FDA — New COI Rules

This Week the Food and Drug Administration (FDA) Announced New Rules for Conduct and Conflict of Interest of Advisory Committees:

Conflict of Interest:

·         If an individual, his spouse, or minor child has potentially conflicting financial interests totaling more than $50,000, he or she would not be allowed to participate in that meeting. 

·         The guidance specifies four scenarios where the conflict is significant and FDA does not intend to issue a waiver, even if the potential personal conflict is below $50,000.  (For example, if the advisor is the principal investigator of a clinical trial of a product about which the committee will be providing advice, the advisor will not be allowed to participate in that meeting.)

·         Before the FDA issues any waiver, FDA will require justification that the waiver is necessary to afford the committee essential expertise.

·         As now required by law, FDA will limit the number of waivers they grant.

Procedure:

·         Advisory committee documents will be posted 48 hours in advance of the meeting.

·         Information on Wavier recipients will be posted on the FDA website 30 days prior to the meeting.

·         Advisory Committees will now vote simultaneously on issues as opposed to one member at a time, to avoid voting momentum (the act of waiting to see what others are doing).

·         And as all government agencies like to do, they raised their user fees to industry.

·         In addition they are revising their website to make it easier to find documents.

This will help to quell some of the critics on Capitol Hill.  A fifty thousand dollar limit seems reasonable given the size of the industry.

One does have to wonder, if we continue this path of incremental changes at the agency and continue to raise the bar for approving drugs, won’t this have the reverse effect of discouraging the development of life saving for smaller populations and rare diseases, and further reduce innovation in the US?  For now though these changes may help move the process along faster.  At least the fund managers will have the FDA information sooner.

FDA Advisory Committee Page

Final Guidance on Procedures For Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees

Final Guidance on Public Availability of Advisory Committee Members’ Financial Interest Information and Waivers

Final Guidance on Voting Procedures at Advisory Committee Meetings

Final Guidance on Preparation and Public Availability of Information Given to Advisory Committee Members

Draft Guidance on When FDA Convenes an Advisory Committee

Fact sheet summarizing all five of the August 2008 advisory committee guidance documents

Consumer Article: Strengthening the Advisory Committee Process