FDA vows transformation, better drug safety.

In response to mounting criticism of its effectiveness in protecting consumers from drug hazards, the FDA in January promised "a series of changes and improvements to its drug safety system." Andrewvon Eschenbach--who took office as the agency's 20th commissioner in December 2006--said in a press statement, "Our ongoing assessment of the drug and medical product safety system has affirmed that it is essential that our processes and scientific methods keep pace with the rapid evolution of science, technology, and the health care system."

The agency detailed a series of planned actions, including establishing committees, hiring consultants, sharing information with Department of Veterans Affairs hospitals, and initiating a pilot program to review postmarket drug safety.

The FDA came under fire last year in a widely publicized report by the Institute of Medicine (IOM), which had assessed the agency's drug safety programs at the FDA's request. The report noted that a "lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of postapproval data about drugs' risks and benefits have hampered the U.S. Food and Drug Administration's ability to evaluate and address the safety of prescription drugs after they have reached the market."

Other groups have found similar agency shortcomings. Surveys by the Union of Concerned Scientists revealed FDA scientists worried about the integrity of agency actions. (See Allison Torres Burtka, Jurors and FDA Scientists Lack Confidence in Agency, Surveys Say, TRIAL 20 (Oct. 2006).) The Government Accountability Office, which had been urged to investigate the FDA after the withdrawal of Vioxx, said in a March 2006 report that the agency "lacks a clear and effective process for making decisions about, and providing management oversight of, postmarket drug safety issues." (See Allison Torres Burtka, GAO Report Criticizes FDA Drug Safety Oversight, TRIAL 22 (July 2006).)

The IOM report made 25 recommendations to the FDA to improve drug safety, including concrete steps such as setting labeling requirements and advertising limits for new medications (including putting a "new drug" symbol on drug labels), clarifying regulatory authority and the FDA's role in gathering and communicating information about drugs' risks and benefits, requiring registration of clinical trial results, setting performance goals, and increasing staffing at the agency.

"To really understand what they're doing, you have to go back to the Institute of Medicine's report on all that's wrong with the agency," said Bert Black, a Minneapolis attorney who represents plaintiffs in pharmaceutical products litigation. "The FDA's response is pretty weak. They deny some of the problems, and they're only doing ineffective things about the others."

The FDA pinned some of the responsibility for fixing these problems on Congress. The agency said that reauthorizing the Prescription Drug User Fee Act (PDUFA) would allow it to respond to some of the IOM recommendations by increasing much-needed resources and funding for the agency.

The agency touted 18 actions it has instituted after its own internal assessment--eight of which are part of the proposed PDUFA. Instead of taxpayers paying for product reviews, "in the new [PDUFA], industry provides the funding in exchange for FDA agreement to meet drug-review performance goals, which emphasize timeliness," the agency explained in its January statement.

Black said the FDA operates at a "confluence of converging issues that makes it uniquely susceptible to not working well. It regulates an industry that really doesn't want to be regulated and has put a lot of money into avoiding it. We should be glad that they're doing at least something, but very worried and skeptical because it's so little."

Problems lie in the agency's management and organization, Black said, echoing the IOM and other FDA critics. And when the agency comes up with a solution, it follows old patterns rather than creating new ones, he added. For instance, the proposed review of drugs 18 months after they hit the market "is not the best way to do it."

A good plan for postmarket surveillance, he said, would be to establish a registry and require that for the first two years a drug is sold, every time it is prescribed it would be entered in the registry and the patient would be tracked to see what effects the drug had.

"You'd be getting 100 percent of the effects that way, rather than the 10 percent or so you get now with the voluntary reporting system," said Black. "But that's not what the FDA is talking about. It means taking the same look 18 months after marketing that it now takes before marketing. The problem is the lack of the right kind of information, not just a failure to look at it."

In March, the Wall Street Journal reported that a consultant's study found the FDA has bungled attempts to build a computer system to track postmarket data and will have to rely on its "dysfunctional" voluntary Adverse Event Reporting System for several more years. (Anna Wilde Mathews, Report on FDA Blasts Effort to Track New Drugs, Wall St. J. Al (Mar. 3-4, 2007).)