Clamor over Approval Times Fans FDA Reform Debate

Article excerpt

Fact or fiction: There is a drug lag, and Americans are being denied lifesaving medicines--available first overseas--by a slow, overly protective U.S. Food & Drug Administration. In the past few months, the charges and counter charges have been flying. They are now taking on new importance because they go to the heart of the FDA reform debate. Congress this year is expected to vote on legislation proposing a massive overhaul of an agency whose regulatory sweep extends from caviar to lipstick, as well as medicines and devices from aspirin and antibiotics to tongue depressors and dialysis machines.

The divide over the drug lag was sharply etched at the same forum last month by two protagonists: Rep. Thomas Bliley (R, Va.), a former undertaker whose House Commerce Committee is drafting a reform bill, and David A. Kessler, the pediatrician with a law degree who has headed the FDA since 1990. Speaking at the annual meeting of the Food & Drug Law Institute, Bliley said, "It breaks my heart to see American citizens having to travel overseas to get the drugs and devices they need to stay alive. Yet, for thousands of Americans, the only way to gain access to an innovative, lifesaving drug or device--drugs and devices developed by American firms--is to go overseas to be part of a clinical trial."

Just moments earlier, Kessler had released a report comparing U.S. drug approval times with those of Germany, Great Britain, and Japan. "It is time to put to rest the incorrect perception that American patients generally suffer because of the so-called drug lag," Kessler declared. "In fact, a significant number of therapies that provide important health benefits are available in the United States but have yet to be approved elsewhere. If there is a drug lag, it is not in America."

Kessler also cited an earlier report by the General Accounting Office, the investigative arm of Congress, indicating that drug approval review times had declined in recent years (Drug Topics, Nov. 20, 1995). "We found a considerable reduction in approval times for NDAs [New Drug Applications] submitted in 1987 and 1992," GAO said. "It took an average of 33 months for NDAs submitted in 1987 to be approved but only 19 months on average to approve NDAs submitted in 1992. Further, the reduction in time was observed for all NDAs and not just for those that had been approved."

The Pharmaceutical Research & Manufacturers of America responded that the GAO report was "misleading" because it focused solely on N[)A review time. …