The Right Kind of FDA Defense

The FDA drug safety law finally made it through Congress yesterday, despite a last minute hold-up over the perennially thorny issue of pre-emption.

The broad outlines of the bill have been clear, and the final passage doesn’t change the big picture impact we’ve been telling you about. (You can read our take on the drug development impact here, and on the new rules for DTC here.)

Still, it is somehow appropriate that pre-emption was the final stumbling block to enactment of the new legislation, because at its heart the FDA Revitalization Act is about rebuilding the credibility of the agency as a drug safety regulatory.

The agency’s credibility is critical in product liability cases, and brand name companies are frustrated that it isn’t more formally recognized as a defense against lawsuits. Industry has long wanted more protection in liability cases, arguing that they should not face lawsuits that in effect second-guess FDA’s decisions about whether labeling appropriately warns of a product’s risks. They want an explicit “FDA defense,” and they hoped that Congress would spell that out as part of the sweeping drug safety changes included in the FDA Revitalization Act.

That didn’t happen. Instead, at the last minute the House inserted a clause stipulating that nothing about the new law can be interpreted as relieving the sponsor of the obligation to “maintain its label in accordance with existing requirements.” Former FDA Deputy Commissioner Scott Gottlieb outlined the issue in yesterday’s Wall Street Journal and makes the case for why industry should be upset.

There is no doubt that the technical-sounding change is a setback for manufacturers facing liability suits. But the glass is still more than half full. Even without new product liability protections, the law should help manufacturers immensely by letting FDA rebuild its credibility as a regulator.

The tradeoff is clear: a tougher and more formally regulatory system that will restrict the market size for many new products. The payoff should come in the form of fewer rejections of pending applications, fewer nasty setbacks like the Avandia debacle or the Zelnorm withdrawal—and ultimately in fewer punitive actions by policymakers or juries who have lost faith in the ability of FDA to assure the safety of medicines.

It is not just product liability cases where the loss of faith in FDA’s credibility is costing the industry dearly. It is in product decisions made or not made, and in policy actions by state governments designed to step into the void. (The RPM Report took an in depth look at the cost of FDA’s credibility problems in this story. If you are not a subscriber, click here to register for a free 10-day trial.)

During the Food & Drug Law Institute advertising and promotion conference September 17, one session focused on a whole host of state legislative initiatives designed to clamp down on professional promotion by manufacturers. Pharmaceutical Research & Manufacturers of America VP Jan Faiks suggested that all of the legislative initiatives can be traced back to the premise that “FDA is in the pocket of the drug manufacturers and therefore the states must become mini-FDAs and do their own compliance and regulation.”

The new legislation holds that promise of reversing the impression that FDA just does industry’s bidding. In that end, that kind of FDA Defense may be even more valuable that a pre-emption clause.