[Congressional Record Volume 159, Number 162 (Thursday, November 14, 2013)]
[Senate]
[Pages S8027-S8029]
From the Congressional Record Online through the 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.
[[Page S8028]]
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. 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
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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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