On September 28 as the budget crisis loomed, the House of Representatives passed the Drug Quality and Security Act by a voice vote. At a time when the two sides seem bitterly opposed, the Senate and House committees reached a consensus on this much-needed legislation. The bill is a 2-part bill, setting out guidelines for the safety of compounded drugs and outlining a new pharmaceutical supply chain. The need for this legislation was brought to focus after the 2012 meningitis outbreak, linked to medications manufactured at the New England Compounding Center (NECC).
The Senate has not passed the bill and as the budget battle (i.e., federal shutdown) continues, with the debt ceiling debate looming, it is uncertain when this bill will be taken up in the Senate. The voice vote and the bipartisan support for this bill should ensure its passing in the Senate. But in today’s political climate we can not trust that anything is working smoothly in our government.
This legislation is essential to the health and safety of the American public. As the number of compounding pharmacies has grown in the US, the FDA has been struggling to monitor manufacturing conditions and ensure safety standards. To date 64 people have died as a result of the NECC’s manufacturing practices. And, although H.R. 3204 is a good first step it contains a weak point that will allow these gigantic compounding warehouses to continue practice as usual. As noted in the Senate press release, “ Compounders who wish to practice outside the scope of traditional pharmacy practice can register as outsourcing facilities…”
Registration is not mandatory. Compounders ‘can’ register or they ‘can’ opt out. The onus will be on purchasers of these compounding medications to identify the facilities that have registered with the FDA, implying a higher standard of manufacturing. A doctor or hospital will have to go to the FDA list of registered manufacturers if they want to order medications from compounding companies that are willingly complying with FDA standards.
The compounders who do register will be listed as outsourcing facilities and will be subject to the same FDA oversight as traditional pharmacies. The Government Accountability Office (GAO) has weighed in, saying that more legislation is needed to clarify exactly how the U.S. Food and Drug Administration (FDA) will carry out oversight of these large-scale drug compounders. The nonpartisan office wrote that “this lack of consensus and differing FDA authority to oversee compounded drugs across the country has resulted in gaps in oversight of drug compounding,” poses a grave threat to public health.
The second component of H.R. 3204, the Drug Quality and Security Act, is the Drug Supply Chain Security Act. Introduced by Senator Bennet, the bill requires tracking distribution across all sectors—manufacturers, distributors and the dispensers of compounding medications. It also deals with licensure requirements and, over a four-year period, will require nationwide drug serial numbers.
The Energy and Commerce Committee released a statement on September 25, announcing the bipartisan legislation, “The bill will correct the constitutional defect in FDA’s drug compounding statute that has wreaked havoc on the Agency’s ability to effectively enforce the law for years. It will also give FDA the opportunity to have broad oversight of a new category of large compounding pharmacies. This is undoubtedly a step forward for public health. Further, we have developed a uniform system for tracking and tracing drugs to prevent counterfeits from entering the supply chain that maintains the strengths of the groundbreaking California system.”
This is a much-needed piece of legislation. Let’s hope that the current mess in Congress can be straightened out soon so that our elected representatives can get to work doing the work of the people, which includes, as a primary objective, keeping us as safe as possible.
The Senate Press Release LINK: http://www.help.senate.gov/newsroom/press/release/?id=85b2c80c-4f49-4e61-b5e2-be14ac326877
Energy and Commerce Committee Fact Sheet: H.R. 3204 Link: http://energycommerce.house.gov/fact-sheet/hr-3204-drug-quality-and-security-act