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REYE'S SYNDROME ASPIRIN LABELING BILL FROM REP. MADIGAN (R-ILL.)

Executive Summary

REYE'S SYNDROME ASPIRIN LABELING BILL FROM REP. MADIGAN (R-ILL.) has been resubmitted as a new emergency labeling bill (HR 3640) following favorable action by Rep. Waxman's (D-Calif.) Health Subcmte. on Oct. 23 ("The Pink Sheet" Oct. 28, T&G-2). The Madigan bill would change the graphic highlighting requirements for the label warning from the initial Waxman proposal. Waxman's original bill called for arrows on the outside of the box warning to draw attention to the warning; the Madigan bill would require only a box warning. The Madigan warning -- accepted at the subcmte. mark-up by Waxman -- would also reduce the length of the warning from 47 words to 33. The Madigan warning would, however, require direct mention of Reye's Syndrome, which goes beyond some of the voluntary labeling efforts by the OTC industry. The Madigan amendment also would permit HHS to remove the mandatory label warning if "the Secretary determines, on the basis of new evidence, that there is not a causal link between aspirin or any other salicylate and Reye's Syndrome." That statement could be the focus for continued industry lobbying. In the Madigan bill, HHS would be required in essence to prove no risk; the trend in risk assessment decisions has been to allow FDA and HHS discretionary authority to determine the extent of risks before making a regulatory decision.
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