Pharma Pulse: Vinay Prasad Reinstated as FDA CBER Head, New COVID-19 Risk Data, and the Industry’s Response to Rising Costs

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering leadership changes at the FDA, new research on COVID-19 risks for childhood cancer survivors, and strategies pharma companies are using to stay competitive as healthcare costs climb.

Vinay Prasad, MD, MPH, is back at the helm of the FDA’s Center for Biologics Evaluation and Research—just weeks after resigning from the post in late July. Prasad, who was appointed in May, stepped down following public criticism from political commentator Laura Loomer, who targeted his past support for Democratic politicians and his role in the temporary halt of Sarepta’s Elevidys shipments.

Multiple media reports indicate his return came at the request of FDA Commissioner Marty Makary, with the White House reviewing the remarks that had sparked controversy. An HHS spokesperson stated that the administration would not allow “fake news media” to distract from the agency’s work.

In other news, a recent study published by investigators in The Lancet Regional Health reveals that adults who survived childhood cancer face a significantly higher risk of severe COVID-19 outcomes. These individuals were more likely to require hospitalization, intensive care, or mechanical ventilation compared to peers without a cancer history. Researchers point to long-term health effects from cancer treatment—such as organ damage and immune suppression—as potential contributors. The findings underscore the need for tailored preventive strategies, including vaccination prioritization and ongoing monitoring, for this vulnerable population.

Finally, with global healthcare costs on the rise, pharma companies are exploring ways to remain competitive while delivering value. Strategies include optimizing supply chains, investing in digital health solutions, and shifting toward value-based pricing models that link reimbursement to real-world patient outcomes. Analysts, including Philip Sclafani of PWC, note that companies able to combine operational efficiency with innovation will be better positioned to weather pricing pressures and meet growing demand for affordable, high-quality care.

From leadership shifts at the FDA to new public health research and evolving market strategies, these stories highlight how science, policy, and economics intersect to shape the pharmaceutical landscape.

That’s it for this episode of Pharma Pulse. For more insights on trends transforming pharmaceutical access and care delivery, visit pharmaceuticalcommerce.com.

Thanks for listening—until next time, stay well and stay informed.

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