FDA Strengthens Conflict Of Interest Policies For Advisors

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Main Category: Regulatory Affairs / Drug Approvals
Article Date: 07 Aug 2008 - 3:00 PDT

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The US Food and Drug Administration (FDA), the federal body that regulates food and drug safety, announced this week that it had strengthened policies and procedures, such as those governing conflict of interest, for FDA advisory committees: the independent national and global experts that make recommendations to the bureau on decisions about complex medical and scientific issues.

There were 48 FDA advisory committee meetings last year, considering issues ranging from diabetes drugs to new cancer treatments for children.

The improved policies now put stricter limits on financial conflicts of interest, strengthen voting, and increase transparency of information about comittee members and what they discuss in advisory meetings. The new guides were made available on the Federal Register on Monday; copies can be downloaded from the FDA website. Most of them will be fully implemented within the next 120 days, said the FDA, with the financial guides going into effect immediately.

Dr Randall Lutter, FDA deputy commissioner for policy, said on Monday:

"The FDA's regulatory decisions affect the health of millions of Americans, and we don't make those decisions in a vacuum."

It's imperative that we seek advice from independent experts, and that we do so in a way that is public, open, and transparent. Today's announcement strengthens our processes," he added.

On conflicts of interest, FDA staff will now be screening each advisory committee member before each meeting. They will determine for example if a member is in receipt of grants from, holds stock or has contracts with companies and organizations that could be affected by the panel's recommendations. If the total of such interests comes to more than 50,000 dollars, the expert will not be allowed to participate in the meeting, although the FDA has the power to waive the cap in certain cases, for instance if that person's expertise is critical.

When the FDA does exercise a waiver, it will post the details on its website, showing the extent of the individual's personal financial interest and the reason their expertise was considered so essential, before the meeting. The bureau is also improving the templates it uses for showing the information so they are clearer, more consistent, and easier to understand.

Under another policy change, the briefing materials given to advisory committees will be made available for public view on the FDA website at least 48 hours before the meeting. The new guides also describe how documentation should be assembled and included in the briefing pack, with a suggested timetable for submission.

Regarding voting, the new guidance recommends that members vote at the same time and not one after the other, to remove even the "perception" that votes might be manipulated, or that members are influenced by each other's vote, as can happen when voting is sequential, the process under current use where the chair invites each member to vote individually. The new rules also recommend that votes are announced immediately in the meeting and the agency said it will post lists on its website showing how each individual member voted.

Other changes include new criteria to clarify when the FDA should involve an advisory committee, and improvements to the advisory committee website to make it easier for the public to use and get information such as briefing materials, meeting schedules, financial disclosures and agendas.

Click here for FDA Advisory Committee website.

Sources: FDA.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
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