The House Energy and Commerce Committee made quick work of a bill (H.R. 3580) aimed at expediting the Food and Drug Administration’s (FDA) approval of medical devices and products. After a bipartisan compromise was reached, the committee unanimously approved the legislation by voice vote on October 1.
Sponsored by Reps. James Greenwood (R-PA) and Anna Eshoo (D-CA), the measure would establish a user fee program for producers of medical devices and products submitting their products for FDA review. Supporters of the legislation said that it would ensure the timely review and approval of products, thereby benefiting patients. Opponents countered that by fast-tracking products, patient safety could be compromised.
In addition to establishing the user fee program, H.R. 3580 would require 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 would be required under the legislation. One study by the Comptroller General would 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 would 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) also would be directed to submit a report to Congress on the status of research on breast implants. The NIH would be directed to conduct prospective or retrospective research to determine the long-term implications of saline and silicone breast implants.
