FDA Often Fails to Disclose Advisers' Corporate Ties: WSJ

Larry Hand

December 10, 2014

Numerous financial ties exist between medical device makers and physicians and scientists serving on committees that advise the US Food and Drug Administration (FDA) on whether to approve new devices, the Wall Street Journal (WSJ) has reported.

Almost 10% of FDA advisers have received something, such as consulting fees or research support, from companies whose products they evaluate, yet the FDA reports about 1% of the corporate connections during advisory committee sessions, the WSJ notes.

FDA commissioners are not required to follow the advice of the agency's advisory committees, but they often do when deciding whether to approve a new product for marketing.

The WSJ article cites some examples of recently undisclosed corporate ties and FDA advisers:

  • a cardiologist who had consulted for device makers with products up for review by an FDA advisory committee of which he was a member;

  • a gynecologist who resigned from one advisory committee after the WSJ reported he had received payments from a device maker;

  • an orthopedic surgeon who received consulting fees from an artificial hip device maker with hip implants up for review by an advisory committee of which he was a member; and

  • another gynecologist who resigned from a committee he sat on had received consulting fees from surgical mesh and power morcellator makers with products up for review.

Reaching a Balance

The WSJ quoted FDA Associate Commissioner Jill Hartzler Warner as saying that a financial relationship with a product sponsor or related firm, as long as it is not related to the specific product being reviewed at a meeting, is not a disqualifying factor for being on a committee.

The agency has issued waivers for advisers when the agency feels they are needed, and those waivers are read aloud at the beginning of an advisory committee meeting.

However, the WSJ points out, the agency also has what is called a "502 authorization" that allows advisers with financial ties to serve on panels without being publicly disclosed.

The goal at the FDA is to reach a balance on disclosing corporate ties but still get the best advice, according to the FDA official in the WSJ report.

Corporate payments to physicians on advisory committees ranged from $500 to more than $100,000.

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