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FDA finds Drug Quality and Security Act insufficient

Posted in FDA Regulation

Julian Hattem of RegWatch, a blog curated by TheHill, reports in a piece that the US Food and Drug Administration is “not sold” on a recent pharmacy compounding bill.

The mixing and distributing of medications happens at various compound pharmacy clinics found all throughout the United States, and these compounding clinics have been the source of some recent controversies and have taken the stoplight in the medical world.  A large outbreak of fungal meningitis linked to “tainted steroid injections” from a compounding pharmacy killed 64 people this year.  More than 750 cases of infection were reported in that outbreak.

Such problems with compounding centers are not novel, but this most recent incident has pushed some to call for more federal oversight of the compounding process.  While the FDA is not necessarily looking for new responsibilities to shoulder, in light of the developing health and safety problems the Administration feels it can help create a better national standard.

FDA Commissioner Margaret Hamburg praised a bill being brought to the Senate for a vote in the coming weeks titled, “The Drug Quality and Security Act,” a bill that will hopefully help tackle some of the problems we have seen with compounding pharmacies.  Hattem states, “It would give the FDA power to regulate large compounding facilities but leave smaller plants to be overseen by state boards of pharmacy.”  Margaret Hamburg notes that the bill would not solve all the problems we are facing, but is a step in the right direction, stating “I don’t think it’s going to be as comprehensive as we initially had hoped,” but recognizes that it is “a step.”

However, the White House is not yet completely sold on the new legislation and has some concerns over the authority that will be given to the federal government with the oversight process.