On March 12, the Senate approved, by unanimous consent, 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 originally approved S. 1881 on November 25 (see The Source, 11/26/03). The House approved an amended version of the bill on March 10 (see The Source, 3/12/04). It will now go to the White House for President Bush’s signature.
Sponsored by Sen. Lamar Alexander (R-TN), the measure, in addition to making technical changes, would require the secretary of the Department 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.
