On March 3, the House Energy and Commerce Committee approved, by voice vote, a bill (S. 1881) to make technical corrections to the Medical Device User Fee and Modernization Act of 2002 (P.L. 107-250). The Senate approved S. 1881 on November 25 (see The Source, 11/26/03). The House approved a similar measure (H.R. 3493) on January 27 (see The Source, 1/30/04).
The measure, in addition to making technical changes, would require the Secretary 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.
Prior to the final vote, the committee approved, by voice vote, a substitute amendment offered by Rep. Jim Greenwood (R-PA). The substitute 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 substitute 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 substitute 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.