Pa. Lawmaker Warns Unregulated Compounded GLP-1 Copycats Put Patients at Risk, Urges Stronger Enforcement

Justin Fleming, a Democratic state representative from Dauphin County, has put his name to a warning about a product he says is spreading through Pennsylvania: knockoff versions of GLP-1 weight-loss drugs, sold by compounding pharmacies without any approval from the Food and Drug Administration. His argument appeared as a guest column in the Erie Times-News, and it is an opinion piece. The claims in it are his, though several rest on FDA warnings and on an enforcement action he describes.

Fleming's core point is that compounded GLP-1s are not the same thing as the medications doctors prescribe for weight loss and chronic disease. The real drugs go through rigorous testing for FDA approval, and they are prescribed with safeguards for dosage accuracy and purity. The copycats, he writes, often rely on untested or contaminated ingredients and skip the quality controls the approved drugs must meet. They reach buyers, he says, through aggressive online ads and promises of affordability.

He points to the FDA's own warnings. The agency has flagged overdoses, contamination and hospitalizations tied to compounded versions of semaglutide and tirzepatide. According to Fleming, patients have landed in emergency rooms because these products were mislabeled or improperly dosed. With an injectable medication, he writes, there is no margin for error, and the companies selling these versions operate without the oversight that would protect patients.

He offers one local example. The Shapiro administration recently held a Chester County pharmacy accountable for compounding and packaging 30,000 doses of injectable weight-loss drugs in facilities that had not been inspected.

A large part of the column concerns who is being targeted. Fleming says the sellers go after low-income families and communities of color, the groups already hit hardest by obesity and chronic disease. He cites figures: Black Pennsylvanians make up 13% of the state's population but 25% of Medical Assistance recipients. Nationally, 43% of Black adults live with obesity, compared with 33% of white adults. He attributes those gaps to decades of structural inequity, including less access to healthy food, safe places to exercise and preventive care. In his telling, predatory companies now exploit the same inequities, seeing rising demand and cost barriers and selling dangerous products to people with the fewest options. He calls the motive profit over people.

Fleming writes as someone who grew up in Dauphin County, served in local government, and now co-chairs the PA Diabetes Caucus. He lays out three things he wants. First, stronger enforcement to shut down illegal compounders and keep their products out of Pennsylvania communities. Second, close work with federal partners so unsafe ingredients do not enter the state. Third, protection of access to real, FDA-approved GLP-1 medications through Medical Assistance, so that people are not forced to choose between going untreated and using a dangerous, unregulated copy.

He says he is working on legislation to protect patients, but that the federal government can act now. His request to the FDA is direct: verify the validity of these products or prohibit their sale altogether.

He closes on trust. No parent, he writes, should have to wonder whether the medicine they give their child or themselves is real or a dangerous fake. What to watch is whether his bill materializes, whether state enforcement follows the Chester County case, and whether Medical Assistance coverage of approved GLP-1 drugs changes.