Much Too Slow for Comfort : Federal review process of new drugs needs to wake up to reality

“For cancer and AIDS patients time is running out . . .” With those ominous words, a presidential advisory panel signaled the pressing need to slash the time it takes to get new drugs on the market in order to fight these life- threatening diseases. Right now the government’s tortuously long drug-approval process only adds to the grief cancer and AIDS victims already suffer.

The Bush Administration should move quickly to follow the panel’s recommendations. It now takes an average of seven years for an experimental drug to clear the government-testing process, time that adds little to the odds for survival for the hundreds of thousands of victims who face these ravaging diseases. The panel recommended modifying the criteria for evaluating a drug’s effectiveness to reduce the review process to five years .

In the case of AIDS, the Food & Drug Administration has shortened the review process by allowing for “compassionate use” distribution of some anti-viral drugs before they have been tested thoroughly. But critics rightly contend that this is not enough. In its report, the National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS recommended that Congress “give prompt attention to the inadequate resources, staff and facilities of the FDA.” It might also help if the Administration named a successor to Commissioner Frank E. Young, who resigned last year.

Speedier access to promising drugs is the only glimmer of hope for people who otherwise face certain death from AIDS and cancer. Granted, an accelerated approval process may expose patients to greater risks of unforeseen side effects or even to drugs that eventually may be found to be ineffective. But as the panel concluded, “Faced with the consequences of a lack of therapy for AIDS and cancer, an expanded mechanism for early access to investigational drugs is morally, ethically and scientifically justified.” The only choice now is to expedite the process.