Moving at unusual speed, the House of Representatives on Saturday (28 September 2013) voted to pass the Drug Quality and Security Act (DQSA), a piece of legislation that would overhaul the regulation of pharmaceutical compounding and institute a new track and trace system to better secure the pharmaceutical supply chain.
The most recent iteration of the legislation emerged on 25 September 2013, reflecting a bipartisan consensus and a blend of language from previous iterations of related bills introduced in the House and Senate.
For a background primer on the legislation, please see Focus' 26 September 2013 story, "New Legislative Draft Mixes Congressional Approaches on Compounding, Track and Trace."
The legislation may be found online here.
The bill's pharmaceutical compounding elements received a mixed reaction from industry and public interest groups, even those representing similar interests.
The National Community Pharmacists Association (NCPA), for example, endorsed the bill and urged its immediate passage, saying it would strike a balance between preserving patient access to compounded medications while "taking steps to enhance protections" against some of the industry's most nefarious practices.
NCPA said it was particularly encouraged by the creation of a new, voluntary "outsourcing facility" registration category which would exempt some compounders from existing regulations under Section 502(F)(1), 505 and 582 of the Federal Food, Drug and Cosmetic Act.
IACP: Definitions Insufficient
However, a similar group, the International Academy of Compounding Pharmacists (IACP), called the bill flawed, saying its lack of "key definitions to govern compounding practice" reflected a failure by legislators to listen to the group's concerns.
"This bill, in its failure to recognize the very real problems in the draft legislation that we have identified over many meetings, will without question result in patients' inability to obtain access to needed medications," said David Miller, CEO of IACP. "This bill will not further the safety of compounded medication, which was its only purpose."
Miller said the terms "office use," "anticipatory compounding" and "outsourcing facility" were insufficiently defined in the bill. In addition, IACP took issue with the bill granting to FDA what it called "sweeping, unprecedented authority in determining what pharmacies can compound."
Public Citizen: Bill Makes Existing Problem Worse
A third group, Public Citizen, also criticized the bill, calling it insufficient to improve federal oversight over pharmaceutical compounders. In a statement, Public Citizen argued FDA already has the authority necessary to go after compounders, but has failed to exercise this authority.
"The FDA can do more to prevent another NECC-like disaster by being more aggressive in enforcing existing law," the group wrote. "Congress also can help by passing a law that clarifies the line between drug manufacturing and compounding, and does other important things like requiring warning labels for compounded drugs, and giving the FDA authority to inspect pharmacy records."
Public Citizen said the bill failed to implement any of the aforementioned recommendations, and instead "preserves the provisions that compounding pharmacies have abused under existing law and lax FDA oversight, and that they have used to produce unproven, unsafe drugs."
Public Citizen also cried foul at the "outsourcing facilities" section of the bill, saying it would allow compounders to mass-produce drug products without first obtaining FDA approval. "This kind of large-scale production is not compounding; it is drug manufacturing, and it is illegal under current law," the group claimed.
Despite industry pushback, the bill passed on 28 September 2013 in the House of Representatives via a voice vote. Some industry observers said the legislation's passage was unusual given both its recent introduction and the myriad of issues Congress is currently grappling with. If Congress fails to pass a budget by 30 September 2013-a scenario that now seems increasingly plausible, if not likely-nearly half of FDA staff will be furloughed until a budget can be passed.
"With the passage of this bill, the FDA will have the authority it needs, but we have to also make sure that they have the fortitude to take action on any compounding pharmacy that they see not up to the high level of standards the FDA sets, that all citizens expect," said Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA) in a statement. "[In] all cases the FDA will have the authority to make sure they have the inspections and they have the team that can go in there and take solid action when these centers do not adhere to those high standards."
"I hope the passage of the Drug Quality and Security Act will usher in a new day of accountability," added Rep. Michael Burgess (R-TX).