Ozempic knockoffs flood US market thanks to ‘blind spot’ in FDA rules

An obscure federal statute is allowing US pharmacies to flood the market with unvetted knockoffs of Ozempic , the pricey weight-loss drug that is reducing and transforming the weight and silhouettes of millions of Americans.

According to a Bloomberg investigation published Monday, a “blind spot” in Food and Drug Administration (FDA) regulations that allows pharmacies and compounders to reproduce drugs that are in short supply has helped to create a market of unbranded weight-loss drugs worth $1bn annually.

Injectable weight-loss medications including Zepbound, Mounjaro, Wegovy and Ozempic all have been in short supply as of late, according to the FDA’s drug shortage list.

While they are approved for diabetes but not formally for weight loss, an estimated 15.5 million US adults – or 6% of the population – have used them as of this past May.

Alongside the shortages, the high cost of the drugs at about $1,000 monthly is not typically covered by insurers, causing people to seek cheaper alternatives. The market for Ozempic alone was estimated at $11bn this year and projected to hit $16.5bn by 2029, according to Mordor Intelligence.

The copycat drugs, according to the outlet, are less reliable than brand-name medications created by over-stretched suppliers, including makers Eli Lilly and Company and Novo Nordisk A/S.

Bloomberg reported that one consumer, Lindsay Posey, took one dose of the appetite-suppressant that worked well, a second that didn’t and a third that caused her to breakout in acne on her cheeks, nose, chin and forehead.

Acne is not listed as a potential side-effect of semaglutide medications, which include nausea, diarrhea, constipation, vomiting, stomach pain, headache, fatigue, dizziness, bloating, belching, gas, heartburn and runny nose or sore throat.

“My skin just went absolutely crazy,” Posey said.

When her doctor suggested it might be the medication, she reflected: “That’s not really something you want to hear.”

According to the American Pharmacists Association, “compounding is the creation of a pharmaceutical preparation – a drug – by a licensed pharmacist to meet the unique needs of an individual patient (either human or animal) when a commercially available drug does not meet those needs”. That includes when “a patient may require a drug that is currently in shortage or discontinued”, the pharmacists association says.

Copycat or reformulated drugs are not tracked through FDA prescriptions systems or by many state pharmacy boards.

In a statement, Scott Brunner, chief executive officer of the Alliance for Pharmacy Compounding, told the Guardian: “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.”

He said: “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.

“We’re not talking about known side effects of a drug, but serious health-threatening effects. When they do occur, they must be thoroughly investigated to determine the cause of the adverse event.”

Nonetheless, a pharmacy in Louisiana produced nearly 300 vials of injectable weight-loss shots without doing proper contaminant testing. In Arizona, drugs were mixed in non-sterile conditions. Investigations are underway in Massachusetts and Mississippi.

Drugs produced by compounders have caused problems in the past. In 2012, an outbreak of fungal meningitis was traced to a pharmacy in Massachusetts that had produced injectable steroids.

More than 750 people in 20 states developed fungal infections, and more than 60 people died, according to the CDC .

The extraordinary demand for injectable weight-loss drugs is producing 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.

US federal court judge Roy Altman wrote that Lilly was trying to preempt the Federal Food, Drug and Cosmetic Act. 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 are known to have bacteria or high levels of impurities.

In May, Lilly settled with Totality Medispa, which it claimed had misled consumers into believing it was selling its FDA-approved drugs.

The company said it was “deeply concerned that products fraudulently claimed by compounding pharmacies or counterfeiters to be FDA-approved tirzepatide, Mounjaro or Zepbound may expose patients to serious health risks”.

In at least one instance, the product was nothing more than sugar alcohol.

The agreement, the company said, was “an important step forward”.

“This is not a problem that Lilly can solve alone,” the company also said, adding that it supported “state and federal regulators taking action to deter and punish compounding pharmacies, counterfeiters and others who put patients at risk by selling unsafe products claiming to be tirzepatide”.