[Congressional Record (Bound Edition), Volume 159 (2013), Part 12]
[Senate]
[Pages 17220-17225]
[From the U.S. 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withdrawn, the pending motion and amendments be withdrawn, and the 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.
  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.

[[Page 17221]]

  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, 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

[[Page 17222]]

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 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

[[Page 17223]]

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 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

[[Page 17224]]

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 of 
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 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

[[Page 17225]]

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 D.C. 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. President, today the Senate will consider yet another qualified 
nominee to be a D.C. 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 D.C. 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 D.C. 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 D.C. 
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 D.C. 
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 D.C. 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.

                          ____________________