By Lisa Seachrist

Washington Editor

WASHINGTON — Ending speculation that began as early as last November, President Clinton confirmed Tuesday he will nominate the University of New Mexico's Jane Henney as FDA commissioner — a post that has been left vacant since former commissioner David Kessler left to head Yale University's medical school in February 1997.

The nomination will set the stage for confirmation hearings by the Senate's Labor and Human Resources Committee. Should Henney win Senate confirmation, she would be the first woman to head the FDA.

Having just shepherded the Food and Drug Modernization and Accountability Act into law last year, committee chairman Sen. Jim Jeffords (R-Vt.) likely will focus those hearings on Henney's ability to implement FDA reform.

"In January Sen. Jeffords sent the president a letter stating that the primary measure of any nominee would be their willingness to embrace the letter and the spirit of [FDA reform]," a Jeffords spokesman said.

Both the biotechnology and pharmaceutical industries echo Jeffords' concern that Henney be dedicated to continuing the timely implementation of FDA reform.

"We really have no preconceived notions about Henney," said Jeff Trewhitt, media spokesman for the Pharmaceutical Research and Manufacturers of America. "We are looking forward to getting to know her better and getting to know how she will approach the task of implementing the new law."

Henney To Take Over High-Profile Post

Carl Feldbaum, president of the Biotechnology Industry Organization (BIO), agreed that the first order of business for the biotechnology industry will be to get acquainted with Henney; since she left the agency in 1994, the number of biotechnology products at the agency has skyrocketed.

"As Kessler's legacy, the office of the commissioner of FDA has never had a higher profile," Feldbaum said. "We intend to be active in the process that explores Henney's ability to maintain the highest standards of safety and efficacy while at the same time pressing forward with FDA reform."

Prior to accepting the post at the University of New Mexico in 1994, 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 and her oncology training at the 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 vice chancellor for health 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 as well as the NIH's biotechnology committee. In addition, she is president of U.S. Pharmacopeia, a nonprofit group that sets purity and quality standards for medicine.

In announcing the plan to nominate Henney, the White House stressed her role in implementing the Prescription Drug and User Fee Act of 1992 and her management of the major consolidation of the University of New Mexico's hospitals, schools of medicine, nursing and pharmacy and specialized facilities for mental health, cancer and pediatrics.

In response to industry concerns, several senators have been adamant that any nominee display management acumen as well as scientific skills.

Over the next few weeks, the Clinton administration will deliver to the Senate the needed paperwork to officially nominate Henney to the post. In the meantime, Henney may begin to make courtesy visits to the senators on the committee. Once the paperwork is in hand, Jeffords can move toward hearings.

"Sen. Jeffords has tried to move nominations in his committee forward as quickly as possible," a Jeffords spokesman said. "There are only a handful of legislative days left before the end of Congress. But I can assure you that we will address this confirmation hearing faster than Clinton addressed this vacancy."

Over the past few months, legislators, industry representatives and consumer activists have expressed concern that the position has remained vacant for the past 17 months.

Feldbaum noted, "This is a position that needs permanence. It has already taken too long."

Henney's nomination offers the biotechnology industry the opportunity to help set the course of the agency as more and more biotechnology products come under its purview.

"This will be an important nomination for BIO," Feldbaum said. "The last time a person was confirmed was well before the industry had a great many drugs at FDA. Today there are over 300 biotech drugs at various stages of development now awaiting FDA action. This industry wants to be a major player in the future of the agency." *