CRITICAL PATH INITIATIVE SLOWED BY FUNDING SHORTFALLS, CONTROVERSIES

The FDA's Critical Path Initiative, which is supposed to speed the introduction of new products to market, is being held back by limited agency funding, as well as several ongoing controversies, according to agency and industry officials.

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 believes efforts to introduce new devices can be improved as well, he said during a recent presentation before the agency's dental products medical devices advisory panel.

Aiming to speed such products to market, the FDA introduced the Critical Path Initiative in March 2004, which seeks to use biomarkers and new technologies to weed out unsuccessful candidates early in the development process. But while details have become available about the plan since last year, the agency has yet to implement the initiative. Funding levels have played a role in the delay, according to Kessler and industry representatives.

Recent controversies over the FDA's relationship with industry have also delayed the initiative, said Mark Brager, spokesman for the Advanced Medical Technology Association. For example, the FDA has been under fire for how it handled problems with Vioxx (rofecoxib) and implantable cardioverter defibrillators (ICDs). Lawmakers on both sides of the aisle have used these controversies to allege that the FDA is too close to industry. Such scrutiny only chills any agency efforts to collaborate with industry, Brager said.

But recent controversies point to the need for greater collaboration, 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.