Eli Lilly has joined as a defendant in a lawsuit filed by a pharmacy industry group against the Food and Drug Administration (FDA), seeking to end a lawsuit brought by a pharmacy industry group against the Food and Drug Administration (FDA), alleging the “entitlement” some pharmacies have made with mass-market copies of high-quality drugs. He says he wants to end it. A popular GLP-1 treatment.
The case in question concerns the FDA's decision to formally declare that the shortage of both forms of the GLP-1 drug tirzepatide, Mounjaro and Zepbound, ends in October. The lawsuit was filed by the Outsourcing Facilities Association (OFA), a trade group representing 503B compounding pharmacies, seeking to overturn the FDA's decision.
After the lawsuit was filed, the FDA paused to reconsider its declaration to eliminate the shortage, but ultimately reaffirmed its decision in December, asking whether the current supply of tirzepatide meets demand. , it was once again found that it exceeded that.
Munjaro and Zepbound are both exclusive products from Eli Lilly, but pharmacies are allowed to manufacture and sell counterfeit versions of these drugs in case of shortages. And for nearly two years when tirzepatide was in short supply, telemedicine companies, medical spas, and other compounding pharmacy customers had access to the much-needed drug.
Following FDA reconfirmation, 503B compounding pharmacies must stop selling compounded tirzepatide until March 19th.
In a motion filed on New Year's Day, Eli Lilly said it seeks to “intervene as a defendant in this litigation to protect our interests and contribute to the expedited conclusion of this litigation.”
The pharmaceutical giants argued that the goal of OFA's lawsuit, which was to overturn the FDA's decision that the tirzepatide shortage was over, would undermine its ability to protect its interests. Eli Lilly noted that billions of dollars have been invested in this drug.
“On top of the billions of dollars we spend developing, testing and bringing innovative medicines to market, Lilly has committed more than $23 billion to improve our manufacturing capabilities.”
The company also said it is seeking intervention because it believes the FDA is not adequately representing Eli Lilly's interests. The FDA argued that it was not trying to defend the Deficiency Elimination Declaration, but only its enforcement authority.
Additionally, if the court rules in OFA's favor, the FDA may not be able to appeal, so the company is seeking to join the lawsuit as a defendant.
“The FDA's decision to resolve the tirzepatide shortage was correct and the compounder's lawsuit against the FDA is without merit,” an Eli Lilly spokesperson said in a statement to The Hill. “Anyone marketing or selling unapproved Tirzepatide counterfeit products must stop.”
OFA and FDA did not immediately respond to requests for comment.
