14 October 2022 - The decision by law makers to drop regulatory reforms of dietary supplements, cosmetics and diagnostic tests from the recent FDA user fee reauthorisation constitutes a “profound missed opportunity” to strengthen the agency’s ability to protect consumers, former FDA Commissioners Scott Gottlieb and Mark McClellan wrote in a JAMA piece published Thursday.
The ex-FDA chiefs acknowledged that congressional leaders have indicated intent to further negotiate the provisions and potentially add them to an end-of-year omnibus package to fund the government, but Gottlieb and McClellan warned such a possibility is unlikely in the absence of broad bipartisan support.