3 Lawmakers Seek to Delay Effort to Accelerate FDA Drug Approval

The chairmen of three key congressional panels Wednesday urged Food and Drug Administration Commissioner David A. Kessler to delay implementing major reforms in the drug approval process while they study the proposals.

Sen. Edward M. Kennedy (D-Mass.), chairman of the Senate Labor and Human Resources Committee, and Reps. John D. Dingell (D-Mich.), chairman of the House Energy and Commerce Committee, and Henry A. Waxman (D-Los Angeles), chairman of the energy panel’s subcommittee on health and the environment, said that they have “serious concerns” about certain elements of the plan.

The three, who head panels that specifically deal with the FDA and its regulatory authority, said that they support the plan to speed new drugs for life-threatening and other serious conditions, such as AIDS and cancer.

But they questioned the need to accelerate the process for all other drugs, particularly the proposals that would allow drug review by outside organizations under contract to the FDA, or would rely on safety and efficacy data gathered by foreign governments.

”. . . The use of any prescription drug entails a risk of life-threatening adverse reactions,” the lawmakers wrote in a letter to Kessler. “These risks will be compounded if decisions about safety and efficacy are delegated to private contractors or foreign governments.”

A spokesman for Vice President Dan Quayle, who announced the reforms Wednesday, said that the Bush Administration does not intend to wait.

“We will always consult with Congress, but we do not need their permission to institute these reforms,” said Jeff Nesbit, a Quayle spokesman.

The lawmakers said that they fear the proposals are “thinly veiled efforts to weaken the agency.

The recommendations were drawn up by the Council on Competitiveness, a special panel headed by Quayle and established by President Bush to review the policies and practices of federal agencies, and assess their impact on the economy.