April 21, 2013

Regarding the April 12 front-page article “FDA finds safety problems at specialized pharmacies”:

Food and Drug Administration officials Margaret Hamburg and Howard Sklamberg state that compounding pharmacies continue to challenge the agency’s inspection authority and do not register with the FDA, making it difficult for the agency to regulate these companies.

These arguments are a red herring. Regardless of the FDA’s authority over traditional compounders, the agency clearly does have the authority to inspect and require registration of drug manufacturers. The agency can and should impose these requirements on those companies calling themselves “compounding pharmacies” that actually manufacture drugs on a large scale. The FDA has failed to use this existing authority consistently in the past; as a result, the industry of compounder-manufacturers has grown to a scale that will be expensive to regulate.

We would support legislation granting the FDA clearer authority to inspect and require registration of traditional compounding pharmacies. Yet it is much more important for the FDA to enforce a firm line between compounding and drug manufacturing and to require compounder-manufacturers to either scale down their operations or comply with current federal regulations governing drug manufacturing. This can be done by the FDA investing resources in better enforcement, with or without a new statute.

Michael A. Carome and Sarah Sorscher, Washington

The writers are, respectively, deputy director and attorney for the Public Citizen’s Health Research Group.