After plugging billions into its manufacturing network to meet rampant demand for Mounjaro and Zepbound, Eli Lilly is looking to protect its investment by wading into a lawsuit that seeks to allow compounding pharmacies to continue churning out knockoffs to the popular diabetes and obesity drugs.
Lilly on Wednesday filed a motion to intervene in a lawsuit brought by compounding industry group the Outsourcing Facilities Association (OFA) and compounder FarmaKeio Custom Compounding in U.S. District Court in Fort Worth, Texas.
The October lawsuit, which names the U.S. FDA and its current commissioner Robert Califf, M.D., as defendants, seeks to persuade the regulator to reverse its decision to formally declare a long-running shortage of Lilly’s dual GIP/GLP-1 meds resolved.
Shortly after the OFA filed its lawsuit, the FDA said it would review its decision to remove Lilly’s tirzepatide products from its shortage list—though the agency ultimately stuck by its original determination in a December declaratory order.
With tirzepatide and its Novo Nordisk rival semaglutide facing extended shortages in recent years, compounders have been able to step in and produce their own versions of the drugs, which are often marketed online or through telehealth services.
But under the FDA’s compounding standards, state-licensed pharmacies under Section 503A of the Food, Drug and Cosmetic (FD&C) Act must now stop dispensing copycat tirzepatide by Feb. 18. Larger outsourcing facilities, which fall under the purview of Section 503B of the FD&C Act, must wind down their tirzepatide compounding activities by March 19.
In the original lawsuit against the FDA, lawyers for the OFA called the decision to end the shortage determination “reckless and arbitrary,” with the organization’s chairman, Lee Rosebush, warning in a press release that the move could have “tremendous implications” for patients and doctors given the sheer volume of demand for the drugs at issue.
Meanwhile, in a filing supporting its motion to intervene in the lawsuit, Lilly argued that compounders and telehealth startups have been “mass-manufacturing and mass-marketing their own untested, unapproved knock-off versions of Lilly’s medicines." The company warned that compounded versions of tirzepatide are not beholden to the same safety and quality standards as their branded counterparts.
The company argued that following a $23 billion manufacturing scale-up campaign, all doses of Mounjaro and Zepbound have been available in the U.S. since August, several months before the shortage was formally ended by the FDA.
In the new filing, Lilly says it wants to wade into the legal proceedings to “protect its interests and help bring this suit to a swift end.”
The company’s lawyers further contend that OFA’s position “not only poses significant patient safety risks and challenges the integrity of the FDA’s regulatory framework … but it also directly affects Lilly’s interests in preserving its exclusive right to sell its FDA-approved medicines.”
Beyond the OFA’s lawsuit, multiple other compounding outfits and organizations have protested the FDA’s decision to formally declare the U.S. tirzepatide shortage resolved.
Late last month, Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said in a statement that the FDA decision was “not necessarily the end of the story,” adding that he was not “persuaded” that the regulator had the data necessary to truly determine whether the shortage had ended.
“We continue to hear from pharmacies that the FDA-approved tirzepatide drugs are not attainable from wholesalers in quantities needed to meet demand by patients transitioning from compounded to commercial versions of the drug,” he said.
Novo Nordisk has also struggled to keep up with demand for its GLP-1 rivals to Mounjaro and Zepbound, which are marketed as Ozempic and Wegovy, respectively.
In late October, the FDA listed the final remaining dose of Novo’s semaglutide-based drugs that had been in shortage as “available.”
A Novo spokesperson said at the time that the company was now shipping all doses of Ozempic and Wegovy to wholesalers around the U.S., but, as of January, the FDA still has not formally declared the semaglutide shortage resolved. In turn, compounders can continue to make imitation versions of Novo’s popular metabolic medicines.
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