House and Senate negotiators were able to work out differences on legislation (H.R. 5651) to create a new user fee program at the Food and Drug Administration (FDA) to speed the approval of medical devices. As a result, the House approved the measure by unanimous consent on October 16. The Senate approved the compromise on October 17 by unanimous consent, sending it to the President’s desk.
Sponsored by Reps. James Greenwood (R-PA) and Anna Eshoo (D-CA), the measure establishes a user fee program for medical device producers submitting their products for FDA review. The final legislation authorizes a $225 million increase over ten years for the FDA. Of that amount, medical device manufacturers will pay $150 million in fees over five years. Additionally, the user fee program will expire if Congress fails to appropriate $60 million during the first five years of the program.
The original House-passed measure (H.R. 3450) would have authorized $225 million over five years for the user fee program and would have sunset the program if Congress failed to appropriate $45 million over the first three years (see The Source, 10/11/02) .
In addition to establishing the user fee program, H.R. 3450 requires the Institute of Medicine to conduct a study on whether the FDA’s post-market surveillance system for medical devices provides adequate safeguards for the use of these devices in pediatric populations.
Several studies on breast implants also are required under the legislation. One study by the Comptroller General will determine the content of information provided by health professionals to women seeking breast implant surgery, whether that information was provided verbally or in writing, whether the information presented a fair and balanced assessment of the risks and benefits from the surgery, and whether the women understood the information. The study also will examine the number of adverse events associated with the implants that have been reported and whether those events were adequately investigated.
The National Institutes of Health (NIH) is directed to submit a report to Congress on the status of research on breast implants. The NIH is directed to conduct prospective or retrospective research to determine the long-term implications of saline and silicone breast implants.
