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Pink Sheet Podcast: How Will Trump’s Second Term Impact The US FDA?

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

Pink Sheet reporter and editors discuss potential changes that the incoming Trump Administration could make to the FDA, as well as worries about political interference in decision-making, and policy and staffing changes.

Pink Sheet podcast
Will Trump reshape the FDA during his second term? • Source: Citeline/Shutterstock

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Interim Editor-in-Chief Nielsen Hobbs consider how Donald Trump could change the US Food and Drug Administration during his second term, including whether a new commissioner or Health and Human Services Secretary could exert more influence over drug approval and other decisions. They also consider whether ideas from Robert F. Kennedy Jr. and others intended to improve Americans’ health could lead to policy or other changes at the agency, as well as the potential impact on upcoming user fee reauthorization negotiations.

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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.

More from Elections

US Tariff Impact On Korea Dissected As Country Gears For Presidential Election

 
• By Jung Won Shin

Analysts expect a limited impact on South Korean pharma from US tariffs, even if imposed at a later date. Meanwhile, the early June domestic presidential election is set to determine the direction of policies in the sector.

‘A Lot Of That, It’s Meant To Start A Conversation’: How To Work With Trump

 
• By Alaric DeArment and Jessica Merrill

Biotech execs and lobbyists try to explain the Trump Administration's policy strategy and how to thrive in it.

Bracing For RFK At HHS: Vaccine Safety Commission Likely First Step

 
• By Michael McCaughan

Robert F. Kennedy Jr. will become HHS secretary while retaining his anti-vaccine positions. His first action likely will be creating a new safety commission, which industry must hope holds off more drastic action.

Trump And Tariffs Top Generic Industry Concerns

 
• By Dave Wallace

At a lively AAM Access! conference in Florida, AAM President and CEO John Murphy acknowledged the negative effects of potential tariffs, but also suggested that the second Trump Administration could be an opportunity for the generics and biosimilars sectors to advance market reforms.

More from Agency Leadership

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

 
• By Barnaby Pickering

Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.