[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.
Next up was Kevin Outterson, talking about opacity of R&D information; all we see are the shadows of data. There are $250 billion of branded drug sales, with something like $200 billion in patent rents in the U.S. alone (twice that globally). Patent theory describes this as the engine behind development in drugs – but it’s not free; we pay in higher drug prices. We’re paying for R&D, not the pills themselves, which would be priced at the generics’ cost. There’s no industry that celebrates inefficiency the way drugs do, touting the $1.2 billion figure for drug development. Don’t blame patent law, though! They require up-front disclosure. But that doesn’t apply to clinical data, which is kept locked away, only accessible to FDA. This process, which society pays for, is anathema to the scientific process.