The FDA’s ongoing commitment to transparency reached a new level last week, when the agency announced it would disclose the CVs of advisory committee members. The form will not include confidential or redacted information, said FDA.
Outside experts often weigh in on scientific and medical issues that pertain to new drugs and devices, and FDA has about 50 committees. These advisors are not subject to the conflict of interest rules adhered to by government employees. In June, however, an FDA draft guidance noted that both regular and special employees “must take appropriate steps to avoid even an appearance of violating these ethical principles.”
In January, Commissioner Robert Califf admitted that FDA’s reliance on advisory committees has led to criticisms, noting “ACs have been the subject of ongoing discussions concerning their impartiality, their transparency, and how they affect decisions made about FDA-regulated products.”
Califf also noted that internally, “the AC system is seen as overburdened with unnecessary paperwork” and that efforts to improve transparency may also lead “some within FDA and key leaders in various scientific fields to question the value of ACs in their current form.”
In the CV memo, FDA says that in order to preserve agency resources individual advisory members will determine what information is released publicly. Advisory committee members will be given a consent form for transparency included with four other document types in the nomination process. Existing committee members will be asked to submit updated CVs.
Califf says he hopes to see more changes to how advisory committees are developed, including providing clarification the concept of an imputed interest, which is currently “interpreted so that academic leaders with significant experience and insight are considered to have conflicts relating to grants and contracts held by faculty members at the same institution—even if they themselves have no involvement with the project.”
“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.”
[Want to stay more on top of MDO content? Subscribe to our weekly e-newsletter.]