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Pfizer's Direct-To-Consumer Digital Platform Not Limited To Its Own Treatment Options

 
• By Jessica Merrill and Cathy Kelly

The launch of Pfizer's new direct-to-consumer program for vaccines and migraine drugs follows the introduction of Eli Lilly's LillyDirect in January. Company-branded initiatives are careful to partner with third-party vendors and allow the use of treatments marketed by other companies to avoid compliance pitfalls. 

Pfizer is launching an end-to-end digital platform for some of its medicines and vaccines. • Source: Shutterstock

Pfizer Inc.’s new digital treatment platform was unveiled to make some of its vaccines and medicines available to patients faster and more conveniently. But the program will not limit the treatment options available through the program to Pfizer products or constrain the options recommended by participating clinicians to help ensure compliance with US Food and Drug Administration regulations on promotion.

Announced 27 August, the PfizerForAll system can connect patients to health care providers for same-day appointments and deliver vaccines, medicines...

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Pfizer’s Advertising Challenge Against BridgeBio’s Attruby Leverages US FDA Untitled Letter

 
• By Sue Sutter

Pfizer, which markets Vyndamax for transthyretin amyloid cardiomyopathy, said an FDA violation letter shows BridgeBio made false and misleading superiority claims, but BridgeBio refused to participate in the National Advertising Division process.

MLR Reviews: How To “Shift Left” With Agentic AI, Balance Compliance And Creativity

 
• By Vibha Ravi

Experts from UCB, Alnylam, Lantheus and Medtronic deliberate on the best use of agentic AI in the MLR review process, its human replaceability quotient and ways to balance creativity with compliance, a significant discussion amid DTC advertising and US FDA scrutiny

US FDA Social Media Crackdown Looms As Industry Awaits Next Drug Ad Enforcement Wave

 
• By Sue Sutter

The first round of ad/promo violation letters largely left social media untouched despite a vow to go after “dark ads” and violative influencer claims. Industry wants more information on the new, de facto standards suggested in the initial DTC and healthcare provider promotion letters.

Pink Sheet Podcast: Another FDA Inspection Reorg, Industry Navigating New DTC Landscape

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the FDA’s plans to undo a previous reorganization and make facility and other inspectors generalists again, as well as industry efforts to adapt to the new direct-to-consumer advertising landscape.

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Oz: CMS Developing Plans To Incentivize Domestic Manufacturing

 
• By Sarah Karlin-Smith

The Trump Administration’s efforts to encourage more US-based pharmaceutical manufacturing have largely centered on FDA plans and Trump’s threats of tariffs and Most Favored Nation pricing, but Oz hinted Medicare and Medicaid soon may soon announce new incentives.

New GMP Reliance Approach In Argentina Could Save Time For Companies

 
• By Francesca Bruce

New rules in Argentina mean that good manufacturing practices certificates for foreign drug manufacturing plants issued by certain regulatory authorities could lead to quicker GMP certification evaluations.

Pink Sheet Podcast: US FDA Cuts Biosimilar Requirements, Clarifies Inspection Reform

 
• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss FDA announcements that clinical efficacy studies would no longer be required for biosimilar development, as well as the additional information from the agency on the intent of its “Simple Reform” of the inspection staff.