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FDA Tackles Ethics

Posted by Jane Akre
Thursday, April 22, 2010 10:57 AM EST
Category: Major Medical
Tags: FDA, Conflict-of-Interest, Hamburg


FDA Ethics



Ethics seem to be in the air.

The Food and Drug Administration has issued guidance that requires expanded disclosure for those who participate in advisory committee meetings.

With 49 committees and 600 participants, the FDA frequently relies on experts in a field to set a direction for a drug, medical device or a health care policy.

Pharmalot reports that the draft guidance would expand disclosure requirements before the committee meetings. The FDA proposes posting any financial interest with a committee member as well as the type of conflict.

The law allows the FDA to grant conflict-of-interest waivers for scientific advisers. Current law requires the FDA post on its web site when a waiver of conflict of interest is granted.

Some Conflicts Allowed

There are different types of conflict.

If a researcher works for an institution that takes money from industry but the researcher does not personally participate in the studies, FDA commissioner Margaret Hamburg sees that as a case of “not all conflicts are created equal.” In other words, that person has an indirect relationship to the conflict. Other experts without conflicts will be sought, says Hamburg in a letter to staff.

Conflicts could include stock holdings, research grants, and patents, consulting and speaking fees. Anyone taking under $50,000 from a drug or device maker or industry grant can be on an advisory committee if that person’s value outweighs the possible conflict, but they cannot vote.

Advisory committees are supposed to provide independent, expert advice on scientific, technical and policy matters related to drugs, biological products, medical devices and food. Most FDA advisory committee members are appointed as special or regular government employees. #

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