Information and Resources

Holes in U.S. Drug Safety Net

Dec. 5, 2005 - Millions of Americans unknowingly risk rare but serious drug side effects, Consumer Reports says.

In its January 2006 issue, the independent consumer magazine points to a dozen common prescription drugs linked to serious risks -- including death. These risks, the article says, were "undetected or underestimated when the FDA approved them for use."

The issue isn't these 12 drugs. For people who need them, their benefits outweigh their risks. What's flawed is the U.S. drug safety system, says Marvin M. Lipman, MD, chief medical advisor for Consumers Union and emeritus professor of medicine at New York Medical College, Valhalla.

"This is a report that criticizes not only the preapproval process, but also the postapproval surveillance system," Lipman tells WebMD.

System Geared for Approval

Once upon a time, the FDA was very slow to approve new drugs. That changed in the early '90s, when Congress passed the Prescription Drug User Fee Act (PDUFA). The law gave the FDA deadlines for making approval decisions. In return, it charged drug companies fees used to hire new drug reviewers.

The Consumer Reports article quotes a former FDA reviewer as saying that the tight deadlines were frustrating. Indeed, a 2003 HHS survey found that 20% of FDA reviewers said they felt pressured to recommend approval despite reservations.

"The relationship of the FDA to the pharmaceutical industry has to be examined very closely," Lipman says. "Under the PDUFA law, a lot of money is paid by the drug companies to have their drugs reviewed. There is something inherently bad about that. It doesn't smell right."

Drug Industry Reaction

Jeff Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA), says PDUFA fees improve drug safety.

"PDUFA has raised hundreds of millions of dollars for FDA in a time when Congress has approved only stagnant funding, even though regulators' duties have expanded dramatically," Trewhitt tells WebMD. "PDUFA money is also being used to increase staffing in the Office of Drug Safety at FDA. It's recently allowed FDA to double the number of safety officers from 100 to 206 officers."

And Trewhitt notes that fewer than 3% of drugs are withdrawn from the market due to safety concerns -- a rate that hasn't changed since PDUFA took effect.

Laurence B. Gardner, MD, chairman of the department of medicine at the University of Miami Miller School of Medicine, agrees with most of the points made by the Consumer Reports article. But he says the FDA's preapproval process isn't the problem.

"Consumer Reports implies that people at the FDA rush approvals through and don't look at safety data," Gardner tells WebMD. "But we are still the safest country in the world when it comes to drug approval. That being said, there are a lot of issues with our health care system. And current regulations don't protect the consumer."