• Compounding problems

    The FDA’s clearest authority to regulate compounding was struck down by a 2002 Supreme Court case, Thompson v. Western States. Struck down on First Amendment grounds. Congress held hearings in 2003, but no legislative fix emerged.

    Now, almost a decade later, industrial scale compounding has led to contaminated injections, more than a hundred cases of fungal meningitis, and at least nine deaths.

    As I said in the NYTs on Sunday:  “The Food and Drug Administration has more regulatory authority over a drug factory in China than over a compounding pharmacy in Massachusetts.”

    Additional interviews at PBS NewsHour Monday.



    • Ain’t deregulation great. The recent article in Newsweek on thalidomide also made my hair stand on end…..www.thedailybeast.com/newsweek/2012/09/09/the-nazis-and-thalidomide-the-worst-drug-scandal-of-all-time.html

    • Mr. Outterson, will you please compare and contrast your statement about the FDA’s authority with that of Senator Blumenthal?http://www.blumenthal.senate.gov/newsroom/press/release/blumenthal-calls-for-stronger-federal-oversight-of-compounding-pharmacies-that-manufacture-drugs

    • The use of drugs from the compounders has become more common. A couple of months ago I was using drugs with labels saying Joe’s Pharmacy. Joe’s is not local. Not very reassuring. Local compounders have real incentives to make sure that they do not cut corners with their products. They are selling to local people they know. When they start selling out of their area, they lose some of that incentive to provide quality. Short term profit seeking may dominate longer term concerns. I think this is a set up for a market failure.


    • Regardless of the 2002 SC case, the FDA today, without a single new law or regulation, has the absolute authority, and obligation, to seize illegally manufactured drug products. NECC was manufacturing and distributing (on a huge scale) misbranded drugs (meaning that they have not received approval from the FDA). As a pharmacy NECC was legally permitted to compound prescription products in response to prescriptions for individual patients. But everyone, including the FDA, knows that is not what they were doing.

      Deb Autor, from the FDA, recently said “We’ve had our eye on them [NECC] for quite a while now.” Somebody, Congress perhaps, needs to ask Ms. Autor, who heads the Office of Compliance at FDA, why they did nothing to stop NECC from killing 15 people when it’s clear from her comment that they knew NECC was not following the law.

      • Of course the FDA has authority once a problem like this is identified. The relevant question is whether the FDA had clear authority (and resources from Congress) to actively regulate the 3000 compounding pharmacies before a problem happens.

        • Well, then I guess you’ll agree that the FDA completely dropped the ball in this case since they very clearly knew exactly what NECC was doing (manufacturing vs. compounding). The FDA themselves investigated NECC years ago, and yet did nothing to follow-up on that prior investigation.

          In addition, I personally complained to the Agency about NECC’s sister company, Ameridose, for three and a half years because they were doing the same thing that NECC was doing (namely, manufacturing, not compounding, huge quantities of unapproved drug products). I provided solid evidence regarding Ameridose’s activities and nothing was ever done. NOTHING. Not even a damn Warning Letter was sent.

          Had the Agency acted on either their own prior knowledge of NECC, or my complaints about Ameridose, it is likely that 21 people would not be dead from an infected steroid product.

          Now, you want to talk about resources…take a walk around the FDA’s White Oak Campus and you will see resources wasted on a scale that I’d wager you cannot even imagine. And yet, the Agency was supposedly too busy and too poor to respond to solid evidence about illegally manufactured and marketed unapproved drug products. If you want to stand up and defend the Agency’s honor and reputation, go ahead, but at least say a prayer for the families of the 21 victims afterwards.