CFSAN budget, user fees among 140 FDA questions for Henney from Senate.

FDA COLOR ADDITIVE REGULATION SUBJECT OF LABOR COMMITTEE INQUIRY to FDA Commissioner-nominee Jane Henney, MD, forwarded by Senate Labor & Human Resources Committee Chairman James Jeffords (R-Vt.) July 31. Among a list of 140 questions posed for the committee's review prior to a confirmation hearing with Henney, the nominee is asked: "What priority would you assign to the modernization of scientific standards for food additives, color and animal drugs."

The question is in the context of the Delaney Clause (de minimis standards) and whether FDA identified any "problems" with the 1996 congressional action to replace the agency's blanket pesticide residue standard under Delaney with a focused, scientifically-based standard for measuring harm.

With regard to the Center for Food Safety & Applied Nutrition, Jeffords says "the repeated use of unapproved user fees to provide the appearance of a higher program level for CFSAN in annual budget submissions raises serious questions regarding the Administration's commitment to this center's national responsibilities. As further evidence of the Administration's neglect of CFSAN," Jeffords cites Interim Deputy Commissioner of Operations Linda Suydam during 1995 congressional testimony. "Officials at FDA," the senator says, "have testified that resources have been shifted away from the center to support user-fee funded activities, in particular drug reviews."

As she would be a participant in the Administration's budget request each year, Henney is asked by the Labor Committee chairman if FDA "served as the primary advocate for user fees as a funding source of CFSAN? If not, who champions that recommendation and what was the basis for selecting that funding source? As FDA commissioner, how do you expect to reconcile the Administration's low budget priority for CFSAN with its high expectations in the area of food safety regulation?"

User fees in the cosmetics area became an issue during the most recent FDA appropriations debate. The Senate Appropriations bill (S 2159) includes a user fee amendment, sponsored by Sen. Dale Bumpers (D-Ark.) and Thad Cochran (R-Miss.), banning unauthorized user fees for FY 2000. The Cosmetic, Toiletry and Fragrance Association submitted testimony to the House Appropriations/Agriculture Subcommittee hearing stating that funding for the center's cosmetic activities "should be provided through increased appropriations rather than through reallocation of existing resources or through user fees" ("The Rose Sheet" April 6, p. 3). A date for a House and Senate conference to rectify the two appropriations bills has not been set.

The majority of Jeffords' questions, however, center around issues related to the implementation of the FDA Modernization Act; the Vermont Republican has said he intends to use the confirmation process as the primary mechanism for oversight of the implementation of FDAMA.

Nonetheless, the question list does include several more politically sensitive topics that could pose significant obstacles if they become the primary focus of the confirmation process. The committee plans to hold the confirmation hearing Sept. 1 assuming Henney is able to respond to the question list by a timely date.

Sen. Dan Coats (R-Ind.) has been said to be the committee member most interested in raising the question about FDA approval of RU-486 in light of the agency's mission to protect the public health as part of any hearings for Henney. She apparently was not involved in the solicitation of the RU-486 application during her first tenure at FDA from 1992-94 and is said to believe it is not the agency's role to solicit applications, especially where a social controversy exists. The Administration is understood to believe the RU-486 issue will not be a major obstacle in the confirmation process.

A long section of the questionnaire seeks to pin down Henney's position on the agency's tobacco proposal and on related issues, such as the use of tax revenues from cigarettes. The committee also asked Henney whether the tobacco initiative will draw resources from other agency functions.

Human cloning is another politically sensitive topic raised by the committee. Henney is asked for her position on the acceptability of human cloning and the extent of FDA's jurisdiction in the field. She is asked to specify what section of the FD&C Act gives FDA authority over human cloning and whether it would be considered a drug, biologic, combination, cell or tissue.