The judge in the case, District Judge Mark Pittman, granted the FDA’s request, adjourned the Oct. 15 hearing and ordered the parties to submit a joint status report on Nov. 21.
Pharmaceutical companies also react.
The move was celebrated by the Outsourcing Facilities Association (OFA), which filed the lawsuit.
“We believe this is a fair resolution given the agency’s imprudent decision to delist this drug at a time when the agency acknowledged a ‘supply disruption.’ “This has created major access issues for patients around the world,” OFA said. Chairman Lee Rosebush said in a statement. “Most importantly, if FDA repeats its removal decision when a shortage truly exists, we will return to court.”
The move is also likely to be welcomed by patients who have come to rely on combination drugs that are cheaper and more readily available. For some, combination products may have been the only access to tirzepatide. Still, these drugs are not without risks. The FDA has repeatedly emphasized that compounded drugs are not FDA-approved and do not undergo the same safety, efficacy, and quality reviews. And the agency warned: administration error others safety concerns Use the combined version.
Eli Lilly and Co. are clearly unhappy with the FDA’s move. A cease-and-desist letter was reportedly sent to the compounder.. In an emailed statement to Als, a Lilly spokesperson said the company’s drug is in sufficient supply and continued use of the combination drug is not justified. “As acknowledged by the FDA, nothing changes the fact that Mounjaro and Zepbound are available and the shortage remains ‘resolved,'” the spokesperson said.
Lilly also cited the FDA’s safety concerns about synthetic versions, noting that independent testing of some synthetic products has found impurities, bacteria, strange colorations, inaccurate potency, mysterious chemical structures, He added that in some cases the product was found to be just a sugar alcohol.
“It is important that all doses of Lilly’s FDA-approved medicines are available and patients are not at risk of taking untested, unapproved counterfeit products,” the spokesperson said.
Regarding the supply “disruptions” cited by the FDA and reportedly experienced by some patients and pharmacies, Lilly said the supply chain is complex and there are many reasons why a particular pharmacy may not have a particular dose on hand. He said there is. Refrigerated storage space.
