PDUFA bill clears Senate in a squeaker

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Hours before the expiration of the Prescription Drug User Fee Act, the Senate approved legislation renewing the program and giving the FDA new powers to police drug safety, thus averting imminent FDA layoffs.

Passage came after Sens. Tom Coburn (R-OK) and Richard Burr (R-NC) released holds related to a provision they favored that would have bolstered the legal standing of drug makers in product liability lawsuits. That measure, which Burr placed in the Senate version of the bill, would have given FDA new powers over drug labeling, solidifying the preemption defense that drug companies have used against litigation, but was scuttled in the version passed by the House. The bill now goes to the president, whose sign-off is almost certain.

Burr's amendment aside, the pharmaceutical and advertising industries largely got what they wanted out of the final bill. The House passed the legislation by a vote of 405-7 Wednesday, having toned down several worrisome provisions. Representatives 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 measures 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.

Advertising Coalition executive director Jim Davidson called it “one of the biggest victories on advertising, communication and speech issues in the last two decades.” PhRMA chief Billy Tauzin praised “a critical step to make our nation's drug safety system – which already is the best in the world – even better.” Sen. Ted Kennedy (D-MA) and House Majority Leader Nancy Pelosi (D-CA) also had kind words for the bill, as did FDA commissioner Andrew von Eschenbach.

The bill includes funding for FDA to expand reviews of DTC ads and establishes a system of adjudicating disputes over advertising similar to that used by the Federal Trade Commission. Under that system, if the FDA determines an ad to be false and misleading and a company chooses to challenge the agency's decision, the matter goes to an administrative law judge. If the judge determines that the ad is, indeed, false and misleading, agency can fine the company up to $250,000 for each day that the offending ad ran after notification.
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