Posted 22 January 2014
By Alexander Gaffney, RAC
It's about to become a little bit easier to become a member of the US Food and Drug Administration's (FDA) Advisory Committees, the agency said today.
No, FDA isn't relaxing its standards for admittance to the committees-those are staying the same.
What is changing is the way in which nominations are seen by the public and submissions are sent to the agency. In a 22 January 2014 announcement, FDA said it had launched an advisory committee membership nomination portal, "an online, interactive system that allows interested individuals to submit nominations for membership."
The portal is set to work with all 33 of FDA's advisory committees, and will allow an applicant to apply entirely online, bypassing the need to send in paper applications or documents.
"Applicants will experience an interactive, step-by-step process that eliminates confusion and accelerates the timeframe for submitting and processing an application," said Jill Hartzler Warner, acting associate commissioner of the FDA's Office of Special Medical Programs, in a statement.
FDA said the system will allow the agency to more easily develop metrics to assess the applicant pool and more quickly select quality candidates.
In a sign the agency may be expecting more nominations under the new system, FDA has also posted new presentation slides on how nominees can conform to FDA's conflict of interest (COI) policies, and which interests may serve to disqualify them from serving on a committee.
Applicants will have to set up an account with FDA, then upload copies of their curriculum vitae, a written confirmation that the nominee is aware of the nomination, letters of recommendation, and (if applicable) any cover letters demonstrating active participation in a community organization.
But in the wake of a recent break-in to the databases of the Center for Biologics Evaluation and Research (CBER), some may be worried about submitting nomination information to the agency in digital form. Nominees must provide FDA with information about financial holdings, employment, research grants and contracts-all actually or potentially sensitive information. For its part, FDA said the new system will "securely store all applicant information," indicating that it is aware of information risks. Applicants are also urged not to include Social Security information on any application materials, as these forms are usually made public.
FDA's advisory committees provide input and guidance to FDA on general and specific regulatory matters, such as whether a drug or medical device should be approved. Through FDA is not obligated to follow an Advisory Committee's advice, it does so in the majority of cases.
FDA Statement on Advisory Committee Membership Nomination PortalAdvisory Committee Membership Nomination Portal