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Pink Sheet Podcast: RFK’s First Actions, Pitch To Extend Current US FDA User Fee Agreement, More Trump Impacts

 
• By Derrick Gingery, Nielsen Hobbs, and Michael McCaughan

Pink Sheet editors and special guest Michael McCaughan of Prevision Policy discuss Robert F. Kennedy Jr.’s first act as HHS Secretary, former FDA Commissioner Scott Gottlieb’s suggestion that industry extend the existing user fee agreement rather than negotiate a new one, and President Trump’s policies impacting FDA advisory committee schedules and staffing.

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What will the presidential commission on reducing chronic disease uncover? • Source: Citeline/Shutterstock

Pink Sheet Executive Editor Derrick Gingery, Editor-in-Chief Nielsen Hobbs, and special guest Michael McCaughan of Prevision Policy look at new Health and Human Services Secretary Robert F. Kennedy Jr.’s first assignment, a presidential commission on reducing chronic disease (:29), as well as former US Food and Drug Administration Commissioner Scott Gottlieb’s suggestion that industry extend the existing user fee program rather than negotiate a new agreement in the current political environment (13:30). They also discuss the impact of President Trump’s executive order mandating a reduction in force across the federal government on the US Food and Drug Administration and communications questions affecting the agency’s advisory committee schedule (25:16).

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This and other podcasts are available on the Pink Sheet podcast page, as well as the Citeline channel on Apple Podcasts, SoundCloud, TuneIn and Spotify Podcasts, and via smart speakers if one of these platforms has been set up as your default podcast provider.

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Pink Sheet Podcast: US FDA Productivity Complaints Emerge, Internal Return To Office Headaches

 
• By Derrick Gingery, Sarah Karlin-Smith, and Nielsen Hobbs

Pink Sheet reporter and editors discuss industry worries about delays in the FDA’s work since the Trump Administration took office, as well as the chaotic return of staff to a White Oak headquarters that cannot handle them.

Pink Sheet Podcast: Buyouts, Departures and Other US FDA Chaos

 
• By Derrick Gingery, Sarah Karlin-Smith, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the early retirement and buyout offers to FDA employees and significant agency departures in the Center for Biologics Evaluation and Research and chief counsel’s office as a new commissioner moved closer to confirmation.

Pink Sheet Podcast: What We Learned From US FDA Commissioner Nominee Makary’s Confirmation Hearing

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporters and editors discuss FDA Commissioner nominee Martin Makary answers to senators’ questions and the potential impact of his views on the agency.

Pink Sheet Podcast: Laid Off US FDA Staff Called Back, Vaccine Adcomm Cancelled, Lilly’s Manufacturing Push

 
• By Derrick Gingery, Sarah Karlin-Smith, Nielsen Hobbs, and Elizabeth Orr

Reporter and editors from the Pink Sheet and Medtech Insight discuss the impact of the FDA’s decision to call back many of the employees it laid off, the decision to cancel an upcoming FDA advisory committee meeting on flu vaccines, and Eli Lilly’s plans to increase domestic manufacturing.

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PharmaMar’s Aplidin Back On EMA’s Agenda After Conflict Of Interest Controversy

 
• By Neena Brizmohun

The European Medicines Agency is re-evaluating the marketing application for Aplidin. The initial application was rejected in 2018, but that rejection was revoked last year following a court case for another company’s drug that clarified impartiality requirements for experts consulted by the EMA.

US CDC Vaccines AdComm Rescheduled For April Without Influenza Vote

 
• By Bridget Silverman and Sarah Karlin-Smith

The disruption of CDC’s Advisory Committee on Immunization Practices meeting schedule adds fuel to concerns about potential alterations of the vaccine schedule raised by former FDA Commissioner Scott Gottlieb.

Testosterone, TRAVERSE, And A Label Change 15 Years In The Making

 
• By Bridget Silverman

The Pink Sheet drug review profile investigates the long and rigorous process behind the FDA’s recent relaxation of the cardiovascular safety warning for testosterone products.