GOP lawmakers balk at giving FDA more authority over compounding pharmacies

    By Jonathan Block

    Modern Healthcare

    Posted: April 16, 2013 – 4:30 pm ET

     

    House Republicans signaled they are not convinced the Food and Drug Administration needs more statutory authority to police the activities of compounding pharmacies like the one blamed for a meningitis outbreak last year that killed 53 people.

    “Ten years of warning signs, alarm bells and flashing red lights were deliberately ignored,” Rep. Tom Murphy (R-Pa.), chairman of the committee’s Subcommittee on Oversight and Investigation, told FDA Commissioner Margaret Hamburg at a House Energy and Commerce subcommittee hearing today. “Ultimately, the FDA knew NECC was breaking the law but chose to do nothing.”

    Murphy added that in 2011, the agency put on hold enforcement actions against NECC as a result of FDA attorneys finishing a revision of a guidance document, which described FDA’s authority to conduct inspections of certain compounding pharmacies.Read More