A novel idea for a post-marketing commitment

A novel idea for a post-marketing commitment

I was at a joint Forum for Collaborative HIV Research/FDA meeting in Washington today focused on issues for CCR5 antagonists, a new class of drugs working its way through clinical development. The meeting featured productive panel discussions including representatives from the FDA, National Cancer Institute, European Union, community activists, academic researchers, diagnostics companies, and pharmaceutical companies. (The meeting is available on the web if you want to watch.)

When new drugs are approved, especially in areas like HIV and oncology where fast-track approval is the norm, the FDA often asks for post-launch studies to resolve outstanding issues. Companies don’t do a great job of fulfilling their commitments, as I’ve described before, and the FDA isn’t well equipped to police these commitments.

One member of the audience offered a novel suggestion: rather than the FDA seeking commitments for follow-up studies on the specific CCR5 drug approved, they should ask for a commitment to fund existing patient cohorts to study a broader set of questions than could be addressed by a continuation of trials on the specific drug. There are some specific scientific reasons to recommend such cohort studies in this case, but it would also have the advantage of making it easier to track compliance.

May 31, 2006

Leave a Reply

Your email address will not be published. Required fields are marked *