The Food and Drug Administration (FDA) is tweaking the way it treats advisory committee members who have financial conflicts of interest. FDA will require more detailed information on the financial interests of members who have been granted waivers to serve on committees despite a potential conflict, according to draft guidance released Wednesday.

FDA uses advisory committee to “provide independent, expert advice on scientific, technical, and policy matters related to the development and evaluation of products regulated by FDA.” Generally, persons with a financial interest in a product or industry in question cannot serve on committees. But, FDA may grant a waiver to permit conflicted individuals to serve.

The most significant change in the draft guidance, it appears to me, is the requirement that panel members with conflicts of interest identify the name of the firm or organization to which they are financially tied. Previously, the FDA only disclosed the general category, i.e. competitor or shareholder.

The change should instill greater accountability into committee proceedings. The public will now be armed with more information to judge whether a panelists’ views are unbiased by a financial interest.

The draft guidance is open for public comment until June 21. FDA last revised its guidelines on committee members and conflicts of interest in August 2008. This week’s guidance would make only minor changes to the 2008 guidance, which critics accused of being weak.

Accompanying the guidance, FDA Commissioner Margaret Hamburg sent a letter to senior agency officials providing her perspective on the conflict of interest issue. In the letter, she said committees “should search far and wide for experts who have the requisite knowledge without conflicts of interest” but added that in certain situations conflicts are inevitable, in her view.

When a conflict does arise, Hamburg identified three criteria for her staff to apply when deciding whether a waiver is appropriate:

1. The nature of the conflict, writing that, “Not all conflicts are created equal;”
2. The committee’s charge, asserting that conflicts are less problematic for broad, issue-based committees than for product-specific decisions; and
3. The process for searching for unconflicted members and the justification of the need for the conflicted member, which staff must explain.