Commissioner's letter to FDA staff on disclosure of financial conflicts of interest
April 21, 2010
Scientific advisory committees provide an important service to the FDA and the public. We rely on these committees to provide independent, expert advice on significant scientific, technical, and policy matters to assist in our mission to protect and promote the public health.
I am writing to share with you my perspective on the challenge of assembling top experts to advise the agency while maintaining the integrity of our decision making processes.
I am also writing to make you aware of a new draft guidance on transparency and advisory committees that should help the agency rise to this challenge.
FDA is advised by 49 committees and panels with more than 600 members. These committees provide advice on specific regulatory decisions, such as product approvals, and general policy matters, such as regulations and guidance.
The primary goal of the advisory committee process is to bring high-quality input to FDA in order to support agency decisions. The Office of the Commissioner recently asked senior agency staff throughout the product review centers and offices within the Office of the Commissioner about the challenge of finding appropriate scientific experts to serve on advisory committees.
A common theme was that for highly technical topics, review centers can have difficulty finding experts with the appropriate training and background to provide the agency with informed advice. As one career official noted, some meetings require expertise that is limited to a handful of experts, and those experts can often have conflicts of interest.
The law permits FDA to grant waivers for experts on its advisory committees. FDA may not exceed a cap set in the law on the number of waivers to be granted. For fiscal year 2010, this cap is set at about 13% of all advisory committee members participating in advisory committee meetings; we currently are granting waivers for less than 5%.
Conflict-of-interest waivers for scientific advisers have been controversial, however. If FDA is perceived to rely heavily on conflicted experts, then confidence in the agency’s decision making can be undermined.
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. Including an advisory committee member with a conflict of interest is a difficult judgment call best made by senior career agency officials, who are themselves prohibited from having conflicts of interest.
To minimize the concerns that such situations raise, I request that you take three steps, which are consistent with existing agency policy.
First, I ask that you consider the nature of the conflict of interest before recommending a waiver. 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.
Second, I ask that you consider 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.
Third, I ask that you justify a waiver recommendation 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.
All waivers should be reviewed by the Center director for consistency with these principles (in the case of Office of Commissioner advisory committees, the review should be conducted by the relevant deputy Commissioner).
Current law requires that we post on our website – whenever a waiver of conflict of interest is granted – the type, nature, and magnitude of the conflict so that the public has ready access to this information.
FDA has a rigorous policy on reviewing and assessing conflict of interest, which is guided by federal law. Currently, when a decision to grant a waiver of conflict of interest is made, FDA discloses whether the interest is associated with the sponsor, a competitor, or another affected firm, such as “holds $0-5,000 of stock in a competitor company.”
The agency is releasing a draft guidance today that would bring FDA’s practice more in line with standard practice in the academic community,. The guidance proposes that the agency expand the information disclosed about waivers, so that the name of the company or institution associated with the financial interest would also be posted to the internet prior to committee meetings.
By making fully informed decisions when considering waivers of conflict of interest, and by improving the transparency of those waivers that are granted, FDA can both obtain needed input and maintain external credibility.
I look forward to discussing these issues further with you.
Dr. Margaret A. Hamburg
Commissioner of Food and Drugs
Guidance and Notice of Availability