Eli Lilly Asks to Join Lawsuit Against FDA Over Weight-Loss and Diabetes Drugs
Eli Lilly has filed a motion to join a lawsuit brought by compounding pharmacies against the US Food and Drug Administration (FDA) over the agency’s decision that Lilly’s weight-loss and diabetes drugs are no longer in short supply. The drugs, Zepbound and Mounjaro, have the same active ingredient, tirzepatide, and the FDA’s decision allows compounding pharmacies to sell cheaper versions of the drugs.
The FDA declined to comment, and the Outsourcing Facilities Association, which brought the lawsuit along with a Texas compounding pharmacy, did not immediately respond to requests for comment. The lawsuit will determine whether compounding pharmacies and facilities can continue to sell cheaper versions of the drugs.
Lilly argues that it cannot rely on the FDA to fully defend its interests in the case and needs to join the lawsuit to protect its own interests. The company also believes that compounding pharmacies may not manufacture compounded drugs even if there is a shortage, which may be at odds with the FDA’s view.
The FDA decided in October that there was no longer a shortage of the tirzepatide drugs and reaffirmed its decision in December. However, the compounding industry is still seeking a court order reversing the agency’s decision. The FDA has agreed to reconsider its decision but has not taken any enforcement action against compounding pharmacies.
Lilly has also taken steps to prevent the sale of compounded versions of its drugs, sending cease-and-desist letters to telehealth companies, wellness centers, and medical spas and filing lawsuits against those falsely claiming to sell FDA-approved versions of the drug.
