Jane Henney wins panel approval to lead FDA

November 1, 1998

Pharmaceutical Representative

The Senate Labor and Human Resources Committee approved the nomination of Jane Henney, M.D. to lead the Food and Drug Administration.

The Senate Labor and Human Resources Committee approved the nomination of Jane Henney, M.D. to lead the Food and Drug Administration.

Henney, vice president of health sciences at the University of New Mexico and former deputy director of the National Cancer Institute, still needs to win the approval of the Senate in order to assume the responsibilities of FDA commissioner. However, panel approval signifies a promising outcome for the nominee.

The position of commissioner has been vacant since February 1997, when the controversial David Kessler resigned. In the interim, as officials considered potential candidates, Michael Friedman, M.D. carried out the duties of the office. Henney served under Kessler as deputy commissioner from 1992 to 1994.

In panel questioning sessions, Henney addressed pre- and post-marketing drug safety requirements, expressed her willingness to carry out the intent of the FDA Modernization Act and addressed her stance on controversial drugs such as the abortifacient RU486.

Questions about drug safety were prominent in the approval process because of recent product withdrawals, including Posicor and Duract. The Food and Drug Administration has been working to attain more resources to pursue post-marketing surveillance projects. Henney indicated she would need to study the agency's post-marketing surveillance program before reaching a decision, but endorsed the agency for the stringent pre-approval standards it already has in place.

"In my opinion, the FDA's current pre-approval requirements for showing drug safety are adequate," Henney said.

Henney's willingness to approve drugs such as RU486 lost her the support of one panel member. Sen. Michael Enzi (R-WY) cast the sole vote against Henney because of her attitude regarding the product. PR

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