When sound science and smart policy can’t find common ground at the FDA, people suffer. In this case, people with obesity (PwO).
Late last month, FDA officials erred when they declined to update critical product labeling information that doctors need to know when treating PwO. And that’s no small cohort. Obesity is not a rare or orphan disease. Obesity 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.
Welcome to the bureaucratic abyss. FDA’s experts agree there’s important information to share with healthcare providers but, their argument against doing so is that it might be too “confusing” for doctors. I was in the meeting. I am not making this up. The FDA’s true north used to be that sound science made for smart policy and healthcare providers are unambiguous. They want updated labels for patients with obesity. They aren’t confused. Doctors want clarification. FDA’s job isn’t to regulate the practice of medicine – it’s to help make the practice of medicine better through more up-to-date and precise information sharing – and product labels are the agency’s most potent tool for healthcare provider communications.
At the center of this argument is a seven-year-old discovery made by a leading metabolic scientist, Dr. David Greenblatt of Tufts University. Greenblatt and his researchers found in 2018 that posaconazole, a long-used anti-fungal often administered to immune compromised patients ahead of other toxic treatments, stays in the body of people with obesity about 50% longer than in normal weight people. A side effect of Posaconazole is inhibition of a key enzyme the body needs to break down many of the other toxic medications these patients are due to receive. This was a groundbreaking discovery and crucial information for practitioners and their patients.
In layman’s terms, when posaconazole is in the body, it compromises the body’s ability to process these other drugs. Why is it important that this information appears on the product label? Because knowledge is power. A recent survey of 100 oncologists who prescribe this drug found that most were unaware of the prolonged for obese patients -- and all of them want information should be on the label. There was no confusion on that point.
The FDA’s response? Ignore it. Advocates for people with obesity chose not to. People with obesity – nearly 40% of the US population -- are used to being disrespected by the FDA. They are often excluded from clinical trials even though it’s common scientific knowledge that adipose tissue can meaningfully alter how drugs behave in the body. And FDA-approved drug labels rarely address these issues so physicians can account for these issues in medication management.
For the past two years, patient and physician advocates have been pleading the FDA to update product labels. At first, the agency tried to argue the clinical consequence of the information wasn’t important, that the half-life change was not clinically meaningful. Finally (due in no small part to Dr. Greenblatt’s interventions) agency officials finally acknowledged a labeling update would offer meaningful information – but that it might confuse doctors. Really?
At issue here is not the credibility of the science. All sides agree. And yet – regulatory inertia. It’s another unfortunate example of the FDA lifers choosing inaction over progress. FDA Commissioner 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 a status quo “sock puppet,” and adopt smart science and sound policy that advances 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.
Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest and a Visiting Professor at the University of Paris School of Medicine.
