Drug Quality and Security Act

Floor Speech

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 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.

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