FDA Retains Personal Touch In Monitoring Drug Promotions

Based on a sales rep’s comments overheard at a pharmacist meeting, FDA warns Ortho-McNeil-Janssen about making unsubstantiated claims for pain killer Nucynta. The general pain relief claim granted the drug does not qualify it for use in the chronic pain condition discussed by the sales rep, FDA says.

An untitled letter to Ortho-McNeil-Janssen Pharmaceuticals Inc. serves as a reminder to drug companies that FDA continues to monitor company marketing efforts the old-fashioned way, by listening to sales reps’ statements at society meetings and exhibitions.

In this case, the date was Dec. 8, 2010, and the occasion was an American Society of Health-System Pharmacists meeting...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Marketing & Advertising

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

 

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

 

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 

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.

Novo, Lilly Ad Challenges Cause Discontinued Claims For Compounded GLP-1s

 
• By 

Two pharmacies, a medical spa and a telehealth company voluntarily removed efficacy, safety and quality claims for compounded GLP-1 products after innovator companies filed challenges with the National Advertising Division.

More from Compliance

BIO CEO On Industry And US FDA, Trump’s Vaccine Views And MFN Counter Proposals

 

John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.

UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 

EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.