The Clinton Administration's budget for FY 2001, released Feb. 7, would allocate $2.5 mil. to CFSAN for an adverse event monitoring system for dietary supplements.

In a talk paper discussing the budget request, FDA notes it must be "prepared to track any adverse events reported to the agency in order to protect the mushrooming number of Americans who rely on dietary supplements to enhance their quality of life and health." To accomplish this goal, the agency needs a "modern, integrated science-based system for monitoring and evaluation."

The Center for Food Safety & Applied Nutrition had requested the same amount for fiscal 2000, but did not receive the funding in the final version of the bill. At a Consumer Healthcare Products Association regulatory forum on dietary supplements Jan. 13, CFSAN Director Joseph Levitt promised to intensify his efforts to obtain funding for the system.

The center's AE monitoring system for supplements came under attack at a May 27 House Government Reform Committee hearing, during which committee Chairman Dan Burton (R-Ind.) criticized the program, in part, for not clarifying whether AERs are serious, moderate or mild and for not being purged of incorrect information (¹ Also see "CFSAN AE Monitoring System To Receive $2.5 Mil., Contractor Help - Levitt" - Pink Sheet, 31 May, 1999.).

The FY 2001 budget request also calls for a $1.7 mil. discretionary increase in inspectional activities for supplements, pesticides and chemical contaminants. Such appropriations will be on an "as needed" basis, and will largely cover expenses for laboratory work.

Under the heading "bringing new technologies to market," CFSAN is requesting an additional $200,000 to improve its science base and "start getting academia and other groups involved" with dietary supplements, Levitt said at a Feb. 7 briefing.

The three line items are the only ones pertaining to supplements specifically described in a CFSAN summary of requested budget increases for FY 2001. Funding levels for other supplement-related issues highlighted by CFSAN in its 2000 priorities and 10-year strategic plan are not provided in the budget documents (² Also see "Dietary Supplement Enforcement Procedure Streamlining Planned By CFSAN" - Pink Sheet, 14 February, 2000.).

Overall, the foods program would receive $302.6 mil. in budget authority for 2001; including user fees, it would be allocated $328.9 mil. CFSAN's share is $162 mil., while field activities are slated to receive $167 mil. The food safety initiative would receive a $30 mil. boost and 131 FTEs under the proposal.

CFSAN is requesting $5 mil. to continue construction on new facilities in College Park, Md. Levitt said the center aims to move to the new site on Oct. 1, 2001.

The budget would allocate $235 mil. for human drugs; including user fees totaling $94.8 mil., the drug program would receive $329.8 mil. in FY 2001. Nearly $250 mil. would go to the Center for Drug Evaluation & Research while the remaining $81 mil. would go toward field activities.

Including user fees, FDA as a whole would receive $1.39 bil. for the fiscal year, up $163.2 mil., or 13.3%. The Prescription Drug User Fee Act would levy $149.3 mil. in fees while food additive petition user fees, food export certificate user fees and premarket medical device user fees would total $19.5 mil. The remaining fees would go toward biologics.

As part of the funding, FDA hopes to receive a $10 mil. increase to monitor Internet sales of drugs. While the thrust of its activities would focus on Rx medications, the agency also could focus its efforts on Web sites selling supplements with unapproved claims. FDA's own Web site recently began allowing consumers to electronically report sites that may be illegally selling drugs, supplements or medical devices (³ Also see "FDA Web site" - Pink Sheet, 3 January, 2000.).

The President's budget also proposes allocating $1 mil. to the University of South Alabama for its birth defects monitoring and prevention activities under the Centers for Disease Control & Prevention. A bill that would provide $20 mil. for an educational campaign on the benefits of folic acid was introduced in the House July 15 (⁴ Also see "Folic Acid Awareness Campaign Supported By $20 Mil. Proposed In House Bill" - Pink Sheet, 19 July, 1999.).

The National Center for Complementary & Alternative Medicine would receive $71.4 mil. in FY 2001; the center received $68.8 mil. in fiscal 2000. The budget would provide the National Institutes of Health with $18.81 bil. overall.

Other programs funded under the budget include the Special Supplemental Food Program for Women, Infants & Children, which would be allocated $4.15 bil. The budget also contains a provision that would require states to "cover prescription and non-prescription smoking cessation drugs for Medicaid beneficiaries."

Supplement AE Monitoring System Would Receive $2.5 Mil. In 2001 Budget

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