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REYE's SYNDROME WARNING PROPOSED INTERIM REG WOULD EXPIRE TWO YEARS AFTER IT GOES INTO EFFECT; SENATE COMPROMISE MEASURE AWAITS SECTY. HECKLER's APPROVAL

Executive Summary

The proposed Reye's Syndrome warning regulation that has emerged from the Senate in lieu of legislation would be a temporary measure that expires two years after it goes into effect. The interim proposed reg, which would mandate Reye's Syndrome label warnings for all OTC aspirin products except topicals, mouthwashes, toothpastes and flavorings, states that the reg "shall cease to be effective two years after the . . . effective date unless the FDA readopts it on or before the expiration date in accordance with the procedures for notice and rulemaking." The proposed interim reg emerged as a compromise measure this past weekend between Senators Hatch (R-Utah) and Metzenbaum (D-Ohio) and the aspirin industry. Hatch had been opposed to requiring Reye's Syndrome label warnings via the legislative route. The interim proposed reg is now reportedly awaiting Heckler's approval before going on to the next hurdle at OMB. The White House and FDA Com. Young have supported voluntary label warnings. Hatch was opposed to legislation requiring Reye's Syndrome label warnings, on the grounds that industry was proceeding with a voluntary labeling effort. Metzenbaum, who introduced a bill (S 538) to mandate a strong warning statement, contended that legislation was needed because many salicylate-containing products currently lack warnings about use in children with flu or chicken pox and because no products currently labeled, except for those manufactured by Plough, mention Reye's Syndrome specifically. Rep. Waxman May Continue To Pursue Legislation Requiring Reye's Syndrome Warnings On Aspirin Labels FDA, which would issue the reg pursuant to the agreement, has publicly stated that the industry's voluntary labeling program is proceeding successfully and that legislation is not needed. The interim proposed reg is now reportedly awaiting HHS Secty. Heckler's approval. There is not agreement unless the administration is willing to implement a reg. The wording of the label warning in the proposed reg is shorter and draws less of a direct association between Reye's Syndrome and aspirin than the label warning that would be required by Rep. Waxman's bill, H.R. 1318. Under the proposed interim reg, the Reye's Syndrome labeling will state -- "WARNING: Children and teenagers should not use this medicine for chicken pox or flu symptoms before consulting a doctor about Reye's Syndrome, a rare but serious illness." The Waxman bill warning states: ". . . Aspirin may increase the risk of developing Reye's Syndrome, a rare but serious illness." Despite the agreement in the Senate, Waxman reportedly intends to continue to pursue legislation in the House requiring a Reye's Syndrome label warning for aspirin products. In addition, the proposed reg contains a "sunset clause" that would allow the FDA commissioner to "amend or revoke" the reg "at any time on the basis of new evidence." The wording of the proposed reg stresses that it is an interim measure "pending further ]FDA[ consideration of the scientific issues, including the results of ongoing studies." The proposed reg would become effective for products initially introduced into interstate commerce after May 30, 1986. Despite the agreement struck in the Senate, Rep. Waxman (D-Calif.), the cosponsor of Metzenbaum's bill in the House, is planning to maintain the threat of legislation. Waxman reportedly will pursue his previous efforts for a new law through legislation. The Waxman bill was amended prior to passing the House Energy and Commerce/Health Subcmte. on Oct. 23 to delete aspirin "advertising and other printed and descriptive matter" from being required to contain Reye's Syndrome warnings. The amendments to the bill, introduced by Rep. Madigan (R-Ill.) also exclude, like the proposed reg, aspirin containing topical products, mouthwashes, toothpastes and flavorings.
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