FDA Faces Questions About Drug Safety for People with Obesity
At a hearing this week fo the U.S. House Committee on Energy and Commerce, Representative Robin Kelly asked the Director of the FDA Center for Drug Evaluation and Research, Patrizia Cavazzoni, what the agency is doing to ensure that drug labeling adequately protects the safety of people with obesity:
“Patients with obesity are frequently excluded from trials due to comorbid conditions, hindering safe and effective dosing data collection. FDA-approved medications may lack proper dosing or pose risks for patients with obesity, as post marketing studies reveal. This highlights the need for inclusive trials and tailored dosing for this population’s safety.
“What specific steps has the agency taken to ensure adequate representation in trials and how does the FDA promptly update drug labels with the new dosing data?”
“We’re Working on It”
Cavazzoni replied that this is an important issue and FDA is working on it:
“We have issued extensive guidance for sponsors indicating that we don’t want the inclusion or exclusion criteria for trials to be so restrictive that it really impacts the generalizability of the data.”
Dodging the Question of Problematic Drug Labels
But Cavazzoni dodges the question about safety of FDA-approved drug dosing instructions for people with obesity. This is no small issue. Obesity medicine physician Fatima Cody Stanford explains:
“It is imperative that we give equity to including persons with obesity in all drug trials across all drug classes. It delights me to see this in the conversations on Capitol Hill. As we see the rates of obesity increase in our country, we must recognize that over two-thirds of the country has overweight and obesity. It would be a travesty to see that these medications receive inadequate evaluation in a large majority of the population. Let’s do this right and include all persons.
“In fact, we know that dosage adjustments are necessary for some drugs that are already out there. So FDA and Pharma should act promptly to update drug labels with this information.”
This is no small issue. Two examples are posaconazole and brexpiprazole. These are two very different drugs and the instructions for use of each drug have distinct issues that can put patients at risk.
Scientists know this is a problem. FDA can fix it. They should.
Click here for this part of the hearing, here, here, here, and here for further background on this issue.
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May 24, 2024
