George Tidmarsh, the U.S. Food and Drug Administration’s top drug regulator, has raised eyebrows in the biotech community by publicly questioning the safety of voclosporin, a drug approved in 2021 for lupus nephritis. In a LinkedIn post, Tidmarsh characterized voclosporin as having “significant toxicity” and lacking demonstrated clinical benefits, leading to a notable 16% drop in the stock price of Aurinia Pharmaceuticals, the drug’s manufacturer. This incident is particularly striking as it is uncommon for an FDA official to use personal social media to critique a specific drug without substantiating evidence, potentially signaling a shift in regulatory communication practices and raising concerns about the implications for drug approval processes.
In another development, the Pharmaceutical Research & Manufacturers of America (PhRMA) is set to launch a new website, AmericasMedicines.com, aimed at enabling patients to purchase prescription drugs directly from manufacturers. This initiative, scheduled for January, seeks to bypass pharmacy benefit managers and reduce out-of-pocket costs, reflecting the industry’s response to increasing pressure for lower drug prices. Amid ongoing discussions about drug pricing reform, this move may reshape the landscape of pharmaceutical distribution and access, particularly in light of governmental calls for price reductions and alternative purchasing models.
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