Marketing & Advertising
By challenging claims across Teams backgrounds, in addition to websites and television ads, the FDA signaled a broader front in its drug promotion oversight.
ARS Pharmaceutical and Altor BioScience received second untitled letters for identical or similar promotional claims that the agency flagged as violative in its September enforcement blitz.
To give teeth to its enforcement blitz, the FDA could move against companies that have not discontinued or revised ads cited as violative, experts said. In the meantime, the National Advertising Division is serving as an alternative enforcement mechanism.
A wave of FDA warning and untitled letters left drug marketers rethinking risk disclosures, visuals and promotional claims as well as bracing for more enforcement letters in 2026, with a close eye on social media promotion and vaccine advertising.
A webpage for PharmaTher’s ketamine product lacked risk information and made misleading claims about the approved indication, the FDA said in a rare ad/promo violation letter to an ANDA holder.
New Zealand is also lifting its prohibition on advertising unapproved medicines at medical conferences and trade shows in order to boost its appeal as a host for such events and generate millions of dollars in revenue.
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.
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
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 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.
Sponsors should consider whether their TV commercials contain the same number of scene changes during the major statement as ads that received a violation letter.
The extent of FDA and Justice Department coordination on recent warning and untitled letters is unclear, but the “squishy” issues cited in many of the letters and recent elimination of DoJ’s Consumer Protection Branch could influence legal action, industry lawyers said.
An AI tool developed by the Office of Prescription Drug Promotion for reviews is believed to still lack generative capabilities, said former senior staffer Jason Cober, who also raised concerns about intellectual property protections for sponsors’ advertising and promotion submissions.
Recent Justice Department filings may suggest it is rethinking allowances for drug manufacturers to communicate scientific information on unapproved uses to healthcare providers.
Claims for the dermatological appearing on websites and social media were challenged by Dupixent marketer Sanofi. Galderma said it would comply with the National Advertising Division’s recommendations, a move that underscores the challenging times for DTC advertisers.
The bolus of untitled letters signals the FDA's approach to enforcement of the final rule on the presentation of the major statement in direct-to-consumer TV ads in a clear, conspicuous and neutral matter.
Just eight of the 68 warning letters posted by the FDA to date went to innovator companies, but GLP-1 agonists still were a focus.
Ad spending changes in response to the FDA's new DTC policy could force the agency to shift the focus of its regulatory resources.
FDA Commissioner Martin Makary also wrote in a JAMA article that the agency is not banning pharmaceutical advertising, but said industry has exploited weak enforcement.
Pink Sheet reporter and editors discuss the FDA’s decision to remove the “adequate provision” loophole in its advertising regulations and other pharma industry issues that emerged from the Make America Health Again Commission report.