FDA Reform: Critics Still Unsatisfied

Even though outgoing US Food and Drug Administration Commissioner DavidKessler speeded up the approval process for drugs and medical devices, it seems that the approval process is not yet fast or simple enough to satisfy its critics. At the same time, consumer groups want the FDA to tighten its actions against those who work outside the rules.

The Pharmaceutical Research & Manufacturers of America's top priority is renewing the user fee legislation, which has helped cut approval time from 30 months to 18 months in the four years it has been on the books, a PhRMA spokesman told Reuters. Still, the goal set by Congress is six months, and if the process is to improve, the law must be renewed. A sharp reduction in the data required for drug approvals is also needed, he said; applications can run to 100,000-200,000 pages. Also, a better harmonization of worldwide approval standards will make it easier for industrial nations to accept another country's drug trials and documentation.

The Health Industry Manufacturers Association also wants faster approvals, said HIMA senior vice president for technology and regulatory affairs, James Benson. A large part of the problem is the many details required for new applications. The FDA has done a good job of meeting the 90-day review deadline for devices with known risks, but problems arise when an application has to be revised. When the FDA seeks more data, the clock stops and goes back to zero. For high-tech products the required timetable is 180 days, but approvals can take up to 700 days.