Compounding pharmacies have been on FDA’s priority list since the 61 deaths and 749 cases of fungal infections from steroid injections contaminated during manufacture by New England Compounding Center (“NECC”), last fall. When appearing before Congress last November, FDA Commissioner Margaret A. Hamburg, M.D. plead a lack of regulatory authority in the wake of the Western States U.S. Supreme Court decision. Arguably, it is unclear if Western States struck down just the regulation of advertisements (as industry has contended) leaving the regulatory structure untouched or if it invalidated the authorization of compounding pharmacies (as FDA has contended, since the 9th circuit held the provisions not-severable and that decision was affirmed), leaving compounding pharmacies technically illegal but ignored by FDA regulatory discretion. Either way, FDA appeared to retain certain regulatory authority over compounding pharmacies, but FDA’s scope was unclear.
Congress did not want to leave the deaths resulting from compounded drugs alone, so S. 959 was proposed to fix the problem, despite the lack of clarity what problem needed to be fixed. Among other things, S. 959 would forbid compounding pharmacies to copy FDA-approved but nonpatented medicines. But do we want all medications (including compounded drugs) to require premarketing approval? Do we want more frequent inspections of compounding pharmacies, and if so how do we pay for it? Do we just want someone to be held responsible–who: FDA, pharmacy boards, or someone else?
The basic dilemma is simple: we want safe and effective medicines, but we also want them at a price that we can afford. Compounding pharmacies may provide certain formulations of medicines without the overhead and costs related to commercially-manufactured and regulated medications. In some instances, compounding pharmacies may be able to offer medications with the same active compounds used in conventional drugs but with different inactive ingredients at lower costs than commercial medications. When such pharmacies are too small, few people realize the benefits of customized medications due to availability or cost. When they are too big, they are viewed as traditional drug manufacturers by FDA, leading to questions about what regulatory oversight is appropriate or warranted.