Posted 28 June 2016
By Michael Mezher
The US Food and Drug Administration (FDA) on Tuesday issued a new draft guidance detailing its approach to determining whether advisory committee members can participate in decisions when the appearance of a conflict might signal an actual conflict of interest.
FDA maintains around 50 advisory committees, comprised of experts from outside the agency, to weigh in on specific scientific and medical issues. These committees are typically convened when FDA wants input on a new drug or medical device, or when the agency is looking into a specific safety or labeling issue for an approved product.
Under federal regulations (5 CFR § 2635.502), government employees are required to recuse themselves from decisions on matters where there is a conflict of interest, or even the appearance of one. While most FDA advisory committee members are not regular government employees (RGEs), most are appointed as special government employees (SGEs), and are thus subject to Section 502.
However, some advisory committee members, such as industry representatives, are not subject to the conflict of interest rules, as they are expected to "provide the point of view of the industry they represent."
To comply with Section 502, FDA says it screens its advisory committee member's financial interests to determine if they must recuse themselves. Then, FDA says it looks for "appearance issues," or "other interests and relationships that do not create a recusal obligation … but may create the appearance that a member lacks impartiality."
As such, government employees, both regular and special, "must take appropriate steps to avoid even an appearance of violating these ethical principles," FDA writes.
While FDA has issued guidance on its process for evaluating advisory committee members for clear conflicts of interest, this is the first time the agency has detailed its approach to determining appearance issues.
However, under the conflict of interest regulations, FDA and other government agencies have the ability to authorize an individual with an appearance issue to participate in a particular matter.
For FDA, the decision to authorize a committee member with an appearance issue is based on whether or not "the interest of the Government in the member's participation outweighs the concern that a reasonable person may question the integrity of the agency's programs and operations."
Then, if a committee member does have an appearance issue, FDA says it looks into "whether the Government's interest in the member's participation outweighs the concern" over the appearance of a conflict of interest.
Just last May, FDA issued an authorization to allow the chair of its Circulatory System Devices advisory committee to participate in a meeting where there was a conflict of interest. In that case, FDA said it was "difficult to identify panelists with relevant expertise who had no affiliation with a clinical study site" for the device in question, and noted that the committee chair did not have any involvement or oversight of the study in question.