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Misconstruing Single-Arm Study Data Lands BMS In Trouble With US FDA

 
• By Sarah Karlin-Smith

The lung cancer drug Krazati from Bristol Myers Squibb’s Mirati Therapeutics drew an FDA ad/promo untitled letter, highlighting the agency's trend of pursuing false or misleading efficacy claims, particularly when data comes from outside approved labeling.

doctor that appears to be "holding" lungs
The BMS lung cancer drug was the subject of the FDA's third OPDP letter of the year. • Source: Shutterstock

Bristol Myers Squibb Company’s Mirati Therapeutics, Inc. landed a US Food and Drug Administration untitled letter for the health care provider website of its lung cancer drug Krazati (adagrasib) due to repeated misrepresentations of data from a single-arm study and use of off-label data the FDA could not verify.

Key Takeaways

  • The FDA untitled letter dings BMS for making claims about its lung cancer drug that are not supported by the single-arm trial cited.

  • The agency emphasized that caveats, often in tiny font, are not enough to avoid problems

The Krazati letter is the third Office of Prescription Drug Promotion letter of 2024 and continues a broader trend of the FDA pursuing false or misleading misrepresentations of efficacy in advertisements and promotion. A particular focus has been promotional claims that are not specifically in the drug’s label. (Also see "Drug Promotion: Sponsors Are Running Afoul Of US FDA’s CFL Guidance" - Pink Sheet, 6 May, 2024

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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.

US FDA Cites Taiho’s Lytgobi Healthcare Provider Website For Misleading Efficacy Claims

 
• By Sue Sutter

Results from a single-arm study cannot support representations on overall survival, progression-free survival and disease control rate for the cancer drug, the Office of Prescription Drug Promotion said in another “untitled” letter implicating the agency’s CFL guidance.

How To Leverage US FDA’s ‘Consistent With Labeling’ Guidance In DTC Ads

 
• By Sue Sutter

Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.

Ad/Promo: Improved Adherence Claim For Dexcel’s Hemady Not Supported, US FDA Says

 
• By Sue Sutter

A retrospective analysis does not support a claim that multiple myeloma patients are more adherent to Hemady than generic dexamethasone, OPDP said in an "untitled" letter suggesting increased enforcement focus on promotions leveraging the agency’s 2018 CFL guidance.

More from Compliance

US FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel

 
• By Sue Sutter and Derrick Gingery

Alonza Cruse, director of the Office of Human and Animal Drugs Inspectorate, and two other senior inspection officials are departing, along with Mark Raza, chief counsel from 2021 until January.

Companies Advised To Assess Potential Impacts Of Landmark Global Pandemic Treaty

 
• By Neena Brizmohun

Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.

ICH Modernizes Stability Testing Guideline

 
• By Vibha Sharma

The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.