12.18.23 OMA Board Book

like posaconazole before resuming normal dosing. But drug labeling does not advise doctors that this phenomenon occurs in pa�ents with obesity. “Drug companies have an interest in reducing inter-subject variability, because in narrower subsec�ons, drugs are more likely to perform as expected, thereby increasing the odds of ge�ng approved, ” says Jamy Ard, MD, FTOS, President-Elect of TOS, the leading professional society focused on obesity scien ce, treatment, and preven�on. “ Unfortunately, varia�on in body size is easy to iden�fy and as a result, drug companies o�en structure clinical trials to exclude people with obesity.” Congress and the FDA have the power to require drug companies to test new drugs on relevant subsec�ons of the popula�on prior to approval. Drugs meant for use by all adults were rou�nely tested only on men un�l the FDA and Congress required them to be tested on women as well in 1993. Drugs meant for use by children in addi�on to adults weren ’ t rou�nely tested on children un�l the FDA and Congress required it in the early 2000s. More recently, the FDA provided clear guidance that drugs that might have certain adverse effects on the kidneys or liver to be tested on pe ople with kidney or liver disease, respec�vely. Given that 42% of U.S. adults have obesity compared to 2.2% with kidney disease and 1.7% with liver disease 8 , it should be required that drug companies assess relevant drugs for safety and efficacy in people with obesity. This failure to atend to the needs of people with obesity is both harmful and erodes the trust they have in healthcare. “You’re either invisible, or the answer is to lose weight, even with mental health,” says a failed Rexul� user a�er learning that the drug was not tested on people with obesity. “ We must ensure drugs are safe and effec�ve and labeled correctly for everyone for whom they are intended,” says Angela Fitch, MD, FACP, FOMA, Dipl. ABOM, and President of the OMA, the largest organiza�on of physicians, nurse prac��oners, physician assistants, and other health care providers working every day to improve the lives of pa�ents affected by obesity . “Drug companies don’t get a pass on people with obesity.”

8 Centers for Disease Control. Summary Health Sta�s�cs for U.S. Adults: Na�onal Health Interview Survey, 2018 n.d. htps://www.cdc.gov/nchs/fastats/kidney - disease.htm (accessed May 8, 2023).