WASHINGTON -- Armed with assurances from Secretary of Health and Human Services Donna Shalala and from the nominee herself, Senate Majority Whip Don Nickles (R-Okla.) withdrew his objections to Jane Henney's nomination for FDA commissioner.
In a statement on the Senate floor, Nickles said that as a result of correspondence and conversations with Shalala and Henney, he was satisfied that Henney was up to the job of heading the agency and encouraged his colleagues to approve her nomination.
Two weeks ago, Nickles stalled Henney's nomination over concerns that Henney intended to legislate via regulation. Nickles identified the FDA's regulation of tobacco and the approval of the French abortion pill, RU-486, as the most troubling issues.
The FDA has operated without a confirmed commissioner since David Kessler left the post for Yale University Medical School in February 1997.
Nickles said he had received assurances form Henney and Shalala that Henney would not attempt to usurp legislative power from Congress via regulations. His withdrawal of the roadblock puts Henney's nomination back on track for confirmation before the Senate adjourns for the year.
"It truly is time to have a confirmed commissioner in place," said Carl Feldbaum, president of the Biotechnology Industry Organization. "[Nickles' objection] was the last stand against Dr. Henney."
Since Kessler's departure, Michael Friedman has steered the agency through FDA reform and the Prescription Drug and User Fee Act reauthorization, as well as the initial implementation of FDA reform -- all to rave reviews from the biotechnology and pharmaceutical sectors. However, as acting commissioner, Friedman doesn't pull as much weight during key budget battles, Feldbaum said.
"Despite Dr. Friedman's great ability and performance, being confirmed makes some difference," Feldbaum said. "It's a significant moment. As we move toward the implementation of the law that we've worked on these past three years, we need a confirmed head of the agency to address issues of FDA appropriations."
With the objections to Henney seemingly out of the way, several industry sources are predicting that Henney could be confirmed as commissioner Tuesday night or Wednesday morning.
"Chances are, it's going to happen, and when it does, it will come as a unanimous consent motion," one industry source said. "But then again, with this Senate, you never know."
Henney is currently vice president for health sciences at the University of New Mexico in Albuquerque. Prior to accepting that post, Henney, an oncologist, served two years as deputy commissioner for operations at the FDA. Henney received her medical training at the Indiana University School of Medicine, in Indianapolis, and her oncology training at M.D. Anderson Hospital and Tumor Institute, in Houston.
Before she joined the FDA, Henney served as deputy director of the National Cancer Institute and as vice chancellor for programs and policy at the University of Kansas Medical Center, in Kansas City. She currently serves on the National Institutes of Health (NIH) advisory committee to the director and on the NIH's biotechnology committee. *