Congress likely to approve FDA prescription drug safety reforms in 2007

The Baltimore Sun on Friday examined how Democrats' takeover of Congress and the expiration of a law that requires drug manufacturers to pay user fees to FDA "is driving a flurry of activity that could lead to major changes" in the agency's drug safety policies.

The 2004 market withdrawal of Vioxx because of safety issues led to a number of initiatives that did not "radically alter the way the government handles new drugs," the Sun reports. However, FDA officials last month "kicked off the recent spate of proposals" with a plan that would increase user fees to pay for the safety monitoring of drugs after they reach the market. FDA officials also proposed new user fees to cover the cost of reviewing direct-to-consumer advertisements. Last week, FDA officials announced additional safety measures, including a pilot program to monitor the side effects of recently approved drugs; a newsletter about the medicines; and a program to detect side effects by studying large medical databases. FDA critics have said that the agency's proposals "were really designed to pre-empt more radical moves by Congress," the Sun reports. Sens. Chuck Grassley (R-Iowa) and Christopher Dodd (D-Conn.) are sponsoring a bill (S 467) that would create an independent office at FDA to monitor the safety of drugs that have reached the market. A separate proposal (S 484) by Senate Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.) and ranking member Michael Enzi (R-Wyo.) would require drug regulators and companies to develop plans to monitor each new drug for side effects during its first three years on the market. In addition, a coalition of drug companies, advocacy groups and former policymakers is urging Congress to raise funding by $40 million per year for five years. President Bush's fiscal year 2008 budget proposal includes an additional $11 million for drug safety.

"If you're going to be serious about drug safety, you've got to spend the money. You can't do this on the cheap," said William K. Hubbard, a former FDA associate commissioner who is helping the coalition. Sheila Burke, who chaired an Institute of Medicine panel that last year recommended changes at FDA, said, "You have an odd configuration of the stars that may lend itself to resolution this year." Grassley said, "Congress will act on FDA-related legislation this year, and meaningful structural reforms to the agency need to be a part of what Congress does with regard to drug safety." Kennedy in a statement said, "We need a more effective system to identify and assess the serious risks of drugs, inform health care providers and patients about such risks, and manage or mitigate these risks as soon as they are detected." Scott Lassman, senior assistant general counsel for the Pharmaceutical Research and Manufacturers of America, said, "What FDA needs is not new authority. What it needs is more resources and a more modernized approach, and that's what [the agency's user fee proposal] would do" (Rockoff, Baltimore Sun, 2/9).