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Pink Sheet Podcast: SubQ Drugs And Price Negotiations, GLP-1s In Court, US FDA Approach To Black Box AI

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

Pink Sheet reporter and editors discuss an emerging pharma strategy to avoid Medicare price negotiations, legal wrangling related to compounding GLP-1 drugs for obesity and diabetes, and the varying opinions of FDA officials on the acceptability of artificial intelligence models that are not fully explainable.

Pink Sheet podcast
Will the FDA successfully defend its GLP-1 shortage decision? • Source: Citeline/Shutterstock

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Cathy Kelly and Interim Editor-in-Chief Nielsen Hobbs discuss an new pharma strategy to create subcutaneous injectable versions of drugs that can avoid Medicare price negotiations (:25), the legal wrangling to maintain an official shortage of GLP-1 drugs for diabetes and weight loss, which would continue allowing the products to be compounded (14:20), and potential concerns with the US Food and Drug Administration’s varying opinions on the black box nature of some artificial intelligence models (29:08).

More On These Topics From The Pink Sheet

This and other podcasts are available on the Pink Sheet podcast page, as well as the Citeline channel on Apple Podcasts, Google Podcasts, SoundCloud, TuneIn, 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: Understanding The Impact Of The Latest HHS Layoffs On The US FDA

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

Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.

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.

More from Compliance

How To Leverage US FDA’s ‘Consistent With Labeling’ Guidance In DTC Ads

 
• By Sue Sutter

Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.

US FDA May Lose Some Autonomy Under Health Department’s General Counsel Reorg

 
• By Sarah Karlin-Smith

Health and Human Services Secretary Robert F. Kennedy Jr. is moving FDA Chief Counsel Robert Foster to a new senior position as Chief Counsel for Food, Research, and Drugs at HHS. Hilary Perkins will become FDA chief counsel.

EU’s Critical Medicines Act: A Major Milestone Or Too Weak?

 
• By Neena Brizmohun

Newly proposed legislation for bolstering the EU’s drug manufacturing capacity and reducing its overreliance on foreign manufacturers includes a number of measures, such a requirement for EU countries to prioritize the security of supply over price when procuring drugs.