An obscure federal statute is allowing U.S. pharmacies to flood the market with unvetted knockoffs of Ozempic, a pricey weight-loss drug that is transforming the weight and silhouettes of millions of Americans.
FDA Blind Spot Creates a Lucrative Market
According to a Bloomberg investigation, a “blind spot” in FDA regulations permits pharmacies and compounders to reproduce drugs that are in short supply. This loophole has created a market for unbranded weight-loss drugs worth $1 billion annually. Injectable weight-loss medications, including Zepbound, Mounjaro, Wegovy, and Ozempic, have all been in short supply recently, according to the FDA’s drug shortage list. Though primarily approved for diabetes, an estimated 15.5 million U.S. adults have used these medications for weight loss as of this past May.
High Costs Drive Demand for Alternatives
The high cost of these drugs, about $1,000 monthly, is often not covered by insurers, prompting people to seek cheaper alternatives. The market for Ozempic alone is estimated at $11 billion this year, with projections to hit $16.5 billion by 2029. The copycat drugs, however, are less reliable than brand-name medications produced by suppliers like Eli Lilly and Novo Nordisk A/S.
Consumer Risks and Side Effects
Bloomberg reported that consumers have faced varied and sometimes adverse effects from these copycat medications. For example, one consumer experienced severe acne, a side effect not listed for semaglutide medications, which include nausea, diarrhea, constipation, vomiting, stomach pain, headache, fatigue, dizziness, bloating, belching, gas, heartburn, and runny nose or sore throat.
Compounding Regulations and Challenges
The American Pharmacists Association defines compounding as the creation of a pharmaceutical preparation by a licensed pharmacist to meet the unique needs of an individual patient when a commercially available drug does not suffice. This includes situations when a drug is in shortage or discontinued. However, compounded or reformulated drugs are not tracked through FDA prescription systems or by many state pharmacy boards.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, stated: “There’s no blind spot or loophole in FDA guidance that allows state-licensed compounding pharmacies to prepare copies of FDA-approved drugs when those drugs are in shortage. It’s an intentional policy designed to assure patients don’t have to do without often life-saving medications when drugmakers can’t manage their supply chain. Unfortunately, patients can occasionally experience an adverse event when taking a compounded medication, just as they can with FDA-approved drugs.”
Oversight Failures and Historical Precedents
Despite these defenses, there have been significant oversight failures. For instance, a pharmacy in Louisiana produced nearly 300 vials of injectable weight-loss shots without proper contaminant testing, and drugs in Arizona were mixed in non-sterile conditions. Investigations are underway in Massachusetts and Mississippi. Historical precedents, such as the 2012 fungal meningitis outbreak linked to a Massachusetts pharmacy that produced injectable steroids, highlight the potential consequences of inadequate regulation and oversight.
Legal Battles and Industry Response
The extraordinary demand for injectable weight-loss drugs is also leading to lawsuits. Last year, a Florida judge ruled against Eli Lilly, maker of tirzepatide, the active ingredient in Zepbound, after it tried to use state law to block reformulated versions of the drug. Novo Nordisk, maker of Ozempic and Wegovy, has also challenged compounding pharmacies and wellness clinics for marketing altered versions of semaglutide. Novo has alleged that some compounded drugs had impurities or lower concentrations of semaglutide than they should, while Lilly has said some of the knock-off products contained bacteria or high levels of impurities.
In May, Lilly settled with Totality Medispa, which it claimed had misled consumers into believing it was selling FDA-approved drugs. Lilly expressed deep concern about products fraudulently claimed by compounding pharmacies or counterfeiters to be FDA-approved tirzepatide, Mounjaro, or Zepbound, potentially exposing patients to serious health risks. In at least one instance, the product was nothing more than sugar alcohol.
Conclusion
The balance between making life-saving medications accessible during shortages and ensuring drug safety remains a significant challenge. The current situation calls for stringent oversight and clearer regulatory guidelines to protect consumers from potentially unsafe and unreliable medications.