The boom in imitation Ozempic went bust for one pharmacy and its clients

The orders for custom weight-loss drugs flooded into ACA Pharmacy in Nashville, where white bins holding prescriptions were stacked as tall as the staffers filling them.

Over several months in 2023, ACA produced tens of thousands of its own variety of prescription weightloss medications. A FedEx truck arrived regularly to ship the chilled boxes across the nation. Wallmounted TV monitors inside the specialized pharmacy displayed its rising monthly revenue. Then, in late July, it all came crashing down.

ACA’s rapid rise and sudden closure last year, as described by former employees and in internal documents, highlight the profitable but risky business spawned by the popularity of Ozempic and Mounjaro. The medications, which are coveted for their weight-loss effects, brought in more than $9 billion and nearly $3 billion, respectively, for their manufacturers in the first three quarters of 2023. Patients’ desire for these drugs has made them hard to get, leading the Food and Drug Administration to declare a shortage. The FDA’s designation which could change at any time has opened the door for pharmacies like ACA to make and sell custom versions of the medications in sterile labs.

Compounding pharmacies typically craft smallbatch drugs for customers with special medication needs, but many have jumped at the opportunity to cash in by making weight-loss drugs. ACA’s pivot into weight loss was particularly forceful, with such products accounting for the vast majority of its orders, according to seven former employees. The pharmacy made millions in the first seven months of last year as it ramped up to fill more than 1,000 prescriptions per day, according to three former employees and internal records, although its exact haul couldn’t be determined. The Washington Post interviewed a total of eight former employees, most of whom spoke on the condition of anonymity to discuss sensitive internal matters, and some feared retaliation from their prior employer.

ACA’s leaders have attributed its closure to the death of a key employee, but that isn’t the whole story. As it increased production, ACA’s staff swelled to about a dozen pharmacists and 30 technicians, including some with little to no experience working in a pharmacy, two former employees said. The Post found that clients complained that patient medications were sent to the wrong address, the company’s national accreditation lapsed after just a few weeks, and an inspection by state regulators went poorly.

Three former employees told The Post that staffers openly used ACA’s weightloss medications on themselves, including two who said they had done so without a prescription.

Ned Ashley, chief executive of ACA’s parent company, Rx Partners, said in a statement that closing ACA was a “nuanced and multifaceted” decision, adding that the death of its chief operating officer “played a large part.” The death was a suicide, according to public records.

Ashley said questions submitted by The Post about ACA’s finances, operations and regulatory problems contained “various inaccuracies” but declined to elaborate. ACA has no record of receiving any reports of serious patient harm linked to its compounded weight-loss medications, he said, adding that he has no knowledge of employees using the pharmacy’s drugs without a prescription.

Dean Flener, a spokesman for the Tennessee Department of Health, wouldn’t comment on the findings of the inspection.

The state health agency issued a disciplinary order to ACA in August that doesn’t cite specific deficiencies but indicates areas where staff would have to be retrained before ACA could resume compounding, including keeping equipment free of contaminants and ensuring proper employee hygiene and cleaning.

“It’s apparent they were having issues maintaining sterility,” said Dan Troy, a former FDA chief counsel who’s now a managing director at Berkeley Research Group who reviewed the disciplinary order.

“Maintaining sterility is hard even for the largest, best-funded, most sophisticated pharmaceutical manufacturers,” he said, adding that compounding pharmacies have struggled with this for years.