Appropriations Report Reminds FDA To Notify Congress Of Drug Safety Changes

Congress' omnibus spending bill conference report chastises FDA for failing to promptly provide documents to House and Senate Appropriations Committees.

"The conferees find it necessary to remind" FDA "that the committees on Appropriations perform critical oversight functions for the agency," the report states. "The ultimate expression of this oversight is the funding decisions for the agency and accompanying language in the statement of managers."

"The conferees expect that members of Congress will be provided requested information from FDA so that the committees can perform their oversight function. It is insupportable that in some cases FDA has given information about major policy matters to the press before providing the same information to Congress."

The spending bill (HR 4818) was approved by the House and Senate Nov. 20.

The language in the conference report stems from FDA's response to concerns raised by the Vioxx withdrawal and the review of antidepressant safety.

The omnibus bill also references FDA's ongoing efforts to address concerns about how the agency handles drug safety issues.

The centerpiece of the agency's five-part drug safety initiative is an Institute of Medicine study of the post-marketing safety regulatory system (¹ (Also see "FDA Drug Safety Review Will Consider Pros And Cons Of Separate Safety Agency" - Pink Sheet, 5 Nov, 2004.)).

"The conferees direct FDA to regularly advise the committees about any changes that FDA anticipates regarding drug safety, and to provide the committees with regular progress reports on the IoM review and with a copy of the IoM report as soon as it is completed," the report states.

Senate Finance Committee Chair Chuck Grassley (R-Iowa) supports greater separation between FDA's Office of New Drugs and Office of Drug Safety (see ² (Also see "Sen. Grassley Plans Legislation On Independence Of FDA Drug Safety Office" - Pink Sheet, 23 Nov, 2004.) ).

- Tericke Blanchard