FDA Changing Rules on Advisory Committee Service

The Food and Drug Administration is changing the rules on who can serve on its advisory committees. Some members who have advised the agency on drugs and medical devices have had financial dealings deemed to represent conflicts of interest.

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The Food and Drug Administration calls in outside experts when it isn't sure about the best way to weigh the risks and benefits of a drug or medical device. Committees meet to take up such hot issues as the safety of anti-depressants for kids or problems with a new antibiotic.

But there's been a lot of criticism lately because some members of those committees have financial dealings with drug companies or device makers. And so the FDA is taking steps to make sure its advisors have no conflicts of interest, as NPR's Joanne Silberner reports.

JOANNE SILBERNER: The FDA held 57 Advisory Committee hearings last year. Just about every one began the way this one did back in 2004.

Unidentified Woman: I'd like to read the meeting statement into record now.

SILBERNER: An FDA employee reads the conflict of interest statement.

Unidentified Woman: The following announcement addresses the issue of conflict of interest and is made a part of the record to preclude even the appearance of such at this meeting.

SILBERNER: And then the employee reads a list of advisors who, in one way or another, take money from drug companies or device manufacturers. Maybe the panel member is paid by a drug company to lecture about statins, or gets a consulting fee, or owns stock in a firm that makes medical devices.

Right now, the FDA permits them to vote on whether the agency ought to approve a product made by that company or by a competitor. In some committees, a quarter or even half of the members may have a conflict. The FDA can do better says Democratic Congressman Maurice Hinchey of New York.

Representative MAURICE HINCHEY (Democrat, New York): They have allowed those advisory boards to be filled with members who can vote as to whether or not drug products should be allowed on the market even though they have financial conflicts of interest.

SILBERNER: The FDA has rules about such things but they're complicated and not binding. So in a teleconference yesterday, FDA senior policy advisor Jill Hartzler Warner described a new proposal. First, people with smaller, disqualifying financial conflicts - less than $50,000 - could serve on the committees but not vote.

Ms. JILL HARTZLER WARNER (Senior Policy Advisor, Food and Drug Administration): Second, if an individual has disqualifying financial interests whose combined value exceeds $50,000, he generally would not participate in the meeting, regardless of the need for his expertise.

SILBERNER: Only a special waiver from the commissioner would allow someone with a conflict of interest greater than $50,000 to be on a committee. Third, she says, even the appearance of a problem would be enough to disqualify someone.

The FDA's acting deputy commissioner for policy, Randall Lutter, couldn't say exactly how many current advisory committee members would be affected by the proposal. It would be a substantial fraction, he says, but it's worth it.

Mr. RANDALL LUTTER (Acting Deputy Commissioner for Policy, Food and Drug Administration): We're committed to making the FDA Advisory Committee process even stronger and better understood so that the public has confidence in the integrity of Advisory Committee recommendations.

SILBERNER: In light of this proposal, Congress has already started to ease up on the agency. Again, Representative Maurice Hinchey.

Rep. HINCHEY: Well, I'm very happy about it. What we're seeing here is the leadership at the FDA is now, for the first time in decades, acting in the public interest.

SILBERNER: That's not to say all pressure is off the agency. Hinchey is still considering legislation that would change the way the FDA is financed and require it to more closely scrutinized drugs already on the market. And other proposed legislation would restructure the agency itself. The FDA will consider public comment on this new proposal for 60 days before publishing final rules.

Joanne Silberner, NPR News, Washington.

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