FDA to Publicly Disclose Advisory Committee Members' CVs

February 8, 2017
By Mark Terry, BioSpace.com Breaking News Staff

The U.S. Food and Drug Administration (FDA) relies heavily on approximately 50 advisory committees made up of outside experts. These experts evaluate drug applications and provide expertise on a variety of scientific and medical issues.

In an effort to provide more transparency, the FDA announced recently that it will publicly disclose the curricula vitae (CVs) of advisory committee members. The CVs will not include confidential information.

Although employees of the FDA and other government agencies are subject to conflict of interest rules and regulations, the outside advisors are not. However, in June 2016, the FDA provided draft guidance pointing out that regular and special employees, “must take appropriate steps to avoid even an appearance of violating these ethical principles.”

Robert Califf, the present, likely interim FDA Commissioner, said internally in January, “the AC system is seen as overburdened with unnecessary paperwork” and that plans to promote transparency may also lead “some within FDA and key leaders in various scientific fields to question the value of ACs in their current form.”

The advisory committee members are chosen via a nomination process. Qualified nominees can self-nominate or be nominated. The FDA has an online portal, the FDA Advisory Committee Membership Application and accepts applications for several categories, including “Academician/Practitioner,” “Consumer Representative” and “Industry Representative” membership types.

In addition to stating that the “FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities,” it also requires nominees “be technically qualified experts in their field (e.g., clinical medicine, engineering, biological and physical sciences, biostatistics, and food sciences) and have experience interpreting complex data.”

Currently, the Trump administration has not appointed a new leader for the FDA. Shortly after winning the presidential election, the Trump administration indicated plans to reform the FDA “to put greater focus on the need of patients for new and innovative medical products.” Some of the names suggested for the position include Jim O’Neill, a venture capitalist and former HFH official, and Balaji Srinivasan, co-founder of genetics testing company Counsyl. Another choice is Scott Gottlieb, a former deputy commissioner of the FDA, although it appears that he is no longer under consideration.

Neither O’Neill nor Srinivasan are physicians, which is traditionally a requirement for FDA commissioner. Both are somewhat controversial—perhaps in keeping with many of Trump’s cabinet picks, who often seem opposed to the mission of the departments they are running. O’Neill in 2014 gave a talk where he said the FDA should just approve drugs based only on safety, not on efficacy. Srinivasan, in conversations with Matthew Herper, writing for Forbes, argued that the FDA’s system was better in the 1920s when insulin was only developed in a few years, apparently arguing that regulation is getting in the way of innovation—even though the point of the FDA is safety and efficacy for consumers.

When a new Commissioner is installed, it’s hard to say whether the new transparency regulations will still be enforced, or who they might be applied to. Califf said, “As we continue to improve the mechanics of ACs and to reduce unnecessary administrative burdens, we must also address the appropriate mix of expertise on committees, so that FDA scientists and staff get the advice they need to make the best decisions on behalf of the American public.”