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Lilly Resolves US FDA Concerns About Emgality TV Ads That Were Not Meant To Run Solo

 
• By Brenda Sandburg

With the Winter Games approaching, case offers lesson for companies with complex advertising packages. Lilly told the agency two commercials featuring Olympic and Paralympic athletes were intended to run sequentially with another ad including indication and risk information.

Paralympics_Allysa Seely
Paratriathlete and gold medalist Allysa Seely appeared in a TV ad for Lilly's migraine drug Emgality • Source: Alamy

The US Food and Drug Administration’s objections to two television ads for Eli Lilly and Company’s migraine drug Emgality (galcanezumab-gnlm) were so quickly quelled that the agency posted its untitled letter and a close-out letter at the same time. It is the first time the Office of Prescription Drug Promotion has posted these letters simultaneously.

On 13 December, OPDP sent an untitled letter to Lilly stating that two of its direct-to-consumer broadcast TV ads...

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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

AI In Manufacturing: EU To Revamp GMP Guidance In Light Of Digital Advancements

 
• By Eliza Slawther

Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.

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.”