On March 10, the House approved, 396-0, a bill (S. 1881) to make technical corrections to the Medical Device User Fee and Modernization Act of 2002 (P.L. 107-250). The House Energy and Commerce Committee approved the measure on March 3 (see The Source, 3/5/04). The Senate approved S. 1881 on November 25 (see The Source, 11/26/03). It will now go to the White House for President Bush’s signature.
The measure, in addition to making technical changes, would require the secretary of the Department of Health and Human Services (HHS) to submit a report to Congress on the availability of medical devices intended for the treatment or diagnosis of diseases and conditions that affect children. In the report, the secretary should include recommendations on how to encourage the invention and development of such devices.
S. 1881 would prohibit the Food and Drug Administration (FDA) from raising medical device user fees by more than is necessary to cover increased costs for the devices. The bill also would bar manufacturers who receive a fee exemption for producing devices intended for children from selling the device for more than the cost of research, fabrication, and distribution. Finally, the measure would direct the HHS secretary to study whether the Food, Drug, and Cosmetic Act has succeeded in encouraging the development of devices intended to treat diseases or conditions that affect fewer than 4,000 children.
Rep. James Greenwood (R-PA), sponsor of the original bill in 2002, stated, “Medical devices are some of our health care system’s most remarkable innovations. The provisions in this technical and clarifying amendments bill will allow the FDA to continue to reduce review times, increase the efficiency of its operations, and allow these wonderful technologies to be delivered to patients more quickly.”
Rep. Sherrod Brown (D-OH) lauded passage of S. 1881, but warned, “The need for noncontroversial technical corrections is not the only obstacle preventing the medical device user program from fulfilling its potential. It is important for colleagues on both sides of the aisle to be aware that continuation of the user fee program…hinges on the appropriations process. User fees do no incremental good if they supplant rather supplement Federal spending…Last year’s appropriation was insufficient to sustain the medical device user fee program. If this year’s appropriation does not address this shortfall, the user fee program could very well fold.”
