By Lisa Seachrist
WASHINGTON — In what Senate Labor and Human Resources Committee chair Sen. Jim Jeffords (R-Vt.) called a "precedent-setting" event, the panel conducted the first confirmation hearing for an FDA commissioner by exploring Clinton nominee Jane Henney's commitment to the letter and the spirit of FDA reform.
Given the opportunity to question Henney in a fashion that the committee said it didn't have the time to do in 1988, when controversial Commissioner David Kessler was tapped to take over the post, it focused its questions on the provisions enacted in the FDA Modernization Act of 1997 (FDAMA).
Rather than a confrontational grilling, the questioning was polite and respectful, leaving the impression that the panel was inclined to recommend Henney's appointment to the full Senate. But such an appointment may not come until the 106th Congress convenes next year.
"We are constrained by the lateness of this nomination," Jeffords said. "We didn't receive notification of the nomination until June 24."
The committee members have until Tuesday to submit additional questions to Henney. Assuming it takes a week for her to respond, panel staff calculate the week of Sept. 14 as the earliest that committee members could vote to recommend Henney. If Senate members are satisfied with the committee's recommendation, Majority Leader Trent Lott (R-Miss.) could forego floor debate and have a vote on Henney's nomination in a pro forma session at the end of a business day.
Objections to Henney's nomination could result in a floor debate, which Jeffords said would have to vie with critical appropriations legislation for time on the Senate's packed calendar.
Throughout the hearing, committee members asked how Henney intends to create a friendlier culture at the agency, which has been accused of viewing companies in the industry it regulates as adversaries.
"With [agency reform], we asked FDA to be more collaborative in its dealing with the sponsors of new products and consistent in the application of its rules," Jeffords said.
Henney acknowledged that, in the past, the agency maintained an adversarial relationship with industry. "Only with a respectful relationship can we achieve our mission," she said. "An adversarial attitude is not one that I will foster."
FDAMA Implementation No. 1 Priority
She repeatedly said that her No. 1 priority is the implementation of FDAMA and that she is committed to working closely with Congress and the regulated industries to ensure that the spirit and intent of the law are preserved.
Sen. Bill Frist (R-Tenn.) questioned how Henney intends to implement the dissemination of medical information provisions, following a ruling by a U.S. District Court on July 30 that dissemination of such information amounts to free speech. The court barred the FDA from regulating the distribution of the materials. The agency is appealing the decision.
"My discipline, oncology, has been the most vigorous in its pursuit of off-label uses for drugs," Henney said. "As information comes out in the literature, I think it is important to bring that collective knowledge in and put it on the label for the benefit of all. I think you really found the right place to be on this issue in FDA reform."
Frist responded that he was very disappointed by the draft regulations that the agency submitted on medical information dissemination. Henney said she would give the issue great attention, and work with Congress to ensure its intent is borne out in final rules.
In response to questions concerning efforts to maintain scientific expertise at the agency in the face of industries that can offer better pay and benefits packages, Henney said that she would focus on ensuring scientists remain up to date on scientific advances.
"We do know if we don't have scientists at the top of their game, we run the risk of having a risk-averse organization that is slow in coming to decisions, or — worse — coming to ones that are just wrong," Henney said.
Agency May Seek Outsiders' Advice More Often
In addition, the nominee said provisions in FDAMA, allowing for third-party review of medical devices, as well as consultation provisions for particularly esoteric scientific issues, offer the agency greater access to scientific expertise. Henney said she would work on strengthening the collaboration between other federal scientific agencies and the FDA, in order to further expand the knowledge pool available when making review decisions.
Most of the questions presented to Henney were "softball" in nature. But Sen. Michael Enzi (R-Wyo.) asked Henney to explain how the agency came to grant an approvable letter for the abortifacient RU-486 without considering the welfare of the fetus. Henney said the drug received an approvable letter based on its safety and efficacy for its intended use — that is, to terminate an early pregnancy.
Enzi wanted to know why Henney supported the decision, given the fact that device reviews have in the past gone beyond the scope of intended use. He asked whether the scope of review should be expanded. The issue was not put to rest during the hearing, and may serve as the trigger to bring Henney's nomination to the Senate floor for debate following committee approval.
Henney currently serves as the vice president for health sciences at the University of New Mexico, in Albuquerque. She served at the FDA as deputy commissioner of operations from 1992 to 1994.
Sen. Christopher Dodd (D-Conn.) asked her why she would leave the calm of academia to return to the contentiousness of Washington.
"Sen. Dodd, you may have never attended a faculty meeting," Henney replied. *