[Congressional Record (Bound Edition), Volume 159 (2013), Part 12]
[Senate]
[Pages 17106-17107]
[From the U.S. Government Publishing Office, www.gpo.gov]




                     DRUG QUALITY AND SECURITY ACT

  Mr. ROBERTS. Mr. President, I come to the floor today to speak in 
support of the Drug Quality and Security Act, H.R. 3204. Getting this 
bill to where it is today--and I thank the leader for just making that 
possible, along with our minority leader--has been a long and sometimes 
very difficult road, one on which I have been working for over a 
decade--yes, 10 years.
  This is an issue that hit far too close to home in Kansas. Several 
years ago, a pharmacist in Kansas City, Robert Courtney, was found to 
be diluting cancer drugs for his patients. Unfortunately, over 4,000 
patients were affected before authorities could stop him. Senator Kit 
Bond at that time and myself worked together to hold the first Health, 
Education, Labor and Pensions Committee hearing on pharmacy 
compounding.
  Since that time I have continued my interest in the compounding-
related issues. Unfortunately, last September, over a year ago, the 
tragic meningitis outbreak began. This outbreak was the result of 
contaminated compounded medications produced by the New England 
Compounding Center.
  Of the 751 people who became ill, 64 people lost their lives. Many of 
those who became ill are still suffering and have experienced painful 
relapses in their condition. Unfortunately, that is not the only 
occurrence in the last 10 years. Without proper safeguards and clear 
authority, I fear that these tragedies would only continue.
  We acknowledged then that we had to buckle down and really get 
something done. Since that time, I have been working with my colleagues 
to draft the pending legislation before this body, the Drug Quality and 
Security Act, with the desire to protect patients and improve 
regulation of the pharmacy compounding industry.
  I think that we have finally achieved what we all intended from the 
beginning, which is a bipartisan, bicameral product that is supported 
by a majority of the stakeholder groups and a variety of those groups. 
This legislation has the support of the pharmacists led by the National 
Community Pharmacists Association and the American Pharmacists 
Association. It has the support of the patient advocacy groups such as 
the Cancer Leadership Council and of industry groups such as the 
Pharmaceutical Distribution Security Alliance. In fact, this is quite a 
long list. I will not take the Senate's time to go over that list. But 
I would ask unanimous consent that this list be printed in the Record 
at this point in its entirety.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

         Supporters of H.R. 3204--Drug Quality and Security Act

       Abbvie (PDSA), Academy of Nutrition and Dietetics, Actavis 
     (PDSA), Allergy and Asthma Network Mothers of Asthmatics, 
     American Medical Student Association, American Pharmacists 
     Association, American Public Health Association, American 
     Society for Radiation Oncology (CLC), American Society for 
     Reproductive Medicine, American Society of Clinical Oncology 
     (CLC), American Society of Health System Pharmacists, 
     American Women's Medical Association, AmerisourceBergen 
     (PDSA), Annie Appleseed Foundation.
       Association of State and Territorial Health Officials, 
     AstraZeneca (PDSA), Bayer (PDSA), Biotechnology Industry 
     Organization (PDSA), Bladder Cancer Advocacy Network (CLC), 
     Blue Ribbon Advocacy Alliance, Boehringer Ingelheim (PDSA), 
     Cancer Action Network (CLC), Cancer Leadership Council (CLC), 
     Cancer Support Community (CLC), CancerCare (CLC), CAPS--
     Central Admixture Pharmacy Services, Cardinal Health, 
     Caregiver Action Network.
       Center for Medical Consumers, Center for Science and 
     Democracy, Union of Concerned Scientists, Chamber of Commerce 
     of the United States of America, The Children's Cause for 
     Cancer Advocacy (CLC), Community Catalyst, Connecticut Center 
     for Patient Safety, Covectra, CreakyJoints.org, DSC/HC 
     (PDSA), EMD Serono, Federation of American Hospitals, Fight 
     Colorectal Cancer (CLC), Friends of Cancer Research, Generic 
     Pharmaceutical Manufacturers Association (PDSA).
       Genentech (PDSA), Global Healthy Living Foundation, Grifols 
     (PDSA), Healthcare Distribution Management Association (Big 
     Drug Wholesalers) (PDSA), HIDA (PDSA), Institute for Nurse 
     Practitioner Excellence, International Myeloma Foundation 
     (CLC), International Warehouse Logistics Association (PDSA), 
     Johnson and Johnson (PDSA), Kidney Cancer Association (CLC), 
     Eli Lilly (PDSA), The Leukemia & Lymphoma Society (CLC), 
     LIVESTRONG Foundation (CLC).
       Lymphoma Research Foundation (CLC), McKesson Corporation, 
     MD Support, Medline (PDSA), Men's Health Network, Merck 
     (PDSA), Mylan (PDSA), National Association of Chain Drug 
     Stores (PDSA), National Association of County and City Health 
     Officials, National Coalition for Cancer Survivorship (CLC), 
     National Community Pharmacists Association (PDSA), National 
     Lung Cancer Partnership (CLC).
       National Patient Advocate Foundation (CLC), North American 
     Menopause Society, Novartis (PDSA), Ovarian Cancer National 
     Alliance (CLC), Pancreatic Cancer Action Network (CLC), 
     Perrigo (PDSA), Pfizer (PDSA), Pharmaceutical Distribution 
     Security Alliance, Pharmedium, PhRMA (PDSA), Premier 
     Healthcare Alliance, Prevent Cancer Foundation (CLC), 
     Prostate Cancer Education and Support Network (CLC), Richie's 
     Specialty Pharmacy, Sarcoma Foundation of America (CLC), 
     Society for Women's Health Research, StopAfib.org, Susan G. 
     Komen Advocacy Alliance (CLC), Takeda (PDSA), Tennessee 
     Pharmacists Association, Terri Lewis, Meningitis Outbreak FB 
     Community Manager, The Pew Charitable Trusts, Trust for 
     America's Health, UPS (PDSA), Us TOO International (CLC), 
     Walgreens (PDSA).

  Mr. ROBERTS. Title I of the Drug Quality and Security Act addresses 
the oversight of compounding pharmacies, and Title II provides a 
mechanism for securing our pharmaceutical drug supply chain. Together, 
we are making patients safer and ensuring that they can better trust 
the drugs that they take.
  This took a significant amount of time and effort. I especially thank 
Chairman Harkin, Ranking Member Alexander, Senators Burr, Bennett, and 
Franken for sticking with it. This is a true bipartisan effort. 
Personally, I thank my staffer Jennifer Boyer for her determined 
dedication and the many hours of work to get this job done.
  In September, with the leadership of Mr. Upton and Mr. Waxman in the 
other body, this legislation was passed by the House by a voice vote. I 
am hoping we can see a similar outcome in the Senate. I urge my 
colleagues to support this legislation and encourage its swift passage 
and the signature by the President of the United States.
  I yield the floor.
  Ms. MIKULSKI. Mr. President, I am here today to talk about the Drug 
Quality and Security Act. This legislation does two things. First, it 
improves the regulation of compounding pharmacies, and second, it 
strengthens the security of our drug supply chain. This legislation has 
been in the works for quite a while and I am so pleased that the HELP 
Committee came together on a bipartisan basis and put together 
legislation that will truly save lives--across the country and in my 
home State of Maryland.
  This bill has been through regular order. We had multiple hearings in 
the HELP committee, we had working groups, of which I was a member, and 
we held a bipartisan markup. Our counterparts in the House did the 
same. And here we are today. This bill has passed the House and it is 
my hope that it will pass the Senate and be signed into law by the 
President.
  Let me first talk about the Compounding Quality Title of the bill and 
why it is so important. Last year, our Nation was devastated by a 
meningitis outbreak that sickened 751 people and killed 64 people. In 
Maryland, 26 people fell ill and 3 people died. As the HELP Committee 
looked into this outbreak, we quickly learned two things. First, these 
illnesses and deaths were caused by contaminated compounded drugs from 
the New England Compounding Center, NECC, located in Massachusetts. And 
second, these illnesses and deaths were entirely preventable.
  Hospitals, doctors, and patients are increasingly relying upon 
compounded drugs, which are supposed to be made on an individual basis 
to respond to a patient's unique health needs. For instance, if a 
patient is allergic to a certain ingredient in a drug, a compounding 
pharmacy can make the drug without that ingredient. Or if a child needs 
a smaller dosage strength, a compounding pharmacy can do that.

[[Page 17107]]

Today, 1 to 3 percent of the U.S. prescription drug market is made up 
of compounded drugs.
  But the problem we have is twofold. The first problem is that where 
there is need, there is greed. Compounded drugs are supposed to be made 
on an individual basis for an individual patient and provided only with 
a prescription from a doctor. What the HELP Committee learned was that 
certain compounding facilities were blatantly and flagrantly violating 
these rules. Not only was NECC mass producing drugs and dispensing them 
across State lines without prescriptions, NECC also knowingly 
disregarded sterility tests and prepared drugs in unsanitary 
conditions. And why? To make a profit.
  The second problem is that our existing regulatory framework is 
insufficient. NECC made drugs in unsanitary conditions, mass produced 
drugs, and provided medicines without prescriptions. And our regulatory 
framework was ill-designed to catch problems and prevent the outbreak.
  We cannot undo the tragedy caused by NECC's actions, but we can and 
must find a way to prevent this from happening again, and that is where 
this legislation comes into play. The bill before us makes two major 
changes, which will help prevent another NECC-like tragedy. First, it 
gives the FDA the authority to regulate large-scale compounding 
pharmacies. Compounders who wish to make large volumes of these drugs 
will be regulated by FDA, will be required to register with FDA, will 
be required to report adverse events to FDA, and will be subject to 
risk-based inspections by FDA. Smaller traditional compounding 
pharmacies will continue to be regulated by State boards of pharmacy.
  Second, this legislation will ensure that patients and providers have 
better information about compounded drugs. The FDA will post online a 
list of compounding facilities they regulate, detailed labeling will be 
required on compounded drugs, and false and misleading advertising will 
be prohibited.
  Let me now talk about the Drug Supply Chain Security Title of the 
bill. This deals with all drugs, not just compounded drugs. Today, we 
have a patchwork of 50 different State laws that govern drug 
distribution in our 50 different States. What this means is that if we 
become aware of a contaminated drug in our supply chain, there is no 
uniform way to track that drug back to its source and get it off the 
market quickly.
  This bill will improve patient safety by replacing today's patchwork 
of product tracing laws with a strong, uniform standard that will 
ultimately lead to an electronic, interoperable product tracing system 
for the entire country. This is commonsense legislation that has been 
long in the making.
  These issues are particularly important to me, not only because 
ensuring the safety of our Nation's drug supply is of the utmost 
importance but also because I have the distinct honor of representing 
Maryland, which is home to the FDA.
  The FDA is our Federal agency tasked with ensuring the safety of our 
Nation's drugs, through the more than 14,000 dedicated, talented, 
hardworking employees who work there. Fifty-five percent of FDA's 
employees were furloughed during the recent government shutdown. I 
would like to take this opportunity to remind my colleagues why the 
work that the FDA does is so important. If we want our drugs to be 
safe, if we want our food to be safe, if we want our medical devices to 
be safe, we cannot furlough our FDA staff and we cannot pursue cuts to 
FDA in coming years.
  This bill was done the right way. We had hearings, markups, and 
working groups in both the House and Senate and we had input from both 
Republicans and Democrats. I want to thank Chairman Harkin and Ranking 
Member Alexander for all of their work to get us here. I urge my 
colleagues to support this bill, which will improve drug safety and 
save lives.
  Mr. COBURN. Mr. President, it has now been about 1 year since the 
fungal meningitis outbreak last fall associated with the tainted 
sterile compounded drugs from the New England Compounding Center. This 
week on the floor of the Senate, we have a bill that is, in many 
senses, Congress's response to the lack of policy clarity that many 
have suggested failed to prevent that tragedy.
  As I have watched the Senators and their staff who have been working 
on this bill over the past several months, I applaud the bipartisan 
manner they have used in creating legislation that could help prevent 
similar tragedies in the future.
  I am planning on voting for this legislation because I do think 
Congress needs to legislate. The courts have not been clear. However, I 
want to note that, despite the strong bipartisan collaboration, this 
legislation leaves some regulatory oversight concerns outstanding that 
I want to comment on and make clear today.
  There has been a lot of concern that by reaffirming section 503(a) of 
the Food, Drug and Cosmetic Act, office use of compounded drugs is not 
recognized as permissible compounding activity. Therefore, I want to 
make clear that this legislation does not change current State law or 
authority over the dispensing or distribution of medications by 
pharmacists, compounded or manufactured, for a prescriber's 
administration to or treatment of a patient within their practice.
  Currently, the compounding and dispensing of prescription drugs for 
in-office administration by a prescriber to their patient is governed 
by State boards of pharmacy, and States have determined what is best 
for their State regarding office use. In fact, more than 40 States have 
passed laws over the last 15 years related to current practices of 
using compounded drugs in the office context.
  The issue of office use, indeed all of pharmacy practice regulation, 
is best left to the States. So the omission of office use from 503(a) 
should not signal to the FDA that it has the authority to encroach upon 
State authority to regulate office use.
  In addition, there have been concerns whether the provisions within 
the legislation that grant authority to the FDA to set up systems of 
procedure for the direct communication between State boards of pharmacy 
and the FDA will give FDA more authority over compounded prescriptions 
shipped across State lines. I want to also take this opportunity to 
make clear that these provisions within the legislation require 
``appropriate investigation'' on complaints and other issues that arise 
by the FDA and in no way provide some new expansive authority to the 
FDA to restrict interstate commerce or regulate intrastate commerce.
  Finally, the legislation does not change the ability of 
ophthalmologists to administer drugs in their office to individual 
patients for the purposes of reducing macular degeneration. Under this 
legislation, physicians retain the ability to use compounding drugs in 
their office for their patients. This is a practice-of-medicine issue, 
so the art and science of medicine should not be impeded by the FDA.
  I will continue to monitor the implementation of section 503(A) in 
consultation with physicians, medical professionals, and pharmacy 
professionals. I also strongly encourage the FDA to ensure that these 
provisions are not used to restrict office use and restrict interstate 
sales of compounded pharmaceuticals within all applicable laws and 
regulations.
  I suggest the absence of a quorum.
  The PRESIDING OFFICER (Ms. Baldwin.) The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. REID. Madam President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.

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