After a couple months of uncertainty, the FDA has told compounding pharmacies that they have 60 to 90 days before the agency will enforce rules to stop their production of GLP-1s.
The FDA confirmed on Thursday that Eli Lilly’s tirzepatide, marketed as Zepbound for weight loss, is no longer in shortage, multiple outlets reported. The agency added that it will give compounders 60 to 90 days before putting a stop to their production of the GLP-1.
In early October, the FDA removed Eli Lilly’s drugs from the shortage list, but compounders quickly pushed back, with the Outsourcing Facilities Association (OFA) launching a lawsuit against the FDA. This led to the FDA reevaluating the move and deciding not to take any action against compounders in the short term—an unprecedented situation.
Now, the FDA has changed course again, confirming its October decision to remove Lilly’s drugs from the shortage list and thereby closing the avenue for compounders to produce these profitable drugs.
The news follows the FDA’s warning letters issued last week to a handful of companies flagging violations regarding the promotion and sale of unapproved weight-loss drugs, including unlicensed versions of the blockbuster therapies semaglutide and tirzepatide.
Original story published Nov. 22:
FDA Still Undecided About Shortage Status of Lilly’s Tirzepatide
Eli Lilly’s weight-loss therapy tirzepatide remains in limbo as the FDA continues to assess its supply status and whether or not a shortage should be declared, according to a court status report on Thursday.
The regulator has “made substantial progress” in reassessing its prior decision to take tirzepatide off its drug shortage list and “continues to prioritize issuing a new decision” on the matter, the report said. The next court status report is due on December 19, 2024, or within seven days of the FDA’s decision—whichever comes earlier.
Today’s update signals that “the FDA has agreed to not take action against compounders of tirzepatide until December 19, unless the agency makes an earlier decision on remand,” according to an investor note from Leerink Partners analyst Michael Chern., He noted that this could have some positive implications for the business of several compounders.
Early last month, the FDA officially declared that the shortage of tirzepatide—sold as Mounjaro for type 2 diabetes and as Zepbound for chronic weight management—had been resolved. Lilly’s drug had previously spent months on the regulator’s shortage list as the pharma struggled to match its manufacturing capacity with the market’s insatiable demand for obesity medications.
With this move, however, the FDA effectively barred compounding pharmacies from producing their ownversions of tirzepatide—something that trade group Outsourcing Facilities Association (OFA) did not take kindly to. Weeks after the end of the shortage, the OFA blasted the FDA’s decision, calling it “arbitrary” and saying it could “deprive patients of a vital treatment for type 2 diabetes and obesity.”
The OFA sued the FDA, alleging that the move to take tirzepatide off shortage lacked “any semblance of lawful process.” The complaint noted that Congress allows certain drugs to be compounded when supply is limited, with the goal of helping the industry continue to deliver therapies to patients who need them.
“Patient demand has been satisfied in precisely the manner Congress contemplated,” the OFA wrote in its lawsuit.
In Thursday’s court update, the OFA said that it has consistently tracked the market conditions for tirzepatide in order to support the FDA’s decision-making and to provide the agency with “evidence that the drug remains in shortage.”
“Survey data from this month shows increasing numbers of patients unable to obtain branded GLP-1 agonist products, including specifically branded Tirzepatide products,” the OFA noted, adding that pharmacies and other distributors “continue to list branded Tirzepatide products as out-of-stock or available in only limited quantities.”
For its part, Lilly has taken a strong stance against compounded versions of tirzepatide. Last month, the pharma sued three retailers for allegedly marketing remixed tirzepatide. Lilly filed similar lawsuits in September 2023 and October 2023, continuing the legal offensive into June 2024.
BMO Capital Markets analyst Evan Seigerman said in a Thursday note that the court update “provides little clarity on the path forward for Lilly’s ongoing battle with compounders.” Still, the firm believes that despite “uncertainty” regarding the lawsuit and tirzepatide’s shortage status, Lilly continues to have strong prospects moving forward.
“With capacity continuing to expand, we anticipate that compounder headwinds will be eliminated in the medium term even if the FDA’s decision on drug shortage is reversed in the near term,” Seigerman said.
