FDA offers draft guidance for financial transparency

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The FDA has put forth a draft guidance with recommendations regarding the agency's policy regarding the public disclosure of financial interests by special government employees (SGEs) and other government employees who participate in advisory committee meetings.

“Advisory committees provide independent, expert advice on scientific, technical, and policy matters related to the development and evaluation of products regulated by FDA, such as human and animal drugs, biological products, medical devices and foods,” the agency stated.

The FDA said that almost always, advisory committee members are appointed as SGEs.

“FDA implements a rigorous process for soliciting and vetting candidates for advisory committee meetings to minimize any potential for financial conflicts of interest,” said the agency. Employees participating in these meetings are required to disclose any financial conflicts of interests prior to the meeting, and on a yearly basis, according to the draft.

Currently, FDA has made revisions to provide added transparency and pinpoint conflicts of interest that government employees appointed to advisory committees may have.

“FDA reviews not only the financial interests of a potential advisory committee participant and his immediate family, but also the financial interests of which he has knowledge, of the participant's business partners, organizations for which he serves as officer, director, trustee, general partner, or employee, and any prospective employer of the member,” the draft stated.

In 2002, the agency issued the draft guidance on Disclosure of Conflicts of Interest for SGEs Participating in FDA Product Specific Advisory Committees. In 2008, FDA set a financial cap of $50,000 for any advisor. The limits prohibit any SGE or government employee with financial conflicts of interest to participate in advisory committee meetings unless granted a waiver by the agency.

The agency will now require the individual's company or institution to be identified rather than identifying the interest as sponsor, competitor, or other. Additionally, the dollar range will be indicated.

The FDA “concluded that it is desirable to implement agency-wide procedures regarding disclosure of financial interest information that apply to all SGE and regular government employees invited to participate in FDA advisory committee meetings subject to Federal Advisory Committee Act.”

According to the FDA, the waiver information and disclosed financial information will be provided on the agency’s committee meeting website 15 days prior to the scheduled meeting. For instances where a waiver is issued, documents will be posted no later than the day of the scheduled meeting.

The draft guidance is open for public comment within 60 days of being published in the Federal Register and comments should be submitted to the FDA’s division of dockets management.