• FDA conference at Harvard Law

    Highlights from this 2 day conference:

    • Peter Barton Hutt, the dean of the FDA bar, on the last 50 years at the FDA.  For example, FDA enforcement over the years has generally shifted from litigation to guidance.
    • Ted Ruger (Penn Law) wins my best comment of the day award when he noted that the FDA was one of the few federal agencies with statutory roots in the pre-1942 Commerce Clause.
    • A major cross-cutting issue was greatly enhanced post-marketing studies, combined with reducing standards for initial (or conditional) approval.
    • Another cross-cutting issue was transparency of clinical trials data, which will also require a transition from Data Exclusivity to Market Exclusivity regimes.
    • Deborah Autor (FDA Dep. Commissioner) gave her last talk before leaving the agency for generic drug maker Mylan.  She opened our eyes to the immense globalization of the supply chain and the huge regulatory challenges that follow.
    • Many talked about communication issues.  Susan Winckler (FDLA) devoted much of her plenary to FDA communication with the public in a social media world.  Many other speakers discussed the post-Caronia issues with commercial speech restrictions.  The panel by Aaron Kesselheim, Chris Robertson and Jessica Flanigan focused specifically on this issue, but many other speakers touched on these First Amendment issues as well.
    • The conference was drug heavy, and light on food law and devices, with just one panel on each.  But that’s common at FDA conferences.

    The conference was live blogged at Bill of Health.  Papers will end up in a Oxford Univ. Press book, but you could email individual authors for working paper versions.

    @koutterson

    Share
    Comments closed
     
    • “Another cross-cutting issue was transparency of clinical trials data, which will also require a transition from Data Exclusivity to Market Exclusivity regimes.”

      Can you elaborate please?

      • Data Exclusivity (DE) relies on the secrecy of the patient-level clinical trials data as the legal mechanism to prevent free riding. Marketing Exclusivity (ME) does not. To the extent you care about transparency of clinical trials (see the GSK initiative), you would prefer ME over DE, all other things being equal.

        I’ll blog on the paper when it’s available.