The U.S. Food and Drug Administration (FDA) has unexpectedly declined to review Moderna’s application for a new influenza vaccine, a decision that may signal a shift in the agency’s regulatory approach towards pharmaceutical companies. This rejection was publicly disclosed by Moderna, which released the correspondence from Vinay Prasad, head of the FDA’s biologics division, alongside a pointed statement from CEO Stephane Bancel. Bancel criticized the decision, asserting it undermines the collective objective of advancing innovative medicine in the U.S. Central to the controversy is the FDA’s contention regarding the control vaccine used in Moderna’s efficacy trials, which employs the same mRNA technology that proved successful in its COVID-19 vaccine.
In a related development, the Trump administration’s recent actions against Hims & Hers may signal the beginning of a broader regulatory crackdown on compounding pharmacies. The FDA has issued warnings, while the Department of Health & Human Services has prompted the Department of Justice to investigate the company. Novo Nordisk has also initiated a patent infringement lawsuit against Hims & Hers. The increasing scrutiny reflects growing regulatory concerns about compounded drugs marketed through national telehealth platforms, particularly as these companies have faced criticism for misleading marketing practices. With compounded medications becoming more prevalent amid shortages, the industry is now bracing for potential regulatory changes that could impact the viability of telehealth compounding practices.
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