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More FDA Oversight Of DTC Ads May Be Needed To Curtail Misleading Claims, Study Argues

 
• By Jessica Merrill

Clearer US guidance on DTC TV advertising and stronger enforcement would help reduce misleading claims and encourage drug makers to include more qualitative benefit/risk information in ads, according to a new study from Yale University researchers published in the Journal of General Internal Medicine.

Researchers at Yale University advocated for more US FDA enforcement of direct-to-consumer (DTC) broadcast ads in a study published in the Journal of General Internal Medicine Feb. 26.

"It would be helpful if there were clearer and more detailed regulations and guidance for DTC broadcast ads, particularly with...

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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.

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

 
• By Sue Sutter

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

Big PBM Dominance Enabled By Affiliated Third Party Administrators Limiting Choices, FTC Told

 
• By Cathy Kelly

Complaints about TPAs offer an explanation of why self-funded employers continue to use the big three PBMs despite concerns about those relationships. Proposed solutions include banning retaliatory fees and data withholding.

EU 15% Tariff Deal Still Leaves Questions For Pharma On Possible Grace Period, Generic Exemption

 
• By Jessica Merrill

While the 15% rate is a substantial blow for pharmaceutical firms, the US-EU deal provides a framework for trade agreements with other countries that could see the industry avoiding higher tariffs elsewhere.

No Surprise Here: Foreign Drug Facilities Should Expect Surprise Inspections, US FDA Says

 
• By Sue Sutter

The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.