House committee passes PDUFA bill

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The once-fearsome PDUFA legislation moving through the House of Representatives now closely tracks its toned-down counterpart in the Senate. The House Energy and Commerce Committee passed a drug-safety bill Thursday that leaves out many of the DTC and professional advertising restrictions the healthcare industry found most offensive.

Most of those measures were struck from the bill earlier this week by members of the Health Subcommittee. Led by several Democratic representatives from New York, advertising’s hometown, members rejected provisions that would have required companies to get approval from FDA before airing an ad, imposed a moratorium on advertising of new drugs and required them to carry a symbol.

However, Rep. Pete Stark (D-CA), chairman of the Ways and Means Health Subcommittee, today introduced a measure that effectively re-introduces many of the anti-DTC measures. The amendment would deny tax deductibility for any drug TV, radio or print ad that the FDA finds does not devote equal airtime, volume levels or space to risks and benefits. The Stark amendment was not in the Commerce bill voted on Thursday but could turn up as a proposed amendment to the PDUFA bill, which is likely to progress to a House floor vote in coming weeks.

The amendment gutting the draconian DTC provisions, co-sponsored by Rep. Edolphus Towns (D-NY) and Steve Buyer (R-IN) with the support of New York City Democratic Reps. Eliot Engel and Anthony Weiner, passed the Health Subcommittee by a vote of 23-9. The Towns-Buyer amendment offers a system of voluntary ad submissions, in which companies can gain quick pre-clearance of ads, and fines to punish firms for false and misleading advertising.

“Checking the principle of prior restraint is very important to the whole media and advertising industry,” said John Kamp, executive director of the Coalition for Healthcare Communication.

The Commerce bill also gives FDA significant new power to respond to drug safety issues. Members, though, voted not to make Risk Evaluation and Mitigation Strategies mandatory for every drug, instead giving the FDA discretion to decide when to execute them. “It’s the difference between a surgical solution and a shotgun approach,” said Kamp.

Also defeated was a provision that would have eroded the FDA’s exclusive authority to regulate drugs, giving more power to states to design their own rules and adding incentive to attorneys general and trial lawyers to bring actions against drug companies.
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