Spurred by a challenge from Public Citizen last year, the Food and Drug Administration announced recently that it will no longer redact information from the curricula vitae (CV) of advisory committee members. Current advisory committee members must send updated CVs to FDA, along with an acknowledgment that information in their CV has not been redacted. This shift in policy is a win for advocates who have pushed for transparency of FDA’s decision-making process.
In isolation, this announcement may seem like a minor policy change, but it shows a continued trend towards increased data transparency, specifically as it relates to advisory committees. In 2014, FDA issued guidance entitled, Public Availability of Advisory Committee Members’ Financial Interest Information and Waiver. This guidance stated that FDA will make publicly available a committee candidate’s financial interest disclosure, which includes the type, nature, and level of the financial interest. Under this guidance, FDA is also required to publicly acknowledge any financial interest disclosure waivers that it grants.
FDA has a number of advisory committees and panels that cover the full range of products it regulates. Advisory committee schedules are publicly available, members of the public can attend, and people may submit comments in advance. The committees provide independent expert advice on a variety of topics to the agency. Some advisory committees provide feedback on general FDA policies and procedures. Others offer guidance and recommendations on specific products (although not every product is reviewed by an advisory committee).
Because members of advisory committees are not FDA employees and, typically, not government employees at all, there has long been concern over potential conflicts of interests. A particular focus is where an advisory committee member votes whether to approve or reject a particular product and where a committee member might have a vested interest in the outcome. While FDA advisory committee findings are not legally binding on the agency, FDA tends to follow the advisory committee’s recommendation. Of particular concern in Public Citizen’s complaint was that FDA categorically redacted certain types of data from the CVs of advisory committee members, such as pending clinical trials and sources of non-government grants involving the committee member, which do not fall under the umbrella of any of the nine Freedom of Information Act disclosure exemptions. The new policy attempts to respond to this concern.