Live Blogging from FDA in the 21st Century Conference, Panel 6: Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars

Posted on behalf of W. Nicholson Price II, Academic Fellow, The Petrie-Flom Center (with the disclaimer re: live blogging - see posts below)] 

The first panel of today is on regulatory exclusivity and generic drugs, moderated by Ben Roin at the Petrie-Flom Center.

Leading off was Kate Greenwood, discussing orphan drug development and recycled molecules.  She started off with Makena, known as 17-P,  first approved in 1976 as Delalutin.  In 1996 FDA withdrew its approval at the manufacturer’s request, as it hadn’t been marketing it.  A few years later, a study showed that the molecule, 17-P, helped prevent premature birth.  Compounding pharmacies started making it, and in 2006, CustoPharm filed a Citizen’s Petition asking whether the way was clear for a generic; FDA said yes, though the route might be challenging.  But in May 2006, a different company filed for a NDA for this new use; it was approved as Makena in January 2007; the company (KV Pharmaceuticals) priced it at $30,000 for a course of treatment (vs. $300 for the compounded version, still available pre-approval).  Responding to criticism, FDA stated that Makena’s reliance on government funding did not prevent Orphan Drug application.  But a few months later, FDA stated that compounding pharmacies could still make 17-P for patients; KV declared bankruptcy and blamed FDA’s decision not to discretionarily enforce Orphan Drug exclusivity.  KV has since sued FDA and HHS, and the case is pending.

Kate moved on to discuss ways to adjust the innovation/access balance, including shortening the exclusivity period, allowing limited competition, or capping or controlling drug prices.  There are concerns, however, that after Makena payers won’t really allow any monopoly price period.

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Posted on May 4, 2013 by petrieflo