By Lisa Seachrist
WASHINGTON — President Clinton's nominee to head the FDA, Jane Henney, has responded to 140 questions covering how she intends to run the agency, should she be confirmed.
The questions were submitted to Henney at the end of July by Labor and Human Resources Committee Chairman Sen. James Jeffords (R-Vt.), and cover everything from biologics to tobacco to food initiatives. Henney's responses, however, may have come too late for the committee to conduct their tentatively scheduled confirmation hearing on Sept. 1.
"The committee requested the responses on August 20," a Jeffords spokeswoman said. "We received the responses on Monday, which will likely push the hearing back a few days."
Jeffords' staffer told BioWorld Today that the committee has yet to determine when the hearing will take place.
Most of the questions put to Henney focused on her commitment to implementing the reforms enacted last year with the Food and Drug Administration Modernization Act (FDAMA). Throughout her responses, Henney emphasized her commitment to the provisions in FDAMA.
"As a general matter, I believe the Agency's primary focus for the immediate future must be full and successful implementation of FDAMA," Henney wrote.
Asked about the regulation of cellular therapies and xenotransplantation, Henney noted that changes implemented through FDAMA and the Reinventing Government Initiative to regulate tissue products based on their relative risks to recipients "is the most significant overhaul of the regulation of biotechnology products ever attempted. This approach also attempts to minimize premarket requirements, so as to allow innovation to proceed while ensuring that proper and appropriate levels of controls for safety and effectiveness are followed."
Nominee Favors Fast-Track, Opposes Human Clones
Henney also stated a firm commitment to the fast-track program established in FDAMA. In addition, she noted that "the key to further reduction of drug development times lies in shortening the period between the filing of an IND and an application [for marketing], and in improving the quality and reviewability of data in the application." She cited the need to improve communication with sponsors to achieve this goal.
Henney also noted that promoting the international harmonization of requirements for data and documentation would reduce drug development time. However, she said the FDA is not likely to be willing to recognize foreign approvals any time soon.
The committee submitted several questions concerning the agency's role in regulating attempts at human cloning. Henney firmly stated that such attempts would involve highly manipulated human tissue and would therefore raise a variety of safety issues. She said she favors legislation making it illegal to create a human being through cloning.
"In banning this particular research, however, we must be very careful not to prohibit important biomedical research that holds the potential cures for serious and life-threatening diseases, including cancer, diabetes and spinal cord injuries," Henney wrote.
The nominee also stated that she believed that user fees collected under the Prescription Drug User Fee Act (PDUFA) should be additive to FDA appropriation and not a substitute for such appropriations. In addition, she noted that user fees only succeed when there is consensus among Congress, FDA, industry and consumers. She said she does not support user fees as a means to fund postmarketing surveillance without such consensus.
While biotechnology and pharmaceutical industry representatives have refrained from taking a position on Henney's nomination, an industry source said, "We do have respect for this woman. She has a [curriculum vitae] to die for."
Many of the questions put to Henney concerned issues pertaining to the regulation of medical devices. The focus on medical devices may have come as the result of the Medical Device Manufacturers Association (MDMA) opposition to the nominee.
The MDMA has voiced some concerns Henney's tenure at FDA was marked by consumer overprotection. It noted that, as co-chair of a task force on silicone breast implants, Henney was instrumental in the agency's decision to ban the material from the market. The organization considers the decision to be based on faulty science. *