Lame duck Food and Drug Administration Commissioner David Kessler, M.D., fought back last week against critics who say his agency has been unnecessarily slow in approving new drugs for use by consumers.
Kessler cited a study he and several other FDA staffers published in the Dec. 11 issue of the Journal of the American Medical Association as evidence the agency is no laggard in making new drugs available.
The study showed that the FDA far outdistanced German and Japanese regulators and edged United Kingdom authorities in the number of new drugs it approved first between 1990 and 1994 (See chart).
"It is fair to say the FDA is a world leader in drug review any way you look at it," Kessler said during a speech last week.
The pharmaceutical industry has long criticized the FDA for trailing other industrialized countries in getting new drugs to market. And despite recent improvements, drugmakers expressed concern that beefed-up FDA data requirements are ultimately slowing the entry of new drugs.
On Kessler's watch, the FDA has revised procedures to allow expedited approval of breakthrough drugs, such as AIDS and cancer therapies. And a 1992 law implementing industry user fees has added more than $350 million to the FDA's budget for drug reviews, the pharmaceutical industry estimates.
In return, the law imposed strict deadlines for FDA action that many observers credit with helping focus the agency on timely drug decisions.
"When the applications go in, the agency is doing its job," said Frank Hurley, chief scientific officer for Quintiles Transnational Corp., a Chapel Hill, N.C., company that assists drug companies with the FDA approval process.
For all the good news, drugmakers expressed concern the FDA is asking for more detailed applications that have added time to the drug development process, offsetting improvement in FDA review times. Hurley said requirements for larger and longer clinical trials often delay companies' submissions.
"What counts is the total time it takes to get the medicine from the lab into the pharmacy, and that time is getting longer," explained Alan Holmer, president of Pharmaceutical Research and Manufacturers of America, a drug trade group. By that measure, things are getting worse not better, Holmer said, citing a study by Tufts University that showed it took an average of 7.2 years between clinical trials and final FDA approval in 1994 and 199s5. That's up from an average of 5.5 years from 1990 to 1993.
"Kessler can lay claim to progress" especially for priority drugs, said David Saks, an analyst at Gruntal & Co., New York. "But there's a lot more that probably can be done."