STAT: In debate over obesity medications, FDA shifts toward importance of drugs in subtle ways
By Elaine Chen
For years now, companies behind weight loss drugs like Wegovy and Zepbound have been trying to convince the medical community and the public that obesity is a disease and medications are the answer. It seems the Food and Drug Administration has now shifted its perspective, too.
This week, amid a slew of new recommendations that the FDA released ahead of President-elect Trump’s inauguration, the agency posted draft guidance on obesity clinical trials, the first time it has done so since 2007.
The new draft calls obesity “a chronic disease,” whereas the previous guidance called it “a chronic, relapsing health risk.”
It mentions the importance of lifestyle interventions less than the previous guidance, omitting a reference to lifestyle modification being seen as “the cornerstone of overweight and obesity management.” It also takes a less conservative view of how companies should test drugs in the pediatric population, removing recommendations that drugmakers should first conduct studies in higher-risk adolescents than other children.
Draft guidance documents issued by the FDA are not binding, but revisions, even subtle, provide a look into the agency’s stances; they also have real-world implications for how experimental drugs and devices are assessed and approved.
The new guidance says that trials of any drugs that act in the brain should assess kids for depression and suicidality. But Sarah Hampl, a pediatrician at Children’s Mercy Kansas City, said she would have wanted to see the FDA explicitly recommend companies track changes in children’s overall mental and emotional health and any signs of eating disorders.
“Non-BMI outcomes need to really be a standard for pharmacotherapy trials as well, like self-esteem, body image, anxiety, depression, disordered eating, all those factors,” said Hampl, who was lead author on the American Academy of Pediatrics’ guidelines on obesity.
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