House committee passes PDUFA bill
Most of those measures were struck from the bill earlier this week by members of the Health Subcommittee. Led by several Democratic representatives from
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.
“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.