FDA's CRITICAL PATH LOOKING AT DEVICES, BUT PROJECT FACES DELAYS

The FDA's much-touted Critical Path Initiative for drug development also could bring greater efficiency to the device approval process, but limited agency funding and multiple controversies have delayed the initiative, according to agency officials and device industry sources.

The agency has long been concerned about the lack of new drugs making it to market, said Larry Kessler, director of the FDA's Office of Science and Engineering Laboratories. The FDA also believes efforts to introduce new devices can be improved, he said during a recent presentation before the agency's dental products medical devices advisory panel.

The Critical Path Initiative, announced in March 2004, seeks to use biomarkers and new technologies to weed out unsuccessful candidates early in the development process. But a lack of agency funding has delayed the initiative, according to Kessler and industry representatives.

Recent controversies over the FDA's relationship with industry also have added to the delay, said Mark Brager, spokesman for the Advanced Medical Technology Association. For example, the FDA has been under fire for how it handled problems with implantable cardioverter defibrillators (ICDs). Lawmakers on both sides of the aisle have used the controversy to allege that the FDA is too close to industry.

But recent controversies point to the need for greater collaboration between the FDA and industry, Kessler said. Problems with ICDs are the "poster child" for development of a process that ensures products are manufactured with more consistent quality, Kessler added. Such a process, known as industrialization, along with methods for assessing safety and effectiveness of products, make up the Critical Path program.