Joint statement calls for FDA to require drug trials to include people with obesity
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Key takeaways:
- Five obesity advocacy groups are asking the FDA to require drug trials to include people with obesity.
- The statement also asked for labeling changes for drugs that may affect people with obesity differently.
Five obesity advocacy organization have issued a joint statement asking the FDA to mandate that all drug approval trials include people with obesity.
On Nov. 28, the Obesity Action Coalition, The Obesity Society, Stop Obesity Alliance, Obesity Medicine Association and American Society for Metabolic and Bariatric Surgery released a statement to the FDA requesting action on two issues regarding drug approvals and how they affect people with obesity.
The statement was released to coincide with a special issue of the Journal of Clinical Pharmacology that includes a series of articles on how to address the need to study people with obesity during the drug development process.
The first item called on the FDA to close gaps in the testing and approval process for new drugs intended for use by people with obesity. The joint statement noted that there is no requirement for new drugs to be tested in people with obesity prior to their approval, and exclusion criteria frequently keep people with higher BMI values from participating in trials.
“Drug companies have an interest in reducing inter-subject variability, because in narrower subsections, drugs are more likely to perform as expected, thereby increasing the odds of getting approved,” Jamy Ard, MD, FTOS, president-elect of The Obesity Society, professor in the department of epidemiology and prevention at Wake Forest School of Medicine, co-director of the weight management center for Advocate Health Wake Forest Baptist, and a Healio | Endocrine Today Editorial Board Member, said in the joint statement. “Unfortunately, variation in body size is easy to identify and, as a result, drug companies often structure clinical trials to exclude people with obesity.”
The authors said changes have been made to drug trial requirements in the past, noting that drugs were routinely tested only among men until the FDA and Congress required trials to include women in 1993. Additionally, drugs meant for children were not routinely tested among children until required by the FDA and Congress in the early 2000s.
The statement also said the FDA requires drugs that may have adverse effects on the kidneys or liver to be tested among people with kidney disease or liver disease. With 42% of the U.S. population having obesity compared with 2.2% of the population having kidney disease and 1.7% having liver disease, the authors said, drug companies should also be required to assess relevant medications for efficacy and safety among people with obesity.
The statement asked the FDA to approve dosing label changes for medications that may affect people with obesity differently than those with a normal BMI. Brexpiprazole (Rexulti, Otsuka/Lundbeck), a medication approved to treat schizophrenia and depression, had studies conducted that excluded people with a higher BMI, according to the statement. According to recent studies, brexpiprazole may take longer to reach effective levels for people with obesity compared with those without obesity. This could cause underdosing for people with obesity and may lead patients and providers to believe the medication is ineffective and discontinue its use, or continue using it at too low of a dose, according to the statement.
The authors also said labeling changes should be made for the antifungal medication posaconazole (Noxafil, Merck). According to the statement, the medication was not tested in people with obesity prior to its approval. A study conducted after approval found the half-life of posaconazole was longer in people with obesity than those with a normal BMI. Since the medication is a strong inhibitor of CYP3A4, a liver enzyme that metabolizes a high percentage of drugs, people with obesity may have prolonged drug-drug interactions for weeks after discontinuing posaconazole.
“We must ensure drugs are safe and effective and labeled correctly for everyone for whom they are intended,” Angela Fitch, MD, FACP, FOMA, Dipl. ABOM, president of the Obesity Medicine Association, associate director of the Massachusetts General Hospital Weight Center and an instructor of medicine at Harvard Medical School, said in the joint statement. “Drug companies don’t get a pass on people with obesity.”
The statement requests that the FDA issue immediate labeling updates for medications that have safety or efficacy concerns for people with obesity so that correct dosing instructions may be followed.
"Proceedings of a workshop organized in part by FDA scientists dealing with this subject were published this month, which tells us that FDA is fully aware of this issue," Joe Nadglowski, president and CEO of the Obesity Action Coalition, said in a press release. "Everyone deserves to know the drugs they use are safe and effective. The FDA and drug companies need to take action now."
Reference:
- Doctors and advocates call for better testing and labeling of drugs for people with obesity. Available at https://www.prnewswire.com/news-releases/doctors-and-advocates-call-for-better-testing-and-labeling-of-drugs-for-people-with-obesity-301996164.html. Published Nov. 28, 2023. Accessed Nov. 28, 2023.
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Joint Statement in Support of Closing Gaps in the Drug Approval Process and Drug Labeling for People with Obesity. Available at https://www.obesityaction.org/statement-drug-approval-labeling. Published Nov. 28, 2023. Accessed Nov. 28, 2023.
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