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Pink Sheet Podcast: US FDA Worries About Celebs Endorsing Drugs, Post-Chevron Lawsuits Emerging

 
• By Derrick Gingery and Sarah Karlin-Smith

Pink Sheet reporter and editor discuss the FDA’s latest advertising enforcement letter, which targeted a migraine treatment TV commercial featuring Serena Williams, and its impact on drug promotion, as well as the now growing list of legal cases targeting agency decisions with Chevron deference overturned.

Pink Sheet podcast
Could sponsors reconsider using celebrity endorsement ads after the FDA's recent enforcement actions? • Source: Citeline/Shutterstock

Pink Sheet Executive Editor Derrick Gingery and Senior Writer Sarah Karlin-Smith discuss the future of celebrity drug promotion after the US Food and Drug Administration flagged an AbbVie Inc. television ad featuring tennis star Serena Williams (:36), as well as the impact of the growing list of lawsuits questioning agency decisions now that the Chevron deference precedent has been overturned (13:32).

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More from Marketing & Advertising

US FDA Cites Taiho’s Lytgobi Healthcare Provider Website For Misleading Efficacy Claims

 
• By Sue Sutter

Results from a single-arm study cannot support representations on overall survival, progression-free survival and disease control rate for the cancer drug, the Office of Prescription Drug Promotion said in another “untitled” letter implicating the agency’s CFL guidance.

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.

Ad/Promo: Improved Adherence Claim For Dexcel’s Hemady Not Supported, US FDA Says

 
• By Sue Sutter

A retrospective analysis does not support a claim that multiple myeloma patients are more adherent to Hemady than generic dexamethasone, OPDP said in an "untitled" letter suggesting increased enforcement focus on promotions leveraging the agency’s 2018 CFL guidance.

DTC Advertising: Industry Learning To Live With US FDA’s Clear, Conspicuous And Neutral Rule

 
• By Sue Sutter

Sponsors should consider the DTC ad's audio as the major statement about a prescription drug’s side effects and then choose strategically how to display the accompanying text. TV ads are now employing banners and larger text to satisfy the rule’s “dual modality” requirement.

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.