Lexology November 28, 2023
On November 21, 2023, the FDA published its final rule changing how prescriptions medicines are advertised to consumers.1 The FDA first issued its proposed rule in 2010, which subsequently went through three public comment periods between 2010 and 2012.2 Interestingly, the FDA provided no opportunities for the public to comment on the rule since 2012. The FDA addressed the over 10-year gap between the last comment opportunity and the issuance of the final rule, explaining that it was due in large part to competing demands for limited Agency resources, including repeated natural disasters, the opioid epidemic, and infectious disease outbreaks including Ebola, Zika, and COVID-19.3 The FDA concluded that no material changes have occurred in the fundamental concepts, scientific research,...
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