Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

REP. TOWNS' DIETARY SUPPLEMENT HEARING SET FOR JULY 20

This article was originally published in The Tan Sheet

Executive Summary

REP. TOWNS' DIETARY SUPPLEMENT HEARING SET FOR JULY 20 to review "FDA's actual and proposed regulations for dietary supplements," the House Government Operations/human resources and intergovernmental relations subcommittee announced July 16. In addition, subcommittee Chairman Rep. Edolphus Towns (D-N.Y.) plans to look at "the public health risks and benefits of dietary supplements," the scientific data supporting health claims for supplements, and the "proper regulatory balance between consumer protection and free trade," according to the press release. "Given the long-standing controversies of regulating these substances and FDA's checkered past in this area, I am concerned that the federal government strike the proper balance in regulating these products," Towns said. He indicated that the appropriate balance lies between allowing continued access to supplements "that provide promising health benefits" and protecting consumers "from harmful products." Towns' hearing will be the first of three congressional hearings expected this summer on FDA's proposed regs for dietary supplements ("The Tan Sheet" June 21, pp. 1-11) and bills introduced earlier this year by Sen. Orrin Hatch (R-Utah) and Rep. Bill Richardson (D-N.M.) ("The Tan Sheet" April 12, p. 6). Rep. Henry Waxman's (D-Calif.) Energy & Commerce/health subcommittee is tentatively scheduled to consider the dietary supplements issue on July 29. Sen. Edward Kennedy (D-Mass.) also is interested in the issue. Testifying at the Towns hearing on behalf of the dietary supplement industry will be Council for Responsible Nutrition President J. B. Cordaro and Washington, D.C. attorney Stephen McNamara (Hyman, Phelps & McNamara). Two food groups also will be represented at the hearing: Regina Hildwine of the National Food Processors Association, and National Nutritional Foods Association President Martie Whittekin are scheduled to testify. In addition to as-yet-unnamed representatives from FDA, New York State Assistant Attorney General Shirley Stark will appear at the Towns hearing. Center for Science in the Public Interest Director of Legal Affairs Bruce Silverglade, who is in favor of tougher FDA regulation of supplements and is opposed to the Hatch and Richardson bills, also is set to testify. The hearing agenda will include a panel of researchers in the dietary supplement field, including: Gladys Block, PhD, University of California-Berkeley; Irwin Rosenberg, MD, Tufts University; Lynn Bailey, PhD, University of Florida; Esther Sternberg, MD, National Institute of Mental Health; Robert McCaleb, Herb Research Foundation; and Ryan Huxtable, PhD, University of Arizona. FDA Deputy Commissioner for Policy David Adams, speaking at the Drug Information Association's annual meeting in Chicago on July 12, warned the pharmaceutical audience to "pay careful attention to what is happening" with dietary supplements "in the legislative arena." Adams characterized dietary supplements as "an important policy issue" that threatens "to undermine the drug approval process as we know it." Adams explained that "portions of the supplement industry are working to "exempt from the drug regulatory process an array of products that are described as dietary supplements which include things that are really medicines, including products that are derived from plants." He maintained that "some of these products within this broadly defined category . . . might, of course, be medicines that are analogous to currently approved products, such as [Bristol-Myers Squibb's prescription anticancer drug] Taxol." Adams suggested that "if these efforts [are] successful . . . there could be created a class of products to compete with approved drugs that are subject to less regulation than approved drugs." He maintained that the establishment of a separate regulatory category for supplements "could undercut exclusivity rights enjoyed by the holders of approved drug applications."
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS081697

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel