Apr 28 2010

New Disclosure Requirements for FDA Advisory Committees

Seldom, very seldom, does complete truth belong to any human disclosure.

– Jane Austen

On 21 April 2010, the FDA announced a newly revised Draft Guidance on Transparency and Advisory Committees.  If implemented, the draft guidance would increase transparency into the financial disclosures and conflicts of interest of Advisory Committee members.

The FDA has 40 Advisory Committees and Panels that it uses to obtain independent, expert advice on both scientific and policy matters.  For example, before rendering a decision for a New Drug Application (NDA), the FDA will convene an Advisory Committee to review the data and provide an opinion on approval.  The FDA usually follows the opinion of the panels, but it is not legally required to.  Committees are convened periodically and the public is invited to attend and provide comment.

Obviously, if a committee member had a conflict of interest it could cast a shadow over their vote or even the opinion of the entire group.  As such, the FDA works hard to keep the committees independent and free of anything that has even the appearance of a conflict of interest.  However, the FDA is allowed to grant waivers for committee members that have such conflicts, but there is a cap to how many it can grant in any one year (e.g., no more than 13% of members can have wavers in FY 2010).

You may be wondering “Why even have waivers?”  Ideally, they wouldn’t be necessary, but sometimes the number of top experts (e.g., “key opinion leaders”) working in a field is limited and, by not granting waivers, vital expertise could be lost.  FDA Commissioner Margaret Hamburg said this on the subject in a letter to FDA staff:

“In my view, it is clearly better for the agency in fulfilling its public health mission when advisors have no conflicts of interest. FDA staff should search far and wide for experts who have the requisite knowledge without conflicts of interest.

At the same time, however, I recognize the fact that many of the top authorities in specific areas may have conflicts of interest. To make the best decisions, FDA must, at times, seek advice from these experts.”

(That this draft guidance and announcement came with a letter from Commissioner Hamburg to the FDA should give you an idea about how seriously the FDA takes this subject.)

So what’s actually being proposed here?  Under the revised draft guidance, the FDA would post the name of the company or institution associated with the financial interest along with the type of conflict of interest.  In this posting the FDA will provide the following details about the nature of the conflict in question:

  • Type of interest (e.g., personal, family, imputed)
  • Nature of the interest including the name of the company or institution where the conflict resides (this is the big one; previously they were only listed as sponsor/competitor/etc)
  • Magnitude of the interest (e.g., dollar range)

In Margaret Hamburg’s letter, she outlined three steps the FDA will take to minimize any concerns about the waiver process (quoted from the press release):

  1. Consideration of the nature of the conflict of interest, recognizing that not all conflicts are created equal. For example, an academic researcher whose institution receives grants from an affected company but who does not personally participate in the studies has a more tangential relationship to the conflict than the researcher who conducts studies for the company directly.
  2. Consideration of the type of advice to be provided by the advisory committee. A waiver may be more appropriate for a meeting about a policy issue affecting a class of entities or products than for a meeting focusing on approval of a specific product.
  3. Justification of waiver recommendations with a description of the search for equally expert advisors without conflicts and an explanation of why the individual’s participation is needed to afford the advisory committee essential expertise.

As Eye on FDA points out, this is another step towards transparency at the FDA, but correctly notes that the European Medicines Agency goes a step further and provides more detailed information on all of its independent advisors (see Committee for Medicinal Products for Human Use).