House passes PDUFA conference bill, sending it on to Senate
The bill must now pass the Senate before reaching the President, and industry observers say it's unclear whether the Senate will simply sign off on it or haggle over the details. With PDUFA set to expire Sep. 20, the pressure is on for a speedy resolution. FDA commissioner Von Eschenbach said in a memo last week that the agency might be forced to issue layoff notices on 2,000 employees within days if the legislation stalls.
The House agreed to drop language mandating the inclusion of an 800 number for reporting adverse events in TV ads, though the number must appear in print ads and the secretary of Health and Human Services must conduct a study no more than six months after passage of the bill to determine whether the rule should be expanded to TV, or if it would distract from the presentation of risk information. The House also scaled down a provision mandating that companies submit their marketing plans to the FDA as part of their Risk Evaluation and Mitigation Strategies, though they may be required to submit plans for professional communications.
Absent were provisions in earlier legislation that would have imposed a moratorium on consumer ads, required FDA pre-approval of advertising and mandated warning symbols and statements on ads for new drugs. Also gone were provisions aimed at speeding generic biologics to market, which industry had feared might hold up a final bill.
“It may be one of the biggest victories on advertising, communication and speech issues in the last two decades,” said Jim Davidson, executive director of the Advertising Coalition.