FDA seeks to clear away obstacles to drug development

Drug companies pledge to work on producing more breakthrough medications, but a watchdog group says the industry has been creating "me-too" products instead.

By Susan J. Landers, AMNews staff. April 12, 2004.

Washington -- Troubled by the trickle of innovative drugs in the nation's pharmaceutical pipeline, the Food and Drug Administration is offering a helping hand to speed research findings from bench to bedside.

"Many of the most dramatic scientific findings in the lab have not yet had an impact on patient care," said FDA commissioner Mark B. McClellan, MD, PhD, when unveiling the recommendations on March 16.

Despite an explosion in genomics, proteomics, nanotechnology and next-generation information technology, fewer new products are actually reaching the FDA, he said.

To spur on the process, the FDA will hold workshops and other meetings to discuss ideas, said Dr. McClellan in a briefing on the agency report, "Challenge and Opportunity on the Critical Path to New Medical Products."

The agency is well-positioned to provide help because few other groups are able to see the broad picture of drug development, according to the report. The FDA can determine why some products fail while others succeed and can provide advice that would enable firms to avoid pitfalls.

"We think by identifying concrete examples of obstacles on the path from good ideas to safe and effective treatment, we can work much more effectively with outside groups," said Dr. McClellan.

He said the FDA intends to take on roles similar to those held in previous years that resulted in:

• Development of new animal models for assessing safety and efficacy of medicines to combat anthrax, smallpox and other possible bioterror agents.