Pharmaceutical

FDA increases fees in hopes of improving medical device approval process

Medical device manufacturers will have to double the fees they pay to the Food and Drug Administration (FDA) in order to have their products reviewed over the next five years as part of a plan to provide faster, more thorough evaluations. The increase would allow the FDA to hire 200 new full-time employees within five years to assist with medical device evaluations. As part of the approval process, evaluators would be required to meet with device applicants midway through the review process in order to address concerns.

Medical device makers are in favor of a plan that would allow for faster approvals, arguing that the current approval process is often delayed by last minute requests for safety data and other information. This is balanced by the watchdog groups that have criticized the FDA’s expedited approval process for moderate risk medical devices, which allows products to be approved if they are similar to ones already on the market.

This accelerated approval process was singled out in particular after the recall of the DePuy ASR XL hip replacement and hip resurfacing systems due to a higher than expected number of failures. The devices, which were made of metal-on-metal parts, were also found to be leaching heavy metals into the bloodstream, potentially causing a type of blood poisoning known as metallosis. Many patients have had to undergo revision surgery to replace their defective hip implant.

Medical device makers have been negotiating with the FDA over the fee increase for more than a year. Prior to 2001, device companies paid no fees for reviews. The FDA says the fees are needed to ensure adequate staffing for proper review of these devices before they are allowed on the market.

Source: Business Week