[Congressional Record (Bound Edition), Volume 159 (2013), Part 12]
[Senate]
[Pages 16916-16917]
[From the U.S. Government Publishing Office, www.gpo.gov]




                     DRUG QUALITY AND SECURITY ACT

  Mr. MARKEY. Madam President, I wish to begin by thanking Chairman 
Harkin, Ranking Member Alexander, Senators Franken and Roberts, and all 
of their staffs for their tremendous leadership on this bill. This bill 
was also developed in concert with our counterparts in the House of 
Representatives. I extend my thanks to ranking member Henry Waxman and 
chairman Fred Upton and their staffs of the Energy and Commerce 
Committee. What we have now is a bipartisan, bicameral bill that 
addresses two very serious issues: the safety of compounded drugs and 
the security of our entire drug supply.
  Last fall an outbreak of fungal meningitis stunned the Nation and 
thus far has claimed the lives of 64 people and has sickened 751 in 20 
States. This issue hits home for me because it started in 
Massachusetts. At the center of this tragedy was the New England 
Compounding Center, also known as NECC. It is located in Framingham, 
MA. I met some of the victims of this terrible outbreak and heard about 
their struggles, people like Jerry Cohen, a resident of Pikesville, MD, 
who went to the doctor for routine steroid injections to treat 
recurring back pain and received two doses that came from the 
contaminated lots. Jerry suffered a stroke and had to adjust to a new 
life, dealing with dizziness, nausea, weakness, and exhaustion. Melanie 
Norwood's mother Marjorie went into a Tennessee hospital to treat an 
acute back injury she suffered while mowing the lawn. Instead of 
walking out of the hospital, Marjorie became severely sick, spent 
months in the hospital and a nursing home, and now has permanent nerve 
damage and medical bills that are close to putting her into bankruptcy.
  For the last decade complaints about sterility, safety, lack of valid 
prescriptions, and mass production of drugs have been lodged against 
NECC. Yet the company was allowed to continue operating largely 
unchecked, falling between the regulatory checks that exist between 
Federal oversight of drug

[[Page 16917]]

manufacturers and State oversight of pharmacies.
  Sadly, NECC was not an isolated instance. Almost a year ago I issued 
a report detailing more than a decade of violations and problems at 
compounding pharmacies all across our Nation. Contaminated IV 
solutions, tainted steroid injections, and fouled eyedrops permanently 
impacted thousands of patients' lives across this country and killed or 
injured dozens across 34 States. The New England Compounding Center, 
like many large compounding facilities, fell into a regulatory black 
hole. That is because there are two kinds of compounding pharmacies: 
the neighborhood pharmacist you have known and trusted for years and 
the large drug manufacturers operating in the shadows that have slipped 
through the regulatory cracks.
  Traditional compounding pharmacies make custom medication that fits 
the needs of an individual patient, such as creating a liquid 
medication instead of a pill for an elderly patient or a child because 
it is easier to swallow. We are familiar with that corner-store 
pharmacist who does that for a patient. These pharmacies are an 
important tool in our medical arsenal and have historically fallen 
under the jurisdiction of the States. They are the corner pharmacies 
that people grew up with. They are the corner pharmacies that people 
trust.
  But there has been a recent disturbing trend of larger compounding 
pharmacies entering the market, making high-risk drugs sold to 
hospitals and clinics throughout the country. These compounding 
facilities are operating more as modern-day drug manufacturers rather 
than the mortar-and-pestle compounders of yesteryear on the corner near 
your home. They are not on Main Street, and they do most of their 
business out of site and under the FDA's radar.
  In 1997 Congress passed a law to define FDA's role in the oversight 
of compounding pharmacies, but just 2 days before the new law was to 
take effect seven compounding pharmacies sued to block its enactment. 
Since then, the law and the FDA's authority to regulate compounding 
pharmacies have been mired in litigation and uncertainty. The result is 
that oversight of even large-scale drug manufacturers, such as NECC, 
has been largely relegated to the States.
  How are the States doing their job? Well, last April I issued an 
investigative report that took a deep look at how States actually 
oversee and govern the activities of compounding pharmacies. What I 
found was a regulatory state of disarray. My investigation found that 
nationwide most State regulators did not look at the safety of 
compounding pharmacies. They do not make all their activities and 
investigations public. Some of them did not even know how many 
compounding pharmacies exist in their State, and States typically are 
not equipped to regulate the safety of large companies shipping massive 
quantities of drugs outside their own borders into States all across 
our country.
  Since the NECC outbreak, some States have made efforts to improve 
their regulations and guidelines over compounding pharmacies, but the 
results are not consistent. Within the last month my home State of 
Massachusetts passed through its house and senate a bill that I am 
proud to say will put in place the strongest State regulations in the 
country overseeing the compounding pharmacy industry. However, while 
Massachusetts has become a national leader in the oversight of 
compounding pharmacies in the aftermath of what happened at NECC, this 
does little to protect the residents of other States. It cannot protect 
residents of Massachusetts from drugs that are shipped in from other 
States that do not have strong safety standards in place.
  The Drug Safety and Security Act in front of us today helps to solve 
that problem by creating for the first time a national and uniform set 
of rules for compounding pharmacies that wish to register with the FDA 
and be subject to FDA oversight and enforcement. The bill also provides 
transparency by requiring the FDA to publish a list of the name and 
location of registered facilities that are compounding drugs in large 
quantities without a prescription. The Drug Safety and Security Act 
also mirrors several concepts from the VALID Compounding Act of 2013, 
legislation which I introduced in the House of Representatives. The 
bill distinguishes between compounders engaging in traditional pharmacy 
work and those making large volumes of compounded drugs without 
individual prescriptions. It places limits on the types and quality of 
ingredients that can be used to compound drugs. It ensures that drugs 
removed for the market for safety and effectiveness reasons are not 
compounded. The bill requires reporting of adverse events, such as 
patient sickness or hospitalizations that could be caused by 
compounding pharmacies that are registered with the FDA. It provides 
more information on the label of compounded drugs, including 
identification of the drug as being compounded--the first time ever 
that this information will be required.
  Because of this bill, for the first time ever, the FDA will know who 
these large sterile compounding entities are and what they are making. 
The FDA will be given the resources it needs to conduct inspections of 
those facilities. For the first time ever, hospitals and health care 
facilities will have the option of purchasing compounded drugs that are 
subject to rigorous FDA quality standards and oversight. Because this 
bill removes the legal ambiguities of existing law, compounding 
pharmacies will no longer fly under the radar. This bill will go a long 
way in ensuring that public health is protected and compounded drugs 
are safe.
  I specifically thank Chairman Harkin and his staff for including in 
this bill a provision that I authored requiring the GAO to examine 
whether States and Federal authorities are doing their jobs to properly 
ensure the safety of compounded drugs.
  Congress needs to continue to keep a close eye on the FDA and this 
industry, holding them accountable for their new responsibilities. This 
study will assist us in carrying out effective oversight of this new 
law. We need to ensure that a tragedy like the NECC meningitis outbreak 
is never repeated.
  With the passage of the Drug Safety and Security Act, today we have a 
clear example of what Congress can accomplish when both sides come 
together in a bipartisan fashion. We can protect the public, we can 
hold industry to high but achievable standards, and we can support 
small businesses that have been doing the right thing for years.
  This is a very important, historic piece of legislation. It goes 
right to the heart of what Congress can do to make sure that when drugs 
are in interstate commerce, we are protecting people so that the health 
of their families is, in fact, being protected. That is the essence of 
what Congress should be doing.
  It is a very good day when Congress is working to protect the people 
of our country. Today is one of those days. Throughout the course of 
this week we are going to have a discussion about the role the Federal 
Government has to play in ensuring that the drugs which families in our 
country use are, in fact, safe for their consumption, that the 
representations that are made to those families are accurate. We cannot 
accept a rollback of the protections, which did happen in this area. 
That exposed families to the kinds of risks that generations ago were 
common within our country. It is a big day. It is a historic piece of 
legislation. I urge its unanimous passage through this body.
  I yield the floor and suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. BLUNT. 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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