The Food and Drug Administration takes too long to review new drugs for treating AIDS and cancer, the chairman of a presidential committee that has been reviewing the FDA said yesterday in recommending a significant overhaul of its procedures.
"The current procedures simply don't work well," said Louis Lasagna, chairman of the National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS. "The agency has been more demanding on occasion than it needed to be."
Lasagna, a Tufts University pharmacologist who has been a consultant to the drug industry, said the recommendations could cut "a couple of years" off the time from when clinical trials are begun to when a drug is finally approved. He said that process now takes an average of seven years.
The FDA said in a statement that it had already taken major steps to speed the drug-evaluation process. It noted that the approval of the AIDS drug AZT had been the fastest in its history.
The presidential committee's final report, released yesterday, calls for an independent committee to monitor the way the FDA regulates and approves drugs. It also recommends that the FDA rely more heavily on outside experts and said the agency's technical advisory committee system, in which outside experts review adverse reactions and some drug applications, needs a "fundamental restructuring" including having independent staffs and reporting directly to the FDA commissioner.
The committee also recommended that insurance companies and Medicare and Medicaid provide identical coverage nationwide for all investigational and ancillary medical care for cancer and AIDS patients. Such coverage now varies from state to state.
"We strongly oppose the current anarchy" in coverage, Lasagna said. "While the insurance folks . . . strongly deny that economics is a problem, in fact we all know that it is."
The committee also suggested that drug companies be given the option of hiring independent contractors to review their new drug applications and to present a report to the FDA instead of waiting for the agency to go through the entire process.
Some consumer advocates question the wisdom of taking such a review away from the FDA.
"To set up these outside extra-governmental, psuedo-regulatory bodies is to ask for trouble," said Sidney Wolfe, director of the Public Citizen Health Research Group. "Industry, directly or indirectly, is not capable of regulating itself."