By Lisa Seachrist
WASHINGTON — Late Wednesday, the Biotechnology Industry Organization (BIO) endorsed Jane Henney — the Clinton administration's nominee to head the FDA — in a letter to Senate Majority Leader Trent Lott (R-Miss.).
Henney's nomination stalled last week when a group of senators led by Majority Whip Don Nickles (R-Okla.) blocked the nomination from coming to the Senate floor for a vote following a strong recommendation from the Senate Labor and Human Resources Committee. (See BioWorld Today, Oct. 12, 1998, p. 1.)
The dispute over Henney's nomination centered on the perception that she would blur the lines separating the legislative and executive branches by regulating tobacco and taking action on the French abortion pill RU-486.
Both BIO and the Pharmaceutical Research and Manufacturers of America (PhRMA) had declined to give the nominee an endorsement, until now stating only that the she was well-qualified for the job. PhRMA continues to maintain its neutral stance.
"We picked a strategic moment to endorse Henney," said Carl Feldbaum, president of BIO. "It's been a very complex situation and we thought it prudent not to weigh in too early." Feldbaum said he was informed Wednesday by both Republican and Democratic Senate staff that the budget and nomination gridlocks were about to be resolved and that BIO's endorsement could be very important to the Senate's voting on Henney.
"She has a substantial amount of support among CEO's in the industry," Feldbaum said. "We think that Dr. Henney's credentials are solid and substantial. Institutionally, we think the FDA would benefit from a permanent and confirmed commissioner."
In his letter to Lott, Feldbaum noted that "Dr. Henney has indicated throughout the confirmation process that she will adhere to both the letter and the spirit of the recently enacted FDA Modernization Act (FDAMA), and continue to streamline and improve FDA operations."
In addition, Feldbaum rained praise on Acting Commissioner Michael Friedman. Feldbaum told BioWorld Today, "Friedman has done a superb job over the past 18 months. It's been a very tough time to be an acting commissioner and we think very highly of him."
Former commissioner David Kessler announced his decision leave the post in November 1996 and took over as dean of the Yale Medical School, in New Haven, Conn., in February 1997. In the intervening time, Friedman led the negotiations on FDAMA and has overseen the implementation of the law to date.
Nevertheless, Feldbaum noted the time has come for the agency to have a permanent head. With the renewal of the Prescription Drug and User Fee Act, BIO has a vested interest in ensuring that the agency has adequate operating resources so the user fees are used to the greatest potential, Feldbaum said.
"With a confirmed commissioner in place, the agency will have more strength in the budgeting process," Feldbaum said. "We need a strong baseline appropriation for the user fees to have an effect."
Feldbaum said BIO feels the time was right to endorse Henney, because in all likelihood, should her nomination stall during this Congress, Clinton will simply renominate her at the beginning of the 106th Congress and the process will ultimately result in her confirmation. *