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FDA’s Tactical Exparel Label May Suggest Broader Off-Label Strategy

 
• By Michael McCaughan

Inclusion of failed studies in US label for Pacira’s Exparel label is unusual but appropriate given regulatory history with that application. Could FDA take that approach with other products to address unapproved uses in the context of uncertainty about prohibitions against 'off-label' promotion?

Balanced stones (Anatoli Styf/Shutterstock.com)

The US FDA’s drug reviewers are used to balancing competing interests.

Every new drug application involves weighing an efficacy benefit versus some level of safety risk. More broadly, the agency is...

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More from Marketing & Advertising

Lilly’s Direct-To-Consumer Portal Implicated In Texas Anti-Kickback Suit

 
• By Cathy Kelly

Complaint names LillyDirect in action targeting the company’s free nurse and reimbursement support programs for health care providers.

Lawyers Weigh In On ‘Sunshine’ Clause In EU Pharma Reform Package

 
• By Eliza Slawther

The Council of the EU has not taken forward a proposal from the European Parliament that would require companies to disclose the transfers of value they make to health care professionals and health care organizations – lawyers weigh in on the diverging proposals.

EU Pharma Overhaul May Reshape Aspects Of Drug Promotion And HCP Partnerships

 
• By Eliza Slawther

Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”

‘Sex Pill For Women’: Sprout CEO’s Addyi Instagram Post Draws US FDA Warning Letter

 
• By Sue Sutter

Cindy Eckert’s social media post with a People.com story failed to include any risk information, made misleading representations about benefits and omitted material information about the indication, said the agency, which flagged similar concerns about an Addyi radio ad five years ago.

More from Compliance

Drug Distributors Face Aug. 27 Deadline For Electronic Exchange Of Product Tracking Data

 
• By Sue Sutter

Compliance deadline comes three months after manufacturers were required to start sending accurate, electronic product tracking data to distributors. The Healthcare Distribution Alliance said its members are ready and it does not anticipate major supply chain issues.

Results Reporting: UK Registry To Offer More Flexibility Than US-Based ClinicalTrials.gov

 
• By Vibha Sharma

ISRCTN says its new system for reporting clinical trial results summaries will simplify compliance, and includes features to reduce data entry errors, improve accuracy, enhance accessibility and the reuse of trial results.

Lilly’s Direct-To-Consumer Portal Implicated In Texas Anti-Kickback Suit

 
• By Cathy Kelly

Complaint names LillyDirect in action targeting the company’s free nurse and reimbursement support programs for health care providers.