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Lilly InDirect? Telehealth Program Leans Into Third-Party Approach To Avoid Compliance Pitfalls

 
• By Cathy Kelly

LillyDirect program for Zepbound, Emgality, insulins aims to ease points of friction for drug access, including delays in seeing physicians and inconsistent supply at pharmacies. Co-pay assistance tailored to skirt insurance plan tactics.

Lilly Program Expected To Be A Model For Other Big Pharmas • Source: Shutterstock

Eli Lilly and Company’s new telehealth-based prescribing program for its obesity, diabetes and migraine drugs has built-in safeguards against violating US Food and Drug Administration rules around drug promotions and kickbacks, according to the company.

Drugs Covered By LillyDirect

  • Zepbound

  • Emgality

  • Humalog

  • Humulin

  • Lyumjev

  • Rezvoglar

  • Basaglar

Launched 4 January, the LillyDirect program offers access to independent telehealth providers to insured and uninsured individuals seeking treatment for the three conditions.

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Pharma DTC Ad Tax Break Targeted By US HHS, Congress

 
• By Derrick Gingery

Health and Human Services Secretary Robert F. Kennedy Jr. said a policy that would remove the tax write-off for pharma advertising expenses would be coming in a few weeks.

Sarfez Pharma’s Promotional Claims For Diuretic Soaanz Draw US FDA Warning Letter

 
• By Sue Sutter

Webpages, a healthcare professional pamphlet and a medical conference exhibit booth panel make unsupported comparative superiority claims about generic torsemide products and misrepresent risks, the Office of Prescription Drug Promotion says in its first warning letter of 2025.

Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.

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.

More from Compliance

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
• By Jessica Merrill

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.

Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.