GDUFA-style user fees provide one possible source of funding for FDA compounding regulations

WHAT IT MEANS AND WHY IT'S IMPORTANT — Given the extent of the meningitis outbreak linked to a compounding pharmacy in Massachusetts, new regulations for such pharmacies might be a good idea, but how to implement them remains uncertain.

(THE NEWS: Meningitis outbreak linked to compounding pharmacy spawns new proposed legislation. Click here to read the story.)

One question that the bill — proposed by Rep. Ed Markey, D-Mass., to empower the Food and Drug Administration to regulate compounding pharmacies — appears to have left open was where the funding would come from for an agency that National Community Pharmacists Association SVP government affairs John Coster called "already stretched." The current makeup of Congress suggests that legislators may be reluctant to hand over more money to regulators, but some of the agency's recent history provides clues of how it could get the funding and staffing. The reauthorization of the Prescription Drug User Fee Act that President Barack Obama signed into law earlier this year included the Generic Drug User Fee amendments, which call on the agency to collect user fees from generic drug makers so it can hire workers to inspect manufacturing plants in the United States and abroad. 

According to the International Academy of Compounding Pharmacists, there are 7,500 pharmacies in the United States that compound, as well as 8,200 associated with hospitals and other health institution that also do. The compounding industry makes up 1% to 3% of the U.S. prescription market, but a national survey showed that 76% of independent pharmacists compound medications, in addition to virtually all home-health specialty pharmacies, hospital pharmacies and nuclear pharmacies. Needless to say, it's a pretty large and widespread industry.

Whatever the case may be as far as the effectiveness of the current regulatory system for compounding pharmacies is concerned, the unsanitary conditions found at the pharmacy linked to the meningitis outbreak, the New England Compounding Center, show what can happen if the regulatory radar misses even one of them. According to Reuters, there is evidence that state and federal regulators were aware of problems at the NECC as early as 2002, and the FDA sent it a warning letter in 2006, but there was little evidence of a follow-up.

Regulations governing compounding pharmacies, particularly at the federal level, remain limited and fragmented, according to a report filed several days ago by Rep. Markey. For the moment, regulation happens mostly at the state level, through state boards of pharmacy. At the same time, the U.S. Pharmacopeia's standards are integrated into the practice, and the Pharmacy Compounding Accreditation Board has national standards in place. While officials from the PCAB physically visit every compounding pharmacy seeking the organization's accreditation, accreditation itself is not mandatory for any pharmacy that wants to compound medicines. The proposed legislation would help the FDA fill what Markey called a regulatory "black hole."  

As of Friday, the meningitis outbreak linked to the NECC had resulted in 29 deaths and sickened 404 people in 19 states, according to the Centers for Disease Control and Prevention.


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