Pharma giant seeks to join lawsuit against FDA over weight loss drugs
Source: The Hill
01/02/25 6:21 PM ET
Eli Lilly is seeking to end a lawsuit filed by a pharmacy trade group against the Food and Drug Administration (FDA) by joining as a defendant, stating it wants to end the “entitlement” some pharmacies have practiced in mass-marketing copies of its highly popular GLP-1 medications. The lawsuit in question concerns the FDA’s decision to officially declare the shortages of Mounjaro and Zepbound, both forms of the GLP-1 drug tirzepatide, to be over in October.
The suit was filed by the Outsourcing Facilities Association (OFA), a trade group that represents 503B compounding pharmacies, seeking to overturn the FDA’s decision. After the suit was filed, the FDA temporarily paused to reconsider the declaration to end the shortage but ultimately reaffirmed its decision in December, finding once again that the supply of tirzepatide currently meets or exceeds demand.
Both Mounjaro and Zepbound are exclusive to Eli Lilly, but compounding pharmacies are permitted to make and sell copycat versions of such drugs when they’re in shortage. And in the nearly two years that tirzepatide was in shortage, telehealth companies, medical spas and other clients of compounding pharmacies were able to get in on the highly in-demand drug. Following the FDA’s reaffirmation, 503B compounding pharmacies have until March 19 to stop selling compounded tirzepatide.
In its motion filed on New Year’s Day, Eli Lilly stated it seeks to “intervene as a defendant in this case to protect its interests and help bring this suit to a swift end.”
Read more: https://thehill.com/policy/healthcare/5064331-eli-lilly-seeks-join-lawsuit-against-fda-over-weight-loss-drugs/
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