Senate gears up to debate FDA drug safety system

By Aliya Sternstein

April 30, 2007

Drug safety legislation up for debate in the Senate Monday afternoon would require pharmaceutical companies and the Food and Drug Administration to pool public and private reports of adverse drug reactions into one FDA computer system.

The proposal is part of a bill that would reauthorize and amend a program that collects fees from drug manufacturers for drug reviews and safety evaluations.

Negotiations to divvy up system responsibilities are ongoing, according to Craig Orfield, spokesman for Sen. Mike Enzi, R-Wyo., ranking member on the Senate Health, Education, Labor and Pensions Committee. The committee approved the program's reauthorization earlier this month.

"It is a work in progress. The development of the system, that burden, would be placed on the FDA," Orfield said. The FDA would be collaborating with private entities, as well as academic institutions, to aggregate mainly pre-existing data. It is anticipated the system would be operational within two years of the bill's enactment, he said. Up to $30 million in appropriations would go toward funding the project.

While many agree that additional drug safety surveillance is needed, the design of the system has watchdog groups concerned.

Arthur Levin, director of the nonprofit Center for Medical Consumers, said: "You can't prove causality by data mining. All you're doing is identifying [red flags]. Then you've got to go figure out the connection."

And he is skeptical that $30 million is enough to cover the cost of staffing, computational programming and extraction of useful data. "This may be a good first step. . .but it certainly doesn't go far enough. Much more has to be done," Levin added, saying that the "much more" has to do with where the analytic piece would be housed and where it would be paid for.

John Pippin, a senior medical and research adviser at the Physicians Committee for Responsible Medicine and a cardiologist, said, "The FDA has not yet shown the ability to establish effective computer-based methods. He cited the recent uncovering of a November 2006 report that detailed the FDA's mismanagement of an upgrade to its computerized adverse-event reporting system, which FDA staff use for post-marketing drug safety inspection. The system "was bungled, leading to cost overruns and major delays in implementation," he said.

Earlier this month, Alan Goldhammer, deputy vice president for regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said the industry wants drug review to be electronic from creation in the lab to sale on pharmacy shelves. As of Monday morning, PhRMA was not taking a position on specific provisions in the new legislation.

PhRMA President and CEO Billy Tauzin said in a statement on Friday, "Significant increases called for in PDUFA funding proposed by the FDA would provide the resources necessary to improve and modernize the agency's already strong drug safety monitoring system."

By Aliya Sternstein

April 30, 2007