Pharmacogenetic Tests: US FDA Tries Off-Label Approach To Guide Consumers
US FDA’s latest effort to provide guidance for consumers on pharmacogenomics tests underscores the challenges the agency faces in the absence of a clear regulatory framework for lab-developed tests – and with no easy mechanism to update labels for off-patent drugs.
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Asking whether FDA’s decision to allow emergency use of two old anti-malarial drugs was ‘political’ misses the point. The issue already was political, and FDA’s action may well be the best way to keep some measure of federal control on supplies of a drug with important other uses.
FDA Commissioner Stephen Hahn was added to the White House's pandemic task force as the outbreak grew, but he remained in a background role. That all changed the morning of 18 March, when President Trump tweeted: “I will be having a news conference today to discuss very important news from the FDA concerning the Chinese Virus!” A day later, Hahn was standing with Trump at the podium for the now-daily press briefings on Covid-19.