Henney pledges FDA cooperation with OAM/ODS on alternative medicine therapies.

DSHEA PROVIDES "TOOL" FOR FDA ACTION AGAINST DANGEROUS SUPPLEMENTS, FDA Commissioner-nominee Jane Henney, MD, told the Senate Labor & Human Resources Committee at her confirmation hearing Sept. 2. In response to a question from Sen. Tom Harkin (D-Iowa) on the adequacy of public health protection provided by the Dietary Supplement Health & Education Act, Henney said: "I think Congress in its deliberations tried to strike the right balance in terms of the law that was finally enacted to make dietary supplements available" but also to "give a tool for the FDA to take action when necessary."

Henney's comments expanded upon written responses to a series of questions on dietary supplement issues forwarded to her by Harkin prior to the hearing. "To the best of my knowledge," she wrote, DSHEA provides "adequate statutory authority" to protect the public's health. Harkin had asked whether, as commissioner, she would pursue additional statutory authority to increase FDA's regulatory power over dietary supplements ("The Tan Sheet" Aug. 31, p. 1).

One of the primary sponsors of DSHEA, Harkin noted FDA representatives have suggested the law improperly curtails the agency's authority to pursue potentially unsafe dietary supplements or "ties their hands." Former FDA Commissioner David Kessler, MD, blamed DSHEA constraints in response to initial public concern that the agency may not have acted aggressively enough to address adverse reactions associated with ephedra-containing dietary supplements. But "in fact," Harkin maintained, "DSHEA provided FDA with additional authority to take action against dietary supplements that pose an `imminent hazard' to the public health."

Harkin criticized the pace of the agency's development of good manufacturing practices for dietary supplements, and asked Henney if she would "work to ensure this important consumer protection mandated by DSHEA is quickly implemented."

While acknowledging she was "not aware of where the agency was in terms of the development" of GMPs, Henney said: "Yes, I would give it my full support, consideration and attention." The agency published an advance notice of proposed rulemaking on dietary supplement GMPs in February 1997 and a proposed rule is pending ("The Tan Sheet" Feb. 10, 1997, p. 1). A Labor committee vote on Henney's nomination is not expected before the week of Sept. 14.

Henney also pledged FDA cooperation with the National Institutes of Health Office of Dietary Supplements and Office of Alternative Medicine in promoting research on supplements and complementary alternative therapies. She said "it is critical that in our dealings with all industries we have a respectful relationship" and that "we need to be open to the possibilities and merits of complementary medicines and what they might offer."

The University of New Mexico VP-Health Sciences noted that "at our home institution at the University of New Mexico, because we have a relatively small population for the size of our state but a very diverse population and one that has very strong traditions and beliefs about methods of healing, we do try to incorporate much of what we learn from other cultures and traditions into what our health professionals will need to know in order to serve their patients best."

Henney also suggested FDA "ought to be watching all of what goes on at NIH to see what our next response in terms of products that might come into the agency...as well, so we make that a tight collaborative relationship. I am strongly supportive of that effort."