A new report just published by the Government Accountability Office (GAO) confirms what US Food and Drug Administration (FDA) officials have long argued: They simply don't have sufficient authority to regulate compounding pharmacies with the same level of vigor as they do traditional pharmaceutical manufacturers.
In the waning months of 2012, a massive outbreak of fungal meningitis was linked to supposedly sterile versions of methylprednisone acetate manufactured by the New England Compounding Pharmacy, a pharmaceutical compounder based in Massachusetts. An inspection of that facility by FDA would unveil horrific violations, including "white, filamentous substances," green residue in manufacturing hoods, and fungal growth in vials stored at the facility.
In the wake of the outbreak, legislators in both the House and Senate hauled several FDA officials before committees and subjected them to testy hearings, demanding to know why FDA didn't act to shut NECC and facilities like it down sooner.
FDA Commissioner Margaret Hamburg's response: The agency simply doesn't have clear authority to inspect those firms or shut them down thanks to conflicting judicial precedents, a lack of resources and a paucity of legislative authority. While some legislators seemed swayed by this argument, others-mostly Republican members of the House Energy and Commerce Committee-said FDA had all the authority it needed to go after the compounders, even if it would have been more difficult than regulators would have liked.
GAO Report: FDA Correct
That tension between FDA's argument (we need more authority) and legislators (you have the authority, now use it) has continued to simmer over the last several months as subsequent hearings have continued to explore possible solutions in the form of legislation.
Now the Government Accountability Office (GAO) report is giving FDA's argument more firepower, concluding that "the authority of FDA…to oversee drug compounding is unclear."
Citing FDA's argument regarding differing judicial interpretations, the report notes that instead of being able to simply inspect compounding facilities, it now needs to obtain warrants to inspect facilities as the result of several court cases, giving those facilities ample time to hide evidence.
In addition, FDA's resource constraints are also identified in the report, which notes that the agency "lacks timely and reliable information to oversee the entities that compound drugs." Hamburg has floated the idea of requiring compounders to pay user fees to FDA to permit greater inspection resources to go into oversight-an idea that has received a positive response in both the House and Senate.
Unlike some GAO reports, this one makes only minor recommendations as to how to solve the identified problems, saying that FDA needs to:
- take steps to consistently collect reliable and timely information in FDA's existing databases on inspections and enforcement actions associated with compounded drugs
- clearly differentiate in FDA's database, those manufacturers of FDA-approved drugs that FDA inspects for compliance with good manufacturing practices from those entities compounding drugs that are not FDA-approved and that FDA does not routinely inspect
Congress, meanwhile, was instructed to "help ensure appropriate oversight of the safety of [compounded products]."
The relatively sparse recommendations-two paragraphs buried within the 50-page report-may ultimately be less influential than the report's acknowledgement of FDA's arguments, which could serve to soften Republican opposition in the House.
At present, both the House and Senate are working on separate versions of compounding reform legislation, and have been for at least the past 10 months. With Congress scheduled to be out of session for much of August 2013, it now seems unlikely that any legislation will see passage in either chamber until September 2013 at the earliest, and more likely not until later in the fall.
GAO Report on Compounding