FDA initiative aimed to speed product review

Rockville, Md.-

The Food and Drug Administration (FDA) unveiled a broad initiative to help make pioneering medical technologies in veterinary and human medicine available sooner.

FDA's strategy was outlined in the report, "Improving Innovationin Medical Technology: Beyond 2002," released Jan. 31. It would reducethe costs of developing safe and effective medical products while maintainingFDA's traditional standards of consumer protection, according to the agency.

The plan bundles all four of FDA's medical product review centers (drugs,biologics, devices and veterinary medicine).

To achieve the goals, the initiative hinges on three actions:

* Reduce delays and avoidable product development costs by avoidingmultiple FDA review cycles when possible through early communication andsteps to improve product application quality.

* Improve the quality and efficiency of the review process byadopting a quality systems approach to medical product reviews.

* Facilitate new product development by providing clear updatedguidance for diseases and emerging technologies.

The report summarized FDA's product review performance in 2002, gradingthe agency with mixed marks. Total products approved increased, includingnew antimicrobials for cattle and swine, and a chewable tablet for painand inflammation in dogs. Some product areas carried longer approval times,but approval times for significant new animal drug applications decreased.

FDA Commissioner Mark B. McClellan, MD, Ph.D., commended the agency forapproving various new medical products in 2002. However, he raised concernsover a noted decline in product applications from some key manufacturers,which contributed to increased average and median review times.

"There is some evidence that this finding is a result of technologydevelopment becoming more costly, and reorienting to new areas as a resultof breakthroughs in basic research," says McClellan. "These resultscall for decisive action now, so that the trends of the future are not towardfewer products with higher development costs."

Many of FDA's initiatives will be developed in collaboration with othergovernment agencies and expert groups, including the National Institutesof Health.

To address marketing delays and increasing product development and reviewcosts, the agency will analyze the root causes of product approvals thatrequire more than one review cycle. FDA believes it can help speed potentiallyimportant emerging technologies to the market by reducing regulatory uncertaintyand increasing the predictability of product development.

A spokesperson from the FDA's Center for Veterinary Medicine was unavailablefor comment.

The FDA's report can be found on its Web site at www.fda.gov/bbs/topics/NEWS/2003/beyond2002/report.html.