[Congressional Record Volume 153, Number 140 (Thursday, September 20, 2007)]
[Senate]
[Pages S11831-S11841]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007
Mr. KENNEDY. Mr. President, I ask unanimous consent that the Senate
proceed to the immediate consideration of H.R. 3580, received from the
House and is at the desk.
The PRESIDING OFFICER. The clerk will report the bill by title.
The bill clerk read as follows:
A bill (H.R. 3580) to amend the Federal Food, Drug, and
Cosmetic Act to revise and extend the user-fee programs for
prescription drugs and for medical devices, to enhance the
postmarket authorities of the Food and Drug Administration
with respect to the safety of drugs, and for other purposes.
There being no objection, the Senate proceeded to consider the bill.
Mr. KENNEDY. Mr. President, every day, families across America rely
on the Food and Drug Administration in ways they barely realize. When
they put dinner on the table, they are counting on FDA to see that it
is free from contamination. When they care for a sick child, they are
trusting FDA to make sure the drugs prescribed are safe and effective.
From pacemakers to treatments for cancer to the foods we eat, FDA
protects the health of millions of Americans, and oversees products
that account for a quarter of the U.S. economy. The agency does all
this on a budget that amounts to less than 2 cents a day for each
citizen.
Yesterday, the House of Representatives approved legislation on FDA
reform by a broad bipartisan majority of 405 to 7. Our House colleagues
from all parts of the political spectrum united to send that bill to
the Senate with a resounding bipartisan endorsement. We cannot wait
another month, another week--or even another day. We must take action
here and take action now to send that bill to the President.
The stakes could not be higher. Funding for the FDA's vital safety
mission is reaching the breaking point. Unless we act, the FDA
Commissioner will send a letter tomorrow to over 2,000 employees
informing them that their jobs are slated for termination. This
legislation provides nearly $500 million in new resources for FDA--
including over $50 million for drug safety and $6 million for review of
direct to consumer ads.
Americans are worried about the safety of the products they use--from
food to toys to drugs--and they are right to be worried. Dangerous
lapses in safety oversight have exposed American families to
intolerable risks from lead paint in toys, to bacteria in foods, to
drugs that cause unreported and lethal side effects. The right response
is comprehensive, considered and bipartisan legislation--and that is
what we have before us today.
At the heart of our proposal is a new way to oversee drug safety that
is flexible enough to be tailored the characteristics of particular
drugs, yet strong enough to allow decisive action when problems are
discovered.
A second major element of our legislation is a public registry of
clinical trials and their results. A complete central clearinghouse for
this information will help patients, providers and researchers learn
more and make better health care decisions. Now, the public will know
about each trial underway, and will be able to review its results.
Our bill recognizes that innovation is the key to medical progress by
establishing a new center, the Reagan-Udall Foundation, to develop new
research methods to accelerate the search for medical breakthroughs.
The bill helps preserve the integrity of scientific review by
improving FDA's safeguards against conflicts of interest on its
scientific advisory committees, and it will end the abuse of citizens
petitions that are too often used not for their intended purpose of
brining important public health concerns to the attention of the FDA,
but rather to delay the approval of generic drugs.
The proposal before the Senate today strikes the right balance on
this issue. It rightly states that the mere filing of a citizen
petition should not be cause for delay, but allows FDA to delay the
approval of a generic application if it determines that doing so is
necessary to protect public health. This is the right approach. It
prevents abuse, but protects health.
The legislation also includes important reforms of direct-to-
consumer, or DTC, advertising. I thank Senator Roberts and Senator
Harkin for working with Senator Enzi and me and with many members of
the committee on this important provision.
Instead of the moratorium included in our original bill, the current
proposal puts in place strong safety disclosures for DTC ads, coupled
with effective enforcement. Under current law, safety disclosures can
be an afterthought--a rushed disclaimer read by an announcer at the
conclusion of a TV ad while distracting images help gloss over the
important information provided. Our proposal requires safety
announcements to be presented in a manner that is clear and conspicuous
without distracting imagery. We also give FDA the authority to require
safety disclosures in DTC ads if the risk profile of the drug requires
them.
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Our legislation also takes important first steps toward a safer food
supply. These are only first steps--our committee will work on a
comprehensive package of food safety legislation in the fall--but they
are important steps. Consumers and FDA have too little information
about contaminated food. Our bill creates a registry and a requirement
to report food safety problems. Consumers will have information about
recalls at their fingertips, and FDA's response will not be slowed by
antiquated and inefficient reporting systems. Our bill also establishes
strong, enforceable quality standards for the food we give our pets, to
guard against the problems of tainted pet food that we have seen in
recent months.
In this new era of the life sciences, medical advances will continue
to bring immense benefits for our citizens. To fulfill the potential of
that bright future, we need not only brilliant researchers to develop
the drugs of tomorrow, but also strong and vigilant watchdogs for
public health to guarantee that new drugs and medical devices are safe
and beneficial, and that they actually reach the patients who urgently
need them. Congress has ample power to restore the luster the FDA has
lost in recent years, and this bipartisan consensus bill can do the
job. I ask my colleagues to approve this needed legislation without
delay.
H.R. 3580, the Food and Drug Administration Amendments of 2007, does
a great deal to improve the regulatory process and to strengthen FDA's
ability to enforce drug safety standards, particularly in the
postmarket period. A recent study by the Institute of Medicine
described FDA's post-market drug safety authority as ``aging and
inadequate.'' Currently, FDA's ability to address potential health
problems that become known after the drug has gone on the market is
very limited. This is a serious weakness in the present system that
must be corrected. This legislation will give FDA the authority, for
the first time, to compel a drug company to add warnings of newly
discovered risks on the drug label. As a result, in many cases the
health risks involved in using potentially dangerous drugs will be
disclosed to the public much sooner than they are today.
At the same time, this legislation makes clear that drug companies
will continue to have the same independent responsibility to update the
warning labels on their drugs in the future that they have under
current law today. If a drug company learns of new dangers that its
product potentially poses to the patients taking it, the company has a
legal responsibility to immediately warn those patients of the risk of
injury.
By enacting this legislation, we do not intend to alter existing
state law duties imposed on a drug manufacturer to obtain and disclose
information regarding drug safety hazards either before or after a drug
receives FDA approval or labeling. We do not believe that the
regulatory scheme embodied in this act is comprehensive enough to
preempt the field or every aspect of state law. FDA's approved label
has always been understood to be the minimum requirement necessary for
approval. In providing the FDA with new tools and enhanced authority to
determine drug safety, we do not intend to convert this minimum
requirement into a maximum. The Institute of Medicine and others have
found that FDA's past performance has been inadequate. While we fully
expect substantial improvement as a result of the enactment of this
bill, we cannot and do not expect the FDA or this new process to
identify every drug specific safety concern before a drug manufacturer
becomes aware or should have become aware of such concerns. Nor are the
bill's requirements that companies disclose certain safety information
to the government intended to substitute for the disclosure
requirements that may be required under state law.
No one should be under the mistaken impression that the new
authorities and resources provided under H.R. 3580 lessen in any way
the obligation of a drug company to scrutinize vigilantly the safety
signals for their drugs and proactively study such signals or change
their labels when the evidence supports such a change. This new
postmarket authority for FDA is not intended to alter the drug
companies' independent obligation to promptly warn consumers of a
drug's risks. Under current FDA regulations, a drug company is required
to add new warnings to its labels as soon as it learns about new risks
potentially posed by its drugs. The company must add the new warning
even if FDA has not required a labeling change.
It is worth putting the situation in a little perspective. The
legislation increases FDA's resources for post-market drug safety
efforts significantly. FDA's current resources of about $25 million are
increased by almost $55 million in the first year, to nearly $80
million. There will be increases in the next four years of $10 each
year, so that FDA's post approval drug safety budget will be at about
$120 million in 2012. This is the entire budget at the FDA to collect
and analyze post-market safety information and respond with appropriate
regulatory action. FDA must use these resources to police every
prescription drug on the market--thousands of drugs.
By contrast, the drug industry had annual revenues in 2005 of over
$200 billion. To be sure, significant portions of these revenues
support research and development, profits, and marketing of drug
products, but a mere 1 percent of these sales exceeds the entire budget
of the FDA. It exceeds the agency's budget for postmarket drug safety
by a factor of over one thousand. Many major brand drugs have annual
revenues that exceed FDA's annual budget for postapproval drug safety.
Consider the top 200 selling drugs in 2006: Merck's drug Fosamax Plus D
came in 200th in 2006, with U.S. sales of $140 million. Sales from this
one drug alone exceed the entire $120 million FDA budget for drug
safety in the last year of this program. The 100th drug, Abbott's
Kaletra, had 2006 sales of $350 million, nearly three times the FDA's
annual drug safety budget for 2012. Thirtyeight drugs had U.S. sales
exceeding $1 billion in 2006. The top selling drug, Pfizer's Lipitor
had 2006 sales of nearly $6.6 billion, an amount more than 50 times
FDA's annual drug safety budget in 2012 under this legislation.
Clearly, the resources of the drug industry to collect and analyze
postmarket safety data vastly exceed the resources of the FDA, and no
matter what we do, they will always have vastly greater resources to
monitor the safety of their products than the FDA does. It is absurd to
argue that the FDA, even with the enhanced resources and authorities
provided by this legislation, commands the field when it comes to
postmarket drug safety. The drug companies have the capacity to do a
far more comprehensive job. If we are serious about quickly alerting
the public to the health risks posed by drugs, the companies must be
required to take the initiative in monitoring the safety of their
products and immediately warning the public of newly discovered risks.
Drug manufacturers cannot be allowed to ignore their responsibility and
wait for the FDA to act.
To be sure, the legislation gives FDA the authority to command some
of the resources of a drug company. FDA can order an epidemiological
study or even a clinical trial, but this authority is not unlimited.
Certain standards must be met before FDA can act to require a drug
company to investigate a safety signal.
Importantly, a drug company has the ability and the responsibility to
conduct these studies or clinical trials on its own initiative. Nothing
in H.R. 3580 requires a company to wait and react to an order from the
FDA for such a study or clinical trial, or to wait for FDA to order the
company to change its label. The legislation retains the current,
ongoing requirement, found in section 502(a) of the Federal Food, Drug,
and Cosmetic Act, for a drug company to ensure that its label is not
false and misleading. This statutory imperative is recognized in
current FDA regulations. Section 901 of H.R. 3580 cites these
regulations in the new section 505(o) of the Federal Food, Drug, and
Cosmetic Act. These regulations obligate a company to propose a
labeling change to enhance a warning or improve safety information
without waiting to hear from FDA, and allow the company to implement
the labeling change before the FDA has reviewed and approved the
change.
In most cases, a drug company will learn about new risks from its
product before the FDA does. Usually, it is the
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manufacturer that possesses the information demonstrating a potential
danger from the product. It is imperative that patients and health
professionals learn about those new health risks as quickly as
possible. For that reason, drug companies have, and must continue to
have, an independent duty to warn drug users of the danger as soon as
the company becomes aware of it. Otherwise, there will be long delays
before consumers are alerted, and the number of injuries caused by the
product will multiply.
What should motivate a drug company to investigate drug safety
signals and take appropriate action to mitigate a safety risk? You can
find the answer in several places: from the simple moral duty to do the
right thing; from the duty to one's customers, who use one's products
with the understanding, often promoted by direct-to-consumer
advertising, that the company's highest interest is to bring safe and
effective cures to the sick and ill of the Nation; and from a duty
under State law to offer products that are free of defects, with
adequate warnings about their risks. This legislation changes none of
these duties, in any way, whether they arise from simple ethics,
principles of contract law, or of tort law. Rather, the legislation
provides FDA with additional resources and authority to be better able
to step in when a company fails to live up to these responsibilities.
But some drug companies don't want to fully inform the public about
these risks to patients' health, and they don't want to be held
accountable when patients are injured or killed by their drugs. They
would have liked this legislation to change the law to escape this
responsibility. These drug companies wanted to convert FDA regulation
from a safety floor into a ceiling, from a minimum safety standard
designed to protect consumers into a liability shield designed to
protect the drug companies. But Congress firmly rejected this approach.
If companies were allowed to conceal safety information until the FDA
ordered them to disclose it, consumers would continue taking these
dangerous drugs without knowing their risks for months or even years
after the risks were discovered. Then, when the public finally learned
of the risk, the drug company would be immune from suit for failing to
warn its customers. Those who were seriously injured by the drug would
have no legal recourse, even though the company had concealed the risk.
The company would completely escape accountability for its failure to
warn consumers. That would be totally unacceptable, and is not what we
intend by this legislation.
Regulation by the Food and Drug Administration and product liability
lawsuits against the manufacturers of harmful drugs work together to
protect consumers. Both are needed to force drug companies to disclose
health risks posed by their products as soon as those risks are
discovered. Both are essential to identifying dangerous drugs and
getting them off the market quickly. Effective regulation by the
federal government and litigation by victims of dangerous drugs work
hand-in-hand to keep patients safe and make drug companies more
responsible. This legislation improves FDA oversight of postmarket drug
safety, and does not undermine or preempt the efforts by injured
patients to seek redress under State product liability law.
Congress has stated very clearly in the legislation that we do not
intend the new authority being given to FDA to preempt common law
liability for a drug company's failure to warn its customers of health
risks. The legal duty of drug companies to warn consumers of the health
risks of their products as soon as those risks are discovered is
essential to effectively protecting the public from dangerous drugs.
Legislation designed to protect consumers from dangerous drugs must not
be distorted into a shield protecting drug companies from
accountability.
Mr. ENZI. Mr. President, I rise today in support of HR 3580, the Food
and Drug Administration Amendments of 2007. This comprehensive bill
will enhance drug safety and provide key resources to the Food and Drug
Administration. I am pleased that the House passed this bill yesterday,
and that we have a chance to act on it today. It's been a long road for
this bill, and I strongly urge my colleagues to vote yes and endorse
the most comprehensive drug safety overt1aul in more than a decade.
This key FDA package includes four reauthorizations that must be done
this year, along with essential new authorities for FDA to be able to
react in a timely way to any safety problems that arise after a drug
has been brought to market. With this new toolbox, FDA has the ability
to identify side effects after the drug is marketed through active
surveillance. FDA also has the authority to request labeling changes in
response to new safety information, as well as a separate study or
clinical trial to learn more about a particular, potential safety
problem.
Not everyone got everything they wanted in this bill. That is as true
of me as it is of anyone. I am deeply concerned about the provisions
related to labeling changes and liability, given that we do not fully
understand the implications of that language. This new rule of
construction was part of the House-passed language and not something
the Senate fully debated. If I would have drafted the bill, that
language would not have been included. But this is a compromise bill,
one that provides important new authorities, while preserving the
quality we have come to expect of the agency. The changes made in the
drug safety components of this legislation are critical to restoring
peace of mind to Americans who want to be assured that the drugs they
purchase to treat illnesses and chronic medical conditions can be
relied upon and trusted. By acting today, we are ensuring that nearly
2000 dedicated public servants at FDA can continue to evaluate drugs
and devices in a timely and thorough way, speeding these discoveries to
patients while protecting the public health.
These new authorities will assist the agency in quickly and
effectively responding to potential safety issues, including making
labeling changes and requiring post-market studies to more fully
examine potential risks. In addition, this bill expands access to
clinical trials information for patients and providers and creates new
methods to address potential conflicts of interest of advisory
committee members to ensure greater accountability and preserve
scientific integrity.
FDA currently has no mechanism for active, routine surveillance of
potential safety problems. It cannot easily detect safety problems
after a drug has been put on the market. This legislation fixes that
challenge and ensures that FDA has the right tools to address drug
safety after the drug is on the market. The legislation creates the
capacity for routine, active, safety monitoring using large linked
databases, what I like to call ``health IT for drug safety.'' I want to
thank Senator Gregg for being the champion of this provision and
ensuring that we crafted this provision appropriately.
This bill also includes renewal of two key provisions focused on
children--the ``Best Pharmaceuticals for Children Act'' and the
``Pediatric Research Equity Act,'' which together ensure that drugs
used in children are tested on children; as well as a proposal that
will increase our ability to develop medical devices for children.
There has been a lot of attention paid to medical products in this
debate. But we mustn't forget the ``F'' in FDA. This bill contains
important food safety provisions to better protect our pet food supply,
and track when food is adulterated.
I want to thank my colleagues Senators Roberts and Harkin for their
tireless efforts to provide an appropriate balance for direct-to-
consumer advertising. I would also like to thank one of my colleagues
on the other side of the Capitol, Representative Schakowsky of
Illinois, for her constructive involvement in these issues. It was not
an easy task to reconcile some very different opinions, and I am so
pleased that we were able to reach a resolution to this issue that we
could all support.
I would like to thank Senator Alexander, Senator Allard, Senator
Bond, Senator Dodd, Senator Clinton and others for their leadership on
behalf of kids. Finally, I would like to thank Senator Hatch for his
work on the antibiotics and other Hatch-Waxman issues.
On the other side of the Capitol, I would like to thank Chairman
Dingell, Ranking Member Barton, and
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Representatives Pallone and Deal for shepherding this legislation
through the process.
I want to take a few minutes to thank the staff, who have spent
countless hours over the past months negotiating and drafting this
legislation. This dedication to public service often overlooked. They
spent many evenings and weekends away from their homes and their
families.
My health team worked overtime to get this bill to the floor and
passed in the Senate. I would first like to thank my Health Policy
Director, Shana Christrup. I also want to greatly thank Amy Muhlberg,
for her work on drug safety, food safety and PDUFA. Her knowledge and
drafting skills were central to this bill. I would also thank Keith
Flanagan for his work on the children's statutes in this bill and Dave
Schmickel, our resident drug patent expert for his work on citizens
petitions and antibiotics issues. I would also like to thank Todd
Spangler who provided the required backup that goes with moving a bill
of this magnitude. Finally, I would like to thank my Staff Director,
Katherine McGuire, whose steady hand and negotiating and communication
skills provided the cement for the entire process.
I would also thank Ilyse Schuman, my chief counsel for her precision
and attention to the details. Finally, I thank Amy Angelier Shank for
her great work on the budget aspects of the bill and my press team
Craig Orfield and Mike Mahaffey. My Chief of Staff Flip McConnaughey
was great at putting out brush fires throughout the process.
Megan Hauck with Senator McConnell's office, David Boyer with the
White House, Craig Burton and Vince Ventimiglia at HHS and Stephen
Mason of FDA were key to helping with both policy and process issues
throughout the negotiations.
On Senator Kennedy's staff, I would like to thank: Michael Myers,
David Bowen, and David Dorsey. Senator Kennedy's staffers were
reasonable negotiators throughout the process and open and patient to
hearing all sides of any issue.
On the other side of the Capitol, I would like to thank Chairman
Dingell, as well as John Ford, Virgil Miller and Pete Goodloe of his
staff for their tireless work. Bobby Clark with Mr. Pallone and John
Little with Mr. Deal were also instrumental in the negotiations.
Ranking Member Barton and his staff Ryan Long and Nandan Kenkeremath
were outstanding. Yesterday, when this bill passed the House, Mr.
Barton reported that Ryan had been up all night working on the bill and
was therefore wearing the same clothes as the day before. I would like
to state for the record that all my staff showered today--I think.
Warren Burke with House Legislative Counsel and Stacy Kern-Sheerer of
Senate Legislative Counsel were tremendous in handling a long and
complex bill with lots of moving parts. There would be no bill without
their efforts.
I would like to thank Senator Hatch and his staff Pattie DeLoatche,
Trisha Knight, Remy Yucel and Matt Sandgren for their efforts on the
bill overall, but particularly on the Citizen Petitions, antibiotics,
and enantiomers provisions. Leigh-Anne Ross of Senator Cochran's staff
and Landon Stropko of Representative Cubin's office were also key on
these antibiotic provisions.
With Senator Gregg's office, and for their assistance with ``health
IT for drug safety,'' I thank Dave Fisher and Liz Wroe. Stephanie
Carlton, from Senator Coburn's staff and Jenny Ware with Senator Burr
were also integral to many parts of the bill.
I would also like to thank my colleague from Kansas, Senator Roberts,
and his staff Jennifer Swenson, for their incredible work on direct-to-
consumer advertising. I also thank my colleague Senator Harkin and his
staffer Janelle Krishnamoorthy for their hard work on this issue.
Lindsay McAllister of Representative Schakowsky's office was also
integral to the success of these negotiations.
I would like to thank Isaac Edwards and Amanda Makki of Senator
Murkowski's staff, Tyler Thompson with Senator Isakson, and Jennifer
Claypool with Senator Allard for their hard work and dedication.
Ellie Dehoney of Senator Brown's office was critical to reaching
agreement on the Citizen Petitions and tropical disease provisions.
Melanie Benning of Senator Brownback's office was also instrumental on
the tropical disease issue.
I would like to thank Mary-Sumpter Johnson with Senator Alexander,
Kelly Childress with Representative Rogers, Jennifer Nieto with
Representative Eshoo, Ann Gavaghan with Senator Clinton, Tamar Magarik
and Jeremy Sharp with Senator Dodd for their exceptional work on the
pediatric provisions.
And last, but not least, Cameron Bruett of Senator Chambliss's
Agriculture Committee staff, Adela Ramos of Chairman Harkin's
Agriculture Committee staff, and David Lazarus of Senator Durbin's
staff were extraordinarily helpful on the food safety provisions in the
bill.
As you can see, this was a real team effort. I urge my colleagues to
vote yes on this important bill. Patients are waiting. I yield the
floor.
Mr. LEAHY. Mr. President, I am pleased that today the Senate is
poised to pass H.R. 3580, a bill regarding the Food and Drug
Administration. This legislation addresses many important health care
issues and I commend the Senate leaders and relevant committee chairmen
for coming to agreement on this complex bill. I have been monitoring
the ongoing negotiations between the House and Senate on this
legislation because a slight variation in language between the two
relevant bills could have affected the claims of thousands of injured
American consumers.
Last week, I chaired a Senate Judiciary Committee hearing on the
emergence of regulatory agencies like the FDA asserting that its
regulations preempt all State laws, even in the absence of
congressional intent to do so. At this hearing we received extensive
testimony that the Bush administration has been using this approach to
shield corporations from civil liability. This regulatory preemption
model has been especially troubling in the area of pharmaceutical
drugs. Several times in the past several years we have learned from
whistleblowers and smoking gun documents that certain corporations knew
of dangers in their medical products yet failed to adequately warn
consumers. Many consumers have been injured as a result of this
corporate misconduct and it is certainly not congress' intent to shield
such corporate decisionmaking.
The legislation we are set to pass today contains a rule of
construction making clear that Congress has again decided that we are
not preempting State law regarding the responsibility of drug
manufacturers to immediately notify consumers of dangers without
waiting for the FDA to act. Drug companies maintain the authority to
correct their warning labels if they learn of any information that
their products could harm consumers. These corporations can and must
immediately correct any existing warning that has been issued and
cannot hide behind the Byzantine regulatory structure of the FDA to
shield them from liability for causing serious injury. To do otherwise
would endanger all Americans who may be injured by their products and
would remove the important incentive the corporations currently have to
make their products safer and to adequately warn consumers of potential
dangers.
Mr. HATCH. As the Senate completes its consideration of H.R. 3580,
the Food and Drug Administration Amendments Act of 2007, I want to take
this opportunity to commend publicly the Food and Drug Administration
and especially to express support and appreciation to the dedicated FDA
employees who work so hard to ensure the safety of our drug and food
supply. They are led by a very capable and hard-working Commissioner,
Dr. Andrew von Eschenbach.
In our race to legislate and regulate, we often forget the impact of
our actions on agency employees and their ability to safeguard American
consumers. And so I want to take this opportunity to thank them for
their work.
While I will not belabor the point here, as the legislation makes
clear, the agency is operating under severe funding constraints. That
is a pressing public health issue of great priority and the Congress
must work to address it in a meaningful way.
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With passage of this legislation today, we will end the protracted
game of ``chicken'' that threatened the jobs of hundreds of FDA
employees, the stability of the agency, and indeed the integrity of
Congress, an institution which has been under public criticism for not
doing its job.
I am proud to support the passage of H.R. 3580. I want to applaud the
efforts of HELP Chairman Kennedy and Ranking Republican Member Enzi.
They have worked tirelessly to ensure this bill would be completed
before the expiration of the user fee programs at the end of this
month. They have worked in a bipartisan way and they have worked very
hard to embrace the views of each and every member of our committee.
Let me highlight some of the important components of the FDARA bill.
First, it is imperative that we continue the drug and device user fee
programs. This is true for one simple fact--the agency relies greatly
on the funding from these programs, and without it there would be
unconscionable delays in drug and device reviews.
This is particularly important for Utah, a State with the hallmark of
innovation, a State which is the home to countless drug and device
manufacturers.
And while there are some problems with how these programs have
worked--problems I have been pursuing, and will continue to pursue,
with the FDA--all in all it must be recognized that there is no
alternative to the user fee programs being continued.
The drug safety provisions that Chairman Kennedy and Ranking Minority
Member Enzi developed will be seen as an important hallmark in our
Nation efforts to improve the safety of pharmaceuticals that Americans
rely on.
The food safety legislation that our colleague Senator Durbin
developed--again, that is a vital component. I am supportive of that
language, and especially appreciative to my colleagues for including
the three pieces of language Senator Harkin and I authored to make
certain that the new food reporting system did not override the Dietary
Supplement Health and Education Act's regulatory structure and that it
did not supersede the serious adverse event reporting system for
dietary supplements enacted last year--the Dietary Supplement and
Nonprescription Drug Consumer Protection Act.
This legislation also includes many other laudable provisions. One
particular provision in this legislation establishes a new and enhanced
mechanism for the prompt consideration of new safety-related
information and sets forth strict timelines for the evaluation of such
new data. That provision is designed to ensure that all potential
safety-related labeling changes are promptly raised and duly considered
by the agency in carrying out its statutory duty to oversee the
appropriate and accurate content of a drug's labeling.
This new procedure is designed to implement a more thorough and
regularized methodology for the consideration and implementation of
safety-related labeling changes and to ensure that FDA is the ultimate
authority in making certain that drug labels convey safety information
in a clear and consistent way.
This provision, which adds a new section 505(o) to the Federal Food,
Drug and Cosmetic Act, is designed to ensure that both the agency and
pharmaceutical companies are able to modify quickly with the agency's
approval drug labels so that physicians are alerted promptly to new or
increased risks associated with a drug. The provision does not affect
the agency's general policy on labeling or its current labeling rules
and policy.
Also, the legislation promotes pharmaceutical and medical device
advancements in pediatric therapies. The bill reauthorizes the Best
Pharmaceuticals for Children Act and the Pediatric Research and Equity
Act which have been vital for important research used by doctors and
parents. The final language on both these provisions is a good
compromise between the House and Senate bills.
Finally, it is my profound regret that the bill we consider now does
not contain the Biologics Price Competition and Innovation Act,
legislation that Senators Kennedy, Enzi, Clinton, Schumer, and I have
authored. This bill is intended to offer consumers access to lower cost
biosimilar products, copies of such important medications as insulin or
human growth hormone, while preserving the incentives for researchers,
universities and manufacturers to develop and market the innovator
biologics.
I am extremely disappointed that the bill could not be contained in
H.R. 3580, but I recognize the importance of allowing the House to
develop its version in regular order.
It remains my high priority, and I believe the priority of my
colleagues as well, that this legislation be enacted in 2007.
Mr. DURBIN. Mr. President, today, the Senate will send a bipartisan
bill to the President that will improve the FDA's ability to assure the
safety of drugs in our medicine cabinets and the food in our kitchens.
The FDA is an essential guardian of the public's health and safety.
In recent years, FDA's reputation has been marred by drug safety
incidents and questions about its scientific independence.
In 2004, the public learned that taking Vioxx, a heavily marketed
pain medication, increased your risk of a heart attack and stroke. The
revelation raised serious questions about how the drug manufacturer
responded to signs of a problem and how FDA handled disagreements among
its staff.
The Vioxx episode and problems with other FDA-approved drugs in
recent years exposed significant weaknesses in our Nation's drug-safety
system.
This year, Congress decided to do something about it. In addition to
reauthorizing user fee programs for prescription drugs and medical
devices, we have engaged in a serious effort to improve drug safety.
The bill gives the FDA more tools to detect the safety problems of
drugs after they are available to consumers. It also creates an active
surveillance system that will help detect problems that were not
apparent during the clinical trials conducted prior to a drug's
approval and it promotes greater openness by requiring disclosure of
clinical trials performed by drug companies. Lastly, the FDA is given
greater authority to require drug companies to add warning labels and
to conduct safety studies.
I note the provisions in the bill that give FDA the authority to
compel a drug company to make changes to a drug's labeling. That
authority should not be seen as an absolution of the companies'
responsibility regarding drug labeling. Consumers should be made aware
of a drug's risks at the earliest possible moment, and drug companies
remain responsible for ensuring that consumers are provided with prompt
and adequate warning of a drug's risks.
We have noticed a creeping trend in recent years towards implied and
agency preemption of state laws. Last week, a Senate Judiciary
Committee hearing looked at techniques that Federal agencies, including
FDA, have recently used to assert that agency rulemakings preempt state
liability laws. The drug labeling provisions in today's legislation
include a rule of construction that makes clear that Congress does not
intend to preempt state requirements regarding drug companies'
responsibilities. Rather, this legislation recognizes that State
liability laws, including liability laws for improper drug labeling,
play an essential role in ensuring that drug products remain safe and
effective for all Americans.
The bill addresses two other issues of particular interest to me, new
restrictions on conflicts of interest for FDA advisory committees and
important provisions related to food safety.
I have been troubled by the large number of waivers of conflicts-of-
interest rules that FDA issues to members of its advisory committees.
The public depends on these committees to make independent assessments
about the safety and effectiveness of drugs. Including members with
financial conflicts can erode the public's trust in the process.
When the Senate debated this bill in May, I offered an amendment with
Senator Bingaman that would have limited the number of waivers to one
per advisory committee meeting. While the amendment was defeated on a
47-47 vote, the House included the language in its FDA bill.
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The final bill includes a 25-percent reduction in waivers over the
next 5 years. I would have preferred more of a reduction, but this
compromise moves us in the right direction and I commend the conferees
for addressing concerns raised in both chambers around conflicts of
interest.
On the issue of food safety, I am happy to report that the bill
includes food safety language that I originally offered on the floor of
the Senate. The language passed on the Senate floor by a 94-0 vote.
The language creates a new reporting requirement for food companies
that determine there is a significant adulterated food product in their
supply chain. Previously, companies consulted trade associations and
attorneys to determine when to report significant adulterations to the
FDA. Uncertainty about reporting requirements and an incentive to keep
products on store shelves resulted in uneven, delayed reporting of
significant incidents to FDA.
Under this new policy, companies will now be required to report these
types of incidents to FDA within 24 hours of determining the presence
of such an adulteration. These reports will trigger an FDA review and,
depending on the findings of the review, FDA would then have the
authority to require further action from the company, including an
investigation, submission of additional information, and the sending of
notifications to affected parties in the supply chain. Companies would
be required to maintain records of reports and notifications for a
period of 2 years. Failures to report incidents, falsify reports, or
comply with follow-up FDA requirements would be subject to civil and
criminal penalties.
The effect of this language will be to involve Federal regulators in
the review process earlier, resulting in faster recalls, alerts, and
notifications through the supply chain. Contaminated products will be
tracked and removed from the supply chain earlier and faster. Recalls
will be more targeted to specific lots and batches of contaminated
products. We will minimize some of the uncertainty around the extent of
contaminations once they are discovered.
This provision is an important step forward for food safety.
In addition to this provision, the language directs FDA to establish
pet food ingredient, processing, and nutrition labeling standards.
Previously, these standards were completely voluntary and did not carry
the weight of law. This section also directs FDA to establish an early
warning and surveillance system to identify pet food adulterations and
outbreaks of disease. In addition, the language directs FDA to improve
its outreach and coordination with professional associations,
universities, and state and local authorities during recalls. The
agency is also asked to enhance the display of recalls on its website.
The bill directs FDA to strengthen its coordination with states to
ensure the safety of fresh and processed produce and requires the
Department of Health and Human Services to submit more detailed reports
to Congress on the number of inspections conducted each year and the
number of violations and adulterants discovered through inspections.
Lastly, it includes sense-of-Congress language that commits this
Congress to working on comprehensive food safety reform.
On that note, I want to emphasize one thing--the food safety
provisions in this legislation are only the starting point for more
comprehensive efforts to improve our Nation's food safety system.
For too long we have gone without updating the resources and
authorities for our food safety efforts, and a broad coalition of
stakeholders understands that our system is broken. We need to close
the gaps in our current system.
Several months ago, Robert Brackett, Director of the FDA's food arm
said this in response to the pet food recall, ``These outbreaks point
to a need to completely overhaul the way the agency does business. We
have 60,000 to 80,000 facilities that we're responsible for in any
given year. We have to get out of the 1950s paradigm.''
Also in response to this recall, Dr. Stephen Sundlof, Director of the
Center for Veterinary Medicine of FDA, implied the same when he said,
``We're going to have to look at this after the dust settles and
determine if there is something from a regulatory standpoint that we
could have done differently to prevent this incident from occurring.''
I agree with their sentiments and look forward to making more
progress on the issue of food safety.
I would like to thank my colleagues, Chairman Kennedy and Senator
Enzi, for their cooperation and willingness to work on this language. I
would also like to highlight the efforts of the following members of
their staffs: David Noll; Amy Muhlberg; David Dorsey; and David Bowen.
I look forward to working with the Senate HELP Committee on future food
safety efforts. I would also like to thank Senators Harkin, Brown,
Hatch, and Casey for their assistance with this language.
In particular, I also would like to thank Chairman Kennedy and
Senator Enzi for their extraordinary leadership and hard work on this
overall bill.
Mr. ALLARD. Mr. President, today I wish to speak on an issue that is
weighing on the minds of many Members of this body, employees of the
Federal Government, and patients in the United States.
Many people working for the FDA are faced with the possibility of
receiving a reduction in force notice if new user fee legislation is
not passed quickly. The FDA needs the necessary resources so that they
may approve drug applications within a timely manner. Being able to
access new drugs can allow patients to live fuller lives, and in some
cases, save them from death.
I am frustrated by what I have seen as a desire to have a partisan
debate on an issue of liability. We have been working for some time now
on a bipartisan level to ensure that we have a bill passed by Friday.
We should not be throwing partisan politics into the debate during the
11th hour. Because I am committed to working on a bipartisan level, I
continue to hope that we will have legislation passed to ensure that
patients can get the drugs that they desperately need.
Some believe that the Senate position on liability may have favored
the pharmaceutical companies. However, I am of the opinion that the
House position favored the trial lawyers. Should we make any changes we
should also ensure that any labeling change authority would not provide
for an opportunity for partiality by the courts. I strongly believe
that every individual should be allowed to argue equally for their
particular case in court.
Currently the FDA regulation allows for labeling changes by accepting
submissions from companies, and the company may make a label change.
This is referred to as ``changes being effected'' or CBEs. A company
also has the opportunity to discuss the change with the FDA before
making a label change, since the regulations have a particular bound on
what sort of changes can and cannot be made under this regulation.
The current authority may not be adequate to deal with all cases in
which a labeling change may be necessary. An example that is referenced
frequently deals with a Vioxx label change in which FDA had been
talking to the company for 18 months. This situation has led to many
pending suits related to Merck's ``failure to warn'' people that the
drug had some potential side effects.
In the user fee reauthorizations this year both the House and Senate
decided to give FDA the authority to do an expedited labeling change
provision. In addition to this new authority, the House and Senate
language included provisions that made it clear that the ``changes
being effected,'' CBE, regulations should still stand. However, the
House and Senate took different stances as to how that additional
information or regulatory option should play out in court.
The Senate-passed language, which was done on a bipartisan level,
would have established a new labeling change process. This language
would have also implied that if a company was already in discussions
with the FDA about the labeling issue, and attempting to determine if
the labeling change was necessary, then a future lawsuit would have to
argue how the company was acting in an improper way. In this situation,
the FDA regulation would have ``occupied the field'' with respect to
liability for failure to warn.
The House-passed language would have the opposite effect. Essentially
a
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company would not be able to use the argument that they were in the
midst of discussion with the FDA as a defense. In my mind, the House
language is a huge boon to trial lawyers. It also makes it harder for
companies that are working in the best interest of the patient to prove
that they are doing so. I have long been a supporter of reducing the
opportunity for frivolous lawsuits, and in my mind the House language
increases this.
I would even be happy dropping both the House and Senate language
regarding liability. This would leave a situation in which either side
would be on an equal playing field to argue a case on failure to warn.
This situation would allow suits to be determined on a case-by-case
basis. Congress would not be weighing in one way or the other.
The legislation that is expected to pass uses the House language on
liability. It provides a source for bias in the courts and opens the
floodgates for frivolous lawsuits. This is a definite boon for trial
lawyers.
As with many other instances in which Congress has addressed the
demands of trial lawyers, I am not willing to risk the livelihood of
the employees at the FDA or the health of my constituents who rely on
the drug applications approved by the FDA. I will not hold up the
legislation, but I wanted to take this opportunity to express my dismay
at the partisan way that the liability issue was addressed.
Mr. DODD. Mr. President, I rise today to voice my support for H.R.
3580, the FDA Amendments Act of 2007. H.R. 3580 contains two bills
which I authored, the Best Pharmaceuticals for Children Amendments of
2007 and the Pediatric Medical Device Safety and Improvement Act of
2007. I believe these bills will go a long way toward improving the
health and safety our Nation's children. The bill will also make
important changes to our Nation's drug safety system so that the FDA
has clear authority backed up by new enforcement tools to ensure the
safety of prescription drugs once they are on the market.
As the original author of BPCA in 1997 and its two subsequent
reauthorizations, I am proud to say that no other program in history
has done more to spur research and generate critical information about
the use of prescription drugs in children than this one. In 10 years,
nearly 800 studies involving more than 45,000 children in clinical
trials have been completed due to BPCA. Useful new pediatric
information is now part of product labeling for more than 119 drugs. In
sum, there has been a twentyfold increase in the number of drugs
studied in infants, children, and adolescents as a result of BPCA since
its enactment.
Ten years ago when Senator Mike DeWine and I undertook this effort,
only 11 drugs on the market that were being used in children had
actually been tested and studied for their use. Prior to the enactment
of BPCA 10 years ago, pediatricians were essentially flying blind
because they lacked information regarding the safety and effectiveness
of drugs they were prescribing for children. But it was children who
suffered the most from taking drugs where so little was known about
their effects.
With BPCA, we have changed the landscape both for drug companies and
the FDA with respect to prescription drugs and children. However, we
still have much further to go because even with the progress we have
made so far, still less than half of all drugs being used in children
have been studied for their use. H.R. 3580 makes several key
improvements to BPCA that will better inform parents, pediatricians,
and the public about the safety and effectiveness of drugs used in
children. For instance, H.R. 3580 will improve transparency and
accountability by making written requests for pediatric studies public
and it will improve the accuracy and speed of labeling changes as a
result of BPCA studies.
However, H.R. 3580 represents a real missed opportunity to inject a
measure of rationality into this program to ensure that it will
continue to thrive well into the future. H.R. 3580 dropped a Democratic
compromise provision reducing the length of pediatric exclusivity from
the current 6 months to 4.5 months only for blockbuster drugs, drugs
with annual sales exceeding $1 billion. Five years ago and again
recently, my colleagues on both sides of the Capitol dome have
criticized this program over the 6-month length of the exclusivity that
may be granted if the FDA believes a drug company successfully
completed the pediatric studies it requested of them.
Most recently, data released by researchers at Duke University show
that some companies receive as much as 73 times the amount they spent
to conduct the pediatric trial under the 6 months of exclusivity. BPCA
has always been about balancing the needs of children with the cost to
consumers. That is why I strongly supported the provision I authored in
the Senate bill, S. 1082, which reduced the length of exclusivity to 3
months for blockbuster drugs.
I was proud to have brokered a compromise between the House and
Senate of 4.5 months for blockbuster drugs because this agreement was
the right policy. But I am profoundly disappointed that the decision
was made to drop this compromise. When my colleagues seek to make
similar changes to the length of exclusivity in 5 years, I believe that
the deal the House and Senate cut in H.R. 3580 will only make doing so
more difficult.
I must also express my strong disappointment that the final bill
inserts a 5-year sunset on the Pediatric Research Equity Act. As an
original cosponsor of the reauthorization of PREA and a long-standing
supporter of ensuring FDA has the authority to require pediatric
studies of drugs in certain circumstances, there should be no
expiration date on FDA's authority to ensure the safety of drugs in
children.
The interplay between BPCA and PREA is changed slightly in H.R. 3580
from the Senate-passed bill. It is my understanding that H.R. 3580 will
not delay the FDA's ability to utilize PREA's authority to require a
pediatric assessment of new drugs that have not yet been approved
should a company decline a written request under BPCA for such drug.
Similarly, an exhaustion provision was retained in BPCA that would
allow the Secretary to take up to 30 days to certify in the affirmative
that the Foundation for the National Institutes of Health has
sufficient funding to initiate and fund all studies in a declined
written request before determining whether an assessment under PREA can
be required. Although the Secretary may take up to 30 days to make such
a certification, the Secretary need not impose any delay before
determining whether an assessment under PREA is warranted. As the
Government Accountability Office found in its March 2007 report on
BPCA, contributions to the Foundation for the National Institutes of
Health by the drug industry totaled a mere $4 million since 2002. While
I hope contributions to the foundation will improve significantly,
there should be no unnecessary delays when it comes to important safety
information about medications prescribed to our children.
Mr. President, BPCA has shown us that it is unsafe to simply treat
children as small adults. Children face a similar inequity with respect
to medical devices. Far too few medical devices are specifically
designed for children's small and growing bodies. Experts say that the
development of children's medical devices lags 5 to 10 years behind
that of adults. That is largely due to the limited size of the market
for pediatric devices.
When a medical device suitable for a child is needed to save that
child's life but it does not exist, doctors are often forced to ``jury-
rig'' adult versions of the device or, in some cases, perform a riskier
surgery on the child. Ventilator masks, for instance, are far too large
to fit over a baby's mouth. Often, the only alternative is to run an
invasive tube down the baby's throat.
Because of what we witnessed over the past 10 years with the market
incentives provided under BPCA, I introduced an initiative, the
Pediatric Medical Device Safety and Improvement Act, to create similar
incentives for device manufacturers. I am pleased that this legislation
is contained within H.R. 3580 and I believe it will produce tremendous
improvements in children's health.
This legislation streamlines the approval process for cutting-edge
technology and establishes grants for matchmaking between inventors and
manufacturers and the Federal Government. It is my hope that the FDA
will
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utilize its Office of Orphan Products Development to administer these
matchmaking demonstration grants.
Balancing safety with reasonable incentives, this legislation closely
mirrors recommendations made by the IOM in its 2005 report on pediatric
medical device safety to improve the serious flaws in the current
postmarket safety surveillance of these devices. Specifically, the IOM
called for and the legislation allows the FDA to require postmarket
studies as a condition of clearance or approval for certain categories
of devices and it gives the FDA the ability to require studies longer
than 3 years with respect to a device that is to have significant use
in pediatric populations if such studies would be necessary to address
longer-term pediatric questions, such as the impact on growth and
development. This provision should not be seen to encourage or promote
off-label pediatric use of devices that have been cleared or approved
for adult use but for which there is no or limited safety and
effectiveness data concerning uses in children.
H.R. 3580 will also go a long way toward restoring the public's
confidence in the FDA to protect them against harmful prescription
drugs and foods. For too long, the FDA has lacked the clear authority
to require labeling changes when new safety information about a drug
arises. H.R. 3580 will change that.
For too long, the pressure on FDA to approve drugs has outweighed the
necessity to have a systemic, unbiased review of the post-market safety
of drugs whereby the FDA can take swift action should new safety
information arise. I am pleased that the drug safety provisions of H.R.
3580 will require contain requirements that the FDA's office
responsible for post-market safety of drugs have equal footing with the
office responsible for reviewing drugs.
As the author of S. 467, the Fair Access to Clinical Trials Act, I am
pleased that H.R. 3580 contains many major improvements to the clinical
trials provisions. Physicians, researchers, and the public will now
have access to a clinical trials registry with information on results,
making it tougher for companies to hide or skew undesirable clinical
trial results data.
I would like to thank Chairman Kennedy for his leadership on this
bill and his willingness to work so closely with me to improve
children's health. I would also like to recognize the many staff who
put in long hours and weekends working on this legislation. In
particular, I would like to commend Tamar Magarik and Jeremy Sharp, of
my staff, who worked extensively on this bill.
Mr. President, the past several years have been marked with major
drug controversies--Vioxx, Ketek, Avandia--with millions of families
affected. The public deserves better. The mission of the FDA, to
protect the public health by assuring the safety, efficacy, and
security of human and veterinary drugs, must be restored. H.R. 3580
provides the necessary reforms to restore the FDA as the gold standard
for assuring the safety of the public for many years to come.
Mr. BURR. Mr. President, I stand here with a heavy heart. Congress
had the chance to reauthorize many important programs at the Food and
Drug Administration and pass a targeted drug safety bill. Instead, we
are passing a massive bill that triples FDA regulation and
responsibility, puts clinical data out in the general domain that may
be misleading to patients, and contains conflict of interest language
that could harm participation on the FDA's advisory committees--a key
part of the drug approval process.
I will start with a good part of the bill. This bill reauthorizes
many important programs at the FDA, including the pediatric exclusivity
program. The Best Pharmaceuticals for Children Act was originally
enacted as part of the Food and Drug Administration Modernization Act
in 1997, legislation I sponsored on the House side and was reauthorized
in 2002. The goal of BPCA is to encourage the study of more drugs in
the pediatric population. BPCA provides that incentive by giving drug
companies an additional six months of market exclusivity to a product,
or pediatric exclusivity, in exchange for conducting voluntary studies
of prescription drugs on children.
Since its enactment, BPCA has been viewed as a highly successful
program and has produced at least 132 completed studies, leading to
approximately 120 pediatric label changes. According to the most recent
General Accountability Office study on BPCA, issued March 22, 2007,
prior to enactment of the Food and Drug Administration Modernization
Act few drugs were studied for pediatric use. As a result, there was a
lack of information on optimal dosage, possible side effects, and the
effectiveness of drugs for pediatric use. Almost all the drugs--about
87 percent--that have been granted pediatric exclusivity under BPCA
have had important labeling changes as a result of pediatric drug
studies conducted under BPCA. Exclusivity is working.
Senator Dodd tried to change the Best Pharmaceutical for Children Act
by decreasing the exclusivity for some drugs. At a Health, Education,
Labor, and Pension Committee hearing, witnesses expressed concern about
Senator Dodd's idea and speculated whether it would decrease the number
of drugs studied for pediatric indications. I am pleased that the final
bill does not include that misguided change to the pediatric program.
From the beginning of the HELP Committee's consideration of the drug
safety issue I recognized the need to clarify existing authority or
provide the FDA with a few new authorities in order to improve the
interaction between the FDA and drug companies on safety issues. It was
clear that labeling changes and clinical trials and studies were two
key areas in which Congress should act.
To that end, I offered an amendment during the committee markup that
provided the Secretary with additional authority and control over a
drug or biological product's approved labeling, including the authority
to require the holder of an approved application to make safety-related
changes following an accelerated labeling review process. Under the new
procedures added by my language, if either the Secretary or the holder
of an approved application became aware of ``new safety information''
that the party believed should be included in the labeling, the other
party should be notified promptly, and discussions should be initiated
regarding whether a labeling change is needed and, if so, the content
of any such labeling change.
That construct made sense to me and it made sense to Chairman Kennedy
who passed the amendment by unanimous consent. Given that current
practice today is for a company to call the FDA when they become aware
of new safety information, I thought it was a good idea to put current
practice into statutory law. I want companies and the FDA to talk to
each other about drug safety issues.
I support the safety labeling language in H.R. 3580, which reinforces
the FDA's broad authority over prescription drug labels. These
provisions allow the FDA to mandate changes to a drug's approved
labeling whenever the FDA becomes aware of new safety information that
it believes should be communicated in the labeling. Although the FDA
already has broad authority over drug labeling and must approve all but
the most minor labeling changes, this provision will enhance FDA's
authority and help to ensure that labeling changes are made
expeditiously using a process that facilitates dialogue between the
drug company and the FDA. FDA has comprehensive authority over the
regulation of drug products, particularly drug labeling, and this
provision further accomplishes that goal.
As I said earlier, I have three main concerns with H.R. 3580. First,
the bill is a complex web of regulation. It is going to take months, if
not years, for drug companies and the FDA to understand all of the new
regulations. I supported improving the FDA's authority in two areas:
safety labeling changes, and clinical studies and trials. This bill
goes far beyond those two areas and sets up a structure called REMS--
Risk Evaluation and Mitigation Strategy. The REMS does not add any
significant new authority. The FDA currently uses Risk Maps which do
the same things as REMS. Now Risk Map regulations, which have never
been studied for their effectiveness, are becoming law. It means more
paperwork, deadlines, and checkpoints for drug companies, with
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no guarantee that it will improve patient safety. I do not support
regulation for the sake of regulation.
Second, H.R. 3580 expands the scope of the Government's current
clinical trials website, www.clinicaltrials.gov, and adds clinical
trial results. I understand the desire of some members to make clinical
trials transparent and the desire of scientists to have as much access
as possible to clinical trial data. But I am very concerned that
average citizens will not understand all of the complex scientific
information being presented to them and instead of talking to their
physicians to understand the data about adverse events, primary and
secondary outcomes, and baselines, they will instead avoid taking drugs
that could make them feel better or save their lives. I hope that the
National Institutes of Health and the Food and Drug Administration are
very careful while implementing this title of H.R. 3580. If expanded
improperly, clinicaltrials.gov will frighten people, not educate and
assist them.
Third, this legislation changes the FDA process for granting waivers
for participation on advisory committees. The FDA has 23 advisory
committees that meet to discuss applications pending before the FDA and
other issues. Currently, only four of those advisory committees have
complete membership. Serving on an advisory committee is not a
glamorous job, even though we rely on those committees to guide the
FDA's approval and regulatory processes. Understandably, scientists
that serve on the committees have more to gain from doing their
research and making tenure, than working part-time for the Government.
Given all of those issues, instead of creating incentives to work on
the committees, this legislation makes it more burdensome and complex.
People have expressed concern about biased committee members, but the
facts demonstrate that the FDA is quite vigilant about screening
individuals to serve on the committees. And the FDA has been working on
new regulations to strengthen the screening process even more. I hope
that we do not see a slowdown in the drug approval process due to an
inability to fill the membership of advisory committees.
Senator Brown and I also worked on language that would help bring new
antibiotics and generic versions of old antibiotics to market. At the
last minute, that language was stripped out of the House bill in order
to pay for a half month of pediatric exclusivity. I hope that
Representatives Dingell and Barton hold to their promise of moving that
antibiotics legislation in the near future.
Overall, I am disappointed that necessary FDA reauthorizations became
vehicles for legislation that need more work, are overly broad, and
will weigh down the FDA at a time when we need to be helping, not
hurting, the FDA.
Mr. COBURN. Mr. President, today the full Senate will probably agree
to legislation--H.R. 3580, the Food and Drug Administration Amendments
Act of 2007--that constitutes a massive overhaul and expansion of the
Food and Drug Administration's authorities. Up until a couple days ago,
determining the scope and details of the bill was an open and
bipartisan process. Unfortunately, all of that changed at the eleventh
hour and we were locked out of discussions to determine what a final
product would look like. Now we are forced to either accept what we do
not fully agree with or cause thousands of FDA employees to lose their
jobs. This is not the way to ensure that we ``get it right'' with drug
safety.
While this bill achieves the important and necessary objectives of
reauthorizing the Pediatric Research Equity Act, the Best
Pharmaceuticals for Children Act, the Pediatric Medical Device Safety
and Improvement Act, the Prescription Drug User Fee Amendments, the
Medical Device User Fee Amendments, and establishing a scientifically-
based surveillance system for drug safety risks. There was still
important work to be done to complete a bipartisan product. Because of
unfair Democratic Majority tactics I and my colleagues have no
opportunity to further amend and perfect this legislation.
Furthermore, I am frustrated that certain important provisions were
removed from the final language of the bill at the last minute. We lost
a provision to provide incentives for developing new antibiotics--a
disastrous decision at a time when we are seeing a huge rise of
antibiotic resistance in this country. Last minute negotiators also
refused to recognize that patients desiring marijuana for medical
purposes deserve to know critical information about whether or not
marijuana can be safely used. Finally, the final bill did not contain
an important Senate-passed resolution to protect American
pharmaceutical companies' intellectual property rights around the
globe.
This legislation is a very delicate balancing act. No drug is
completely safe--otherwise a doctor's prescription wouldn't be needed--
but we do have to ensure that lifesaving medicines are able to get to
patients. New authorities in the area of Risk Evaluation and Mitigation
Strategies, REMS, labeling, and postmarket commitments should not be
taken lightly. These new authorities we are giving the FDA need to be
used based on a measured assessment of risk vs. benefit in the intended
patient population. For instance, labeling changes should only be
undertaken when reliable data clearly shows safety problems that are
not already reflected in the drug's label. If that data happens to come
from a third party unknown to the application holder they should have
the opportunity to review it along with the Agency so that appropriate
labeling changes can be made based on sound science.
Another new authority granted to the FDA in a REMS is possible
restrictions on distribution and use. If used, this restriction has the
potential to impede patient access to important therapies and therefore
should not be imposed where less burdensome approaches are available.
This concept of a ``less burdensome approach'' is an important one and
it is essential that product manufacturers have the opportunity to
present alternative proposals to the Agency that would accomplish the
goal of safety without imposing unduly restrictive actions to products
and ultimately to patients. This legislation establishes that the FDA
will not limit or restrict distribution or use unless a drug has been
shown to actually cause an adverse event. We absolutely need FDA to
have all the tools necessary to ensure the safety and efficacy of
drugs, but doctors need tools as well, and one of those important tools
is new drugs on the market. I appreciate the significant changes that
were made in this language of the bill between Senate HELP Committee
markup and full Senate consideration. These improvements remain in the
final bill and are critical to ensure that physicians--not the FDA--can
make risk/benefit decisions with their patients.
This bill ensures that the FDA has broad and exhaustive authorities
to make sure that drug companies are doing the right and
scientifically-justified thing when it comes to drug safety and the
labeling of their drugs. This authority is placed rightly in the hands
of highly-trained scientists at the FDA. It is clear that Congress
relies on the scientists at the FDA to assess safety risks and
drug labeling and this should be squarely and solely the FDA's role--
that is why we have spent months and months trying to get this issue of
drug safety right. The newly expanded role of the FDA does and should
preempt State law when it comes to drug safety and labeling. In order
to ensure scientific drug safety the last thing that we need is the
regulatory nightmare of every State court being a mini-FDA.
Let me be clear, the FDA is the expert Federal agency charged by
Congress with ensuring that drugs are safe and effective and that
product labeling is truthful and not misleading. Appropriate preemption
of State jurisdiction includes not only claims against manufacturers,
but also against health care practitioners for claims related to
dissemination of risk information to patients beyond what is included
in the labeling.
Product liability lawsuits have directly threatened the FDA's ability
to regulate manufacturer dissemination of risk information for
prescription drugs. I note a recent case in California, Dowhal v.
SmithKline Beecham, where trial lawyers tried to assert that a drug
company had failed to warn consumers that nicotine-replacement products
allegedly cause birth defects--even though there wasn't scientific
evidence to back that up. In this case, the FDA had previously told
[[Page S11840]]
SmithKline Beecham that they should not include such an unscientific
warning in its label because it would clutter up the label's warnings
that actually were scientifically justified. A California court
asserted that more warnings were always better. Subsequently, that
assertion was overruled unanimously by the California Supreme Court as
the FDA again asserted that its scientific judgment should prevail. The
case was not properly before the court by operation of the doctrine of
primary jurisdiction. Unless State law is preempted in this area, State
law actions can conflict with the FDA's interpretations and frustrate
the FDA's implementation of its statutory and scientific mandate.
Should the FDA's scientific judgment on drug safety and labeling be
set aside, we would risk eroding and disrupting the truthful
representation of benefits and risks that medical professionals need to
make decisions about drug use. As a physician, I know that exaggeration
of risk can discourage the important and right use of a clinically
therapeutic drug. Superfluous liability concerns can create pressure on
manufacturers to expand labeling warnings to include merely speculative
risks and limit physician appreciation of potentially far more
significant contraindications and side effects.
I note that the FDA has previously stated that ``labeling that
includes theoretical hazards that are not well grounded in scientific
evidence can cause meaningful risk information to `lose its
significance.' Overwarning, just like underwarning, can similarly have
a negative effect on patient safety and public health.'' In this bill,
we have created a clear labeling pathway between the FDA and a drug
sponsor in this bill to ensure that consumers get scientifically
accurate and appropriate warning of drug safety risks.
Furthermore, if not preempted in drug safety information and
labeling, State law could conflict with achieving the full objectives
of Federal law if it precludes a firm from including certain labeling
information. If a manufacturer then complies with State law, the firm
would be omitting a statement required under Sec. 201.100(c)(1) as a
condition on the exemption from the requirement of adequate directions
for use, and the omission would misbrand the drug under 21 U.S.C.
352(f)(1). The drug might also be misbranded on the ground that the
omission is material within the meaning of 21 U.S.C. 321(n) and makes
the labeling or advertising misleading under 21 U.S.C. 352(a) or (n).
While it is true that a manufacturer may, under FDA regulations,
strengthen a labeling warning on its own, it is important to understand
that in practice manufacturers typically consult with FDA before doing
so. Otherwise they could risk enforcement action if the FDA ends up
disagreeing.
Some misunderstand the FDA's labeling requirements to be a minimum
safety standard and have used State law to force manufacturers to
supplement safety regulation beyond that required by FDA. I want to be
clear that the FDA's labeling requirements establish both a ``floor''
and a ``ceiling.'' Therefore, risk information beyond what is required
by the FDA could be considered unsubstantiated or otherwise false or
misleading. Given the comprehensiveness of FDA regulation of drug
safety, effectiveness, and labeling additional requirements for the
disclosure of risk information are not necessarily more protective of
patients.
Finally, I want to specifically comment on language in H.R. 3580 that
includes a new mechanism to further encourage the timely and accurate
communication of new safety information on prescription drug labels.
That mechanism reiterates the FDA's primacy in determining the content
of prescription drug labeling, including through the new power to
command a safety labeling change. New section 505(o)(4)(I) also makes
clear that this enhanced safety labeling mechanism does not affect the
obligation of a company to maintain a drug product's labeling in
accordance with FDA's regulations, including 21 C.F.R. Sec. 314.70.
This provision is meant to confirm the basic obligation of a drug's
sponsor to propose--or, in some cases, make--changes to the approved
labeling to reflect changes in the conditions established in the
approved application and/or new information. Nothing in this rule of
construction changes that obligation or FDA's ultimate authority over
drug labeling; nor is it intended to change the legal landscape in this
area. That is because there is an overriding Federal interest in
ensuring that the FDA, as the public health body charged with making
these complex and difficult scientific judgments, be the ultimate
arbiter of how safety information is conveyed. In this manner, there
can be confidence that uniform drug labeling conveys clear, consistent,
and scientifically justified safety and medical information.
In fact, the courts have repeatedly upheld FDA's supremacy over
prescription drug labeling in cases brought under State law. Nearly 20
years ago, the U.S. Court of Appeals for the Fifth Circuit emphasized
that ``. . . manufacturers cannot change the language in the product
insert without FDA approval,'' and accordingly ``[i]t would be patently
inconsistent for a state then to hold the manufacturer liable for
including that precise warning when the manufacturer would otherwise be
liable for not including it.'' Hurley v. Lederle Labs. Div. of Am.
Cyanamid Co., 863 F.2d 1173, 1179 (5th Cir. 1989). As a more recent
Court expressed this bedrock principle, allowing a State to decide what
warnings are appropriate, and thus potentially subject companies to
liability for otherwise FDA-approved labeling, would upset the careful
benefit-risk balance that FDA has struck in approving a product for
market, and doing so would ``undermine FDA's authority to protect the
public health through enforcement of the prohibition against false and
misleading labeling of drug products in the Federal Food, Drug and
Cosmetic Act.'' Sykes v. Glaxo-SmithKine, 484 F. Supp. 2d. 289, 312
(E.D. Pa. 2007) (internal quotation omitted) .
citizens' petitions
Mr. HATCH. Mr. President, I wish to take this opportunity to clarify
one issue related to the language on citizens' petitions and petitions
for stay of agency action which is included in FDARA. As my colleagues
are aware, I was a cosponsor of the citizens' petition amendment
included in the Senate-passed bill, and I was pleased to work closely
with my colleagues in the Senate--Senators Kennedy, Enzi, Brown,
Stabenow, Lott and Thune to develop an acceptable compromise with the
House. I understand the importance of making certain that generic drug
approvals are not delayed unnecessarily, which is the intent of this
amendment.
Mr. KENNEDY. Indeed, that was an important objective of the Food and
Drug Administration Amendments Act, and I agree the citizens' petition
language is an integral part of the final legislative effort.
Mr. HATCH. As my colleagues are aware, we had a number of discussions
about this provision, and one issue we worked hard to balance was the
need for the Food and Drug Administration to have adequate time to
review any meritorious issues raised by a petitioner against the
importance of not holding up the Abbreviated New Drug Applications--or
ANDAs--or applications submitted under section 505(b)(2) of the Federal
Food, Drug and Cosmetic Act. Our colleagues, Senators Brown and
Stabenow, were particularly forceful in their arguments that there
should be a deadline for FDA action on a petition, but that the agency
could have the ability to delay review of an application if it found
that the petition raised a legitimate public health issue.
My concern, which I want to discuss with the chairman, goes to the
discussions we had about the operation of that language. In particular,
I want to discuss the ability of the agency to conserve its resources
and not waste time acting on petitions that do not merit review.
Indeed, the concept we discussed over the course of many days was that
the agency would have the ability to deny a petition or a supplement if
the petition were based on meritless or frivolous issues. We all
recognized, however, that defining ``meritless'' and ``frivolous'' is
imprecise at best. So, the final language contained in the bill we
consider today says that the agency may deny a petition at any point if
the Secretary determines that it was submitted ``with the primary
purpose of delaying the approval of an application and the petition
does not on its face raise valid scientific or regulatory issues . .
.''
MR. KENNEDY. The Senator from Utah is correct.
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Mr. HATCH. One concern that I raised, which we all agreed would have
been included in the conference report language had we filed such a
report was a clarification about the meaning of ``scientific or
regulatory issues.'' It was our agreement during negotiations on FDARA
about what is perhaps an obvious point: if the law requires a delay in
approval of an ANDA or 505(b)(2) application, for example because of a
patent or an exclusivity, this new provision will not change that
required legal result. The law is the law, and its effect should not
depend on whether or not it was brought up in a petition to FDA. I
would appreciate the chairman clarifying if that was the agreement we
had.
Mr. KENNEDY. I do agree. Let us be clear: The citizen petition
provision is designed to address attempts to derail generic drug
approvals. Those attempts, when successful, hurt consumers and the
public health. The citizen petition provisions are not intended to
alter laws not amended by the provision. I thank the Senator.
Medicare Claims Data
Mr. BAUCUS. Mr. President, today we have before us an important piece
of legislation, the FDA Amendments Act of 2007. It has come to my
attention that this bill includes a section that makes an effort to
authorize the FDA to use and release Medicare claims data for use in
postmarket surveillance of drugs approved by the FDA. I fully support
the goal of making drugs safer for all Americans.
As chairman of the Finance Committee, however, I am obligated to
point out that any use of Medicare data is exclusively governed by
title XVIII of the Social Security Act, and that the Finance Committee
has exclusive jurisdiction over title XVIII. I would ask the
distinguished chairman of the Health, Education, Labor and Pensions
Committee, Senator Kennedy, to acknowledge that the Senate Finance
Committee has sole jurisdiction over Medicare data and title XVIII of
the Social Security Act and ask that he endeavor to consult us on
matters before the HELP Committee that touch on the Senate Finance
Committee's jurisdiction. I make the same commitment to him that he
makes to me: I will commit to consult on matters before the Finance
Committee that touch on the Senate HELP Committee's jurisdiction.
To avoid unnecessary confusion as to the jurisdiction of the Finance
Committee or further delay in the consideration of this important
conference agreement, I would agree to accommodate your request to
withhold any objection to the Senate's consideration of it with the
acknowledgement that the release and use of Medicare data are governed
by title XVIII of the Social Security Act and are under the exclusive
jurisdiction of the Finance Committee. This does not represent any
waiver of jurisdiction on the part of the Finance Committee on this
subject.
I would ask the chairman of the HELP Committee, Senator Kennedy,
whether he would agree to this request.
Mr. KENNEDY. It is a great pleasure to work with my distinguished
colleagues from the Finance Committee on this reauthorization of
important programs at the FDA. I know they have a deep interest in
seeing that the medicines that Americans take are safe and effective.
Senator Baucus and Senator Grassley have rightly raised a question
regarding the interpretation of section 905 of this bill. Section 905
adds a new paragraph (3) to section 505(k) of the Federal Food, Drug
and Cosmetic Act. This new paragraph establishes a system for FDA to
query databases regarding information that may help detect adverse drug
effects. It is essential to detect drug safety problems early, so that
they may be corrected before people are hurt and an electronic drug
safety system is one important tool for doing so.
The Medicare claims database is listed as one of several possible
sources of data in section 505(k)(3)(C)(i)(III)(aa). I want to assure
my friends from Montana and Iowa that our intent is that Medicare's
participation will be determined by provisions of the Social Security
Act, over which the Finance Committee has exclusive jurisdiction.
Nothing in this section is intended to infringe on that jurisdiction or
to in any way preempt the ability of the Finance committee to act to
specify the participation or nonparticipation of the Medicare claims
data base in the system established under section 905.
The matter before the Senate amends the Federal Food, Drug and
Cosmetic Act. The section to which you have raised concerns authorizes
use of Medicare data ``as available.'' I acknowledge that under current
law, that is not possible.
Mr. BAUCUS. I thank the chairman. I intend to continue working with
my good friend Senator Grassley to address the release and use of
Medicare data by Federal health agencies and private researchers soon
through legislation written by the Finance Committee.
Mr. GRASSLEY. I agree with my colleague, Senator Baucus. I have been
working a long time on legislation to permit the use of Medicare data
to improve drug safety. After all this is some of the best and most
complete data available. In fact, Senator Baucus and I joined together
to introduce legislation to accomplish just that during the 109th
Congress, S. 3987, the Medicare Data Access and Research Act, and this
Congress, S. 1507, the Access to Medicare Data Act of 2007. Improving
drug safety is a top priority of mine and the appropriate use of
Medicare data will likely enhance drug safety. That will benefit all
Americans. I look forward to completing our goals for Medicare data
later this year and including this on legislation within the purview of
the Finance Committee. We intend to clarify how Federal health agencies
may use and release Medicare data and make the appropriate amendments
in the Social Security Act. At that point, it will be important that
the use of Medicare data be appropriately tied into the drug safety
provisions of the FDA bill under consideration today. We would hope
that our colleague, Senator Kennedy, would agree to make conforming
amendments to the Federal Food, Drug and Cosmetic Act as needed to make
FDA law consistent with appropriate Medicare law.
Mr. KENNEDY. I appreciate that conforming amendments in the Federal
Food, Drug and Cosmetic Act may be necessary as you point out. I agree
to work with the Senator in the future on this issue.
Mr. KENNEDY. Mr. President, I ask unanimous consent that the bill be
read a third time, passed, the motion to reconsider be laid upon the
table, and that any statements relating to the bill be printed in the
Record, without further intervening action or debate.
The PRESIDING OFFICER. Without objection, it is so ordered.
The bill (H.R. 3580) was ordered to a third reading, was read the
third time, and passed.
Mr. KENNEDY. Mr. President, the New England Journal of Medicine,
which is probably the most distinguished medical journal in not only
this country, probably in the world, has made the comment that this
legislation is the greatest progress, in terms of drug safety, in a
century. This ought to be reassuring for every family as to the safety
of their prescription drugs and also in terms of their food.
The PRESIDING OFFICER. The Senator from Massachusetts.
Mr. KERRY. Mr. President, I congratulate my colleague from
Massachusetts on another landmark piece of legislation that he has been
able to shepherd through this institution. It adds to a remarkable
string of legislative accomplishments.
We are all pleased this important reform effort and advance is going
to be made. It is a terrific step forward. I congratulate Senator
Kennedy, Senator Enzi, and others on the committee who worked so hard
to make it happen.
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