On October 9, the House approved, 406-3, a bill (H.R. 3580) aimed at expediting the Food and Drug Administration’s (FDA) approval of medical devices and products. The measure was debated on the House floor on October 7 and approved by the House Energy and Commerce Committee on October 1 (see The Source, 10/4/02).
Sponsored by Reps. James Greenwood (R-PA) and Anna Eshoo (D-CA), the measure would establish a user fee program for medical device producers submitting their products for FDA review. The legislation would authorize a $225 million increase over five years for the FDA. Of that amount, $150 million would be generated by the user fee program and $75 million would be appropriated by Congress. Additionally, the user fee program would expire if Congress fails to appropriate $45 million during the first three years of the program.
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.
“When an industry is innovative, we need to ensure that their devices receive an efficient review by the Food and Drug Administration. The best way we can help is to provide the agency with more resources,” said Rep. Richard Burr (R-NC), adding, “This bill will do just that, by providing the FDA with more than $200 million over the next five years.”
Rep. Eshoo agreed, “The fees will help the FDA hire additional staff and purchase needed equipment so that they can review the products on a timely basis,” noting that the thrust of the bill is “ultimately about patients, patients in our country, about making sure that patients are able to safely benefit from the wonders of medical technology in a very timely manner.”
