FDA ‘lacks authority to oversee compounding pharmacies’
pharmafile | August 2, 2013 | News story | Manufacturing and Production |Â Â FDA, GAO, NECC, TaylorÂ
The US Food and Drug Administration lacks the power to properly regulate compounding pharmacies, according to a new Government Accounting Office (GAO) report.
One of the key problems facing the FDA is a lack of inspection authority, a situation which means it has had to seek warrants in the courts to gain access to some facilities.
Meanwhile there is a lack of clarity in the legislation on the difference between traditional compounding pharmacies and larger outfits that make sterile products without, or in advance of, a prescription and sell those products across state lines, says the GAO.
“This lack of consensus and differing FDA authority to oversee compounded drugs across the country has resulted in gaps in oversight of drug compounding,” says the report.
There is clearly a pressing need for tighter regulation in this area in the wake of the notorious case in 2012, in which a fungal meningitis outbreak caused by dubious production practices at the New England Compounding Pharmacy (NECC) claimed more than 60 lives.
The GAO’s verdict is something of a vindication for the FDA, which was hauled over the coals by Congress in the wake of the NECC scandal, amid claims that it had been aware of the problems at some compounding pharmacies since 2002. The agency has always maintained that it lacked the authority to act on its concerns.
The agency does not escape criticism, however, with the GAO noting that the FDA’s “inspection database cannot identify all of the agency’s inspections of compounding pharmacies, or the final classification of inspection results, for all of the inspections”.
Congress should consider “clarifying FDA’s authority to oversee drug compounding”, while the FDA “should ensure its databases collect reliable and timely data on inspections associated with compounded drugs, and differentiate drug compounders from manufacturers”, it concludes.
Help on the way?
The GAO report comes a bill intended to boost the FDA’s powers in this area is being deliberated in the Senate.
The bill – known as the Pharmaceutical Quality, Security and Accountability Act (S. 959) – makes a makes a clear distinction between traditional compounders which will continue to be regulated primarily by state pharmacy boards and a new category of ‘compounding manufacturers’ that will be regulated by the FDA.
There had been hopes that S. 959 would reach the Senate floor ahead of Congress’ August recess, but the requirement for amendments meant this was not to be, and the bill has now been delayed until after the lawmakers return in September.
S.959 will also introduce a new prescription-drug tracing framework for that will be used to track drugs from the manufacturer to the pharmacy, in a bid to prevent illicit activity such as counterfeiting and diversion.
“Large-scale drug compounders … continue to pose a grave risk to public health,” said Senator Tom Harkin, one of the bill’s sponsors, when amendments to the bill were released towards the end of last month.
“Congress must take action to improve the safety of compounded drugs and prevent the next public health crisis,” he added.
Phil Taylor
Related Content
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
Alto Neuroscience’s schizophrenia treatment granted FDA Fast Track designation
Alto Neuroscience has announced that its investigational treatment for cognitive impairment associated with schizophrenia (CIAS) …
FDA approves Moderna’s updated COVID-19 vaccines targeting new variant
The US Food and Drug Administration (FDA) has approved Moderna’s updated COVID-19 vaccines, Spikevax and …
