FDA Commissioner Henney to Oversee FDAMA Implementation As First Priority

FDA Commissioner-elect Jane Henney, MD, will have about one month at the agency before the Nov. 21 deadline for a dozen regulations and guidances required under the FDA Modernization Act.

Confirmed by the Senate Oct. 21, Henney is expected to be sworn in as commissioner the week of Oct. 26. She will have an opportunity to offer last-minute input into a series of regulations the agency is supposed to complete in time for the one-year anniversary of the passage of FDAMA.

As commissioner, Henney will oversee the final rule on material time/material extent regs for foreign data and OTC sunscreen products, the latter due out before June 1, 1999. She also could be in place for any attempts to revise the Dietary Supplement Health & Education Act.

While the confirmation of Henney will inevitably lead to some changes at the top level of FDA, it may not have much impact on the center-level management. Henney was involved in recruiting five of the six center directors during her previous tenure as deputy commissioner for operations from 1992 to 1994.

Her confirmation came one day after Senate Majority Whip Don Nickles (R-Okla.) lifted a block on the nomination after receiving assurances from the Administration and the nominee about issues related to the abortifacient RU-486, other abortion issues and tobacco ("The Tan Sheet" Oct. 19, p. 10).

In an Oct. 20 floor statement, Nickles complained that under the regime of former Commissioner David Kessler, MD, FDA "too often became a tool of the Administration to push its liberal political agenda."

However, Nickles said, after discussions with Henney, he came to believe the nominee "will try to administer [FDA] as a professional organization to make sure that drugs and medical devices are safe and effective for America's population, and that she won't try to implement legislation through regulation."

In an Oct. 21 statement, Henney emphasized that discussions with members of the Senate "over the past several weeks have reaffirmed my belief that the FDA serves as a non-partisan arbiter of public policy, with decisions that are grounded in science and law."

Henney repeated that her "priority as commissioner will be to implement [FDAMA] and to strengthen the agency's scientific base to ensure the best science guides the critical decisions that need to be made.