Patients with Obesity Call for Fair Drug Standards: New Research Reveals Strong Demand for FDA and Industry Action on Testing and Labeling
PR Newswire
ATLANTA, Nov. 4, 2025
At ObesityWeek 2025, new data show overwhelming public support for ensuring that all medications are evaluated and labeled for safety and efficacy in people with obesity.
ATLANTA, Nov. 4, 2025 /PRNewswire/ -- New research presented today at ObesityWeek 2025, the world's leading international conference on obesity science and care, shows that people with obesity overwhelmingly expect the U.S. Food and Drug Administration (FDA) and pharmaceutical companies to close critical gaps in how medications are tested and labeled.
Although more than 40% of U.S. adults live with obesity, most drugs are not required to undergo pharmacokinetic testing in people with obesity before approval. As a result, prescribing information often lacks data essential for clinicians to ensure safe and effective dosing in this large and growing population. When post-approval studies later show altered drug metabolism or distribution in people with obesity, manufacturers frequently fail to update labeling accordingly.
In a national survey, researchers from leading academic and advocacy institutions found striking reactions from people with obesity once they learned about these omissions:
- 67% were unaware that many drugs are not tested in people with obesity.
- 88% reported feeling angry about this gap in oversight.
- 86% said the FDA should require obesity-specific testing before drug approval.
- 99% agreed that manufacturers must update labels when obesity alters drug response.
"This is a clear and consistent message from the people most affected," said Fatima Cody Stanford, MD, MPH, MPA, MBA, one of the study's authors. "Patients with obesity are demanding equal protection in drug safety and efficacy."
A Case in Point: Posaconazole (Noxafil®)
The study highlights posaconazole, an antifungal medication (Merck) approved without comprehensive testing in people with obesity. Recent pharmacokinetic data show the drug's half-life is significantly longer in people with obesity—a factor clinicians say is vital for proper dosing—but the company has not updated its labeling.
When survey participants were informed of this example:
- 74% said they had been unaware of this difference.
- 73% strongly agreed that the label should include this information.
- 73% strongly agreed the FDA should require Merck to act.
"This isn't a niche issue—it's a public health gap," said Ted Kyle, RPh, MBA, a co-author. "Four in ten adults live with obesity, yet their physiology is too often excluded from research that informs clinical decisions. The public expects better accountability."
About the Study
This national survey of people with obesity was conducted online in May 2025 and is being presented as a scientific poster at ObesityWeek 2025 in Atlanta, Georgia (November 4–7).
Authors:
Clara E. Tandar, BS; John C. Lin, BS; Gwyn Cready, MBA; James Zervios, BA; Lisa Gresco-White; Michelle Vicari; Ted Kyle, RPh, MBA; and Fatima C. Stanford, MD, MPH, MPA, MBA.
About the Obesity Action Coalition (OAC):
The Obesity Action Coalition (OAC) is a national nonprofit organization with more than 85,000 members, dedicated to supporting individuals affected by obesity through education, advocacy, awareness and support.
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SOURCE Obesity Action Coalition
