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Ascend’s EstroGel Promotion Misrepresents Efficacy Compared To Other Products, US FDA Says

 
• By Sue Sutter

Professional sell sheet falsely suggests estradiol gel contains lowest effective dose of estrogen compared to other estrogen products, OPDP says in fourth “untitled” letter of 2018.

Bad Apple
A bad apple?

A professional detailing aid misrepresents the efficacy of Ascend Therapeutics US LLC’s EstroGel relative to other estrogen products approved at lower doses, the US FDA’s Office of Prescription Drug Promotion (OPDP) said in a recent “untitled” letter.

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Are Bigger Ad Policy Changes Coming After US FDA’s Drug Promotion Office Hit Hard By Layoffs?

 
• By Sue Sutter

The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.

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.

More from Compliance

Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
• By Vibha Ravi

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US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 
• By Urtė Fultinavičiūtė

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