Scott Gottlieb on compounding

Yesterday, I wrote about how the conservative Boston Herald attacked Obama for allegedly loosening compounding drug rules. The claim failed the truth test. I praised the WSJ story yesterday, which was accurate.

Today, Scott Gottlieb at the American Enterprise Institute questions the Obama FDA for tightening quality rules on the manufacture of sterile injectable drugs (the type of drugs at issue in the NECC compounding tragedy).

Of the two, Gottlieb’s is by far better rooted in facts, but the essential argument is that when the FDA cracked down on quality problems at drug companies making sterile injectables, it helped to create drug shortages and shifted the demand to a less regulated supply, the interstate compounding pharmacies like NECC.

Gottlieb is careful not to blame the FDA for NECC:

While it’s highly unlikely that the decisions made by the Obama administration led to the recent tragedy, new policies create regulatory challenges that could make similar incidents more likely down the road.

For good reason. A causal chain requires at least two steps to “blame Obama” for NECC. First, that improper FDA action caused a shortage in methylprednisolone acetate. Second, that such a shortage (if proven) shifted demand to NECC.

The FDA maintains a comprehensive list of drug shortages, both current and resolved. Methylprednisolone acetate does not appear on either list. The ASHP reported a shortage of the generic versions of the drug on May 22, 2012, but did not specify a reason.  It is made by Teva and Sandoz. I could find no record of a shortage of the brand named version, produced by Pfizer (as Depo-Medrol). I also could not find the discontinuation date for Watson Labs and Akorn’s generic versions. It’s not clear that the Obama FDA created a shortage in this drug.

In any event, who thinks the solution to the NECC problem is lower sterility standards at more drug plants? We may need a different way to pay for the manufacturing base for common low-cost drugs and vaccines, but no one is seriously arguing for lower quality standards right now.

Prior TIE coverage here. h/t to Brad


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