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.