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FDA rulemaking

This article was originally published in The Tan Sheet

Executive Summary

Agency regulations not solidly grounded in science and policy "should not be sanctioned" merely because FDA is an "expert agency," CHPA Senior VP General Counsel and Secretary Eve Bachrach stated at the New York State Bar Association annual meeting Jan. 27. The "arbitrary and capricious" standard under which most FDA rules are promulgated is "outdated, antiquated and should be replaced...by a modern substantial science standard," she said. Calling the OTC labeling reg "a stark example of runaway agency rulemaking," Bachrach said FDA "provided no adequate basis in the...record to support the different treatment for OTC labels from every other FDA-regulated product label"
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