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12:00 AM
Jun 13, 2005
 |  BioCentury  |  Politics, Policy & Law

Purge politics

The Republican leadership and industry lobbyists were taken by surprise last week when Rep. Maurice Hinchey (D-N.Y.) persuaded the House to vote to bar waivers from financial conflict of interest regulations for FDA advisory committee participants.

The move is touted as the way to purge the rot of pharma industry influence at the agency, but in reality will drain the pool of qualified clinicians and scientists the agency has deemed necessary to assess new therapies. At the same time, the proposed ban entirely misses the reason most COI waivers are issued, which most often does not involve a direct financial interest in the product under review.

Nevertheless, the GOP made little effort to counter the passionate arguments presented by Democrats that drug companies have corrupted both the FDA and its advisory committees. Indeed, when the roll was called, 32 Republicans joined 198 Democrats to pass an amendment to the FDA spending bill in a 218-210 vote.

If the provision becomes law, FDA would be forced to dramatically alter the composition of its advisory panels. In fact, waivers or limits on participation because of conflict of interest issues were granted to either a permanent committee member or an invited consultant at every CDER advisory meeting in which a recommendation on a drug approval was discussed in 2004 and so far in 2005.

If the waiver prohibition had existed at the start of 2004, it would have disbarred a third of all participants at the 13 CDER panel meetings. All told, there would have been 55 empty chairs. This figure does not include meetings, such as the COX-2 safety meeting last February, at which blanket COI waivers were granted to all participants.

Someone's fantasy

Rep. Tom Latham (R-Iowa), the sole member to speak out against the amendment, told his colleagues that COI waivers are necessary to ensure that FDA can draw on a pool of qualified advisors.

"Conflict of interest waivers exist so that the most knowledgeable scientists, the ones you would want to consult if your own family was ill, can advise government agencies," Latham said.

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