People with Obesity are getting the shaft from the FDA. That’s got to change.
It is likely to come as a surprise that, considering all the attention and headlines about the America’s obesity epidemic and GLP-1 drugs such as Ozempic, Zepbound, and Mounjaro, that the FDA does not routinely update drug labels with safety information for people with obesity. The agency that Nobel Prize winner Milton Friedman once accused as being “obsessed with safety” doesn’t know (and it seems doesn’t care) if people with obesity are dosed safely or effectively with approved products since large scale clinical trials regularly and purposely exclude them -- per clinical trial designs approved by the FDA.
Such scientific omission is irrational, unscientific, not in the best interests of patients, contrary to the wishes of the medical profession – and just plain wrong.
Consider the evidence:
Per a 2024 study in Clinical Pharmacokinetics, "Optimal clinical decision making in patients with obesity is impossible without prior study of drug of interest in this population."
The FDA has some explaining to do. The big unanswered question is why neither drug developers nor the FDA have acted on this recognized and solvable public health blind spot.
The FDA’s newly minted Commissioner, Dr. Martin Makary, needs to ask his staff two very direct questions::
Why does the agency require labels to include hepatic impairment pharmacokinetic information, but not information for patients with obesity -- since the population of people with hepatic impairments is a twentieth the size of people with obesity.
According to Harvard researchers, serious gaps exist in what is known about the effects of obesity on drug disposition and current label information on drug use. Why it acceptable for these gaps continue to exist within the universe of FDA-approved medicines and, more importantly, why do they continue to exist unexamined and uncorrected?
The Commissioner should ask his staff for a list of drugs whose labels have been updated to reflect the pharmacokinetics of people with obesity and ask for an explanation as to why the drugs referenced in the Harvard study are not amongst them.
Obesity is not a rare or orphan disease. But that shouldn’t mean the agency can ignore a condition that impacts nearly 100 million adult Americans. It is both shocking and disappointing that the FDA hasn’t acted with more urgency to proactively remediate drug labels so that physicians can be aware of both the problem and the solution. What makes matter worse it that it’s an easy regulatory fix. The FDA must put equal weight behind what happens post-approval, as it does in addressing the much more controlled premarket clinical trial environment. This also raises important questions relative to the current strengths and weaknesses of the agency’s post-market surveillance programs. Dr. Makary should insist that the agency he now leads augment transparency and clarity through more clear and comprehensive labeling updates.
Now is the time to rectify this serious oversight, prove to Health and Human Services Secretary Robert F. Kennedy, Jr. that the agency isn’t an industry “sock puppet,” and help advance the health of a population that represents 40% of the United States population. To continue to ignore this problem is regulatory malpractice of the first order.
It is likely to come as a surprise that, considering all the attention and headlines about the America’s obesity epidemic and GLP-1 drugs such as Ozempic, Zepbound, and Mounjaro, that the FDA does not routinely update drug labels with safety information for people with obesity. The agency that Nobel Prize winner Milton Friedman once accused as being “obsessed with safety” doesn’t know (and it seems doesn’t care) if people with obesity are dosed safely or effectively with approved products since large scale clinical trials regularly and purposely exclude them -- per clinical trial designs approved by the FDA.
Such scientific omission is irrational, unscientific, not in the best interests of patients, contrary to the wishes of the medical profession – and just plain wrong.
Consider the evidence:
Per a 2024 study in Clinical Pharmacokinetics, "Optimal clinical decision making in patients with obesity is impossible without prior study of drug of interest in this population."
The FDA has some explaining to do. The big unanswered question is why neither drug developers nor the FDA have acted on this recognized and solvable public health blind spot.
The FDA’s newly minted Commissioner, Dr. Martin Makary, needs to ask his staff two very direct questions::
Why does the agency require labels to include hepatic impairment pharmacokinetic information, but not information for patients with obesity -- since the population of people with hepatic impairments is a twentieth the size of people with obesity.
According to Harvard researchers, serious gaps exist in what is known about the effects of obesity on drug disposition and current label information on drug use. Why it acceptable for these gaps continue to exist within the universe of FDA-approved medicines and, more importantly, why do they continue to exist unexamined and uncorrected?
The Commissioner should ask his staff for a list of drugs whose labels have been updated to reflect the pharmacokinetics of people with obesity and ask for an explanation as to why the drugs referenced in the Harvard study are not amongst them.
Obesity is not a rare or orphan disease. But that shouldn’t mean the agency can ignore a condition that impacts nearly 100 million adult Americans. It is both shocking and disappointing that the FDA hasn’t acted with more urgency to proactively remediate drug labels so that physicians can be aware of both the problem and the solution. What makes matter worse it that it’s an easy regulatory fix. The FDA must put equal weight behind what happens post-approval, as it does in addressing the much more controlled premarket clinical trial environment. This also raises important questions relative to the current strengths and weaknesses of the agency’s post-market surveillance programs. Dr. Makary should insist that the agency he now leads augment transparency and clarity through more clear and comprehensive labeling updates.
Now is the time to rectify this serious oversight, prove to Health and Human Services Secretary Robert F. Kennedy, Jr. that the agency isn’t an industry “sock puppet,” and help advance the health of a population that represents 40% of the United States population. To continue to ignore this problem is regulatory malpractice of the first order.
