House OKs PDUFA bill, sans DTC restrictionsThe House has approved legislation that would reauthorize PDUFA and strengthen the FDA’s hand, allowing it to require post-market drug safety studies and fine companies as much as $250,000 for airing false and misleading ads.
The vote was 403-16.
Measures imposing a moratorium on advertising of new drugs and requiring preapproval of ads were stripped from the bill in committee last month.
The legislation must now be consolidated with its Senate counterpart. Barring any hitches (a contentious Senate bill on generic biologics could, if thrown into the mix, present a stumbling block) the bill could reach the President’s desk in the next two weeks.
“Now the devil’s in the details,” said John Kamp, executive director of the Coalition for Healthcare Communications. “The [Risk Evaluation and Mitigation Strategies] program giving the FDA more power to ensure drug safety is a victory for everyone. How the FDA exercises that power is going to make all the difference.”