Pharma giant Eli Lilly is seeking to join a lawsuit filed by the Food and Drug Administration (FDA) against 503B compounding pharmacies that market copies of its GLP-1 medications during shortages. The suit, filed by the Outsourcing Facilities Association, aims to overturn the FDA’s decision to end the shortage of Mounjaro and Zepbound.
Eli Lilly wants to intervene in the lawsuit to protect its interests and bring it to a swift end. The company claims that the lawsuit could impair its ability to manufacture more tirzepatide, citing billions of dollars invested into developing and testing the drug. Eli Lilly also argues that the FDA does not adequately represent its interests.
The company has committed over $23 billion to increase its manufacturing capacity for tirzepatide. With this investment, Eli Lilly aims to protect its revolutionary medicines from unapproved knockoffs. The pharmaceutical giant’s spokesperson stated that the compounders’ lawsuit against the FDA is without merit and that marketing or selling unapproved tirzepatide should stop.
The OFA and FDA have not responded to comment on the matter.
Source: https://thehill.com/policy/healthcare/5064331-eli-lilly-seeks-join-lawsuit-against-fda-over-weight-loss-drugs