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Acknowledging Caronia: FDA Takes The First Step To Rethinking Off-Label Policy

 
• By Michael McCaughan

FDA has gotten past the denial phase and now is listening to ideas on how to balance the need to preserve the integrity of the regulatory process with evolving interpretations of the First Amendment as it applies to commercial speech. That is slow but important progress – but towards what goal?

They say the first step towards change is awareness of the need for change. If that is true, then FDA appears to be taking the first step towards changing policies regarding the regulation of off-label promotion.

Acknowledging the evolving understanding of First Amendment protections for commercial speech by pharmaceutical companies was a recurring theme during the 2014 Food & Drug Law Institute annual meeting. The April...

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Pharma DTC Ad Tax Break Targeted By US HHS, Congress

 
• By Derrick Gingery

Health and Human Services Secretary Robert F. Kennedy Jr. said a policy that would remove the tax write-off for pharma advertising expenses would be coming in a few weeks.

Sarfez Pharma’s Promotional Claims For Diuretic Soaanz Draw US FDA Warning Letter

 
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Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.

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More from Compliance

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• By Sarah Karlin-Smith

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At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.

Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.