(b) of title 18, United States
Code, is amended--
(1) by redesignating paragraphs (2) and (3) as paragraphs
(3) and (4), respectively; and
(2) by inserting after paragraph (1) the following:
``(2) Counterfeit drugs.--
``(A) In general.--Whoever commits an offense under
subsection (a) with respect to a drug (as defined in section
201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321)) shall--
``(i) if an individual, be fined not more than $4,000,000,
imprisoned not more than 20 years, or both; and
``(ii) if a person other than an individual, be fined not
more than $10,000,000.
``(B) Multiple offenses.--In the case of an offense by a
person under this paragraph that occurs after that person is
convicted of another offense under this paragraph, the person
convicted--
``(i) if an individual, shall be fined not more than
$8,000,000, imprisoned not more than 20 years, or both; and
``(ii) if other than an individual, shall be fined not more
than $20,000,000.''.
(c) Sentencing.--
(1) Directive to sentencing commission.--Pursuant to its
authority under section 994(p) of title 28, United States
Code, and in accordance with this section, the United States
Sentencing Commission shall review and amend, if appropriate,
its guidelines and its policy statements applicable to
persons convicted of an offense described in section
2320(b)(2) of title 18, United States Code, as amended by
subsection (b), in order to reflect the intent of Congress
that such penalties be increased in comparison to those
currently provided by the guidelines and policy statements.
(2) Requirements.--In carrying out this subsection, the
Commission shall--
(A) ensure that the sentencing guidelines and policy
statements reflect the intent of Congress that the guidelines
and policy statements reflect the serious nature of the
offenses described in paragraph (1) and the need for an
effective deterrent and appropriate punishment to prevent
such offenses;
(B) consider the extent to which the guidelines may or may
not appropriately account for the potential and actual harm
to the public resulting from the offense;
(C) assure reasonable consistency with other relevant
directives and with other sentencing guidelines;
(D) account for any additional aggravating or mitigating
circumstances that might justify exceptions to the generally
applicable sentencing ranges;
(E) make any necessary conforming changes to the sentencing
guidelines; and
(F) assure that the guidelines adequately meet the purposes
of sentencing as set forth in section 3553(a)(2) of title 18,
United States Code.

SEC. 715. EXTRATERRITORIAL JURISDICTION.

Chapter III (21 U.S.C. 331 et seq.) is amended by adding at
the end the following:

``SEC. 311. EXTRATERRITORIAL JURISDICTION.

``There is extraterritorial jurisdiction over any violation
of this Act relating to any article regulated under this Act
if such article was intended for import into the United
States or if any act in furtherance of the violation was
committed in the United States.''.

SEC. 716. COMPLIANCE WITH INTERNATIONAL AGREEMENTS.

Nothing in this title (or an amendment made by this title)
shall be construed in a manner inconsistent with the
obligations of the United States under the Agreement
Establishing the World Trade Organization, or any other
treaty or international agreement to which the United States
is a party.

Subtitle B--Pharmaceutical Distribution Integrity

SEC. 721. SHORT TITLE.

This subtitle may be referred to as the ``Securing
Pharmaceutical Distribution Integrity to Protect the Public
Health Act of 2012'' or the ``Securing Pharmaceutical
Distribution Integrity Act of 2012''.

SEC. 722. SECURING THE PHARMACEUTICAL DISTRIBUTION SUPPLY
CHAIN.

(a) In General.--Chapter V (21 U.S.C. 351 et seq.) is
amended by adding at the end the following:

``Subchapter H--Pharmaceutical Distribution Integrity

``SEC. 581. DEFINITIONS.

``In this subchapter:
``(1) Data carrier.--The term `data carrier' means a
machine-readable graphic that is intended to be affixed to,
or imprinted upon, an individual saleable unit and a
homogeneous case of product. The data carrier shall comply
with a form and format developed by a widely recognized
international standards development organization to ensure
interoperability among distribution chain participants.
``(2) Individual saleable unit.--The term `individual
saleable unit' means the smallest container of product put
into interstate commerce by the manufacturer that is intended
by the manufacturer for individual sale to a pharmacy or
other dispenser of such product.
``(3) Product.--The term `product' means a finished drug
subject to section 503(b)(1).
``(4) Product tracing.--The term `product tracing' means--
``(A) identifying the immediate previous source and
immediate subsequent recipient of a product in wholesale
distribution at the lot level where a change of ownership of
such product has occurred between non-affiliated entities,
except as otherwise described in this subchapter;
``(B) identifying the immediate subsequent recipient of the
product at the lot level when a manufacturer or repackager
introduces such product into interstate commerce;
``(C) identifying that manufacturer and dispenser of a
product at the lot level when a manufacturer ships a product
at the lot level, without regard to the change in ownership
involving the wholesale distributor; and
``(D) identifying the immediate previous source of a
product at the lot level for dispensers.
``(5) Rxtec.--The term `RxTEC' means a data carrier that
includes the standardized numerical identifier (SNI), the lot
number, and the expiration date of a product. The standard
data carrier RxTEC shall be a 2D data matrix barcode affixed
to each individual saleable unit of a product and a linear or
2D data matrix barcode on a homogenous case of a product.
Such information shall be both machine readable and human
readable.
``(6) Suspect product.--The term `suspect product' means a
product that, based on credible evidence--
``(A) is potentially counterfeit, diverted, or stolen;
``(B) is reasonably likely to be intentionally adulterated
such that the product would result in serious adverse health
consequences or death to humans; or
``(C) appears otherwise unfit for distribution such that
the product would result in serious adverse health
consequence or death to humans.
``(7) Verification.--The term `verification' means the
process of determining whether a product has the standardized
numerical identifier or lot number, consistent with section
582, and expiration date assigned by the manufacturer, or the
repackager as applicable, and identifying whether a product
has the appearance of being a counterfeit, diverted, or
stolen product, or a product otherwise unfit for
distribution. Verification of the RxTEC data may occur by
using either a human-readable, machine-readable, or other
method such as through purchase records or invoices.

``SEC. 582. ENSURING THE SAFETY OF THE PHARMACEUTICAL
DISTRIBUTION SUPPLY CHAIN THROUGH THE
ESTABLISHMENT OF AN RXTEC SYSTEM.

``(a) Manufacturer Requirements.--
``(1) Product tracing.--A manufacturer, not later than 4\1/
2\ years after the date of enactment of the Securing
Pharmaceutical Distribution Integrity Act of 2012 and in
accordance with this section, shall--
``(A) apply RxTEC to the individual saleable units and
homogeneous case of all products intended to be introduced
into interstate commerce;
``(B) maintain change of ownership and transaction
information, including RxTEC data that associate unit and lot
level data for each individual saleable unit of product and
homogenous case introduced in interstate commerce; and
``(C) maintain, where a change of ownership has occurred
between non-affiliated entities or, in the case of a return
from the immediate previous source, change of ownership and
transaction information relating to a product, including--
``(i) RxTEC data;
``(ii) the business name and address of the immediate
previous source, if applicable, and the immediate subsequent
recipient of the product;
``(iii) the proprietary or established name or names of the
product;
``(iv) the National Drug Code number of the product;
``(v) container size;
``(vi) number of containers;
``(vii) the lot number or numbers of the product; and
``(viii) the date of the transaction;
``(D) provide the following change of ownership and trans
action information to the

[[Page S3592]]

immediate subsequent recipient of such product--
``(i) the proprietary or established name or names of the
product;
``(ii) the National Drug Code number of the product;
``(iii) container size;
``(iv) number of containers;
``(v) the lot number or numbers of the product; and
``(vi) a signed statement that the manufacturer did not
knowingly and intentionally adulterate or knowingly and
intentionally counterfeit such product; and
``(E) upon request by the Secretary, other appropriate
Federal official, or State official, in the event of a recall
or as determined necessary by the Secretary, or such other
Federal or State official, to investigate a suspect product,
provide in a reasonable time and in a reasonable manner--
``(i) RxTEC data by lot; and
``(ii) change of ownership and transaction information
pursuant to subparagraphs (C) and (D) necessary to identify
the immediate previous source or immediate subsequent
recipient of such product, as applicable.
``(2) Verification requirements.--A manufacturer, not later
than 4\1/2\ years after the date of enactment of the Securing
Pharmaceutical Distribution Integrity Act of 2012 and in
accordance with this section, shall--
``(A) utilize RxTEC data at the lot level, as part of
ongoing activities to significantly minimize or prevent the
incidences of a suspect product in the pharmaceutical
distribution supply chain, as applicable and appropriate,
which--
``(i) may include responding to an alert regarding a
suspect product from a trading partner or the Secretary,
routine monitoring of a suspect product at the lot level
while such product is in the possession of the manufacturer,
and checking inventory for a suspect product at the request
of a trading partner or the Secretary in case of returns; and
``(ii) shall take into consideration--

``(I) the likelihood that a particular product has a high
potential risk with respect to pharmaceutical distribution
supply chain security;
``(II) the history and severity of incidences of
counterfeit, diversion, and theft of such product;
``(III) the point in the pharmaceutical distribution supply
chain where counterfeit, diversion, or theft has occurred or
is most likely to occur;
``(IV) the likelihood that such activities will reduce the
possibility of the counterfeit, diversion, and theft of such
product;
``(V) whether the product could mitigate or prevent a drug
shortage as defined in section 506C; and
``(VI) any guidance the Secretary issues regarding high-
risk scenarios that could increase the risk of a suspect
product entering the pharmaceutical distribution supply
chain; and

``(B) conduct unit level verification upon the request of a
licensed or registered repackager, wholesale distributor,
dispenser, or the Secretary, regarding such product.
``(3) Notification of product removal.--
``(A) In general.--Not later than 4\1/2\ years after the
date of enactment of the Securing Pharmaceutical Distribution
Integrity Act of 2012 and in accordance with this section, a
manufacturer, upon confirming that a product does not have
the standardized numerical identifier or lot number,
consistent with this section, and expiration date assigned by
the manufacturer, or has the appearance of being a
counterfeit, diverted, or stolen product, or a product
otherwise unfit for distribution such that the product would
result in serious adverse health consequences or death to
humans, shall--
``(i) promptly notify the Secretary and impacted trading
partners, as applicable and appropriate; and
``(ii) take steps to remove such product from the
pharmaceutical distribution supply chain.
``(B) Redistribution.--Any product subject to a
notification under this subsection may not be redistributed
as a saleable product unless the manufacturer, in
consultation with the Secretary, determines such product may
reenter the pharmaceutical distribution supply chain.
``(4) Limitation.--Nothing in this section shall require a
manufacturer to aggregate unit level data to cases or
pallets.
``(b) Repackager Requirements.--
``(1) Product tracing.--A repackager, not later than 5\1/2\
years after the date of enactment of the Securing
Pharmaceutical Distribution Integrity Act of 2012 and in
accordance with this section, shall--
``(A) apply RxTEC to the individual saleable unit and the
homogenous case of all product intended to be introduced into
interstate commerce;
``(B) maintain change of ownership and transaction
information, including RxTEC data, that associate unit and
lot level data for each individual saleable unit of product
and each homogenous case of product introduced in interstate
commerce, including RxTEC data received for such products and
for which a repackager applies a new RxTEC;
``(C) receive only products encoded with RxTEC data from a
licensed or registered manufacturer or wholesaler;
``(D) maintain, where a change of ownership has occurred
between non-affiliated entities in wholesale distribution,
change of ownership and transaction information relating to a
product, including--
``(i) RxTEC data;
``(ii) the business name and address of the immediate
previous source and the immediate subsequent recipient of the
product;
``(iii) the proprietary or established name or names of the
product;
``(iv) the National Drug Code number of the product;
``(v) container size;
``(vi) number of containers;
``(vii) the lot number or numbers of the product; and
``(viii) the date of the transaction;
``(E) provide the following change of ownership and
transaction information to the immediate subsequent recipient
of such product--
``(i) the proprietary or established name or names of the
product;
``(ii) the National Drug Code number of the product;
``(iii) container size;
``(iv) number of containers;
``(v) the lot number or numbers of the product; and
``(vi) a signed statement that the repackager--

``(I) is licensed or registered;
``(II) received the product from a manufacturer that is
licensed or registered;
``(III) received a signed statement from the manufacturer
of such product consistent with subsection (a)(1)(D)(vi); and
``(IV) did not knowingly and intentionally adulterate or
knowingly and intentionally counterfeit such product; and

``(F) upon request by the Secretary, other appropriate
Federal official, or State official, in the event of a
recall, or as determined necessary by the Secretary or such
other Federal or State official to investigate a suspect
product, provide in a reasonable time and in a reasonable
manner--
``(i) RxTEC data by lot; and
``(ii) change of ownership and transaction information
pursuant to subparagraph (C) or (E) necessary to identify the
immediate previous source or the immediate subsequent
recipient of such product, as applicable.
``(2) Verification requirements.--A repackager, not later
than 5\1/2\ years after the date of enactment of the Securing
Pharmaceutical Distribution Integrity Act of 2012 and in
accordance with this section, shall--
``(A) utilize RxTEC data at the lot level, as part of
ongoing activities to significantly minimize or prevent the
incidences of suspect product in the pharmaceutical
distribution supply chain, as applicable and appropriate,
which--
``(i) may include--

``(I) responding to alerts regarding a suspect product from
a trading partner or the Secretary, routine monitoring of a
suspect product at the lot level while such product is in the
possession of the repackager; and
``(II) checking inventory for a suspect product at the
request of a trading partner or the Secretary in the case of
returns; and

``(ii) shall take into consideration--

``(I) the likelihood that a particular product has a high
potential risk with respect to pharmaceutical distribution
supply chain security;
``(II) the history and severity of incidences of
counterfeit, diversion, and theft of such product;
``(III) the point in the pharmaceutical distribution supply
chain where counterfeit, diversion, and theft has occurred or
is most likely to occur;
``(IV) the likelihood that such activities will reduce the
possibility of counterfeit, diversion, and theft of such
product;
``(V) whether the product could mitigate or prevent a drug
shortage as defined in section 506C; and
``(VI) any guidance the Secretary issues regarding high-
risk scenarios that could increase the risk of a suspect
product entering the pharmaceutical distribution supply
chain; and

``(B) conduct unit level verification upon the request of a
licensed or registered manufacturer, wholesale distributor,
dispenser, or the Secretary, regarding such product.
``(3) Notification and product removal.--
``(A) In general.--Not later than 5\1/2\ years after the
date of enactment of the Securing Pharmaceutical Distribution
Integrity Act of 2012 and in accordance with this section, a
repackager, upon confirming that a product does not have the
standardized numerical identifier or lot number, consistent
with this section, and expiration date assigned by the
manufacturer, or has the appearance of being a counterfeit,
diverted, or stolen product, or a product otherwise unfit for
distribution such that it would result in serious adverse
health consequences or death to humans, shall--
``(i) promptly notify the Secretary and impacted trading
partners, as applicable and appropriate; and
``(ii) take steps to remove such product from the
pharmaceutical distribution supply chain.
``(B) Redistribution.--Any product subject to a
notification under this subsection may not be redistributed
as a saleable product unless the repackager, in consultation
with the Secretary, and manufacturer as applicable,
determines such product may reenter the pharmaceutical
distribution supply chain.
``(4) Limitation.--Nothing in this section shall require a
repackager to aggregate unit level data to cases or pallets.
``(c) Wholesale Distributor Requirements.--
``(1) Product tracing requirements.--A wholesale
distributor engaged in wholesale distribution, not later than
6\1/2\ years after

[[Page S3593]]

the date of enactment of the Securing Pharmaceutical
Distribution Integrity Act of 2012 and in accordance with
this section, shall--
``(A) receive only products encoded with RxTEC from a
licensed or registered manufacturer, wholesaler, or
repackager;
``(B) maintain, in wholesale distribution where a change of
ownership has occurred between non-affiliated entities,
change of ownership and transaction information, including--
``(i) RxTEC data by lot;
``(ii) the business name and address of the immediate
previous source and the immediate subsequent recipient of the
product;
``(iii) the proprietary or established name or names of the
product;
``(iv) the National Drug Code number of the product;
``(v) container size;
``(vi) number of containers;
``(vii) the lot number or numbers of the product; and
``(viii) the date of the transaction;
``(C) provide the following change of ownership and
transaction information to the immediate subsequent recipient
of such product--
``(i) the proprietary or established name or names of the
product;
``(ii) the National Drug Code number of the product;
``(iii) container size;
``(iv) number of containers;
``(v) the lot number or numbers of the product;
``(vi) the date of the transaction; and
``(vii) a signed statement that the wholesale distributor--

``(I) is licensed or registered;
``(II) received the product from a registered or licensed
manufacturer, repackager, or wholesale distributor, as
applicable;
``(III) received a signed statement from the immediate
subsequent recipient of such product that such trading
partner did not knowingly and intentionally adulterate or
knowingly and intentionally counterfeit such product; and
``(IV) did not knowingly and intentionally adulterate or
knowingly and intentionally counterfeit such product; and

``(D) upon request by the Secretary, other appropriate
Federal official, or State official, in the event of a
recall, return, or as determined necessary by the Secretary,
or such other Federal or State official, to investigate a
suspect product, provide in a reasonable time and in a
reasonable manner--
``(i) RxTEC data by lot; and
``(ii) change of ownership and transaction information
pursuant to subparagraphs (B) and (C), as necessary to
identify the immediate previous source or the immediate
subsequent recipient of such product.
``(2) Verification requirements.--
``(A) In general.--A wholesale distributor engaged in
wholesale distribution, not later than 6\1/2\ years after the
date of enactment of the Securing Pharmaceutical Distribution
Integrity Act of 2012 and in accordance with this section,
shall--
``(i) utilize RxTEC data at the lot level, as part of
ongoing activities to significantly minimize or prevent the
incidence of suspect product in the pharmaceutical
distribution supply chain, as applicable and appropriate,
which--

``(I) may include responding to an alert regarding a
suspect product from a trading partner or the Secretary,
routine monitoring of a suspect product at the lot level
while such product is in the possession of the wholesale
distributor, and checking inventory for a suspect product at
the request of a trading partner or the Secretary; and
``(II) shall take into consideration--

``(aa) the likelihood that a particular product has a high
potential risk with respect to pharmaceutical distribution
supply chain security;
``(bb) the history and severity of incidences of
counterfeit, diversion, and theft of such product;
``(cc) the point in the pharmaceutical distribution supply
chain where counterfeit, diversion, and theft has occurred or
is most likely to occur;
``(dd) the likelihood that such activities will reduce the
possibility of counterfeit, diversion, and theft of such
product;
``(ee) whether the product could mitigate or prevent a drug
shortage as defined in section 506C; and
``(ff) any guidance the Secretary issues regarding high-
risk scenarios that could increase the risk of suspect
product entering the pharmaceutical distribution supply
chain;
``(ii) conduct lot-level verification in the event of a
recall, including upon the request of a licensed or
registered manufacturer, repackager, dispenser, or the
Secretary, regarding such product and recall;
``(iii) conduct verification of a returned product to
validate the return at the lot level for a sealed homogenous
case of such product or at the individual saleable unit of
such product if the unit is not in a sealed homogenous case;
and
``(iv) conduct unit level verification of a suspect
product--

``(I) upon the request of a licensed or registered
manufacturer, repackager, wholesaler, dispenser, or the
Secretary, regarding such product; or
``(II) upon the determination that a product is a suspect
product.

``(B) Limitation.--Nothing in this paragraph shall require
a wholesale distributor to verify product at the unit level
except as required under clauses (iii) and (iv) of
subparagraph (A).
``(3) Notification and product removal.--
``(A) In general.--Not later than 6\1/2\ years after the
date of enactment of the Securing Pharmaceutical Distribution
Integrity Act of 2012 and in accordance with this section, a
wholesale distributor, upon confirming that a product does
not have the standardized numerical identifier or lot number,
consistent with this section, and expiration date assigned by
the manufacturer, or has the appearance of being a
counterfeit, diverted, or stolen product, or a product
otherwise unfit for distribution such that the product would
result in serious adverse health consequences or death to
humans, shall--
``(i) promptly notify the Secretary and impacted trading
partners, as applicable and appropriate; and
``(ii) take steps to remove such product from the
pharmaceutical distribution supply chain.
``(B) Redistribution.--Any product subject to a
notification under this subsection may not be redistributed
as a saleable product unless the wholesaler, in consultation
with the Secretary, and manufacturer or repackager as
applicable, determines such product may reenter the
pharmaceutical distribution supply chain.
``(C) Confidential data.--A wholesale distributor may
confidentially maintain RxTEC data for a direct trading
partner and provide access to such information to such
trading partner in lieu of data transmission, if mutually
agreed upon by such trading partners.
``(d) Dispenser Requirements.--
``(1) Product tracing requirements.--A dispenser, not later
than 7\1/2\ years after the date of enactment of the Securing
Pharmaceutical Distribution Integrity Act of 2012 and in
accordance with this section, shall--
``(A) receive product only from a licensed or registered
manufacturer, repackager, or wholesale distributor;
``(B) receive only products encoded with RxTEC lot level
data from a manufacturer, repackager, or wholesale
distributor selling the drug product to the dispenser;
``(C) maintain RxTEC lot level data or allow the wholesale
distributor to confidentially maintain and store the RxTEC
lot level data sufficient to identify the product provided to
the dispenser from the immediate previous source where a
change of ownership has occurred between non-affiliated
entities (if such arrangement is mutually agreed upon by the
dispenser and the wholesale distributor);
``(D) use the RxTEC lot level data maintained by the
dispenser or maintained by the wholesale distributor on
behalf of the dispenser (if such arrangement is mutually
agreed upon by the dispenser and the wholesale distributor),
as necessary to respond to a request from the Secretary in
the event of a suspect product or recall;
``(E) maintain lot level data upon change of ownership
between non-affiliated entities and for recalled product; and
``(F) for investigation purposes only, and upon request by
the Secretary, other appropriate Federal official, or State
official, for the purpose of investigating a suspect or
recalled product, provide the RxTEC data by lot and the
immediate previous source or immediate subsequent receipt of
the suspect or recalled product, as applicable.
``(2) Verification requirements.--Not later than 7\1/2\
years after the date of enactment of the Securing
Pharmaceutical Distribution Integrity Act of 2012 and in
accordance with this section, a dispenser shall be required
to conduct lot level verification of suspect product only.
``(3) Notification and product removal.--
``(A) In general.--Not later than 7\1/2\ years after the
date of enactment of the Securing Pharmaceutical Distribution
Integrity Act of 2012 and in accordance with this section, a
dispenser, upon confirming that a product is a suspect
product or a product otherwise unfit for distribution,
shall--
``(i) promptly notify the Secretary and impacted trading
partners, as applicable and appropriate; and
``(ii) take steps to remove such product from the
pharmaceutical distribution supply chain.
``(B) Redistribution.--Any product subject to a
notification under this paragraph may not be redistributed as
a saleable product unless the dispenser, in consultation with
the Secretary, and manufacturer, repackager, or wholesaler as
applicable, determines such product may reenter the
pharmaceutical distribution supply chain.
``(C) Limitations.--Nothing in this section shall--
``(i) require a dispenser to verify product at the unit
level; or
``(ii) require a dispenser to adopt specific technologies
or business systems for compliance with this section.
``(e) Ensuring Flexibility.--The requirements under this
section shall--
``(1) require the maintenance and transmission only of
information that is reasonably available and appropriate;
``(2) be based on current scientific and technological
capabilities and shall neither require nor restrict the use
of additional data carrier technologies;
``(3) not prescribe or proscribe specific technologies or
systems for the maintenance and transmission of data other
than the standard data carrier for RxTEC or specific methods
of verification;

[[Page S3594]]

``(4) not require a record of the complete previous
distribution history of the drug from the point of origin of
such drug;
``(5) take into consideration whether the public health
benefits of imposing any additional regulations outweigh the
cost of compliance with such requirements;
``(6) be scale-appropriate and practicable for entities of
varying sizes and capabilities;
``(7) with respect to cost and recordkeeping burdens, not
require the creation and maintenance of duplicative records
where the information is contained in other company records
kept in the normal course of business;
``(8) to the extent practicable, not require specific
business systems for compliance with such requirements;
``(9) include a process by which the Secretary may issue a
waiver of such regulations for an individual entity if the
Secretary determines that such requirements would result in
an economic hardship or for emergency medical reasons,
including a public health emergency declaration pursuant to
section 319 of the Public Health Service Act; and
``(10) include a process by which the Secretary may
determine exceptions to the standard data carrier RxTEC
requirement if a drug is packaged in a container too small or
otherwise unable to accommodate a label with sufficient space
to bear the information required for compliance with this
section.
``(f) Regulations and Guidance.--
``(1) In general.--The Secretary may issue guidance
consistent with this section regarding the circumstances
surrounding suspect product and verification practices.
``(2) Procedure.--The Secretary, in promulgating any
regulation pursuant to this section, shall--
``(A) issue a notice of proposed rulemaking that includes a
copy of the proposed regulation;
``(B) provide a period of not less than 60 days for
comments on the proposed regulation; and
``(C) publish the final regulation not less than 30 days
before the effective date of the regulation.
``(3) Restrictions.--Notwithstanding any other provision of
law, the Secretary shall promulgate regulations implementing
this section only as described in paragraph (2).
``(g) Standards.--The Secretary shall, in consultation with
other appropriate Federal officials, manufacturers,
repackagers, wholesale distributors, dispensers, and other
supply chain stakeholders, prioritize and develop standards
for the interoperable exchange of ownership and transaction
information for tracking and tracing prescription drugs.''.
(b) Prohibited Act.--Section 301 (21 U.S.C. 331), as
amended by section 712, is further amended by inserting at
the end the following:
``(bbb) The violation of any requirement under section
582.''.
(c) Small Entity Compliance Guide.--Not later than 180 days
after enactment of this Act, the Secretary of Health and
Human Services (referred to in this title as the
``Secretary'') shall issue a compliance guide setting forth
in plain language the requirements under section 582 of the
Federal Food, Drug, and Cosmetic Act, as added by subsection
(a), in order to assist small entities in complying with such
section.
(d) Limitations.--
(1) Savings clause.--Nothing in this subtitle or the
amendments made by this subtitle shall preempt any State or
local law or regulation.
(2) Effect on california law.--Notwithstanding any other
provision of Federal or State law, including any provision of
this subtitle or of subchapter H of chapter V of the Federal
Food, Drug, and Cosmetic Act, as added by subsection (a),
such subchapter H shall not trigger California Business and
Professions Code, section 4034.1.
(3) Effective date.--Subsection (c) and the amendments made
by subsections (a) and (b) shall take effect on January 1,
2022, or on the date on which Congress enacts a law providing
for express preemption of any State law regulating the
distribution of drugs, whichever is later.

SEC. 723. INDEPENDENT ASSESSMENT.

(a) In General.--The Secretary shall contract with a
private, independent consulting firm capable of performing
the technical analysis, management assessment, and program
evaluation tasks required to conduct a comprehensive
assessment of the process for the review of drug applications
under subsections (b) and (j) of section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(b), (j)) and
subsections (a) and (k) of section 351 of the Public Health
Service Act (42 U.S.C. 262(a), (k)). The assessment shall
address the premarket review process of drugs by the Food and
Drug Administration, using an assessment framework that draws
from appropriate quality system standards, including
management responsibility, documents controls and records
management, and corrective and preventive action.
(b) Participation.--Representatives of the Food and Drug
Administration and manufacturers of drugs subject to user
fees under part 2 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.)
shall participate in a comprehensive assessment of the
process for the review of drug applications under section 505
of the Federal Food, Drug, and Cosmetic Act and section 351
of the Public Health Service Act. The assessment shall be
conducted in phases.
(c) First Contract.--The Secretary shall award the contract
for the first assessment under this section not later than
March 31, 2013. Such contractor shall evaluate the
implementation of recommendations and publish a written
assessment not later than February 1, 2016.
(d) Findings and Recommendations.--
(1) In general.--The Secretary shall publish the findings
and recommendations under this section that are likely to
have a significant impact on review times not later than 6
months after the contract is awarded. Final comprehensive
findings and recommendations shall be published not later
than 1 year after the contract is awarded.
(2) Implementation plan.--The Food and Drug Administration
shall publish an implementation plan not later than 6 months
after the date of receipt of each set of recommendation.
(e) Scope of Assessment.--The assessment under this section
shall include the following:
(1) Identification of process improvements and best
practices for conducting predictable, efficient, and
consistent premarket reviews that meet regulatory review
standards.
(2) Analysis of elements of the review process that consume
or save time to facilitate a more efficient process. Such
analysis shall include--
(A) consideration of root causes for inefficiencies that
may affect review performance and total time to decision;
(B) recommended actions to correct any failures to meet
user fee program goals; and
(C) consideration of the impact of combination products on
the review process.
(3) Assessment of methods and controls of the Food and Drug
Administration for collecting and reporting information on
premarket review process resource use and performance.
(4) Assessment of effectiveness of the reviewer training
program of the Food and Drug Administration.
(5) Recommendations for ongoing periodic assessments and
any additional, more detailed or focused assessments.
(f) Requirements.--The Secretary shall--
(1) analyze the recommendations for improvement
opportunities identified in the assessment, develop and
implement a corrective action plan, and ensure it
effectiveness;
(2) incorporate the findings and recommendations of the
contractors, as appropriate, into the management of the
premarket review program of the Food and Drug Administration;
and
(3) incorporate the results of the assessment in a Good
Review Management Practices guidance document, which shall
include initial and ongoing training of Food and Drug
Administration staff, and periodic audits of compliance with
the guidance.

TITLE VIII--GENERATING ANTIBIOTIC INCENTIVES NOW

SEC. 801. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS.

(a) In General.--Chapter V (21 U.S.C. 351 et seq.) is
amended by inserting after section 505D the following:

``SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW
QUALIFIED INFECTIOUS DISEASE PRODUCTS.

``(a) Extension.--If the Secretary approves an application
pursuant to section 505 for a drug that has been designated
as a qualified infectious disease product under subsection
(d), the 4- and 5-year periods described in subsections
(c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the 3-year
periods described in clauses (iii) and (iv) of subsection
(c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F)
of section 505, or the 7-year period described in section
527, as applicable, shall be extended by 5 years.
``(b) Relation to Pediatric Exclusivity.--Any extension
under subsection (a) of a period shall be in addition to any
extension of the period under section 505A with respect to
the drug.
``(c) Limitations.--Subsection (a) does not apply to the
approval of--
``(1) a supplement to an application under section 505(b)
for any qualified infectious disease product for which an
extension described in subsection (a) is in effect or has
expired;
``(2) a subsequent application filed with respect to a
product approved under section 505 for a change that results
in a new indication, route of administration, dosing
schedule, dosage form, delivery system, delivery device, or
strength; or
``(3) an application for a product that is not approved for
the use for which it received a designation under subsection
(d).
``(d) Designation.--
``(1) In general.--The manufacturer or sponsor of a drug
may request the Secretary to designate a drug as a qualified
infectious disease product at any time before the submission
of an application under section 505(b) for such drug. The
Secretary shall, not later than 60 days after the submission
of such a request, determine whether the drug is a qualified
infectious disease product.
``(2) Limitation.--Except as provided in paragraph (3), a
designation under this subsection shall not be withdrawn for
any reason, including modifications to the list of qualifying
pathogens under subsection (f)(2)(C).
``(3) Revocation of designation.--The Secretary may revoke
a designation of a drug as a qualified infectious disease
product if the

[[Page S3595]]

Secretary finds that the request for such designation
contained an untrue statement of material fact.
``(e) Regulations.--
``(1) In general.--Not later than 2 years after the date of
enactment of the Food and Drug Administration Safety and
Innovation Act, the Secretary shall adopt final regulations
implementing this section.
``(2) Procedure.--In promulgating a regulation implementing
this section, the Secretary shall--
``(A) issue a notice of proposed rulemaking that includes
the proposed regulation;
``(B) provide a period of not less than 60 days for
comments on the proposed regulation; and
``(C) publish the final regulation not less than 30 days
before the effective date of the regulation.
``(3) Restrictions.--Notwithstanding any other provision of
law, the Secretary shall promulgate regulations implementing
this section only as described in paragraph (2), except that
the Secretary may issue interim guidance for sponsors seeking
designation under subsection (d) prior to the promulgation of
such regulations.
``(4) Designation prior to regulations.--The Secretary may
designate drugs as qualified infectious disease products
under subsection (d) prior to the promulgation of regulations
under this subsection.
``(f) Qualifying Pathogen.--
``(1) Definition.--In this section, the term `qualifying
pathogen' means a pathogen identified and listed by the
Secretary under paragraph (2) that has the potential to pose
a serious threat to public health, such as--
``(A) resistant gram positive pathogens, including
methicillin-resistant Staphylococcus aureus, vancomycin-
resistant Staphylococcus aureus, and vancomycin-resistant
enterococcus;
``(B) multi-drug resistant gram negative bacteria,
including Acinetobacter, Klebsiella, Pseudomonas, and E. coli
species;
``(C) multi-drug resistant tuberculosis; and
``(D) Clostridium difficile.
``(2) List of qualifying pathogens.--
``(A) In general.--The Secretary shall establish and
maintain a list of qualifying pathogens, and shall make
public the methodology for developing such list.
``(B) Considerations.--In establishing and maintaining the
list of pathogens described under this section the Secretary
shall--
``(i) consider--

``(I) the impact on the public health due to drug-resistant
organisms in humans;
``(II) the rate of growth of drug-resistant organisms in
humans;
``(III) the increase in resistance rates in humans; and
``(IV) the morbidity and mortality in humans; and

``(ii) consult with experts in infectious diseases and
antibiotic resistance, including the Centers for Disease
Control and Prevention, the Food and Drug Administration,
medical professionals, and the clinical research community.
``(C) Review.--Every 5 years, or more often as needed, the
Secretary shall review, provide modifications to, and publish
the list of qualifying pathogens under subparagraph (A) and
shall by regulation revise the list as necessary, in
accordance with subsection (e).
``(g) Qualified Infectious Disease Product.--The term
`qualified infectious disease product' means an antibacterial
or antifungal drug for human use intended to treat serious or
life-threatening infections, including those caused by--
``(1) an antibacterial or antifungal resistant pathogen,
including novel or emerging infectious pathogens; or
``(2) qualifying pathogens listed by the Secretary under
subsection (f).''.
(b) Application.--Section 505E of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a), applies only
with respect to a drug that is first approved under section
505(c) of such Act (21 U.S.C. 355(c)) on or after the date of
the enactment of this Act.

SEC. 802. PRIORITY REVIEW.

(a) Amendment.--Chapter V (21 U.S.C. 351 et seq.) is
amended by inserting after section 524 the following:

``SEC. 524A. PRIORITY REVIEW FOR QUALIFIED INFECTIOUS DISEASE
PRODUCTS.

``If the Secretary designates a drug under section 505E(d)
as a qualified infectious disease product, then the Secretary
shall give priority review to any application submitted for
approval for such drug under section 505(b).''.
(b) Application.--Section 524A of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a), applies only
with respect to an application that is submitted under
section 505(b) of such Act (21 U.S.C. 355(b)) on or after the
date of the enactment of this Act.

SEC. 803. FAST TRACK PRODUCT.

Section 506(a)(1) (21 U.S.C. 356(a)(1)), as amended by
section 901(b), is amended by inserting ``, or if the
Secretary designates the drug as a qualified infectious
disease product under section 505E(d)'' before the period at
the end of the first sentence.

SEC. 804. GAO STUDY.

(a) In General.--The Comptroller General of the United
States shall--
(1) conduct a study--
(A) on the need for, and public health impact of,
incentives to encourage the research, development, and
marketing of qualified infectious disease biological products
and antifungal products; and
(B) consistent with trade and confidentiality data
protections, assessing, for all antibacterial and antifungal
drugs, including biological products, the average or
aggregate--
(i) costs of all clinical trials for each phase;
(ii) percentage of success or failure at each phase of
clinical trials; and
(iii) public versus private funding levels of the trials
for each phase; and
(2) not later than 1 year after the date of enactment of
this Act, submit a report to Congress on the results of such
study, including any recommendations of the Comptroller
General on appropriate incentives for addressing such need.
(b) Contents.--The part of the study described in
subsection (a)(1)(A) shall include--
(1) an assessment of any underlying regulatory issues
related to qualified infectious disease products, including
qualified infectious disease biological products;
(2) an assessment of the management by the Food and Drug
Administration of the review of qualified infectious disease
products, including qualified infectious disease biological
products and the regulatory certainty of related regulatory
pathways for such products;
(3) a description of any regulatory impediments to the
clinical development of new qualified infectious disease
products, including qualified infectious disease biological
products, and the efforts of the Food and Drug Administration
to address such impediments; and
(4) recommendations with respect to--
(A) improving the review and predictability of regulatory
pathways for such products; and
(B) overcoming any regulatory impediments identified in
paragraph (3).
(c) Definitions.--In this section:
(1) The term ``biological product'' has the meaning given
to such term in section 351 of the Public Health Service Act
(42 U.S.C. 262).
(2) The term ``qualified infectious disease biological
product'' means a biological product intended to treat a
serious or life-threatening infection described in section
505E(g) of the Federal Food, Drug, and Cosmetic Act, as added
by section 801.
(3) The term ``qualified infectious disease product'' has
the meaning given such term in section 505E(g) of the Federal
Food, Drug, and Cosmetic Act, as added by section 801.

SEC. 805. CLINICAL TRIALS.

(a) Review and Revision of Guidance Documents.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall
review and, as appropriate, revise not fewer than 3 guidance
documents per year, which shall include--
(A) reviewing the guidance documents of the Food and Drug
Administration for the conduct of clinical trials with
respect to antibacterial and antifungal drugs; and
(B) as appropriate, revising such guidance documents to
reflect developments in scientific and medical information
and technology and to ensure clarity regarding the procedures
and requirements for approval of antibacterial and antifungal
drugs under chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.).
(2) Issues for review.--At a minimum, the review under
paragraph (1) shall address the appropriate animal models of
infection, in vitro techniques, valid micro-biological
surrogate markers, the use of non-inferiority versus
superiority trials, trial enrollment, data requirements, and
appropriate delta values for non-inferiority trials.
(3) Rule of construction.--Except to the extent to which
the Secretary makes revisions under paragraph (1)(B), nothing
in this section shall be construed to repeal or otherwise
effect the guidance documents of the Food and Drug
Administration.
(b) Recommendations for Investigations.--
(1) Request.--The sponsor of a drug intended to be
designated as a qualified infectious disease product may
request that the Secretary provide written recommendations
for nonclinical and clinical investigations which the
Secretary believes may be necessary to be conducted with the
drug before such drug may be approved under section 505 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for
use in treating, detecting, preventing, or identifying a
qualifying pathogen, as defined in section 505E of such Act.
(2) Recommendations.--If the Secretary has reason to
believe that a drug for which a request is made under this
subsection is a qualified infectious disease product, the
Secretary shall provide the person making the request written
recommendations for the nonclinical and clinical
investigations which the Secretary believes, on the basis of
information available to the Secretary at the time of the
request, would be necessary for approval under section 505 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) of
such drug for the use described in paragraph (1).
(c) GAO Study.--Not later than January 1, 2016, the
Comptroller General of the United States shall submit to
Congress a report--
(1) regarding the review and revision of the clinical trial
guidance documents required under subsection (a) and the
impact such review and revision has had on the review and
approval of qualified infectious disease products;
(2) assessing--

[[Page S3596]]

(A) the effectiveness of the results-oriented metrics
managers employ to ensure that reviewers of such products are
familiar with, and consistently applying, clinical trial
guidance documents; and
(B) the predictability of related regulatory pathways and
review;
(3) identifying any outstanding regulatory impediments to
the clinical development of qualified infectious disease
products;
(4) reporting on the progress the Food and Drug
Administration has made in addressing the impediments
identified under paragraph (3); and
(5) containing recommendations regarding how to improve the
review of, and regulatory pathway for, such products.
(d) Qualified Infectious Disease Product.--For purposes of
this section, the term ``qualified infectious disease
product'' has the meaning given such term in section 505E(g)
of the Federal Food, Drug, and Cosmetic Act, as added by
section 801.

SEC. 806. REGULATORY CERTAINTY AND PREDICTABILITY.

(a) Initial Strategy and Implementation Plan.--Not later
than 1 year after the date of enactment of this Act, the
Secretary of Health and Human Services (referred to in this
section as the ``Secretary'') shall submit to Congress a
strategy and implementation plan with respect to the
requirements of this Act. The strategy and implementation
plan shall include--
(1) a description of the regulatory challenges to clinical
development, approval, and licensure of qualified infectious
disease products;
(2) the regulatory and scientific priorities of the
Secretary with respect to such challenges; and
(3) the steps the Secretary will take to ensure regulatory
certainty and predictability with respect to qualified
infectious disease products, including steps the Secretary
will take to ensure managers and reviewers are familiar with
related regulatory pathways, requirements of the Food and
Drug Administration, guidance documents related to such
products, and applying such requirements consistently.
(b) Subsequent Report.--Not later than 3 years after the
date of enactment of this Act, the Secretary shall submit to
Congress a report on--
(1) the progress made toward the priorities identified
under subsection (a)(2);
(2) the number of qualified infectious disease products
that have been submitted for approval or licensure on or
after the date of enactment of this Act;
(3) a list of qualified infectious disease products with
information on the types of exclusivity granted for each
product, consistent with the information published under
section 505(j)(7)(A)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(7)(A)(iii));
(4) the number of such qualified infectious disease
products and that have been approved or licensed on or after
the date of enactment of this Act; and
(5) the number of calendar days it took for the approval or
licensure of the qualified infectious disease products
approved or licensed on or after the date of enactment of
this Act.
(c) Qualified Infectious Disease Product.--For purposes of
this section, the term ``qualified infectious disease
product'' has the meaning given such term in section 505E(g)
of the Federal Food, Drug, and Cosmetic Act, as added by
section 801.

TITLE IX--DRUG APPROVAL AND PATIENT ACCESS

SEC. 901. ENHANCEMENT OF ACCELERATED PATIENT ACCESS TO NEW
MEDICAL TREATMENTS.

(a) Findings; Sense of Congress.--
(1) Findings.--Congress finds as follows:
(A) The Food and Drug Administration (referred to in this
section as the ``FDA'') serves a critical role in helping to
assure that new medicines are safe and effective. Regulatory
innovation is 1 element of the Nation's strategy to address
serious and life-threatening diseases or conditions by
promoting investment in and development of innovative
treatments for unmet medical needs.
(B) During the 2 decades following the establishment of the
accelerated approval mechanism, advances in medical sciences,
including genomics, molecular biology, and bioinformatics,
have provided an unprecedented understanding of the
underlying biological mechanism and pathogenesis of disease.
A new generation of modern, targeted medicines is under
development to treat serious and life-threatening diseases,
some applying drug development strategies based on biomarkers
or pharmacogenomics, predictive toxicology, clinical trial
enrichment techniques, and novel clinical trial designs, such
as adaptive clinical trials.
(C) As a result of these remarkable scientific and medical
advances, the FDA should be encouraged to implement more
broadly effective processes for the expedited development and
review of innovative new medicines intended to address unmet
medical needs for serious or life-threatening diseases or
conditions, including those for rare diseases or conditions,
using a broad range of surrogate or clinical endpoints and
modern scientific tools earlier in the drug development cycle
when appropriate. This may result in fewer, smaller, or
shorter clinical trials for the intended patient population
or targeted subpopulation without compromising or altering
the high standards of the FDA for the approval of drugs.
(D) Patients benefit from expedited access to safe and
effective innovative therapies to treat unmet medical needs
for serious or life-threatening diseases or conditions.
(E) For these reasons, the statutory authority in effect on
the day before the date of enactment of this Act governing
expedited approval of drugs for serious or life-threatening
diseases or conditions should be amended in order to enhance
the authority of the FDA to consider appropriate scientific
data, methods, and tools, and to expedite development and
access to novel treatments for patients with a broad range of
serious or life-threatening diseases or conditions.
(2) Sense of congress.--It is the sense of Congress that
the Food and Drug Administration should apply the accelerated
approval and fast track provisions set forth in section 506
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356),
as amended by this section, to help expedite the development
and availability to patients of treatments for serious or
life-threatening diseases or conditions while maintaining
safety and effectiveness standards for such treatments.
(b) Expedited Approval of Drugs for Serious or Life-
Threatening Diseases or Conditions.--Section 506 (21 U.S.C.
356) is amended to read as follows:

``SEC. 506. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS OR LIFE-
THREATENING DISEASES OR CONDITIONS.

``(a) Designation of Drug as Fast Track Product.--
``(1) In general.--The Secretary shall, at the request of
the sponsor of a new drug, facilitate the development and
expedite the review of such drug if it is intended, whether
alone or in combination with one or more other drugs, for the
treatment of a serious or life-threatening disease or
condition, and it demonstrates the potential to address unmet
medical needs for such a disease or condition. (In this
section, such a drug is referred to as a `fast track
product'.)
``(2) Request for designation.--The sponsor of a new drug
may request the Secretary to designate the drug as a fast
track product. A request for the designation may be made
concurrently with, or at any time after, submission of an
application for the investigation of the drug under section
505(i) or section 351(a)(3) of the Public Health Service Act.
``(3) Designation.--Within 60 calendar days after the
receipt of a request under paragraph (2), the Secretary shall
determine whether the drug that is the subject of the request
meets the criteria described in paragraph (1). If the
Secretary finds that the drug meets the criteria, the
Secretary shall designate the drug as a fast track product
and shall take such actions as are appropriate to expedite
the development and review of the application for approval of
such product.
``(b) Accelerated Approval of a Drug for a Serious or Life-
Threatening Disease or Condition, Including a Fast Track
Product.--
``(1) In general.--
``(A) Accelerated approval.--The Secretary may approve an
application for approval of a product for a serious or life-
threatening disease or condition, including a fast track
product, under section 505(c) or section 351(a) of the Public
Health Service Act upon a determination that the product has
an effect on a surrogate endpoint that is reasonably likely
to predict clinical benefit, or on a clinical endpoint that
can be measured earlier than irreversible morbidity or
mortality, that is reasonably likely to predict an effect on
irreversible morbidity or mortality or other clinical
benefit, taking into account the severity, rarity, or
prevalence of the condition and the availability or lack of
alternative treatments. The approval described in the
preceding sentence is referred to in this section as
`accelerated approval'.
``(B) Evidence.--The evidence to support that an endpoint
is reasonably likely to predict clinical benefit under
subparagraph (A) may include epidemiological,
pathophysiological, therapeutic, pharmacologic, or other
evidence developed using biomarkers, for example, or other
scientific methods or tools.
``(2) Limitation.--Approval of a product under this
subsection may be subject to 1 or both of the following
requirements:
``(A) That the sponsor conduct appropriate post-approval
studies to verify and describe the predicted effect on
irreversible morbidity or mortality or other clinical
benefit.
``(B) That the sponsor submit copies of all promotional
materials related to the product during the preapproval
review period and, following approval and for such period
thereafter as the Secretary determines to be appropriate, at
least 30 days prior to dissemination of the materials.
``(3) Expedited withdrawal of approval.--The Secretary may
withdraw approval of a product approved under accelerated
approval using expedited procedures (as prescribed by the
Secretary in regulations which shall include an opportunity
for an informal hearing) if--
``(A) the sponsor fails to conduct any required post-
approval study of the drug with due diligence;
``(B) a study required to verify and describe the predicted
effect on irreversible morbidity or mortality or other
clinical benefit of the

[[Page S3597]]

product fails to verify and describe such effect or benefit;
``(C) other evidence demonstrates that the product is not
safe or effective under the conditions of use; or
``(D) the sponsor disseminates false or misleading
promotional materials with respect to the product.
``(c) Review of Incomplete Applications for Approval of a
Fast Track Product.--
``(1) In general.--If the Secretary determines, after
preliminary evaluation of clinical data submitted by the
sponsor, that a fast track product may be effective, the
Secretary shall evaluate for filing, and may commence review
of portions of, an application for the approval of the
product before the sponsor submits a complete application.
The Secretary shall commence such review only if the
applicant--
``(A) provides a schedule for submission of information
necessary to make the application complete; and
``(B) pays any fee that may be required under section 736.
``(2) Exception.--Any time period for review of human drug
applications that has been agreed to by the Secretary and
that has been set forth in goals identified in letters of the
Secretary (relating to the use of fees collected under
section 736 to expedite the drug development process and the
review of human drug applications) shall not apply to an
application submitted under paragraph (1) until the date on
which the application is complete.
``(d) Awareness Efforts.--The Secretary shall--
``(1) develop and disseminate to physicians, patient
organizations, pharmaceutical and biotechnology companies,
and other appropriate persons a description of the provisions
of this section applicable to accelerated approval and fast
track products; and
``(2) establish a program to encourage the development of
surrogate and clinical endpoints, including biomarkers, and
other scientific methods and tools that can assist the
Secretary in determining whether the evidence submitted in an
application is reasonably likely to predict clinical benefit
for serious or life-threatening conditions for which
significant unmet medical needs exist.
``(e) Construction.--
``(1) Purpose.--The amendments made by the Food and Drug
Administration Safety and Innovation Act to this section are
intended to encourage the Secretary to utilize innovative and
flexible approaches to the assessment of products under
accelerated approval for treatments for patients with serious
or life-threatening diseases or conditions and unmet medical
needs.
``(2) Construction.--Nothing in this section shall be
construed to alter the standards of evidence under subsection
(c) or (d) of section 505 (including the substantial evidence
standard in section 505(d)) of this Act or under section
351(a) of the Public Health Service Act. Such sections and
standards of evidence apply to the review and approval of
products under this section, including whether a product is
safe and effective. Nothing in this section alters the
ability of the Secretary to rely on evidence that does not
come from adequate and well-controlled investigations for the
purpose of determining whether an endpoint is reasonably
likely to predict clinical benefit as described in subsection
(b)(1)(B).''.
(c) Guidance; Amended Regulations.--
(1) Draft guidance.--Not later than 1 year after the date
of enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall issue draft guidance to implement the amendments made
by this section. In developing such guidance, the Secretary
shall specifically consider issues arising under the
accelerated approval and fast track processes under section
506 of the Federal Food, Drug, and Cosmetic Act, as amended
by subsection (b), for drugs designated for a rare disease or
condition under section 526 of such Act (21 U.S.C. 360bb) and
shall also consider any unique issues associated with very
rare diseases.
(2) Final guidance.--Not later than 1 year after the
issuance of draft guidance under paragraph (1), and after an
opportunity for public comment, the Secretary shall issue
final guidance.
(3) Conforming changes.--The Secretary shall issue, as
necessary, conforming amendments to the applicable
regulations under title 21, Code of Federal Regulations,
governing accelerated approval.
(4) No effect of inaction on requests.--If the Secretary
fails to issue final guidance or amended regulations as
required by this subsection, such failure shall not preclude
the review of, or action on, a request for designation or an
application for approval submitted pursuant to section 506 of
the Federal Food, Drug, and Cosmetic Act, as amended by
subsection (b).
(d) Independent Review.--The Secretary may, in conjunction
with other planned reviews, contract with an independent
entity with expertise in assessing the quality and efficiency
of biopharmaceutical development and regulatory review
programs to evaluate the Food and Drug Administration's
application of the processes described in section 506 of the
Federal Food, Drug, and Cosmetic Act, as amended by
subsection (b), and the impact of such processes on the
development and timely availability of innovative treatments
for patients suffering from serious or life-threatening
conditions. Any such evaluation shall include consultation
with regulated industries, patient advocacy and disease
research foundations, and relevant academic medical centers.

SEC. 902. BREAKTHROUGH THERAPIES.

(a) In General.--Section 506 (21 U.S.C. 356), as amended by
section 901, is further amended--
(1) by redesignating subsections (a) through (c) as
subsections (b) through (d), respectively;
(2) by redesignating subsection (d) as subsection (f);
(3) by inserting before subsection (b), as so redesignated,
the following:
``(a) Designation of a Drug as a Breakthrough Therapy.--
``(1) In general.--The Secretary shall, at the request of
the sponsor of a drug, expedite the development and review of
such drug if the drug is intended, alone or in combination
with 1 or more other drugs, to treat a serious or life-
threatening disease or condition and preliminary clinical
evidence indicates that the drug may demonstrate substantial
improvement over existing therapies on 1 or more clinically
significant endpoints, such as substantial treatment effects
observed early in clinical development. (In this section,
such a drug is referred to as a `breakthrough therapy'.)
``(2) Request for designation.--The sponsor of a drug may
request the Secretary to designate the drug as a breakthrough
therapy. A request for the designation may be made
concurrently with, or at any time after, the submission of an
application for the investigation of the drug under section
505(i) or section 351(a)(3) of the Public Health Service Act.
``(3) Designation.--
``(A) In general.--Not later than 60 calendar days after
the receipt of a request under paragraph (2), the Secretary
shall determine whether the drug that is the subject of the
request meets the criteria described in paragraph (1). If the
Secretary finds that the drug meets the criteria, the
Secretary shall designate the drug as a breakthrough therapy
and shall take such actions as are appropriate to expedite
the development and review of the application for approval of
such drug.
``(B) Actions.--The actions to expedite the development and
review of an application under subparagraph (A) may include,
as appropriate--
``(i) holding meetings with the sponsor and the review team
throughout the development of the drug;
``(ii) providing timely advice to, and interactive
communication with, the sponsor regarding the development of
the drug to ensure that the development program to gather the
non-clinical and clinical data necessary for approval is as
efficient as practicable;
``(iii) involving senior managers and experienced review
staff, as appropriate, in a collaborative, cross-disciplinary
review;
``(iv) assigning a cross-disciplinary project lead for the
Food and Drug Administration review team to facilitate an
efficient review of the development program and to serve as a
scientific liaison between the review team and the sponsor;
and
``(v) taking steps to ensure that the design of the
clinical trials is as efficient as practicable, when
scientifically appropriate, such as by minimizing the number
of patients exposed to a potentially less efficacious
treatment.'';
(4) in subsection (f)(1), as so redesignated, by striking
``applicable to accelerated approval'' and inserting
``applicable to breakthrough therapies, accelerated approval,
and''; and
(5) by adding at the end the following:
``(g) Report.--Beginning in fiscal year 2013, the Secretary
shall annually prepare and submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives, and make publicly available, with respect to
this section for the previous fiscal year--
``(1) the number of drugs for which a sponsor requested
designation as a breakthrough therapy;
``(2) the number of products designated as a breakthrough
therapy; and
``(3) for each product designated as a breakthrough
therapy, a summary of the actions taken under subsection
(a)(3).''.
(b) Guidance; Amended Regulations.--
(1) In general.--
(A) Guidance.--Not later than 18 months after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall issue draft guidance on implementing the requirements
with respect to breakthrough therapies, as set forth in
section 506(a) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 356(a)), as amended by this section. The Secretary
shall issue final guidance not later than 1 year after the
close of the comment period for the draft guidance.
(B) Amended regulations.--
(i) In general.--If the Secretary determines that it is
necessary to amend the regulations under title 21, Code of
Federal Regulations in order to implement the amendments made
by this section to section 506(a) of the Federal Food, Drug,
and Cosmetic Act, the Secretary shall amend such regulations
not later than 2 years after the date of enactment of this
Act.
(ii) Procedure.--In amending regulations under clause (i),
the Secretary shall--

(I) issue a notice of proposed rulemaking that includes the
proposed regulation;

[[Page S3598]]

(II) provide a period of not less than 60 days for comments
on the proposed regulation; and
(III) publish the final regulation not less than 30 days
before the effective date of the regulation.

(iii) Restrictions.--Notwithstanding any other provision of
law, the Secretary shall promulgate regulations implementing
the amendments made by section only as described in clause
(ii).
(2) Requirements.--Guidance issued under this section
shall--
(A) specify the process and criteria by which the Secretary
makes a designation under section 506(a)(3) of the Federal
Food, Drug, and Cosmetic Act; and
(B) specify the actions the Secretary shall take to
expedite the development and review of a breakthrough therapy
pursuant to such designation under such section 506(a)(3),
including updating good review management practices to
reflect breakthrough therapies.
(c) Independent Review.--Not later than 3 years after the
date of enactment of this Act, the Comptroller General of the
United States, in consultation with appropriate experts,
shall assess the manner by which the Food and Drug
Administration has applied the processes described in section
506(a) of the Federal Food, Drug, and Cosmetic Act, as
amended by this section, and the impact of such processes on
the development and timely availability of innovative
treatments for patients affected by serious or life-
threatening conditions. Such assessment shall be made
publicly available upon completion.
(d) Conforming Amendments.--Section 506B(e) (21 U.S.C.
356b) is amended by striking ``section 506(b)(2)(A)'' each
place such term appears and inserting ``section
506(c)(2)(A)''.

SEC. 903. CONSULTATION WITH EXTERNAL EXPERTS ON RARE
DISEASES, TARGETED THERAPIES, AND GENETIC
TARGETING OF TREATMENTS.

Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as
amended by section 712, is further amended by adding at the
end the following:

``SEC. 569. CONSULTATION WITH EXTERNAL EXPERTS ON RARE
DISEASES, TARGETED THERAPIES, AND GENETIC
TARGETING OF TREATMENTS.

``(a) In General.--For the purpose of promoting the
efficiency of and informing the review by the Food and Drug
Administration of new drugs and biological products for rare
diseases and drugs and biological products that are
genetically targeted, the following shall apply:
``(1) Consultation with stakeholders.--Consistent with
sections X.C and IX.E.4 of the PDUFA Reauthorization
Performance Goals and Procedures Fiscal Years 2013 through
2017, as referenced in the letters described in section
101(b) of the Prescription Drug User Fee Amendments of 2012,
the Secretary shall ensure that opportunities exist, at a
time the Secretary determines appropriate, for consultations
with stakeholders on the topics described in subsection (c).
``(2) Consultation with external experts.--The Secretary
shall develop and maintain a list of external experts who,
because of their special expertise, are qualified to provide
advice on rare disease issues, including topics described in
subsection (c). The Secretary may, when appropriate to
address a specific regulatory question, consult such external
experts on issues related to the review of new drugs and
biological products for rare diseases and drugs and
biological products that are genetically targeted, including
the topics described in subsection (c), when such
consultation is necessary because the Secretary lacks
specific scientific, medical, or technical expertise
necessary for the performance of its regulatory
responsibilities and the necessary expertise can be provided
by the external experts.
``(b) External Experts.--For purposes of subsection (a)(2),
external experts are those who possess scientific or medical
training that the Secretary lacks with respect to one or more
rare diseases.
``(c) Topics for Consultation.--Topics for consultation
pursuant to this section may include--
``(1) rare diseases;
``(2) the severity of rare diseases;
``(3) the unmet medical need associated with rare diseases;
``(4) the willingness and ability of individuals with a
rare disease to participate in clinical trials;
``(5) an assessment of the benefits and risks of therapies
to treat rare diseases;
``(6) the general design of clinical trials for rare
disease populations and subpopulations; and
``(7) demographics and the clinical description of patient
populations.
``(d) Classification as Special Government Employees.--The
external experts who are consulted under this section may be
considered special government employees, as defined under
section 202 of title 18, United States Code.
``(e) Protection of Proprietary Information.--Nothing in
this section shall be construed to alter the protections
offered by laws, regulations, and policies governing
disclosure of confidential commercial or trade secret
information, and any other information exempt from disclosure
pursuant to section 552(b) of title 5, United States Code, as
such provisions would be applied to consultation with
individuals and organizations prior to the date of enactment
of this section.
``(f) Other Consultation.--Nothing in this section shall be
construed to limit the ability of the Secretary to consult
with individuals and organizations as authorized prior to the
date of enactment of this section.
``(g) No Right or Obligation.--Nothing in this section
shall be construed to create a legal right for a consultation
on any matter or require the Secretary to meet with any
particular expert or stakeholder. Nothing in this section
shall be construed to alter agreed upon goals and procedures
identified in the letters described in section 101(b) of the
Prescription Drug User Fee Amendments of 2012. Nothing in
this section is intended to increase the number of review
cycles as in effect before the date of enactment of this
section.''.

SEC. 904. ACCESSIBILITY OF INFORMATION ON PRESCRIPTION DRUG
CONTAINER LABELS BY VISUALLY-IMPAIRED AND BLIND
CONSUMERS.

(a) Establishment of Working Group.--
(1) In general.--The Architectural and Transportation
Barriers Compliance Board (referred to in this section as the
``Access Board'') shall convene a stakeholder working group
(referred to in this section as the ``working group'') to
develop best practices on access to information on
prescription drug container labels for individuals who are
blind or visually impaired.
(2) Members.--The working group shall be comprised of
representatives of national organizations representing blind
and visually-impaired individuals, national organizations
representing the elderly, and industry groups representing
stakeholders, including retail, mail order, and independent
community pharmacies, who would be impacted by such best
practices. Representation within the working group shall be
divided equally between consumer and industry advocates.
(3) Best practices.--
(A) In general.--The working group shall develop, not later
than 1 year after the date of the enactment of this Act, best
practices for pharmacies to ensure that blind and visually-
impaired individuals have safe, consistent, reliable, and
independent access to the information on prescription drug
container labels.
(B) Public availability.--The best practices developed
under subparagraph (A) may be made publicly available,
including through the Internet websites of the working group
participant organizations, and through other means, in a
manner that provides access to interested individuals,
including individuals with disabilities.
(C) Limitations.--The best practices developed under
subparagraph (A) shall not be construed as accessibility
guidelines or standards of the Access Board, and shall not
confer any rights or impose any obligations on working group
participants or other persons. Nothing in this section shall
be construed to limit or condition any right, obligation, or
remedy available under the Americans with Disabilities Act of
1990 (42 U.S.C. 12101 et seq.) or any other Federal or State
law requiring effective communication, barrier removal, or
nondiscrimination on the basis of disability.
(4) Considerations.--In developing and issuing the best
practices under paragraph (3)(A), the working group shall
consider--
(A) the use of--
(i) Braille;
(ii) auditory means, such as--

(I) ``talking bottles'' that provide audible container
label information;
(II) digital voice recorders attached to the prescription
drug container; and
(III) radio frequency identification tags;

(iii) enhanced visual means, such as--

(I) large font labels or large font ``duplicate'' labels
that are affixed or matched to a prescription drug container;
(II) high-contrast printing; and
(III) sans-serf font; and

(iv) other relevant alternatives as determined by the
working group;
(B) whether there are technical, financial, manpower, or
other factors unique to pharmacies with 20 or fewer retail
locations which may pose significant challenges to the
adoption of the best practices; and
(C) such other factors as the working group determines to
be appropriate.
(5) Information campaign.--Upon completion of development
of the best practices under subsection (a)(3), the National
Council on Disability, in consultation with the working
group, shall conduct an informational and educational
campaign designed to inform individuals with disabilities,
pharmacists, and the public about such best practices.
(6) FACA waiver.--The Federal Advisory Committee Act (5
U.S.C. App.) shall not apply to the working group.
(b) GAO Study.--
(1) In general.--Beginning 18 months after the completion
of the development of best practices under subsection
(a)(3)(A), the Comptroller General of the United States shall
conduct a review of the extent to which pharmacies are
utilizing such best practices, and the extent to which
barriers to accessible information on prescription drug
container labels for blind and visually-impaired individuals
continue.
(2) Report.--Not later than September 30, 2016, the
Comptroller General of the United States shall submit to
Congress a report on the review conducted under paragraph
(1). Such report shall include recommendations about how best
to reduce the barriers experienced by blind and visually-
impaired individuals to independently accessing information
on prescription drug container labels.
(c) Definitions.--In this section--

[[Page S3599]]

(1) the term ``pharmacy'' includes a pharmacy that receives
prescriptions and dispenses prescription drugs through an
Internet website or by mail;
(2) the term ``prescription drug'' means a drug subject to
section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353(b)(1)); and
(3) the term ``prescription drug container label'' means
the label with the directions for use that is affixed to the
prescription drug container by the pharmacist and dispensed
to the consumer.

SEC. 905. RISK-BENEFIT FRAMEWORK.

Section 505(d) (21 U.S.C. 355(d)) is amended by adding at
the end the following: ``The Secretary shall implement a
structured risk-benefit assessment framework in the new drug
approval process to facilitate the balanced consideration of
benefits and risks, a consistent and systematic approach to
the discussion and regulatory decisionmaking, and the
communication of the benefits and risks of new drugs. Nothing
in the preceding sentence shall alter the criteria for
evaluating an application for premarket approval of a
drug.''.

SEC. 906. INDEPENDENT STUDY ON MEDICAL INNOVATION INDUCEMENT
MODEL.

(a) In General.--The Secretary of Health and Human Services
shall enter into an agreement with the National Academies to
provide expert consultation and conduct a study that
evaluates the feasibility and possible consequences of the
use of innovation inducement prizes to reward successful
medical innovations. Under the agreement, the National
Academies shall submit to the Secretary a report on such
study not later than 15 months after the date of enactment of
this Act.
(b) Requirements.--
(1) In general.--The study conducted under subsection (a)
shall model at least 3 separate segments on the medical
technologies market as candidate targets for the new
incentive system and consider different medical innovation
inducement prize design issues, including the challenges
presented in the implementation of prizes for end products,
open source dividend prizes, and prizes for upstream
research.
(2) Market segments.--The segments on the medical
technologies market that shall be considered under paragraph
(1) include--
(A) all pharmaceutical and biologic drugs and vaccines;
(B) drugs and vaccines used solely for the treatment of
HIV/AIDS; and
(C) antibiotics.
(c) Elements.--The study conducted under subsection (a)
shall include consideration of each of the following:
(1) Whether a system of large innovation inducement prizes
could work as a replacement for the existing product
monopoly/patent-based system, as in effect on the date of
enactment of this Act.
(2) How large the innovation prize funds would have to be
in order to induce at least as much research and development
investment in innovation as is induced under the current
system of time-limited market exclusivity, as in effect on
the date of enactment of this Act.
(3) Whether a system of large innovation inducement prizes
would be more or less expensive than the current system of
time-limited market exclusivity, as in effect on the date of
enactment of this Act, calculated over different time
periods.
(4) Whether a system of large innovation inducement prizes
would expand access to new products and improve health
outcomes.
(5) The type of information and decisionmaking skills that
would be necessary to manage end product prizes.
(6) Whether there would there be major advantages in
rewarding the incremental impact of innovations, as
benchmarked against existing products.
(7) How open-source dividend prizes could be managed, and
whether such prizes would increase access to knowledge,
materials, data and technologies.
(8) Whether a system of competitive intermediaries for
interim research prizes would provide an acceptable solution
to the valuation challenges for interim prizes.

SEC. 907. ORPHAN PRODUCT GRANTS PROGRAM.

(a) Reauthorization of Program.--Section 5(c) of the Orphan
Drug Act (21 U.S.C. 360ee(c)) is amended by striking ``2008
through 2012'' and inserting ``2013 through 2017''.
(b) Human Clinical Testing.--Section 5(b)(1)(A)(ii)) of the
Orphan Drug Act (21 U.S.C. 360ee(b)(1)(A)(ii)) is amended by
striking ``after the date such drug is designated under
section 526 of such Act and''.

SEC. 908. REPORTING OF INCLUSION OF DEMOGRAPHIC SUBGROUPS IN
CLINICAL TRIALS AND DATA ANALYSIS IN
APPLICATIONS FOR DRUGS, BIOLOGICS, AND DEVICES.

(a) Report.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary, acting through the
Commissioner, shall publish on the Internet website of the
Food and Drug Administration a report, consistent with the
regulations of the Food and Drug Administration pertaining to
the protection of sponsors' confidential commercial
information as of the date of enactment of this Act,
addressing the extent to which clinical trial participation
and the inclusion of safety and effectiveness data by
demographic subgroups including sex, age, race, and
ethnicity, is included in applications submitted to the Food
and Drug Administration, and shall provide such publication
to Congress.
(2) Contents of report.--The report described in paragraph
(1) shall contain the following:
(A) A description of existing tools to ensure that data to
support demographic analyses are submitted in applications
for drugs, biological products, and devices, and that these
analyses are conducted by applicants consistent with
applicable Food and Drug Administration requirements and
Guidance for Industry. The report shall address how the Food
and Drug Administration makes available information about
differences in safety and effectiveness of medical products
according to demographic subgroups, such as sex, age, racial,
and ethnic subgroups, to healthcare providers, researchers,
and patients.
(B) An analysis of the extent to which demographic data
subset analyses on sex, age, race, and ethnicity is presented
in applications for new drug applications for new molecular
entities under section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355), in biologics license
applications under section 351 of the Public Health Service
Act (42 U.S.C. 262), and in premarket approval applications
under section 515 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360e) for products approved or licensed by the
Food and Drug Administration, consistent with applicable
requirements and Guidance for Industry, and consistent with
the regulations of the Food and Drug Administration
pertaining to the protection of sponsors' confidential
commercial information as of the date of enactment of this
Act.
(C) An analysis of the extent to which demographic
subgroups, including sex, age, racial, and ethnic subgroups,
are represented in clinical studies to support applications
for approved or licensed new molecular entities, biological
products, and devices.
(D) An analysis of the extent to which a summary of product
safety and effectiveness data by demographic subgroups
including sex, age, race, and ethnicity is readily available
to the public in a timely manner by means of the product
labeling or the Food and Drug Administration's Internet
website.
(b) Action Plan.--
(1) In general.--Not later than 1 year after the
publication of the report described in subsection (a), the
Secretary, acting through the Commissioner, shall publish an
action plan on the Internet website of the Food and Drug
Administration, and provide such publication to Congress.
(2) Content of action plan.--The plan described in
paragraph (1) shall include--
(A) recommendations, as appropriate, to improve the
completeness and quality of analyses of data on demographic
subgroups in summaries of product safety and effectiveness
data and in labeling;
(B) recommendations, as appropriate, on the inclusion of
such data, or the lack of availability of such data in
labeling;
(C) recommendations, as appropriate, to otherwise improve
the public availability of such data to patients, healthcare
providers, and researchers; and
(D) a determination with respect to each recommendation
identified in subparagraphs (A) through (C) that
distinguishes between product types referenced in subsection
(a)(2)(B) insofar as the applicability of each such
recommendation to each type of product.
(c) Definitions.--In this section:
(1) The term ``Commissioner'' means the Commissioner of
Food and Drugs.
(2) The term ``device'' has the meaning given such term in
section 201(h) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(h)).
(3) The term ``drug'' has the meaning given such term in
section 201(g) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(g)).
(4) The term ``biological product'' has the meaning given
such term in section 351(i) of the Public Health Service Act
(42 U.S.C. 262(i)).
(5) The term ``Secretary'' means the Secretary of Health
and Human Services.

TITLE X--DRUG SHORTAGES

SEC. 1001. DRUG SHORTAGES.

(a) In General.--Section 506C (21 U.S.C. 356c) is amended
to read as follows:

``SEC. 506C. DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION
OF LIFE-SAVING DRUGS.

``(a) In General.--A manufacturer of a drug--
``(1) that is--
``(A) life-supporting;
``(B) life-sustaining;
``(C) intended for use in the prevention of a debilitating
disease or condition;
``(D) a sterile injectable product; or
``(E) used in emergency medical care or during surgery; and
``(2) that is not a radio pharmaceutical drug product, a
human tissue replaced by a recombinant product, a product
derived from human plasma protein, or any other product as
designated by the Secretary,
shall notify the Secretary, in accordance with subsection
(b), of a permanent discontinuance in the manufacture of the
drug or an interruption of the manufacture of the drug that
could lead to a meaningful disruption in the supply of that
drug in the United States.
``(b) Timing.--A notice required under subsection (a) shall
be submitted to the Secretary--
``(1) at least 6 months prior to the date of the
discontinuance or interruption; or

[[Page S3600]]

``(2) if compliance with paragraph (1) is not possible, as
soon as practicable.
``(c) Expedited Inspections and Reviews.--If, based on
notifications described in subsection (a) or any other
relevant information, the Secretary concludes that there is,
or is likely to be, a drug shortage of a drug described in
subsection (a), the Secretary may--
``(1) expedite the review of a supplement to a new drug
application submitted under section 505(b), an abbreviated
new drug application submitted under section 505(j), or a
supplement to such an application submitted under section
505(j) that could help mitigate or prevent such shortage; or
``(2) expedite an inspection or reinspection of an
establishment that could help mitigate or prevent such drug
shortage.
``(d) Coordination.--
``(1) Task force and strategic plan.--
``(A) In general.--
``(i) Task force.--As soon as practicable after the date of
enactment of the Food and Drug Administration Safety and
Innovation Act, the Secretary shall establish a Task Force to
develop and implement a strategic plan for enhancing the
Secretary's response to preventing and mitigating drug
shortages.
``(ii) Strategic plan.--The strategic plan described in
clause (i) shall include--

``(I) plans for enhanced interagency and intraagency
coordination, communication, and decisionmaking;
``(II) plans for ensuring that drug shortages are
considered when the Secretary initiates a regulatory action
that could precipitate a drug shortage or exacerbate an
existing drug shortage;
``(III) plans for effective communication with outside
stakeholders, including who the Secretary should alert about
potential or actual drug shortages, how the communication
should occur, and what types of information should be shared;
and
``(IV) plans for considering the impact of drug shortages
on research and clinical trials.

``(iii) Consultation.--In carrying out this subparagraph,
the Task Force shall ensure consultation with the appropriate
offices within the Food and Drug Administration, including
the Office of the Commissioner, the Center for Drug
Evaluation and Research, the Office of Regulatory Affairs,
and employees within the Department of Health and Human
Services with expertise regarding drug shortages. The
Secretary shall engage external stakeholders and experts as
appropriate.
``(B) Timing.--Not later than 1 year after the date of
enactment Food and Drug Administration Safety and Innovation
Act, the Task Force shall--
``(i) publish the strategic plan described in subparagraph
(A); and
``(ii) submit such plan to Congress.
``(2) Communication.--The Secretary shall ensure that,
prior to any enforcement action or issuance of a warning
letter that the Secretary determines could reasonably be
anticipated to lead to a meaningful disruption in the supply
in the United States of a drug described under subsection
(a), there is communication with the appropriate office of
the Food and Drug Administration with expertise regarding
drug shortages regarding whether the action or letter could
cause, or exacerbate, a shortage of the drug.
``(3) Action.--If the Secretary determines, after the
communication described in paragraph (2), that an enforcement
action or a warning letter could reasonably cause or
exacerbate a shortage of a drug described under subsection
(a), then the Secretary shall evaluate the risks associated
with the impact of such shortage upon patients and those
risks associated with the violation involved before taking
such action or issuing such letter, unless there is imminent
risk of serious adverse health consequences or death to
humans.
``(4) Reporting by other entities.--The Secretary shall
identify or establish a mechanism by which healthcare
providers and other third-party organizations may report to
the Secretary evidence of a drug shortage.
``(5) Review and construction.--No determination, finding,
action, or omission of the Secretary under this subsection
shall--
``(A) be subject to judicial review; or
``(B) be construed to establish a defense to an enforcement
action by the Secretary.
``(e) Recordkeeping and Reporting.--
``(1) Recordkeeping.--The Secretary shall maintain records
related to drug shortages, including with respect to each of
the following:
``(A) The number of manufacturers that submitted a
notification to the Secretary under subsection (a) in each
calendar year.
``(B) The number of drug shortages that occurred in each
calendar year and a list of drug names, drug types, and
classes that were the subject of such shortages.
``(C) A list of the known factors contributing to the drug
shortages described in subparagraph (B).
``(D)(i) A list of major actions taken by the Secretary to
prevent or mitigate the drug shortages described in
subparagraph (B).
``(ii) The Secretary shall include in the list under clause
(i) the following:
``(I) The number of applications for which the Secretary
expedited review under subsection (c)(1) in each calendar
year.
``(II) The number of establishment inspections or
reinspections that the Secretary expedited under subsection
(c)(2) in each calendar year.
``(E) The number of notifications submitted to the
Secretary under subsection (a) in each calendar year.
``(F) The names of manufacturers that the Secretary has
learned did not comply with the notification requirement
under subsection (a) in each calendar year.
``(G) The number of times in each calendar year that the
Secretary determined under subsection (d)(3) that an
enforcement action or a warning letter could reasonably cause
or exacerbate a shortage of a drug described under subsection
(a), but did not evaluate the risks associated with the
impact of such shortage upon patients and those risks
associated with the violation involved before taking such
action or issuing such letter on the grounds that there was
imminent risk of serious adverse health consequences or death
to humans, and a summary of the determinations.
``(H) A summary of the communications made and actions
taken under subsection (d) in each calendar year.
``(I) Any other information the Secretary deems appropriate
to better prevent and mitigate drug shortages.
``(2) Trend analysis.--The Secretary is authorized to
retain a third party to conduct a study, if the Secretary
believes such a study would help clarify the causes, trends,
or solutions related to drug shortages.
``(3) Annual summary.--Not later than 18 months after the
date of enactment of the Food and Drug Administration Safety
and Innovation Act, and annually thereafter, the Secretary
shall submit to the Committee on Health, Education, Labor,
and Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives a report
summarizing, with respect to the 1-year period preceding such
report, the information described in paragraph (1). Such
report shall not include any information that is exempt from
disclosure under subsection (a) of section 552 of title 5,
United States Code, by reason of subsection (b)(4) of such
section.
``(f) Definitions.--For purposes of this section--
``(1) the term `drug'--
``(A) means a drug (as defined in section 201(g)) that is
intended for human use; and
``(B) does not include biological products (as defined in
section 351 of the Public Health Service Act), unless
otherwise provided by the Secretary in the regulations
promulgated under subsection (h);
``(2) the term `drug shortage' or `shortage', with respect
to a drug, means a period of time when the demand or
projected demand for the drug within the United States
exceeds the supply of the drug; and
``(3) the term `meaningful disruption'--
``(A) means a change in production that is reasonably
likely to lead to a reduction in the supply of a drug by a
manufacturer that is more than negligible and impacts the
ability of the manufacturer to fill orders or meet expected
demand for its product; and
``(B) does not include interruptions in manufacturing due
to matters such as routine maintenance or insignificant
changes in manufacturing so long as the manufacturer expects
to resume operations in a short period of time.
``(g) Distribution.--To the maximum extent practicable, the
Secretary may distribute information on drug shortages and on
the permanent discontinuation of the drugs described in this
section to appropriate provider and patient organizations,
except that any such distribution shall not include any
information that is exempt from disclosure under section 552
of title 5, United States Code, by reason of subsection
(b)(4) of such section.
``(h) Regulations.--
``(1) In general.--Not later than 18 months after the date
of enactment of the Food and Drug Administration Safety and
Innovation Act, the Secretary shall adopt a final regulation
implementing this section.
``(2) Inclusion of biological products.--
``(A) In general.--The Secretary may by regulation apply
this section to biological products (as defined in section
351 of the Public Health Service Act) if the Secretary
determines such inclusion would benefit the public health.
``(B) Rule for vaccines.--If the Secretary applies this
section to vaccines pursuant to subparagraph (A), the
Secretary shall--
``(i) consider whether the notification requirement under
subsection (a) may be satisfied by submitting a notification
to the Centers for Disease Control and Prevention under the
vaccine shortage notification program of such Centers; and
``(ii) explain the determination made by the Secretary
under clause (i) in the regulation.
``(3) Procedure.--In promulgating a regulation implementing
this section, the Secretary shall--
``(A) issue a notice of proposed rulemaking that includes
the proposed regulation;
``(B) provide a period of not less than 60 days for
comments on the proposed regulation; and
``(C) publish the final regulation not less than 30 days
before the regulation's effective date.
``(4) Restrictions.--Notwithstanding any other provision of
Federal law, in implementing this section, the Secretary
shall only promulgate regulations as described in paragraph
(3).''.
(b) Effect of Notification.--The submission of a
notification to the Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') for
purposes of complying with the requirement in section 506C(a)
of the Federal Food, Drug, and

[[Page S3601]]

Cosmetic Act (as amended by subsection (a)) shall not be
construed--
(1) as an admission that any product that is the subject of
such notification violates any provision of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or
(2) as evidence of an intention to promote or market the
product for an indication or use for which the product has
not been approved by the Secretary.
(c) Internal Review.--Not later than 2 years after the date
of enactment of this Act, the Secretary shall--
(1) analyze and review the regulations promulgated under
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.), the guidances or policies issued under such Act
related to drugs intended for human use, and the practices of
the Food and Drug Administration regarding enforcing such Act
related to manufacturing of such drugs, to identify any such
regulations, guidances, policies, or practices that cause,
exacerbate, prevent, or mitigate drug shortages (as defined
in section 506C of the Federal Food, Drug, and Cosmetic Act
(as amended by subsection (a)); and
(2) determine how regulations, guidances, policies, or
practices identified under paragraph (1) should be modified,
streamlined, expanded, or discontinued in order to reduce or
prevent such drug shortages, taking into consideration the
effect of any changes on the public health.
(d) Study on Market Factors Contributing to Drug Shortages
and Stockpiling.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Comptroller General of the United
States, in consultation with the Secretary, the Department of
Health and Human Services Office of the Inspector General,
the Attorney General, and Chairman of the Federal Trade
Commission, shall publish a report reviewing any findings
that drug shortages (as so defined) have led market
participants to stockpile affected drugs or sell them at
significantly increased prices, the impact of such activities
on Federal revenue, and any economic factors that have
exacerbated or created a market for such actions.
(2) Content.--The report under paragraph (1) shall
include--
(A) an analysis of the incidence of any of the activities
described in paragraph (1) and the effect of such activities
on the public health;
(B) an evaluation of whether in such cases there is a
correlation between drugs in shortage and--
(i) the number of manufacturers producing such drugs;
(ii) the pricing structure, including Federal
reimbursements, for such drugs before such drugs were in
shortage, and to the extent possible, revenue received by
each such manufacturer of such drugs;
(iii) pricing structure and revenue, to the extent
possible, for the same drugs when sold under the conditions
described in paragraph (1); and
(iv) the impact of contracting practices by market
participants (including manufacturers, distributors, group
purchasing organizations, and providers) on competition,
access to drugs, and pricing of drugs;
(C) whether the activities described in paragraph (1) are
consistent with applicable law; and
(D) recommendations to Congress on what, if any, additional
reporting or enforcement actions are necessary.
(3) Trade secret and confidential information.--Nothing in
this subsection alters or amends section 1905 of title 18,
United States Code, or section 552(b)(4) of title 5, United
States Code.
(e) Guidance Regarding Repackaging.--Not later than 1 year
after the date of enactment of this Act, the Secretary shall
issue guidance that clarifies the policy of the Food and Drug
Administration regarding hospital pharmacies repackaging and
safely transferring repackaged drugs among hospitals within a
common health system during a drug shortage, as identified by
the Secretary.

TITLE XI--OTHER PROVISIONS

Subtitle A--Reauthorizations

SEC. 1101. REAUTHORIZATION OF PROVISION RELATING TO
EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE
ENANTIOMERS.

(a) In General.--Section 505(u)(4) (21 U.S.C. 355(u)(4)) is
amended by striking ``2012'' and inserting ``2017''.
(b) Amendment.--Section 505(u)(1)(A)(ii)(II) (21 U.S.C.
355(u)(1)(A)(ii)(II)) is amended by inserting ``clinical''
after ``any''.

SEC. 1102. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-
PRIVATE PARTNERSHIPS.

Section 566(f) (21 U.S.C. 360bbb 5(f)) is amended by
striking ``2012'' and inserting ``2017''.

Subtitle B--Medical Gas Product Regulation

SEC. 1111. REGULATION OF MEDICAL GAS PRODUCTS.

(a) Regulation.--Chapter V (21 U.S.C. 351 et seq.) is
amended by adding at the end the following:

``Subchapter G--Medical Gas Products

``SEC. 575. DEFINITIONS.

``In this subchapter:
``(1) The term `designated medical gas product' means any
of the following:
``(A) Oxygen, that meets the standards set forth in an
official compendium.
``(B) Nitrogen, that meets the standards set forth in an
official compendium.
``(C) Nitrous oxide, that meets the standards set forth in
an official compendium.
``(D) Carbon dioxide, that meets the standards set forth in
an official compendium.
``(E) Helium, that meets the standards set forth in an
official compendium.
``(F) Carbon monoxide, that meets the standards set forth
in an official compendium.
``(G) Medical air, that meets the standards set forth in an
official compendium.
``(H) Any other medical gas product deemed appropriate by
the Secretary, unless any period of exclusivity under section
505(c)(3)(E)(ii) or 505(j)(5)(F)(ii), or the extension of any
such period under section 505A, applicable to such medical
gas product has not expired.
``(2) The term `medical gas product' means a drug that--
``(A) is manufactured or stored in a liquefied,
nonliquefied, or cryogenic state; and
``(B) is administered as a gas.

``SEC. 576. REGULATION OF MEDICAL GAS PRODUCTS.

``(a) Certification of Designated Medical Gas Products.--
``(1) Submission.--
``(A) In general.--Beginning on the date of enactment of
this section, any person may file with the Secretary a
request for a certification of a designated medical gas
product.
``(B) Content.--A request under subparagraph (A) shall
contain--
``(i) a description of the medical gas product;
``(ii) the name and address of the sponsor;
``(iii) the name and address of the facility or facilities
where the gas product is or will be manufactured; and
``(iv) any other information deemed appropriate by the
Secretary to determine whether the medical gas product is a
designated medical gas product.
``(2) Grant of certification.--A certification described
under paragraph (1)(A) shall be determined to have been
granted unless, not later than 60 days after the filing of a
request under paragraph (1), the Secretary finds that--
``(A) the medical gas product subject to the certification
is not a designated medical gas product;
``(B) the request does not contain the information required
under paragraph (1) or otherwise lacks sufficient information
to permit the Secretary to determine that the gas product is
a designated medical gas product; or
``(C) granting the request would be contrary to public
health.
``(3) Effect of certification.--
``(A) In general.--
``(i) Approved uses.--A designated medical gas product for
which a certification is granted under paragraph (2) is
deemed, alone or in combination with another designated gas
product or products as medically appropriate, to have in
effect an approved application under section 505 or 512,
subject to all applicable postapproval requirements, for the
following indications for use:

``(I) Oxygen for the treatment or prevention of hypoxemia
or hypoxia.
``(II) Nitrogen for use in hypoxic challenge testing.
``(III) Nitrous oxide for analgesia.
``(IV) Carbon dioxide for use in extracorporeal membrane
oxygenation therapy or respiratory stimulation.
``(V) Helium for the treatment of upper airway obstruction
or increased airway resistance.
``(VI) Medical air to reduce the risk of hyperoxia.
``(VII) Carbon monoxide for use in lung diffusion testing.
``(VIII) Any other indication for use for a designated
medical gas product or combination of designated medical gas
products deemed appropriate by the Secretary, unless any
period of exclusivity under clause (iii) or (iv) of section
505(c)(3)(E), under clause (iii) or (iv) of section
505(j)(5)(F), or under section 527, or the extension of any
such period under section 505A, applicable to such indication
for use for such gas product or combination of products has
not expired.

``(ii) Labeling.--The requirements established in sections
503(b)(4) and 502(f) shall be deemed to have been met for a
designated medical gas product if the labeling on final use
containers of such gas product bears the information required
by section 503(b)(4) and a warning statement concerning the
use of the gas product, as determined by the Secretary by
regulation, as well as appropriate directions and warnings
concerning storage and handling.
``(B) Inapplicability of exclusivity provisions.--
``(i) Effect on ineligibility.--No designated medical gas
product deemed under paragraph (3)(A)(i) to have in effect an
approved application shall be eligible for any periods of
exclusivity under sections 505(c), 505(j), or 527, or the
extension of any such period under section 505A, on the basis
of such deemed approval.
``(ii) Effect on certification.--No period of exclusivity
under sections 505(c), 505(j), or section 527, or the
extension of any such period under section 505A, with respect
to an application for a drug shall prohibit, limit, or
otherwise affect the submission, grant, or effect of a
certification under this section, except as provided in
paragraph (3)(A)(i)(VIII).
``(4) Withdrawal, suspension, or revocation of approval.--
``(A) In general.--Nothing in this subchapter limits the
authority of the Secretary

[[Page S3602]]

to withdraw or suspend approval of a drug, including a
designated medical gas product deemed under this section to
have in effect an approved application, under section 505 or
section 512.
``(B) Revocation.--The Secretary may revoke the grant of a
certification under this section if the Secretary determines
that the request for certification contains any material
omission or falsification.
``(b) Prescription Requirement.--
``(1) In general.--A designated medical gas product shall
be subject to section 503(b)(1) unless the Secretary
exercises the authority provided in section 503(b)(3) to
remove such gas product from the requirements of section
503(b)(1) or the use in question is authorized pursuant to
another provision of this Act relating to use of medical
products in emergencies.
``(2) Exception for oxygen.--
``(A) In general.--Notwithstanding paragraph (1), oxygen
may be provided without a prescription for the following
uses:
``(i) The use in the event of depressurization or other
environmental oxygen deficiency.
``(ii) The use in the event of oxygen deficiency or use in
emergency resuscitation, when administered by properly
trained personnel.
``(B) Labeling.--For oxygen provided pursuant to
subparagraph (A), the requirements established in section
503(b)(4) shall be deemed to have been met if the labeling of
the oxygen bears a warning that the medical gas product can
be used for emergency use only and for all other medical
applications a prescription is required.
``(c) Inapplicability of Drugs Fees to Designated Medical
Gas Products.--A designated medical gas product deemed under
this section to have in effect an approved application shall
not be assessed fees under section 736(a) on the basis of
such deemed approval.''.

SEC. 1112. REGULATIONS.

(a) Review of Regulations.--Not later than 18 months after
the date of enactment of this Act, the Secretary of Health
and Human Services (referred to in this section as the
``Secretary'') shall, after obtaining input from medical gas
product manufacturers, and any other interested members of
the public, submit a report to the Committee on Health,
Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives regarding any changes to the Federal drug
regulations in title 21, Code of Federal Regulations that the
Secretary determines to be necessary.
(b) Amended Regulations.--If the Secretary determines that
changes to the Federal drug regulations in title 21, Code of
Federal Regulations are necessary under subsection (a), the
Secretary shall issue final regulations implementing such
changes not later than 4 years after the date of enactment of
this Act.

SEC. 1113. APPLICABILITY.

Nothing in this subtitle or the amendments made by this
subtitle shall apply to--
(1) a drug that is covered by an application under section
505 or 512 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355, 360b) approved prior to May 1, 2012; or
(2) any of the gases listed in subparagraphs (A) through
(G) of section 575(1) of such Act (as added by section 1111),
or any mixture of any such gases, for an indication that--
(A) is not included in, or is different from, those
specified in subclauses (I) through (VII) of section
576(a)(3)(i) of such Act (as added by section 1111); and
(B) is approved on or after May 1, 2012, pursuant to an
application submitted under section 505 or 512 of such Act.

Subtitle C--Miscellaneous Provisions

SEC. 1121. ADVISORY COMMITTEE CONFLICTS OF INTEREST.

Section 712 (21 U.S.C. 379d 1) is amended--
(1) in subsection (b)--
(A) by striking paragraph (2); and
(B) in paragraph (1)--
(i) by redesignating subparagraph (B) as paragraph (2) and
moving such paragraph, as so redesignated, 2 ems to the left;
(ii) in subparagraph (A), by redesignating clauses (i)
through (iii) as subparagraphs (A) through (C), respectively,
and moving such subparagraphs, as so redesignated, 2 ems to
the left;
(iii) in subparagraph (A), as so redesignated, by inserting
``, including strategies to increase the number of special
Government employees across medical and scientific
specialties in areas where the Secretary would benefit from
specific scientific, medical, or technical expertise
necessary for the performance of its regulatory
responsibilities'' before the semicolon at the end;
(iv) by striking ``(1) Recruitment.--'' and inserting ``(1)
Recruitment in general.--The Secretary shall--'';
(v) by striking ``(A) In general.--The Secretary shall--'';
(vi) by redesignating clauses (i) through (iii) of
paragraph (2) (as so redesignated) as subparagraphs (A)
through (C), respectively, and moving such subparagraphs, as
so redesignated, 2 ems to the left;
(vii) in paragraph (2) (as so redesignated), in the matter
before subparagraph (A) (as so redesignated), by striking
``subparagraph (A)'' and inserting ``paragraph (1)''; and
(viii) by adding at the end the following:
``(3) Recruitment through referrals.--In carrying out
paragraph (1), the Secretary shall, in order to further the
goal of including in advisory committees highly qualified and
specialized experts in the specific diseases to be considered
by such advisory committees, at least every 180 days, request
referrals from a variety of stakeholders, such as the
Institute of Medicine, the National Institutes of Health,
product developers, patient groups, disease advocacy
organizations, professional societies, medical societies,
including the American Academy of Medical Colleges, and other
governmental organizations.'';
(2) by amending subsection (c)(2)(C) to read as follows:
``(C) Consideration by secretary.--The Secretary shall
ensure that each determination made under subparagraph (B)
considers the type, nature, and magnitude of the financial
interests at issue and the public health interest in having
the expertise of the member with respect to the particular
matter before the advisory committee.'';
(3) in subsection (e), by inserting ``, and shall make
publicly available,'' after ``House of Representatives''; and
(4) by adding at the end the following:
``(g) Guidance on Reported Financial Interest or
Involvement.--The Secretary shall issue guidance that
describes how the Secretary reviews the financial interests
and involvement of advisory committee members that are
reported under subsection (c)(1) but that the Secretary
determines not to meet the definition of a disqualifying
interest under section 208 of title 18, United States Code
for the purposes of participating in a particular matter.''.

SEC. 1122. GUIDANCE DOCUMENT REGARDING PRODUCT PROMOTION
USING THE INTERNET.

Not later than 2 years after the date of enactment this
Act, the Secretary of Health and Human Services shall issue
guidance that describes Food and Drug Administration policy
regarding the promotion, using the Internet (including social
media), of medical products that are regulated by such
Administration.

SEC. 1123. ELECTRONIC SUBMISSION OF APPLICATIONS.

Subchapter D of chapter VII (21 U.S.C. 379k et seq.) is
amended by inserting after section 745 the following:

``SEC. 745A. ELECTRONIC FORMAT FOR SUBMISSIONS.

``(a) Drugs and Biologics.--
``(1) In general.--Beginning no earlier than 24 months
after the issuance of a final guidance issued after public
notice and opportunity for comment, submissions under
subsection (b), (i), or (j) of section 505 of this Act or
subsection (a) or (k) of section 351 of the Public Health
Service Act shall be submitted in such electronic format as
specified by the Secretary in such guidance.
``(2) Guidance contents.--In the guidance under paragraph
(1), the Secretary may--
``(A) provide a timetable for establishment by the
Secretary of further standards for electronic submission as
required by such paragraph; and
``(B) set forth criteria for waivers of and exemptions from
the requirements of this subsection.
``(3) Exception.--This subsection shall not apply to
submissions described in section 561.
``(b) Devices.--
``(1) In general.--Beginning after the issuance of final
guidance implementing this paragraph, pre-submissions and
submissions for devices under section 510(k), 513(f)(2)(A),
515(c), 515(d), 515(f), 520(g), 520(m), or 564 of this Act or
section 351 of the Public Health Service Act, and any
supplements to such pre-submissions or submissions, shall
include an electronic copy of such pre-submissions or
submissions.
``(2) Guidance contents.--In the guidance under paragraph
(1), the Secretary may--
``(A) provide standards for the electronic copy required
under such paragraph; and
``(B) set forth criteria for waivers of and exemptions from
the requirements of this subsection.''.

SEC. 1124. COMBATING PRESCRIPTION DRUG ABUSE.

(a) In General.--To combat the significant rise in
prescription drug abuse and the consequences of such abuse,
the Secretary of Health and Human Services (referred to in
this section as the ``Secretary''), acting through the
Commissioner of Food and Drugs (referred to in this section
as the ``Commissioner'') and in coordination with other
Federal agencies, as appropriate, shall review current
Federal initiatives and identify gaps and opportunities with
respect to ensuring the safe use and disposal of prescription
drugs with the potential for abuse.
(b) Report.--Not later than 1 year after the date of
enactment of this Act, the Secretary shall post a report on
the Internet website of the Food and Drug Administration on
the findings of the review under subsection (a). Such report
shall include findings and recommendations on--
(1) how best to leverage and build upon existing Federal
and federally funded data sources, such as prescription drug
monitoring program data and the sentinel initiative of the
Food and Drug Administration under section 505(k)(3) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(k)(3)),
as it relates to collection of information relevant to
adverse events, patient safety, and patient outcomes, to
create a centralized data clearinghouse and early warning
tool;
(2) how best to develop and disseminate widely best
practices models and suggested standard requirements to
States for achieving greater interoperability and
effectiveness of prescription drug monitoring programs,
especially with respect to provider

[[Page S3603]]

participation, producing standardized data on adverse events,
patient safety, and patient outcomes; and
(3) how best to develop provider, pharmacist, and patient
education tools and a strategy to widely disseminate such
tools and assess the efficacy of such tools.
(c) Guidance on Abuse-deterrent Products.--Not later than 6
months after the date of enactment of this Act, the
Secretary, acting through the Commissioner, shall promulgate
guidance on the development of abuse-deterrent drug products.
(d) Study and Report on Prescription Drug Abuse.--Not later
than 1 year after the date of enactment of this Act, the
Secretary shall seek to enter into an agreement with the
Institute of Medicine to conduct a study and report on
prescription drug abuse. Such report shall evaluate trends in
prescription drug abuse, assess opportunities to inform and
educate the public, patients, and health care providers on
issues related to prescription drug abuse and misuse, and
identify potential barriers, if any, to prescription drug
monitoring program participation and implementation.

SEC. 1125. TANNING BED LABELING.

Not later than 18 months after the date of enactment of
this Act, the Secretary of Health and Human Services shall
determine whether to amend the warning label requirements for
sunlamp products to include specific requirements to more
clearly and effectively convey the risks that such products
pose for the development of irreversible damage to the eyes
and skin, including skin cancer.

SEC. 1126. OPTIMIZING GLOBAL CLINICAL TRIALS.

Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as
amended by section 903, is further amended by adding at the
end the following:

``SEC. 569A. OPTIMIZING GLOBAL CLINICAL TRIALS.

``(a) In General.--The Secretary shall--
``(1) work with other regulatory authorities of similar
standing, medical research companies, and international
organizations to foster and encourage uniform,
scientifically-driven clinical trial standards with respect
to medical products around the world; and
``(2) enhance the commitment to provide consistent parallel
scientific advice to manufacturers seeking simultaneous
global development of new medical products in order to--
``(A) enhance medical product development;
``(B) facilitate the use of foreign data; and
``(C) minimize the need to conduct duplicative clinical
studies, preclinical studies, or non-clinical studies.
``(b) Medical Product.--In this section, the term `medical
product' means a drug, as defined in subsection (g) of
section 201, a device, as defined in subsection (h) of such
section, or a biological product, as defined in section
351(i) of the Public Health Service Act.
``(c) Savings Clause.--Nothing in this section shall alter
the criteria for evaluating the safety or effectiveness of a
medical product under this Act.

``SEC. 569B. USE OF CLINICAL INVESTIGATION DATA FROM OUTSIDE
THE UNITED STATES.

``(a) In General.--In determining whether to approve,
license, or clear a drug or device pursuant to an application
submitted under this chapter, the Secretary shall accept data
from clinical investigations conducted outside of the United
States, including the European Union, if the applicant
demonstrates that such data are adequate under applicable
standards to support approval, licensure, or clearance of the
drug or device in the United States.
``(b) Notice to Sponsor.--If the Secretary finds under
subsection (a) that the data from clinical investigations
conducted outside the United States, including in the
European Union, are inadequate for the purpose of making a
determination on approval, clearance, or licensure of a drug
or device pursuant to an application submitted under this
chapter, the Secretary shall provide written notice to the
sponsor of the application of such finding and include the
rationale for such finding.''.

SEC. 1127. ADVANCING REGULATORY SCIENCE TO PROMOTE PUBLIC
HEALTH INNOVATION.

(a) In General.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall develop a strategy and implementation plan for
advancing regulatory science for medical products in order to
promote the public health and advance innovation in
regulatory decisionmaking.
(b) Requirements.--The strategy and implementation plan
developed under subsection (a) shall be consistent with the
user fee performance goals in the Prescription Drug User Fee
Agreement commitment letter, the Generic Drug User Fee
Agreement commitment letter, and the Biosimilar User Fee
Agreement commitment letter transmitted by the Secretary to
Congress on January 13, 2012, and the Medical Device User Fee
Agreement commitment letter transmitted by the Secretary to
Congress on April 20, 2012, and shall--
(1) identify a clear vision of the fundamental role of
efficient, consistent, and predictable, science-based
decisions throughout regulatory decisionmaking of the Food
and Drug Administration with respect to medical products;
(2) identify the regulatory science priorities of the Food
and Drug Administration directly related to fulfilling the
mission of the agency with respect to decisionmaking
concerning medical products and allocation of resources
towards such regulatory science priorities;
(3) identify regulatory and scientific gaps that impede the
timely development and review of, and regulatory certainty
with respect to, the approval, licensure, or clearance of
medical products, including with respect to companion
products and new technologies, and facilitating the timely
introduction and adoption of new technologies and
methodologies in a safe and effective manner;
(4) identify clear, measurable metrics by which progress on
the priorities identified under paragraph (2) and gaps
identified under paragraph (3) will be measured by the Food
and Drug Administration, including metrics specific to the
integration and adoption of advances in regulatory science
described in paragraph (5) and improving medical product
decisionmaking, in a predictable and science-based manner;
and
(5) set forth how the Food and Drug Administration will
ensure that advances in regulatory science for medical
products are adopted, as appropriate, on an ongoing basis and
in an manner integrated across centers, divisions, and
branches of the Food and Drug Administration, including by
senior managers and reviewers, including through the--
(A) development, updating, and consistent application of
guidance documents that support medical product
decisionmaking; and
(B) the adoption of the tools, methods, and processes under
section 566 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb 5).
(c) Annual Performance Reports.--As part of the annual
performance reports submitted to Congress under sections
736B(a) (as amended by section 104), 738A(a) (as amended by
section 204), 744C(a) (as added by section 303), and 744I(a)
(as added by section 403) of the Federal Food, Drug, and
Cosmetic Act for each of fiscal years 2013 through 2017, the
Secretary shall annually report on the progress made with
respect to--
(1) advancing the regulatory science priorities identified
under paragraph (2) of subsection (b) and resolving the gaps
identified under paragraph (3) of such subsection, including
reporting on specific metrics identified under paragraph (4)
of such subsection;
(2) the integration and adoption of advances in regulatory
science as set forth in paragraph (5) of such subsection; and
(3) the progress made in advancing the regulatory science
goals outlined in the Prescription Drug User Fee Agreement
commitment letter, the Generic Drug User Fee Agreement
commitment letter, and the Biosimilar User Fee Agreement
commitment letter transmitted by the Secretary to Congress on
January 13, 2012, and the Medical Device User Fee Agreement
transmitted by the Secretary to Congress on April 20, 2012.
(d) Independent Assessment.--Not later than January 1,
2016, the Comptroller General of the United States shall
submit to Congress a report--
(1) detailing the progress made by the Food and Drug
Administration in meeting the priorities and addressing the
gaps identified in subsection (b), including any outstanding
gaps; and
(2) containing recommendations, as appropriate, on how
regulatory science initiatives for medical products can be
strengthened and improved to promote the public health and
advance innovation in regulatory decisionmaking.
(e) Medical Product.--In this section, the term ``medical
product'' means a drug, as defined in subsection (g) of
section 201 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321), a device, as defined in subsection (h) of such
section, or a biological product, as defined in section
351(i) of the Public Health Service Act.

SEC. 1128. INFORMATION TECHNOLOGY.

(a) HHS Report.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services shall--
(1) report to Congress on--
(A) the milestones and a completion date for developing and
implementing a comprehensive information technology strategic
plan to align the information technology systems
modernization projects with the strategic goals of the Food
and Drug Administration, including results-oriented goals,
strategies, milestones, performance measures;
(B) efforts to finalize and approve a comprehensive
inventory of the information technology systems of the Food
and Drug Administration that includes information describing
each system, such as costs, system function or purpose, and
status information, and incorporate use of the system
portfolio into the information investment management process
of the Food and Drug Administration;
(C) the ways in which the Food and Drug Administration uses
the plan described in subparagraph (A) to guide and
coordinate the modernization projects and activities of the
Food and Drug Administration, including the interdependencies
among projects and activities; and
(D) the extent to which the Food and Drug Administration
has fulfilled or is implementing recommendations of the
Government Accountability Office with respect to the Food and
Drug Administration and information technology; and

[[Page S3604]]

(2) develop--
(A) a documented enterprise architecture program management
plan that includes the tasks, activities, and timeframes
associated with developing and using the architecture and
addresses how the enterprise architecture program management
will be performed in coordination with other management
disciplines, such as organizational strategic planning,
capital planning and investment control, and performance
management; and
(B) a skills inventory, needs assessment, gap analysis, and
initiatives to address skills gaps as part of a strategic
approach to information technology human capital planning.
(b) GAO Report.--Not later than January 1, 2016, the
Comptroller General of the United States shall issue a report
regarding the strategic plan described in subsection
(a)(1)(A) and related actions carried out by the Food and
Drug Administration. Such report shall assess the progress
the Food and Drug Administration has made on--
(1) the development and implementation of a comprehensive
information technology strategic plan, including the results-
oriented goals, strategies, milestones, and performance
measures identified in subsection (a)(1)(A);
(2) the effectiveness of the comprehensive information
technology strategic plan described in subsection (a)(1)(A),
including the results-oriented goals and performance
measures; and
(3) the extent to which the Food and Drug Administration
has fulfilled recommendations of the Government
Accountability Office with respect to such agency and
information technology.

SEC. 1129. REPORTING REQUIREMENTS.

Subchapter A of chapter VII (21 U.S.C. 371 et seq.), as
amended by section 208, is further amended by adding at the
end the following:

``SEC. 715. REPORTING REQUIREMENTS.

``(a) New Drugs.--Beginning with fiscal year 2013 and
ending with fiscal year 2017, not later than 120 days after
the end of each fiscal year for which fees are collected
under part 2 of subchapter C, the Secretary shall prepare and
submit to the Committee on Health Education, Labor, and
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives a report concerning,
for all applications for approval of a new drug under section
505(b) of this Act or a new biological product under section
351(a) of the Public Health Service Act filed in the previous
fiscal year--
``(1) the number of such applications that met the goals
identified for purposes of part 2 of subchapter C in the
letters from the Secretary of Health and Human Services to
the Chairman of the Committee on Health, Education, Labor,
and Pensions of the Senate and the Chairman of the Committee
on Energy and Commerce of the House of Representatives, as
set forth in the Congressional Record;
``(2) the percentage of such applications that were
approved;
``(3) the percentage of such applications that were issued
complete response letters;
``(4) the percentage of such applications that were subject
to a refuse-to-file action;
``(5) the percentage of such applications that were
withdrawn; and
``(6) the average total time to decision by the Secretary
for all applications for approval of a new drug under section
505(b) of this Act or a new biological product under section
351(a) of the Public Health Service Act filed in the previous
fiscal year, including the number of calendar days spent
during the review by the Food and Drug Administration and the
number of calendar days spent by the sponsor responding to a
complete response letter.''.
``(b) Generic Drugs.--Beginning with fiscal year 2013 and
ending after fiscal year 2017, not later than 120 days after
the end of each fiscal year for which fees are collected
under part 7 of subchapter C, the Secretary shall prepare and
submit to the Committee on Health Education, Labor, and
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives a report concerning,
for all applications for approval of a generic drug under
section 505(j), amendments to such applications, and prior
approval supplements with respect to such applications filed
in the previous fiscal year--
``(1) the number of such applications that met the goals
identified for purposes of part 7 of subchapter C, in the
letters from the Secretary of Health and Human Services to
the Chairman of the Committee on Health, Education, Labor,
and Pensions of the Senate and the Chairman of the Committee
on Energy and Commerce of the House of Representatives, as
set forth in the Congressional Record;
``(2) the average total time to decision by the Secretary
for applications for approval of a generic drug under section
505(j), amendments to such applications, and prior approval
supplements with respect to such applications filed in the
previous fiscal year, including the number of calendar days
spent during the review by the Food and Drug Administration
and the number of calendar days spent by the sponsor
responding to a complete response letter;
``(3) the total number of applications under section
505(j), amendments to such applications, and prior approval
supplements with respect to such applications that were
pending with the Secretary for more than 10 months on the
date of enactment of the Food and Drug Administration Safety
and Innovation Act; and
``(4) the number of applications described in paragraph (3)
on which the Food and Drug Administration took final
regulatory action in the previous fiscal year.
``(c) Biosimilar Biological Products.--
``(1) In general.--Beginning with fiscal year 2014, not
later than 120 days after the end of each fiscal year for
which fees are collected under part 8 of subchapter C, the
Secretary shall prepare and submit to the Committee on Health
Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives a report concerning--
``(A) the number of applications for approval filed under
section 351(k) of the Public Health Service Act; and
``(B) the percentage of applications described in
subparagraph (A) that were approved by the Secretary.
``(2) Additional information.--As part of the performance
report described in paragraph (1), the Secretary shall
include an explanation of how the Food and Drug
Administration is managing the biological product review
program to ensure that the user fees collected under part 2
are not used to review an application under section 351(k) of
the Public Health Service Act.''.

SEC. 1130. STRATEGIC INTEGRATED MANAGEMENT PLAN.

(a) Strategic Integrated Management Plan.--Not later than 1
year after the date of enactment of this Act, the Secretary
of Health and Human Services (referred to in this section as
the ``Secretary'') shall submit to Congress a strategic
integrated management plan for the Center for Drug Evaluation
and Research, the Center for Biologics Evaluation and
Research, and the Center for Devices and Radiological Health.
Such strategic management plan shall--
(1) identify strategic institutional goals and priorities
for the Center for Drug Evaluation and Research, the Center
for Biologics Evaluation and Research, and the Center for
Devices and Radiological Health;
(2) describe the actions the Secretary will take to
recruit, retain, train, and continue to develop the workforce
at the Center for Drug Evaluation and Research, the Center
for Biologics Evaluation and Research, and the Center for
Devices and Radiological Health to fulfill the public health
mission of the Food and Drug Administration; and
(3) identify results-oriented, outcome-based measures that
the Secretary will use to measure the progress of achieving
the strategic goals and priorities identified under paragraph
(1) and the effectiveness of the actions identified under
paragraph (2), including metrics to ensure that managers and
reviewers of the Center for Drug Evaluation and Research, the
Center for Biologics Evaluation and Research, and the Center
for Devices and Radiological Health are familiar with and
appropriately and consistently apply the requirements under
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.), including new requirements under parts 2, 3, 7, and 8
of subchapter C of title VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379f et seq.).
(b) Report.--Not later than January 1, 2016, the
Comptroller General of the United States shall issue a report
regarding the strategic management plan described in
subsection (a) and related actions carried out by the Food
and Drug Administration. Such report shall--
(1) assess the effectiveness of the actions described in
subsection (a)(2) in recruiting, retaining, training, and
developing the workforce at the Center for Drug Evaluation
and Research, the Center for Biologics Evaluation and
Research, and the Center for Devices and Radiological Health
in fulfilling the public health mission of the Food and Drug
Administration;
(2) assess the effectiveness of the measures identified
under subsection (a)(3) in gauging progress against the
strategic goals and priorities identified under subsection
(a)(1);
(3) assess the extent to which the Center for Drug
Evaluation and Research, the Center for Biologics Evaluation
and Research, and the Center for Devices and Radiological
Health are using the identified results-oriented set of
performance measures in tracking their workload by strategic
goals and the effectiveness of such measures;
(4) assess the extent to which performance information is
collected, analyzed, and acted on by managers; and
(5) make recommendations, as appropriate, regarding how the
strategic management plan and related actions of the Center
for Drug Evaluation and Research, the Center for Biologics
Evaluation and Research, and the Center for Devices and
Radiological Health could be improved to fulfill the public
health mission of the Food and Drug Administration in as
efficient and effective manner as possible.

SEC. 1131. DRUG DEVELOPMENT AND TESTING.

(a) In General.--Section 505 1 (21 U.S.C. 355 1) is amended
by adding at the end the following:
``(k) Drug Development and Testing.--
``(1) In general.--Notwithstanding any other provision of
law, if a drug is a covered drug, no elements to ensure safe
use shall prohibit, or be construed or applied to prohibit,
supply of such drug to any eligible drug developer for the
purpose of conducting testing necessary to support an
application under subsection (b)(2) or (j) of section 505 of
this Act or section 351(k) of the Public Health Service Act,
if the Secretary has issued a written notice described in
paragraph (2), and the eligible drug developer has

[[Page S3605]]

agreed to comply with the terms of the notice.
``(2) Written notice.--For purposes of this subsection, the
Secretary shall, within a reasonable period of time, consider
and respond to a request by an eligible drug developer for a
written notice authorizing the supply of a covered drug for
purposes of testing as described in paragraph (1), and the
Secretary shall issue a written notice to such eligible drug
developer and the holder of an application for a covered drug
authorizing the supply of such drug to such eligible drug
developer for purposes of testing if--
``(A) the eligible drug developer has agreed to comply with
any conditions the Secretary considers necessary;
``(B) in the event the eligible drug developer is
conducting bioequivalence or other clinical testing, the
eligible drug developer has submitted, and the Secretary has
approved, a protocol that includes protections that the
Secretary finds will provide assurance of safety comparable
to the assurance of safety provided by the elements to ensure
safe use in the risk evaluation and mitigation strategy for
the covered drug as applicable to such testing; and
``(C) the eligible drug developer is in compliance with
applicable laws and regulations related to such testing,
including any applicable requirements related to
Investigational New Drug Applications or informed consent.
``(3) Additional required element.--The Secretary shall
require as an element of each risk evaluation and mitigation
strategy with elements to ensure safe use approved by the
Secretary that the holder of an application for a covered
drug shall not restrict the resale of the covered drug to an
eligible drug developer that receives a written notice from
the Secretary under paragraph (2) unless, at any time, the
Secretary provides written notice to the holder of the
application directing otherwise based on a shortage of such
drug for patients, national security concerns related to
access to such drug, or such other reason as the Secretary
may specify.
``(4) Violation and penalties.--For purposes of subsection
(f)(8) and sections 301, 303(f)(4), 502(y), and 505(p), it
shall be a violation of the risk evaluation and mitigation
strategy for the holder of the application for a covered drug
to violate the element described in paragraph (3), or in the
case of a holder of an application that is a sole distributor
or supplier of a covered drug, to prevent the sale thereof
after receipt of a written notice by the Secretary issued
under paragraph (2). The Secretary shall provide written
notice to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives within 30 days of
the Secretary becoming aware that a holder of an application
of a covered drug has restricted the sale of such a covered
drug to any eligible drug developer after receipt of written
notice as provided in paragraph (2).
``(5) Liability.--Unless the holder of the application for
a covered drug and the eligible developer are the same
entity, the holder of an application for a covered drug shall
not be liable for any claim arising out of the eligible drug
developer's testing necessary to support an application under
subsection (b)(2) or (j) of section 505 of this Act or
section 351(k) of the Public Health Service Act for a drug
obtained under this subsection. Nothing in this subsection
shall be construed to expand or limit the liability of the
eligible drug developer or the holder of an application for a
covered drug for any other claim.
``(6) Certification.--In any request for supply of a
covered drug for purposes of testing as described in
paragraph (1), an eligible drug developer shall certify to
the Secretary that--
``(A) the eligible drug developer will comply with all
conditions the Secretary considers necessary, any protocol
approved by the Secretary, and all applicable laws and
regulations pertaining to such testing; and
``(B) the eligible drug developer intends to submit an
application under subsection (b)(2) or (j) of section 505 of
this Act or section 351(k) of the Public Health Service Act
for the drug for which it is requesting written notice
pursuant to paragraph (2), and will use the covered drug only
for the purpose of conducting testing to support such an
application.
``(7) Definitions.--
``(A) Covered drug.--Notwithstanding subsection (b)(2), for
purposes of this subsection, the term `covered drug' means a
drug, including a biological product licensed under section
351(a) of the Public Health Service Act, that is subject to a
risk evaluation and mitigation strategy with elements to
ensure safe use under subsection (f), or a drug, including a
biological product licensed under section 351(a) of the
Public Health Service Act, required to have a risk evaluation
and mitigation strategy with elements to ensure safe use
under section 909(b) of the Food and Drug Administration
Amendments Act of 2007.
``(B) Eligible drug developer.--For purposes of this
subsection, the term `eligible drug developer' means a
sponsor that has submitted, or intends to submit, an
application under subsection (b)(2) or (j) of section 505 of
this Act or section 351(k) of the Public Health Service Act
to market a version of the covered drug in the United States.
``(8) Effect on other law.--Notwithstanding the provisions
of this subsection, the antitrust statutes enforced by the
Federal Trade Commission, including the Federal Trade
Commission Act (15 U.S.C. 41 58), the Sherman Act (15 U.S.C.
1 7), and any other statute properly under such Commission's
jurisdiction, shall apply to the conduct described in this
subsection to the same extent as such statutes did on the day
before the date of enactment of this subsection.''.
(b) Technical and Conforming Amendments.--
(1) Section 505 1(c)(2) (21 U.S.C. 355 1(c)(2)) is amended
by striking ``(e) and (f)'' and inserting ``(e), (f), and
(k)(3)''.
(2) Section 502(y) (21 U.S.C. 352(y)) is amended by
striking ``''(d), (e), or (f) of section 505 1'' and
inserting ``(d), (e), (f), or (k)(3) of section 505 1''.

SEC. 1132. PATIENT PARTICIPATION IN MEDICAL PRODUCT
DISCUSSIONS.

Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as
amended by section 1126, is further amended by adding at the
end the following:

``SEC. 569C. PATIENT PARTICIPATION IN MEDICAL PRODUCT
DISCUSSION.

``(a) In General.--The Secretary shall develop and
implement strategies to solicit the views of patients during
the medical product development process and consider the
perspectives of patients during regulatory discussions,
including by--
``(1) fostering participation of a patient representative
who may serve as a special government employee in appropriate
agency meetings with medical product sponsors and
investigators; and
``(2) exploring means to provide for identification of
patient representatives who do not have any, or have minimal,
financial interests in the medical products industry.
``(b) Financial Interest.--In this section, the term
`financial interest' means a financial interest under section
208(a) of title 18, United States Code.''.

SEC. 1133. NANOTECHNOLOGY REGULATORY SCIENCE PROGRAM.

(a) In General.--Chapter X (21 U.S.C. 391 et seq.) is
amended by adding at the end the following:

``SEC. 1013. NANOTECHNOLOGY REGULATORY SCIENCE PROGRAM.

``(a) In General.--Not later than 180 days after the date
of enactment of the Food and Drug Administration Safety and
Innovation Act, the Secretary, in consultation as appropriate
with the Secretary of Agriculture, shall establish within the
Food and Drug Administration a Nanotechnology Regulatory
Science Program (referred to in this section as the
`program') to enhance scientific knowledge regarding
nanomaterials included or intended for inclusion in products
regulated under this Act or other statutes administered by
the Food and Drug Administration, to address issues relevant
to the regulation of those products, including the potential
toxicology of such materials, the effects of such materials
on biological systems, and interaction of such materials with
biological systems.
``(b) Program Purposes.--The purposes of the program
established under subsection (a) may include--
``(1) assessing scientific literature and data on general
nanomaterials interactions with biological systems and on
specific nanomaterials of concern to the Food and Drug
Administration;
``(2) in cooperation with other Federal agencies,
developing and organizing information using databases and
models that will facilitate the identification of generalized
principles and characteristics regarding the behavior of
classes of nanomaterials with biological systems;
``(3) promoting Food and Drug Administration programs and
participate in collaborative efforts, to further the
understanding of the science of novel properties of
nanomaterials that might contribute to toxicity;
``(4) promoting and participating in collaborative efforts
to further the understanding of measurement and detection
methods for nanomaterials;
``(5) collecting, synthesizing, interpreting, and
disseminating scientific information and data related to the
interactions of nanomaterials with biological systems;
``(6) building scientific expertise on nanomaterials within
the Food and Drug Administration, including field and
laboratory expertise, for monitoring the production and
presence of nanomaterials in domestic and imported products
regulated under this Act;
``(7) ensuring ongoing training, as well as dissemination
of new information within the centers of the Food and Drug
Administration, and more broadly across the Food and Drug
Administration, to ensure timely, informed consideration of
the most current science pertaining to nanomaterials;
``(8) encouraging the Food and Drug Administration to
participate in international and national consensus standards
activities pertaining to nanomaterials; and
``(9) carrying out other activities that the Secretary
determines are necessary and consistent with the purposes
described in paragraphs (1) through (8).
``(c) Program Administration.--
``(1) Designated individual.--In carrying out the program
under this section, the Secretary, acting through the
Commissioner of Food and Drugs, may designate an
appropriately qualified individual who shall supervise the
planning, management, and coordination of the program.
``(2) Duties.--The duties of the individual designated
under paragraph (1) may include--
``(A) developing a detailed strategic plan for achieving
specific short- and long-term technical goals for the
program;

[[Page S3606]]

``(B) coordinating and integrating the strategic plan with
activities by the Food and Drug Administration and other
departments and agencies participating in the National
Nanotechnology Initiative; and
``(C) developing Food and Drug Administration programs,
contracts, memoranda of agreement, joint funding agreements,
and other cooperative arrangements necessary for meeting the
long-term challenges and achieving the specific technical
goals of the program.
``(d) Report.--Not later than March 15, 2015, the Secretary
shall publish on the Internet Web site of the Food and Drug
Administration a report on the program carried out under this
section. Such report shall include--
``(1) a review of the specific short- and long-term goals
of the program;
``(2) an assessment of current and proposed funding levels
for the program, including an assessment of the adequacy of
such funding levels to support program activities; and
``(3) a review of the coordination of activities under the
program with other departments and agencies participating in
the National Nanotechnology Initiative.
``(e) Effect of Section.--Nothing in this section shall
affect the authority of the Secretary under any other
provision of this Act or other statutes administered by the
Food and Drug Administration.''.
(b) Effective Date; Sunset.--The Nanotechnology Regulatory
Science Program authorized under section 1013 of the Federal
Food, Drug, and Cosmetic Act (as added by subsection (a))
shall take effect on October 1, 2012, or the date of the
enactment of this Act, whichever is later. Such Program shall
cease to be effective October 1, 2017.

SEC. 1134. ONLINE PHARMACY REPORT TO CONGRESS.

Not later than 1 year after the date of enactment of this
Act, the Comptroller General of the United States shall
submit to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives a report that
describes any problems posed by pharmacy Internet websites
that violate Federal or State law, including--
(1) the methods by which Internet websites are used to sell
prescription drugs in violation of Federal or State law or
established industry standards;
(2) the harmful health effects that patients experience
when they consume prescription drugs purchased through such
pharmacy Internet websites;
(3) efforts by the Federal Government and State and local
governments to investigate and prosecute the owners or
operators of pharmacy Internet websites, to address the
threats such websites pose, and to protect patients;
(4) the level of success that Federal, State, and local
governments have experienced in investigating and prosecuting
such cases;
(5) whether the law, as in effect on the date of the
report, provides sufficient authorities to Federal, State,
and local governments to investigate and prosecute the owners
and operators of pharmacy Internet websites;
(6) additional authorities that could assist Federal,
State, and local governments in investigating and prosecuting
the owners and operators of pharmacy Internet websites;
(7) laws, policies, and activities that would educate
consumers about how to distinguish pharmacy Internet websites
that comply with Federal and State laws and established
industry standards from those pharmacy Internet websites that
do not comply with such laws and standards; and
(8) laws, policies, and activities that would encourage
private sector actors to take steps to address the prevalence
of illegitimate pharmacy Internet websites.

SEC. 1135. MEDICATION AND DEVICE ERRORS.

The Secretary of Health and Human Services shall continue
and further coordinate activities of the Department of Health
and Human Services related to the prevention of medication
and device errors, including consideration of medication and
device errors that affect the pediatric patient population.
In developing initiatives to address medication and device
errors, the Secretary shall consider the root causes of
medication and device errors, including pediatric medication
and device errors, in the clinical setting and consult with
relevant stakeholders on effective strategies to reduce and
prevent medication and device errors in the clinical setting.

SEC. 1136. COMPLIANCE PROVISION.

The budgetary effects of this Act, for the purpose of
complying with the Statutory Pay-As-You-Go-Act of 2010, shall
be determined by reference to the latest statement titled
``Budgetary Effects of PAYGO Legislation'' for this Act,
submitted for printing in the Congressional Record by the
Chairman of the Senate Budget Committee, provided that such
statement has been submitted prior to the vote on passage.

SEC. 1137. ENSURING ADEQUATE INFORMATION REGARDING
PHARMACEUTICALS FOR ALL POPULATIONS,
PARTICULARLY UNDERREPRESENTED SUBPOPULATIONS,
INCLUDING RACIAL SUBGROUPS.

(a) Communication Plan.--The Secretary of Health and Human
Services (referred to in this section as the ``Secretary''),
acting through the Commissioner of Food and Drugs, shall
review and modify, as necessary, the Food and Drug
Administration's communication plan to inform and educate
health care providers, patients, and payors on the benefits
and risks of medical products, with particular focus on
underrepresented subpopulations, including racial subgroups.
(b) Content.--The communication plan described under
subsection (a)--
(1) shall take into account--
(A) the goals and principles set forth in the Strategic
Action Plan to Reduce Racial and Ethnic Health Disparities
issued by the Department of Health and Human Services;
(B) the nature of the medical product; and
(C) health and disease information available from other
agencies within such Department, as well as any new means of
communicating health and safety benefits and risks related to
medical products;
(2) taking into account the nature of the medical product,
shall address the best strategy for communicating safety
alerts, labeled indications for the medical products, changes
to the label or labeling of medical products (including black
box warnings, health advisories, health and safety benefits
and risks), particular actions to be taken by healthcare
professionals and patients, any information identifying
particular subpopulations, and any other relevant information
as determined appropriate to enhance communication, including
varied means of electronic communication; and
(3) shall include a process for implementation of any
improvements or other modifications determined to be
necessary.
(c) Issuance and Posting of Communication Plan.--
(1) Communication plan.--Not later than 1 year after the
date of enactment of this Act, the Secretary, acting through
the Commissioner of Food and Drugs, shall issue the
communication plan described under this section.
(2) Posting of communication plan on the office of minority
health website.--The Secretary, acting through the
Commissioner of Food and Drugs, shall publicly post the
communication plan on the Internet website of the Office of
Minority Health of the Food and Drug Administration, and
provide links to any other appropriate webpage, and seek
public comment on the communication plan.

SEC. 1138. REPORT ON SMALL BUSINESSES.

Not later than 1 year after the date of enactment of this
Act, the Commissioner of Food and Drugs shall submit a report
to Congress that includes--
(1) a listing of and staffing levels of all small business
offices at the Food and Drug Administration, including the
small business liaison program;
(2) the status of partnership efforts between the Food and
Drug Administration and the Small Business Administration;
(3) a summary of outreach efforts to small businesses and
small business associations, including availability of toll-
free telephone help lines;
(4) with respect to the program under the Orphan Drug Act
(Public Law 97 414), the number of applications made by small
businesses and number of applications approved for research
grants, the amount of tax credits issued for clinical
research, and the number of companies receiving protocol
assistance for the development of drugs for rare diseases and
disorders;
(5) with respect to waivers and reductions for small
business under the Prescription Drug User Fee Act, the number
of small businesses applying for and receiving waivers and
reductions from drug user fees under subchapter C of chapter
VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379f et seq.);
(6) the number of small businesses submitting applications
and receiving approval for unsolicited grant applications
from the Food and Drug Administration;
(7) the number of small businesses submitting applications
and receiving approval for solicited grant applications from
the Food and Drug Administration;
(8) barriers small businesses encounter in the drug and
medical device approval process; and
(9) recommendations for changes in the user fee structure
to help alleviate generic drug shortages.

SEC. 1139. PROTECTIONS FOR THE COMMISSIONED CORPS OF THE
PUBLIC HEALTH SERVICE ACT.

(a) In General.--Section 221(a) of the Public Health
Service Act (42 U.S.C. 213a(a)) is amended by adding at the
end the following:
``(18) Section 1034, Protected Communications; Prohibition
of Retaliatory Personnel Actions.''.
(b) Conforming Amendment.--Section 221(b) of the Public
Health Service Act (42 U.S.C. 213a(b)) is amended by adding
at the end the following: ``For purposes of paragraph (18) of
subsection (a), the term `Inspector General' in section 1034
of such title 10 shall mean the Inspector General of the
Department of Health and Human Services.''.

SEC. 1140. REGULATIONS ON CLINICAL TRIAL REGISTRATION; GAO
STUDY OF CLINICAL TRIAL REGISTRATION AND
REPORTING REQUIREMENTS.

(a) Definitions.--In this section--
(1) the term ``applicable clinical trial'' has the meaning
given such term under section 402(j) of the Public Health
Service Act (42 U.S.C. 282(j));
(2) the term ``Director'' means the Director of the
National Institutes of Health;
(3) the term ``responsible party'' has the meaning given
such term under such section 402(j); and
(4) the term ``Secretary'' means the Secretary of Health
and Human Services.
(b) Required Regulations.--
(1) Proposed rulemaking.--Not later than 180 days after the
date of enactment of this

[[Page S3607]]

Act, the Secretary, acting through the Director, shall issue
a notice of proposed rulemaking for a proposed rule on the
registration of applicable clinical trials by responsible
parties under section 402(j) of the Public Health Service Act
(42 U.S.C. 282(j)) (as amended by section 801 of the Food and
Drug Administration Amendments Act of 2007).
(2) Final rule.--Not later than 180 days after the issuance
of the notice of proposed rulemaking under paragraph (1), the
Secretary, acting through the Director, shall issue the final
rule on the registration of applicable clinical trials by
responsible parties under such section 402(j).
(3) Letter to congress.--If the final rule described in
paragraph (2) is not issued by the date required under such
paragraph, the Secretary shall submit to Congress a letter
that describes the reasons why such final rule has not been
issued.
(c) Report by GAO.--
(1) In general.--Not later than 2 years after the issuance
of the final rule under subsection (b), the Comptroller
General of the United States shall submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives a report on the implementation of the
registration and reporting requirements for applicable drug
and device clinical trials under section 402(j) the Public
Health Service Act (42 U.S.C. 282(j)) (as amended by section
801 of the Food and Drug Administration Amendments Act of
2007).
(2) Content.--The report under paragraph (1) shall
include--
(A) information on the rate of compliance and non-
compliance (by category of sponsor, category of trial (phase
II, III, or IV), whether the applicable clinical trial is
conducted domestically, in foreign sites, or a combination of
sites, and such other categories as the Comptroller General
determines useful) with the requirements of--
(i) registering applicable clinical trials under such
section 402(j);
(ii) reporting the results of such trials under such
section; and
(iii) the completeness of the reporting of the required
data under such section; and
(B) information on the promulgation of regulations for the
registration of applicable clinical trials by the responsible
parties under such section 402(j).
(3) Recommendations.--If the Comptroller General finds
problems with timely compliance or completeness of the data
being reported under such section 402(j), or finds that the
implementation of registration and reporting requirements
under such section 402(j) for applicable drug and device
clinical trials could be improved, the Comptroller General
shall, after consulting with the Commissioner of Food and
Drugs, applicable stakeholders, and experts in the conduct of
clinical trials, make recommendations for administrative or
legislative actions to increase the compliance with the
requirements of such section 402(j).

SEC. 1141. HYDROCODONE AMENDMENT.

The Controlled Substances Act is amended--
(1) in schedule III(d) in section 202(c) (21 U.S.C.
812(c)), by--
(A) striking paragraphs (3) and (4); and
(B) redesignating paragraphs (5), (6), (7), and (8) as
paragraphs (3), (4), (5), and (6), respectively; and
(2) in section 401(b)(1) (21 U.S.C. 841(b)(1)), by adding
at the end the following:
``(F) In the case of any material, compound, mixture, or
preparation containing--
``(i) not more than 300 milligrams of dihydrocodeinone per
100 milliliters or not more than 15 milligrams per dosage
unit, with a fourfold or greater quantity of an isoquinoline
alkaloid of opium; or
``(ii) not more than 300 milligrams of dihydrocodeinone per
100 milliliters or not more than 15 milligrams per dosage
unit, with one or more active, nonnarcotic ingredients in
recognized therapeutic amounts,
subparagraph (C) shall not apply and such case shall be
subject to subparagraph (E).''.

SEC. 1142. COMPLIANCE DATE FOR RULE RELATING TO SUNSCREEN
DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE.

In accordance with the final rule issued by the
Commissioner of Food and Drug entitled ``Labeling and
Effectiveness Testing; Sunscreen Drug Products for Over-the-
Counter Human Use; Delay of Compliance Dates'' (77 Fed. Reg.
27591 (May 11, 2012)), a product subject to the final rule
issued by the Commissioner entitled ``Labeling and
Effectiveness Testing; Sunscreen Drug Products for Over-the-
Counter Human Use'' (76 Fed. Reg. 35620 (June 17, 2011)),
shall comply with such rule not later than--
(1) December 17, 2013, for products subject to such rule
with annual sales of less than $25,000 and
(2) December 17, 2012, for all other products subject to
such rule.

SEC. 1143. RECOMMENDATIONS ON INTEROPERABILITY STANDARDS.

(a) In General.--The Attorney General and the Secretary of
Health and Human Services may collaborate to facilitate the
development of recommendations on interoperability standards
to inform and facilitate the exchange of prescription
information across State lines by States receiving grant
funds under--
(1) the Harold Rogers Prescription Drug Monitoring Program
established under the Departments of Commerce, Justice, and
State, the Judiciary, and Related Agencies Appropriations
Act, 2002 (Public Law 107 77; 115 Stat. 748); and
(2) the Controlled Substance Monitoring Program established
under section 399O of the Public Health Service Act (42
U.S.C. 280g 3).
(b) Requirements.--The Attorney General and the Secretary
of Health and Human Services shall consider the following in
facilitating the development of recommendations on
interoperability of prescription drug monitoring programs
under subsection (a)--
(1) open standards that are freely available, without cost
and without restriction, in order to promote broad
implementation;
(2) the use of exchange intermediaries, or hubs, as
necessary to facilitate interstate interoperability by
accommodating State-to-hub and direct State-to-State
communication;
(3) the support of transmissions that are fully secured as
required, using industry standard methods of encryption, to
ensure that Protected Health Information and Personally
Identifiable Information are not compromised at any point
during such transmission; and
(4) access control methodologies to share protected
information solely in accordance with State laws and
regulations.
(c) Report.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Attorney General, in consultation
with the Secretary of Health and Human Services, shall submit
to the Committee on the Judiciary and the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on the Judiciary and the Committee on Energy and
Commerce of the House of Representatives a report on
enhancing the interoperability of State prescription
monitoring programs with other technologies and databases
used for detecting and reducing fraud, diversion, and abuse
of prescription drugs.
(2) Contents.--The report required under paragraph (1)
shall include--
(A) an assessment of legal, technical, fiscal, privacy, or
security challenges that have an impact on interoperability;
(B) a discussion of how State prescription monitoring
programs could increase the production and distribution of
unsolicited reports to prescribers and dispensers of
prescription drugs, law enforcement officials, and health
professional licensing agencies, including the enhancement of
such reporting through interoperability with other States and
relevant technology and databases; and
(C) any recommendations for addressing challenges that
impact interoperability of State prescription monitoring
programs in order to reduce fraud, diversion, and abuse of
prescription drugs.

Subtitle D--Synthetic Drugs

SEC. 1151. SHORT TITLE.

This subtitle may be cited as the ``Synthetic Drug Abuse
Prevention Act of 2012''.

SEC. 1152. ADDITION OF SYNTHETIC DRUGS TO SCHEDULE I OF THE
CONTROLLED SUBSTANCES ACT.

[[Page S3608]]

``(iv) 1-butyl-3-(1-naphthoyl)indole (JWH 073);
``(v) 1-hexyl-3-(1-naphthoyl)indole (JWH 019);
``(vi) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole
(JWH 200);
``(vii) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH 250);
``(viii) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH
081);
``(ix) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH 122);
``(x) 1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH 398);
``(xi) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201);
``(xii) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694);
``(xiii) 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR 19 and
RCS 4);
``(xiv) 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole
(SR 18 and RCS 8); and
``(xv) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH
203).''.
(b) Other Drugs.--Schedule I of section 202(c) of the
Controlled Substances Act (21 U.S.C. 812(c)) is amended in
subsection (c) by adding at the end the following:
``(18) 4-methylmethcathinone (Mephedrone).
``(19) 3,4-methylenedioxypyrovalerone (MDPV).
``(20) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C E).
``(21) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C D).
``(22) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C C).
``(23) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C I).
``(24) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C
T 2).
``(25) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine
(2C T 4).
``(26) 2-(2,5-Dimethoxyphenyl)ethanamine (2C H).
``(27) 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C N).
``(28) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C
P).''.

SEC. 1153. TEMPORARY SCHEDULING TO AVOID IMMINENT HAZARDS TO
PUBLIC SAFETY EXPANSION.

SEC. 1154. PROHIBITION ON IMPOSING MANDATORY MINIMUM
SENTENCES.

Mr. REID. Madam President, I move to reconsider the vote and move to
lay that motion on the table.
The motion to lay on the table was agreed to.
The PRESIDING OFFICER. The majority leader is recognized.
Mr. REID. Madam President, I know people are very anxious to move on.
I am, too, but I have to say just a word. I have said in my own caucus
how much I appreciate the cooperation of Senator Enzi. He is a fine
Senator. He and Senator Harkin have worked so well together. It is
exemplary for what the rest of us should do. I appreciate very much the
work they have done. I repeat, it is how we should get other work done.
This is an important piece of legislation, and we made it look
simple; it was not. But because of these two fine Senators, we were
able to get this done in a very short period of time and get good
things done for the American people.
Mr. HARKIN. Madam President, today, with passage of the FDA Safety
and Innovation Act and the reauthorization of the FDA user fee
agreements, we have helped both the FDA and the biomedical industry
ensure that they can get needed medical products to patients quickly
and safely.
This legislation will ensure that the FDA can swiftly approve drugs
and medical devices, save biomedical industry jobs, protect patient
access to new therapies, and preserve America's global leadership in
biomedical innovation. It will keep patients safer by modernizing FDA's
inspection process for foreign manufacturing facilities, while also
improving access to new and innovative medicines and devices. It will
reduce drug costs for consumers by speeding the approval of lower cost
generic drugs and help prevent and address drug shortages. Finally, by
improving the way FDA does business, increasing accountability and
transparency, U.S. companies will be better able to innovate and
compete in the global marketplace.
By passing the FDA Safety and Innovation Act, we have taken an
important step to improve American families' access to lifesaving drugs
and medical devices.
As I have said throughout this debate, the bipartisan process that
produced this excellent bill has been quite remarkable. I have worked
closely with my colleagues on both sides of the aisle, as well as
industry stakeholders, patient groups, and consumer groups to solicit
ideas and improvements on the critical provisions in this bill. We have
a better product thanks to everyone's input.
I extend a special thank-you to my colleague, Ranking Member Enzi. I
have been working with Senator Enzi for over a year on this bill. It
has been a wonderful and cooperative partnership and a trusting
friendship. I can honestly say we would not have gotten this done
without his excellent leadership and wise counsel. I thank him for
that.
I also thank all of the HELP Committee members, as well as members
off the committee, who were thoroughly engaged with this process from
the beginning as part of the bipartisan working groups we established.
Each of them has contributed significantly to this legislation, and I
am sincerely grateful for all their contributions.
Madam President, I will submit for the Record a list of all staff
members who were part of our bipartisan working groups throughout the
past year. We all know we could not have achieved this without the
tireless and diligent work of our loyal staffs. I extend my deep
appreciation for their hard work and extraordinary efforts.
I ask unanimous consent that the list of staff members be printed in
the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

____________________