[Congressional Record Volume 159, Number 164 (Monday, November 18, 2013)]
[Senate]
[Pages S8071-S8076]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
NATIONAL DEFENSE AUTHORIZATION ACT FOR FISCAL YEAR 2014--MOTION TO
PROCEED
Mr. REID. Mr. President, I move to proceed to Calendar No. 91, S.
1197.
The PRESIDENT pro tempore. The clerk will report the bill by title.
The legislative clerk read as follows:
Motion to proceed to Calendar No. 91, S. 1197, a bill to
authorize appropriations for fiscal year 2014 for military
activities of the Department of Defense, for military
construction, and for defense activities of the Department of
Energy, to prescribe military personnel strengths for such
fiscal year, and for other purposes.
Drug Quality and Security Act
Pending:
Reid amendment No. 2033, to change the enactment date.
Reid amendment No. 2034 (to amendment No. 2033), of a
perfecting nature.
Reid motion to commit the bill to the Committee on Health,
Education, Labor and Pensions, with instructions, Reid
amendment No. 2035, to change the enactment date.
Reid amendment No. 2036 (to (the instructions) amendment
No. 2035), of a perfecting nature.
Reid amendment No. 2037 (to amendment No. 2036), of a
perfecting nature.
Mr. REID. I now ask unanimous consent that the cloture motion with
respect to H.R. 3204, the pharmaceutical drug compounding bill, be
withdrawn, the pending motion and amendments be withdrawn, and the
Senate vote on the passage of the bill.
The PRESIDING OFFICER (Mr. Kaine). Without objection, it is so
ordered.
The bill (H.R. 3204) was ordered to a third reading and was read the
third time.
Animal Drug Compounding
Mr. ISAKSON. Mr. President, I wish to thank Mr. Alexander for
his work on this legislation. I am happy to see that all sides have
been able to reach an agreement on clarifying the oversight of large
compounding facilities, while also ensuring that patients continue to
have access to customized medicines at their local pharmacy. I am
grateful to the chairman and ranking member for clarifying that the
intent of this legislation is to maintain current law with respect to
patients' and physicians' access to drugs compounded for office use. I
am also very encouraged that we are finally moving forward on creating
a uniform national standard for the pharmaceutical supply chain, which
will allow patients to have more confidence in the safety of the drugs
they receive while also ensuring that national distributors and third-
party logistics providers do not face the burden of dealing with a
confusing and inconsistent patchwork of State-by-State rules.
I would like to take a moment to discuss an issue that is not
directly addressed in the bill before us. I have heard from my
constituents that there are serious problems, similar to the ones we
are seeking to address today, with the inappropriate compounding of
animal drugs. As with human drugs, mass production of compounded animal
drugs with inadequate safety standards has resulted in suffering and
death.
While the compounding of animal drugs according to a prescription
from a veterinarian for an individual patient is legal, necessary, and
appropriate, it is important to draw a line between compounding and
manufacturing. I am especially troubled by reports that some entities
characterizing themselves as ``compounding pharmacies'' are producing
large quantities of animal drugs that are essentially copies of FDA-
approved products. They are then mass-marketed as cheap alternatives to
approved products, without being subject to any of the safety
requirements and quality controls that manufacturers must comply with.
As with human drugs, the FDA has had mixed success in taking
enforcement action against questionable or abusive animal drug
compounding practices. While I understand that animal drug compounding
raises complicated issues that the bill before us does not address, I
want to make it clear that the absence of animal drug provisions in
this legislation does not constitute an endorsement of the status quo.
I hope that in the months ahead, Congress can begin to investigate the
issues surrounding animal drug compounding in more depth, with an eye
toward spurring the FDA to make this a higher enforcement priority.
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Mr. ALEXANDER. Mr. President, I agree that there are issues
associated with animal drug compounding that should be examined. This
bill does not change the current animal drug regulatory structure, and
it is my hope that FDA would exercise its current enforcement
authorities, as well as work with State pharmacy boards, to ensure that
the law is being followed with respect to animal drug compounding,
including compounding from bulk chemicals and the copying of approved
drugs. In addition, Congress should utilize its oversight authorities
to ensure that the agency acts accordingly. I plan to work with my
colleagues in the Senate and the House to ask the Government
Accountability Office to look at compounding of animal drugs.
Mr. ISAKSON. I thank the chairman, and I look forward to working with
him.
Access to Compounded Drugs
Mr. ALEXANDER. Mr. President, I have been working very hard with
Senator Harkin, members of the HELP Committee, and members of the House
Energy and Commerce Committee on legislation to provide options for
patients and providers who want compounded drugs made in FDA-regulated
facilities. As we debate this bill today, I want to make clear that all
involved on this legislation have no intent of limiting patient or
provider access to quality compounded drugs that fill a clinical need.
The process in the HELP Committee began as soon as news of the
outbreak broke in Tennessee, and I cannot thank enough the folks at the
Tennessee Department of Health, including Dr. Kainer, for all their
good work that prevented so many further cases and lives being
destroyed.
We have been working very hard to reach an agreement on how
compounding should be regulated--and we have come a long way.
Stakeholders including pharmacists, public health groups, and the FDA,
have been sitting around a table to find a consensus solution. We have
made good progress, and I want to talk about this legislation.
For traditional pharmacy, currently regulated under 503A of the Food,
Drug, and Cosmetic Act, we strike the provisions found unconstitutional
by the Supreme Court related to marketing.
In addition, and what will help prevent another New England
Compounding Center, NECC, the Drug Quality and Security Act establishes
a completely separate and distinct section 503B that authorizes FDA to
regulate an optional category for larger compounding facilities.
Sterile compounding facilities that do not want to comply with the
patchwork of State laws and requirements can choose instead to have FDA
regulate their compounding. 503B establishes rigorous quality
standards, registration, adverse event reporting, inspections, and
fees. If there are unintended consequences to this legislation, I stand
ready to work with my colleagues and provide necessary oversight.
It has been almost 10 years since the Supreme Court decision that
left a great deal of uncertainty in the regulation of pharmacy
compounding. We clarify that 503A applies nationwide, and create an FDA
regulated source for sterile compounded drugs. Nothing in the
legislation is intended to limit access to quality compounded drugs for
providers and patients or alter the practice of medicine but, rather,
create a whole new alternative for safe sources of sterile compounded
drugs that are held to a nationwide quality standard. The legislation
does not change current law on office use compounding or repackaging.
Chairman Harkin will discuss the importance of this language, and I
thank him for working with me so hard on this over the last year.
Mr. HARKIN. Mr. President, as Senator Alexander has indicated, we
have been working together for a long time to develop legislation that
will ensure that patients have access to the compounded drug products
they need and that they can have greater confidence that their
compounded drugs are safe. We ultimately landed on a package that
preserves current law for traditional compounders but creates a new
option for entities that choose to operate outside the bounds of
traditional pharmacy practice to allow them to serve as safe sources of
the compounded drugs that providers and their patients need.
We have worked very hard to craft a proposal that preserves patient
access to clinically necessary medications while helping to ensure that
providers have access to safe sources of compounded drugs. As Senator
Alexander noted, section 503A of the current Federal Food, Drug, and
Cosmetic Act governs traditional compounding. This bill preserves
current 503A but removes the unconstitutional advertising provisions so
503A is the uniform policy nationwide.
Similarly, we do not change current law regarding repackaging or
biologics. The Senate bill established a new regulatory regime for
repackaging and biologics, but ultimately, after our bipartisan,
bicameral discussions, we made no changes to current law on those
subjects nor do we change current law on the compounding of animal
drugs. The existing restrictions on animal drug compounding have not
been rigorously enforced. We will be asking GAO to take a closer look
at the laws regulating animal compounding because we weren't able to
address it in this package.
This bill also creates an entirely new source of quality compounded
drugs. It permits entities that want to serve as outsourcers for
entities that need large volumes of clinically necessary compounded
drugs to provide those drugs, as long as they register with FDA and pay
a registration fee, adhere to high quality standards, submit to FDA
inspection, and tell the agency if adverse events occur.
I recognize that many patients need drugs that are not available from
pharmaceutical manufacturers, and I have no interest in cutting off
patients' access to those drugs. But I do want to ensure that when
patients do need a compounded drug, it is safe. By ensuring that
current law--FDCA section 503A--applies nationwide and creating a new
safe source of outsourced drugs, this bill should enhance patients'
ability to get the drugs they need without having to worry about their
safety.
Practice of Medicine
Mr. COBURN. Mr. President, I wish to express support moving forward
with the Drug Quality and Security Act but want to express my concern
that this legislation should not be used by the FDA to interfere with a
doctor's ability to practice medicine and choose the best therapy for
his or her patients. Patients have allergies, conditions, and diseases
on an individual basis. So often drugs in the form made by
manufacturers are not the best option for an individual patient's
needs, especially in some specialties such as ophthalmology. A varying
strength or dose may need to be made by the pharmacy and many States
have laws permitting physician compounding as well.
I understand and have received assurances from my colleague Senator
Alexander that limiting access to necessary treatments by providers and
patients was not the intent of this legislation and look forward to
working with him should any unintended consequences arise.
Mr. ALEXANDER. Mr. President, I thank my friend Dr. Coburn for his
remarks, concern, and assistance with this legislation. I agree with
him, and want to clarify that nothing in this legislation will
constrain a doctor's options to practice medicine. The legislation
tries to ensure that if a doctor or patient needs access to compounded
drugs, that there is an FDA-regulated source for those drugs where the
quality standards are uniform nationwide. Doctors know their patients
best and should have access to accurate information on the safety and
quality of the drugs they use.
If there are unintended consequences to this legislation, I stand
ready to work with my colleagues and provide necessary oversight.
Mr. ALEXANDER. Mr. President, I rise today to speak about the Drug
Quality and Security Act and also to thank the members and staff who
have worked with us to reach an agreement and pass this bill. The
legislation addresses the current ambiguity around the regulation of
compounding pharmacies, one of which is tied to more than 60 deaths. It
also establishes a workable system to get to unit level tracing of the
nearly 4 billion prescriptions filled a year in the U.S. within a
decade. In addition to bipartisan support in Congress, the bill enjoys
broad support from the biomedical industry,
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patient groups, consumer groups, and other stakeholders.
Over a year ago, staff began to work on identifying the cause and
possible solutions to help prevent another meningitis outbreak. A group
of staff from Republican and Democratic offices on the Health,
Education, Labor, and Pensions Committee began a series of standing
meetings and proceeded to meet every week for several months. They met
with stakeholders and discussed policy solutions that each member
thought would solve the problem. After much discussion of the benefits,
costs, and possible unintended consequences, members agreed to a list
of policy concepts. That bill, S. 959, is a strong bill, and was voted
out of committee unanimously. While I believe our Senate bill was a
stronger solution, it would not have gotten through the Chamber on the
other side of the Capitol.
We held bipartisan and bicameral meetings throughout August to try to
find a consensus that could pass both Chambers, and that legislation is
what you see before you. Is it perfect? No, but I believe it is a good
first step and a market-driven solution to this terrible tragedy.
I would like to thank Senator Harkin for his tireless work on this
bill, along with Chairman Upton and Ranking Member Waxman of the Energy
and Commerce Committee. Senator Harkin's staff has also worked
tirelessly on this bipartisan bill. They worked many late evenings,
long weekends, and through countless discussions to get the bill to
where it is today.
Specifically, I want to recognize and thank Jenelle Krishnamoorthy,
Elizabeth Jungman, and Nathan Brown. I also want to thank Pam Smith,
Senator Harkin's staff director, for her leadership in getting this
bill to the finish line.
I also would like to thank Jennifer Boyer with Senator Roberts and
Hannah Katch with Senator Franken for all their help as well.
Senators Bennet and Burr were instrumental in the drug tracing title
on which they have been working for almost 2 years. Rohini Kosoglu with
Senator Bennet and Anna Abram and Margaret Coulter with Senator Burr
worked very hard to craft this section, and I would like to thank them,
too. I would also like to thank our Senate legislative counsels Stacy
Kern Scherer and Kim Tamber, and from the Congressional Budget Office
Julia Christensen, Jean Hearne and Ellen Werble.
Finally, I would like to thank my staff--Grace Stuntz, and my Health
Policy Director, Mary-Sumpter Lapiniski. I also want to thank my staff
director, David Cleary, for his work on this bill. My staff has been
working around the clock for many days and weeks, and I sincerely
appreciate their dedication to getting this bill passed.
I know Members are pulled in many different directions and there is
always a lot of work to complete. We have a bipartisan bill that we
believe will pass the Senate later today and passed the House on
Saturday, September 28th, that takes a big step in addressing the
regulation of compounded drugs and preventing counterfeit, stolen, and
substandard drugs from reaching consumers. I urge my colleagues to
support this compromise.
Mr. BOOZMAN. Mr. President, more than a year ago we witnessed the
fatal New England Compounding Center meningitis outbreak. The Food and
Drug Administration failed to pursue enforcement action against NECC,
despite clear warning signs. Moreover, the Massachusetts Board of
Pharmacy did not do its job. It failed to provide basic oversight. This
inaction allowed a criminal compounder to operate with impunity--ending
the lives of many Americans.
In contrast, the Arkansas Board of Pharmacy is competent and
thorough. It does a great job. Arkansas regularly inspects all
pharmacies. We are a small State, but we run a tight ship.
However, Arkansas has no way of knowing whether other State pharmacy
boards are doing their job.
We need to take steps to protect patients from precarious, poorly
inspected, out-of-State drugs. However, I want to make clear of
something before we move on this legislation.
The practice of pharmacy, including pharmacy compounding, is a State
issue. Nothing in this law changes that. Compounded drugs for office-
use is a State issue. Nothing in this law changes that. Commonplace
drug repackaging for drugs--like Avastin--is a State issue. I relied on
compounders regularly when I practiced in a surgery center. Office-use
compounding and repackaging is acceptable under Arkansas law. Nothing
in this law changes that.
The omission of office-use from section 503(a) of the Food, Drug, and
Cosmetic Act should not signal to the FDA that it has the authority to
encroach upon State authority to regulate office-use. This is not the
intent of the law, and I will closely monitor FDA implementation as
this process moves forward.
If the State of Minnesota wants to prohibit drug repackaging and
compounding--that is its decision. But again, this law is by no means a
green light for the FDA to usurp the rights of States. I want to make
that crystal clear.
Lastly, contrary to much of what has been said, compounders have
really stepped up to assist providers in need. Today, America faces a
serious drug shortage problem. Sterile injectable generic drugs
constitute 80 percent of the drugs in short supply.
Not surprisingly, government pricing caps have caused these
shortages. Thankfully, compound pharmacists in Arkansas and across the
country have been meeting critical market needs that manufacturers have
been unable to satisfy. Compounders have helped address supply chain
gaps and sudden spikes in demand--particularly in rural and neglected
areas. They have plugged holes in the system, and they have tended to
overlooked markets.
Without compounders, doctors would not perform surgeries. Without
compounders, oncologists would be forced to administer alternative
chemotherapy drugs. Without compounders, patients would suffer from
limited access. These are real issues and real problems, and we must
take these realities into consideration. I look forward to working with
all stakeholders to ensure commonsense compounding, repackaging, and
office-use administration of compounded drugs.
Mr. LEVIN. Mr. President, the Senate is poised to pass legislation
aimed at strengthening the safety of compounded pharmaceuticals and the
security of the drug supply chain. It has been more than 1 year since
the public became aware of what quickly became a far reaching fungal
meningitis outbreak affecting citizens in 20 States, including my home
State of Michigan. Following an investigation by the Centers for
Disease Control and Prevention and the Food and Drug Administration,
along with local health departments, it became clear the outbreak was
caused by contaminated steroid injections produced by the now defunct
New England Compounding Center, NECC, a compounding pharmacy in
Framingham, MA. This tragedy brought a spotlight to bear on the opaque
regulation of mass compounding pharmacies.
According to the CDC, over 750 people from across the United States
were affected by tainted pain steroid injections produced by NECC.
Victims numbering 264, more than one third of the hundreds made
severely ill from contaminated injections, reside in Michigan. Sixty-
four of the victims lost their life as a result of illness, including
19 Michiganians. While it is certainly important that we clarify
Federal regulatory responsibilities to help ensure similar tragedies
are not repeated in the future, we could have begun debate on a
solution far earlier. A legislative response is surely long overdue.
Colleagues on both sides of the aisle and the Capitol have worked
through this issue to produce a bill that will both strengthen Federal
authority to regulate mass-compounding facilities and will lay the
groundwork for a nationwide system to track prescription drugs. While
not as far reaching as some may have initially intended, the bill we
are considering does represent an important and necessary step forward
and was unanimously passed by the House of Representatives in
September.
It is important to draw a distinction, as this bill does, between so-
called traditional compounding--where a pharmacist tailors a particular
drug to meet the unique needs of a patient, such as removing a certain
dye or altering the dosage level of an adult
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medication to be suitable for a child--and the mass compounding of
drugs for wholesale distribution. Compounding pharmacists have long
been regulated by State boards of pharmacy. However, as was made clear
in the investigation that followed the meningitis outbreak, NECC, a
mass compounding pharmacy, was operating in a regulatory gray area
where neither the State nor Federal Government took full responsibility
for ensuring their facility and compounding practices were safe and
sterile.
The Drug Quality and Security Act aims to address this regulatory
gray area by clarifying the responsibilities of the FDA with regard to
the oversight of mass compounded pharmaceuticals. Specifically, it
further defines the distinction between traditional compounding and
compounding manufacturers that make large volumes of drugs without
individual prescriptions.
Under this bill, mass compounding pharmacies can choose to register
as outsourcing facilities that would be subject to new FDA regulatory
oversight similar to that of other pharmaceutical manufactures. And, in
an effort to provide patients with better information about compounded
drugs, this legislation calls for detailed labeling of compounded drugs
and directs the FDA to make available on their website a list of FDA-
regulated facilities. Importantly, this legislation also will implement
a new system for tracking drugs from the manufacturer to the pharmacy
in an effort to ensure accountability at every step along the way. This
new system will replace the current State tracing laws with a uniform
standard and also will establish nationwide drug serial numbers to
allow for efficient tracing.
While this legislation will not compensate those who have been harmed
or bring back those who we have lost, I am hopeful it will help to
ensure Americans are not faced with a similarly tragic, avoidable
situation in the future. I urge my colleagues to join me in supporting
final passage of this important legislation.
Mr. WARNER. Mr. President, hundreds of people in Virginia were
sickened and 2 died from an outbreak of fungal meningitis last year
that was traced to a single compounding pharmacy in Massachusetts.
Hundreds more in several States became sick, and dozens perished. This
public health crisis highlighted the critical need for better oversight
of pharmacies that are producing compounded drugs.
The Compounding Quality Act and Drug Supply Chain Security Act, which
the Senate will consider for final passage today, includes important
provisions that ensures that patients and providers have access to safe
compounded drugs.
This legislation also includes important provisions that deal with
how to better monitor and track the drug distribution supply chain. It
improves on patient safety by developing a workable pathway that will
ultimately result in tracing for the entire country. Additionally, it
strengthens licensure requirements for wholesale distributions and
third-party logistics providers, and establishes nationwide drug serial
numbers. Finally, this legislation works to address the growing problem
of pharmaceutical theft, counterfeiting and diversion. The Compounding
Quality Act and Drug Supply Chain Security Act is the most significant
piece of legislation on drug distribution supply chain in 25 years.
I am appreciative of Senators Harkin, Alexander, and all members of
the Health, Education, Labor and Pension committees for their tireless
work on putting together these smart, bipartisan provisions which will
help improve the lives of countless Virginians and Americans.
I offer my strong support to the Compounding Quality Act and Drug
Supply Chain Security Act, and encourage its swift passage.
Mrs. FEINSTEIN. Mr. President, I am proud today to support the Drug
Quality and Security Act because it marks an important step forward in
protecting the safety and integrity of our Nation's drug supply.
California has been a leader in addressing this issue and played a key
role in creating a solution.
Patients deserve peace of mind when it comes to purchasing drugs.
When a parent walks into a pharmacy to pick up a prescription for a
sick child, she should be confident that the drugs she is picking up
are safe and have not been tampered with. What is perhaps not known to
many people, however, is that in today's drug supply system, there is
no standard process for oversight to trace drugs through the supply
chain system and make sure they were in the right hands and properly
stored the whole time.
We hear occasionally about infected or counterfeit drugs. These are
shocking stories. Last year, New England Compounding Center, or NECC, a
compounding manufacturer from Framingham, MA, produced contaminated
medicine that sickened over 750 people all across the country. I'm very
sad to say that 64 people have died, needlessly, because of these
contaminated drugs.
A report by the Senate Health, Education, Labor, and Pensions, HELP,
Committee from earlier this year found that NECC was known to produce
drugs that were mislabeled, did not contain the correct dosage of
active ingredients and were made using equipment that was not properly
sterilized.
You might think that a story like this is rare. What we have learned
is that it is not. The report by the HELP Committee found that in the 8
months immediately after the outbreak caused by NECC-manufactured
drugs, 48 other compounding companies were found to be producing drugs
that were either unsafe or were made in unsafe environments.
The problems do not stop with the manufacturers. People often do not
realize that drugs do not usually travel directly from a manufacturer
to a pharmacist. In fact, they may make many stops along the way.
Manufacturers, resellers, wholesalers, distributors--these are some of
the entities that can receive, resell and ship drugs before they get to
the pharmacist or patient. At any time in the delivery process, there
is opportunity for counterfeit drugs to enter the supply chain or real
drugs to be diverted for illegitimate uses.
In 2009, for example, 129,000 vials of insulin were stolen. These
vials later reappeared and were then sold to pharmacies and hospitals.
We do not know who was handling these vials after they were stolen, or
if they were stored under appropriate conditions--a real threat to
patients.
This bill does the following:
First, it establishes a comprehensive, electronic, interoperable
framework for tracing the distribution history of every individual unit
that passes through the drug supply chain. The effect of this part of
the bill is to establish a ``chain of custody'' or ``pedigree'' for
each prescription drug dispensed to patients. Should a drug be
diverted, this ``chain of custody'' will provide important information
to Federal regulators when counterfeit drugs are detected in the supply
chain.
Second, it clearly distinguishes the scope of what constitutes the
traditional pharmacy practice of drug compounding from those, like
NECC, who seek to exploit a patchwork of current Federal laws and
regulations to produce large quantities of unsafe drug products under
the guise of compounding.
I am proud that California has led the Nation in taking real steps to
address the issue of pharmaceutical supply chain safety.
In fact, California passed a law to require more oversight of the
drug supply chain in 2004. Since then, the State Board of Pharmacy and
State legislators have worked together with representatives from
industry to perfect the law.
This action by California has been a key influence in drafting
language on the Federal level. The Board of Pharmacy has provided many
hours of technical assistance and has really been a team player. I
commend the hard work of Chairman Harkin, Ranking Member Alexander, and
his predecessor Senator Enzi, as well as Senators Bennet and Burr and
their staff who have worked tirelessly to bring this legislation to the
finish line. Many stakeholders were involved in drafting this
bipartisan, bicameral solution that addresses the issue of substandard
manufacturing practices and drug supply chain safety.
This is a remarkable step toward improved safety of medicine that
Americans rely on every day.
Mr. BURR. Mr. President, we worked to ensure that the Drug Quality
and
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Security Act achieves a balanced approach to strengthen the safety,
security and accountability of our Nation's pharmaceutical drug supply
chain. This legislation establishes a uniform electronic unit-level
system over the next decade that will increase security and ensure a
safer pharmaceutical drug supply chain from manufacturers to
dispensers. The charitable distribution of prescription drugs from the
manufacturer to patients through patient assistance programs, PAPs, is
a valuable and unique approach to providing American patients access to
critical, lifesaving medicines. As this legislation is implemented, the
varied and unique approaches of PAPs should be taken into consideration
to ensure patients who access needed treatments through these effective
programs are able to continue accessing the prescription drug
medications provided through PAPs.
The PRESIDING OFFICER. Is there further debate? If not, the question
is on passage of the bill.
The bill (H.R. 3204) was passed.
Mr. REID. I ask unanimous consent that the motion to reconsider be
laid upon the table, with no intervening action or debate.
The PRESIDING OFFICER. Without objection, it is so ordered.
Ms. WARREN. Mr. President, today the Senate passed the Drug
Quality and Security Act. I am proud to have worked together with
Chairman Harkin, Ranking Member Alexander, and all of the Senators on
the HELP Committee from both sides of the aisle over several months to
develop this law, which will create commonsense oversight of the
pharmaceutical compounding industry and the pharmaceutical supply
chain.
Some politicians use the word ``regulation'' as if it were a curse.
Certainly no one wants bad regulations or over regulation, but the
impact of failing to regulate when public safety is at risk can be
dangerous and even deadly.
We have an example just how deadly right in front of us--and an
example of what happens when Congress fails to regulate. It starts with
compounding pharmacies.
Compounding pharmacies serve individual patients who need specialized
drugs. Without these customized products, some of our most vulnerable
patients would not be able to get the precisely formulated medications
they need. But customers have no way to evaluate the safety or purity
or cleanliness of the compounded medications they receive. That is what
regulations are for.
For too long, bad actors in this industry have taken advantage of lax
State enforcement and confusion about Federal regulations. The
consequences of too little regulation and too little enforcement were
brought into sharp focus last year when a compounding pharmacy in
Massachusetts, the New England Compounding Center, was identified as
the source of a widespread fungal meningitis outbreak that sickened 751
people and killed 64. I wish NECC were an isolated case, but companies
like it have engaged in shoddy practices for years practices that have
caused sickness and injuries and even death.
There have been many attempts to fix the law and require FDA
oversight in this area. In 2007 Senator Kennedy worked with Senator
Roberts to develop bipartisan legislation that would have addressed
this issue. If that effort had succeeded, we might have been able to
spare many people great suffering. Sixty-four people from just one
incident would probably be alive today. But the industry lobbyists beat
back their efforts. The result? People got sick and people died.
This issue is of particular importance to Massachusetts, and I am
proud to have worked with my colleagues on the HELP Committee
throughout my first year in the Senate to shape earlier versions of
this legislation. Throughout the bipartisan development process and the
public hearings and votes in the HELP Committee, I pushed for a bill
that would subject compounding pharmacies to strong FDA oversight.
Those efforts, and negotiations with the House of Representatives, have
produced the Drug Quality and Security Act. The bill strengthens
current law and establishes tough, new regulations that will keep us
all safer.
The compounding provisions of this bill are not the final word in
what is needed. I believe the FDA should have more authority to inspect
the records of compounding pharmacies, and we have included in the bill
a GAO study that will assess the impact and effectiveness of this new
law and tell us if more work is needed. But this bill is big step
forward in making people safer, so I support it strongly.
This legislation has another feature that will help make drugs safer.
It creates an important new oversight system to ensure we have a secure
supply chain for our pharmaceutical products. Today, we can track a
gallon of milk in the grocery store all the way back to its producer,
but we can't verify the origins of a prescription drug on the shelves
of our pharmacies. Counterfeit or illegally imported drugs can be
integrated into the supply chain, and currently there is no detection
mechanism. This bill ensures that we can trace a particular drug from
its manufacturer all the way to the pharmacy. It will allow consumers
to buy prescription medications with greater confidence that the drugs
are safe, legal, and free of counterfeit or substandard ingredients. It
will allow patients to have greater confidence that the pills in the
bottle from the pharmacy are exactly what their doctors have ordered--
nothing more and nothing less.
I commend my colleagues for stepping up to the challenge and showing
that it is possible for Congress to do what is right--pass commonsense
reforms that protect patients and consumers from harm. This is one of
the basic functions of government: making sure that markets work by
ensuring that no one cuts corners that the customer can't see or that
put someone's family at risk. When all the manufacturers have to follow
the same standards of cleanliness, when all of them have to account for
where they got the chemicals they used in their products, the playing
field is level and the customer is free to make good, independent
decisions. This is how government should work--through actions to
improve public health and public safety through smart, fair, and
reasonable regulations that will improve the lives of all Americans. I
hope that the Drug Quality and Security Act will do just that. I am
proud to support it.
Mr. HARKIN. Mr. President, today, with final passage of the Drug
Quality and Security Act, we have helped to ensure the safety of
compounded drug products and secure the pharmaceutical supply chain. We
have clarified the law governing traditional compounding and created a
new source of high-quality compounded products for hospitals and other
providers who need large volumes of compounded drugs. We have also set
in motion a revolution in the distribution of pharmaceuticals--within a
decade we will know exactly how our drug products travel through the
often-complicated distribution system so that we can identify
counterfeit and adulterated drugs before they get into American
medicine cabinets.
By passing the Drug Quality and Security Act, we have taken an
important step to improve American families' access to lifesaving drugs
and medical devices.
The bipartisan process that produced this bill has been quite
remarkable. I have worked closely with my colleagues on both sides of
the aisle and both sides of the Capitol, 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 would like to extend a special thank you to my colleague, Ranking
Member Alexander. I have been working with Senator Alexander on this
since he became ranking member, and it has been a wonderful and
cooperative partnership. I can honestly say that we would not have
gotten this done without his excellent leadership and wise council. I
thank the Senator.
I also thank all of the HELP Committee members, as well as members
off the committee and their staff, who were thoroughly engaged with
this process from the beginning as part of the bipartisan working
groups. Each of you has contributed significantly to this legislation,
and I am sincerely grateful for your contributions.
On that note, I specifically thank the staff of Ranking Member
Alexander's office. I thank David Cleary, Mary-Sumpter Lapinski, and
Grace Stuntz. I
[[Page S8076]]
also thank Hannah Katch from Senator Franken's staff, Rohini Kosoglu
from Senator Bennet's staff, Jennifer Boyer from Senator Roberts staff,
and Anna Abram and Margaret Coulter from Senator Burr's staff. I know
that they have developed close working relationships with my staff
throughout this process, and I am sincerely grateful for your dedicated
efforts.
I also thank my own staff on the HELP Committee, who have spent many
a night and weekend with Senator Alexander's staff, other member
offices, and our colleagues in the House working to come to consensus
on the critical policy issues in this legislation. I thank Pam Smith,
Jenelle Krishnamoorthy, Elizabeth Jungman, Nathan Brown, Emily
Schlichting, Allison Preiss, Kate Frischmann, Abraham White, Jim
Whitmire, Chung Shek, Frank Zhang and Evan Griffis.
We would be remiss if we did not also thank the Congressional Budget
Office for their knowledgeable and capable team that dedicated many
hours to estimating the budgetary effects of this legislation. Finally,
we owe an enormous debt of gratitude to the staff members in the
Legislative Counsel's Office--specifically Kim Tamber, Stacy Kern-
Sheerer, and Bill Baird. They, too, worked long hours, nights, and
weekends to assist my staff in drafting this legislation and working
out technical issues.
This bill's final passage is a victory for the millions of Americans
who need safe medicines--a victory that would not have been possible
without the dedicated work of our Senate family. I thank you all for
your extraordinary public service.
Welcoming Back Senator Inhofe
Mr. REID. Mr. President, I see our friend here who has returned from
his surgery and the death of his son, if he wishes to say something
before I complete my remarks.
Mr. INHOFE. Mr. President, the majority leader should go ahead. My
remarks will be longer.
Mr. REID. Mr. President, through the Chair to the senior Senator from
Oklahoma, we are glad to have him back. We all empathize with something
only a parent can understand. I am grateful to him for the example he
sets for all of us.
Schedule
Mr. President, we are going to be in a period of morning business
until 5 o'clock today. Following morning business, the Senate will
proceed to executive session to consider the nomination of Robert
Wilkins to be U.S. Circuit judge for the DC Circuit. At 5:30, there
will be up to two rollcall votes, including cloture on the Wilkins
nomination. If cloture is not invoked, there will be a second cloture
vote on the Defense authorization bill.
Nominations
Mr. REID. Mr. President, today the Senate will consider yet another
qualified nominee to be a DC Circuit Court of Appeals judge, considered
by many to be the second highest court in all the land.
It is troubling that Senate Republicans, for the fourth time this
year, appear poised to reject an exceedingly capable nominee to this
court for blatantly political reasons. Republicans have blocked three
highly qualified female DC Circuit nominees in a row: Caitlin Halligan,
Patricia Millett, and Nina Pillard. Today they are expected to block
confirmation of District Judge Robert Wilkins, an extremely competent
and experienced nominee and one who has bipartisan support. I say that
because no one has questioned his qualifications or abilities;
likewise, no Senator objected to the qualifications of Ms. Halligan,
Ms. Millett or Ms. Pillard. Instead, Republicans have blocked these
nominees solely to deny President Obama his constitutional right to
appoint judges.
In years passed, my Republican colleagues agreed to block judicial
nominees only in ``extraordinary circumstances.'' These are their
words, not mine.
In 2005, the senior Senator from South Carolina Lindsey Graham
defined extraordinary circumstances for the benefit of this body. Being
a highly qualified trial lawyer, I think he is qualified to respond and
set this definition that we all agreed with. Here is what he said:
Ideological attacks are not an ``extraordinary
circumstance.'' To me, it would have to be a character
problem, an ethics problem, some allegation about the
qualifications of a person, not an ideological bent.
No Senator--I repeat, no Senator--has questioned the character,
ethics, or qualifications of these three women that have already been
rejected for the DC Circuit. No one has questioned the character,
ethics or qualifications of Judge Wilkins. So I am frustrated that
Republicans would once again filibuster such a highly qualified
nominee--a nominee so highly qualified, in fact, that he was confirmed
3 years ago by voice vote to become a district court judge.
Judge Wilkins is an Indiana native who graduated cum laude with a
degree in chemical engineering, and then he got a law degree from
Harvard Law School. He has worked as a staff attorney for the DC Public
Defender Service. He was a partner specializing in white-collar
defense, intellectual property, and complex civil litigation at the
private law firm of Venable. That is an outstanding law firm with
lawyers all over the country.
Judge Wilkins also helped shine a national spotlight on national
profiling when he brought a landmark lawsuit against the Maryland State
Police in 1992 after he and three family members were stopped and
searched. Why? Because they were African Americans. It is landmark
litigation.
This nominee has a bright legal mind and a remarkable dedication to
the rule of law. Under normal circumstances, such as the circumstances
of his 2010 confirmation, he would be quickly confirmed, but now he
faces a Republican filibuster. Unfortunately, the type of Republican
obstruction we face today has become quite commonplace. President
Obama's circuit court nominees, including nominees for the vital DC
Circuit, have waited seven times longer than those nominated by
President Bush.
Republicans claim they are blocking nominees to this crucial court
because the court is underworked and doesn't need to fill its
complement of judges. Republicans also claim that filling these three
vacancies would amount to court packing. That is absurd on its face. My
Republican colleagues were happy to confirm four Bush nominees to this
court. In fact, 15 of the last 19 to the DC Circuit were appointed by
Republican presidents. Appointing judges to fill vacant judicial seats
is not court packing, it is the President's right as well as his duty.
I do not ask Republican Senators to support President Obama's
nominees or even that they vote for them, but it is right and proper
that they should give President Obama's nominees the same fair
consideration afforded the nominees that came before them.
Reservation of Leader Time
Would the Chair announce the business of the day.
The PRESIDING OFFICER. Under the previous order, the leadership time
is reserved.
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