A bill is currently making its way through Congress that could potentially give the F.D.A. more power to regulate compounding pharmacies. Traditionally, compounding pharmacies have not been regulated by the F.D.A. because they do not manufacture drugs, as pharmaceutical companies do – they only recombine drugs into specific combinations at the request of hospitals and physicians. Currently, compounding pharmacies are regulated solely by states’ pharmacy boards, even though they may ship their products across state lines.
But then last year a Massachusetts-based compounding pharmacy accidentally made contaminated batches of drugs. The result was more than 700 cases of spinal infections, including meningitis. Sixty-four people from 9 different states died.
The new law would give the F.D.A. much of the same power over the compounding pharmacies that it has over drug manufacturers. The F.D.A. would be able to review the companies’ records and inspect their facilities. In addition, the compounding pharmacy would have to alert the F.D.A. when something goes wrong. However, there’s a big catch; F.D.A. regulation would be voluntary. According to the specific language in the proposed bill, F.D.A. regulation would be available to compounding pharmacies “who wish” to be regulated.
Seriously? Supporters of the bill defend the voluntary nature of the proposed regulation by saying that the market will drive demand, because hospitals and doctors will choose to do business only with compounding pharmacies that are “F.D.A.-regulated”. Maybe, but price often trumps all other considerations. And you, the consumer, will never know where your doctor or hospital gets its compounded drugs.
This is a weak attempt to fix a serious problem. Why not just go all the way and require that all compounding pharmacies be regulated by the F.D.A.?