Posted 03 February 2017
By Zachary Brennan
In a move toward more transparency, the US Food and Drug Administration (FDA) on Friday announced it would publicly disclose the unredacted curricula vitae (CVs) of advisory committee members.
A consent form saying the member’s CV does not include any confidential information will need to be submitted, FDA said.
FDA maintains about 50 advisory committees comprised of outside experts who weigh in on scientific and medical issues, and which typically convene when FDA wants input on a new drug or medical device or when the agency is looking at a safety or labeling issue or another emerging topic.
Under federal regulations (5 CFR § 2635.502), government employees are required to recuse themselves from decisions where there are conflicts of interest, or even their appearance. While most FDA advisory committee members are not regular government employees, most are appointed as special government employees and are subject to Section 502.
Industry representatives, however, are not subject to conflict of interest rules as they are expected to "provide the point of view of the industry they represent."
Government employees, both regular and special, "must take appropriate steps to avoid even an appearance of violating these ethical principles," FDA said in draft guidance released in June.
FDA selects advisory committee members through a nomination process where those who are qualified can self-nominate or be nominated. To identify and select qualified individuals to serve, FDA has established an online portal, the FDA Advisory Committee Membership Application and accepts applications for “Academician/Practitioner,” “Consumer Representative” and “Industry Representative” membership types.
“Nominees who are nominated as scientific members should be technically qualified experts in the field (e.g., clinical medicine, engineering, biological and physical sciences, biostatistics, food sciences) and have experience interpreting complex data. Candidates must be able to analyze detailed scientific data and understand its public health significance,” FDA says.
According to the RAPS advisory committee tracker, there are four upcoming meetings on pediatric-focused safety reviews, recommendations on the selection of the strain for the vaccine for next year’s flu season, discussions on the safety issues and abuse of opioids, and one on strategies, approaches and challenges in model-informed drug development.
The agency also said the move to more transparency on committee members' conflicts of interest “will help conserve limited FDA resources by ensuring that the individual most familiar with the information contained in the CV, as well as any contractual or confidentiality agreements that might affect their ability to disclose that information, assumes the responsibility for determining whether the information may be released publicly.”
The consent form will need to be submitted alongside “the four other types of documents currently requested as part of the nomination process: (1) A CV for each nominee; (2) a written confirmation that the nominee is aware of the nomination (unless self-nominated); (3) a letter(s) of recommendation; and (4) for Consumer Representative applications, a cover letter that lists consumer or community organizations for which the candidate can demonstrate active participation.”
For existing advisory committee members who submit updated CVs and for nominees, the consent form will include the statement: “I consent to publication of my curriculum vitae (CV), and any subsequent updates to my CV that I provide FDA, on FDA’s Web site, without removing or redacting any information. My CV does not include any confidential information, including information pertaining to third parties that I am not permitted to disclose.”
Advisory Committee Nominations; Modification to Process for Collecting and Posting Curricula Vitae