National uniformity delayed by lack of consensus in Senate Labor Cmte.
This article was originally published in The Rose Sheet
Executive Summary
NATIONAL UNIFORMITY LANGUAGE NOT INCLUDED IN SENATE FDA REFORM LEGISLATION as introduced by Labor & Human Resources Committee Chairman James Jeffords (R-Vt.) June 5. The provision, which would allow FDA regulations to transcend local and state governments' safety and labeling statutes for cosmetics and over-the-counter drugs, was expected to be included in the first draft of S 830. At a May 28 press briefing, the committee noted that although specific national uniformity language had not yet been written, the measure was still of high interest and was under development ("The Rose Sheet" June 2, p. 10).
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NATIONAL UNIFORMITY LANGUAGE NOT INCLUDED IN SENATE FDA REFORM LEGISLATION as introduced by Labor & Human Resources Committee Chairman James Jeffords (R-Vt.) June 5. The provision, which would allow FDA regulations to transcend local and state governments' safety and labeling statutes for cosmetics and over-the-counter drugs, was expected to be included in the first draft of S 830. At a May 28 press briefing, the committee noted that although specific national uniformity language had not yet been written, the measure was still of high interest and was under development ("The Rose Sheet" June 2, p. 10). The standstill on the issue reflects continued disagreement within the committee over the appropriate scope of uniformity language. Without a consensus on language, uniformity is unlikely to be included in S 830 for fear of jeopardizing passage of broader FDA reform legislation. Proponents of national uniformity include Sens. Judd Gregg (R-Vt.) and Orrin Hatch (R-Utah). During the 104th Congress, Gregg proposed a national uniformity amendment to former Sen. Nancy Kassebaum's S 1477 FDA reform bill. Although language that appeared in S 1477 only included OTCs, an earlier version of the amendment covered cosmetics as well. Hatch expressed his support for national uniformity during the 104th Congress, suggesting that the issue be expanded past OTC drugs in future deliberations. The Cosmetic, Toiletry and Fragrance Association, has been lobbying for the inclusion of a national uniformity provision in Jeffords' FDA reform bill as part of a six-member industry coalition. The alliance also includes the Nonprescription Drug Manufacturers Association, the Pharmaceutical Research & Manufacturers of America, the Generic Pharmaceutical Industry Association, the National Food Processors Association and the Grocery Manufacturers Association. CTFA stressed that it and the coalition as a whole are "still a forceful advocate for including the provision in the bill." The trade group noted that it hopes cosmetic national uniformity language would make it into the legislation before markup. NDMA, which expressed disappointment at the lack of uniformity language in the bill, said it would continue to educate Senatorial members on the benefit of the provision. The OTC drug trade group pointed out that it would be a step backwards from last year's efforts to not include any such measure. The Delaney clause, a significant topic of discussion during debate on Kassebaum's FDA reform bill last session, is also absent from S 830. CTFA has "put the topic aside for the time being," the group said, adding that there had "not been much discussion" about the provision this year. During the 104th Congress, moves to revise Delaney's zero-risk standard with a de minimus standard for food additives in the Senate met with opposition from both Kassebaum and Sen. Edward Kennedy (D-Mass.). The "FDA mark," detailed in the bill summary, was also omitted from the proposed language. The provision would have permitted companies to claim on labeling that their products were approved by the agency. |