Legal Decisions and FDA Stance
A federal court denied compounding pharmacies' request to continue making copies of and Wegovy, siding with the FDA and Novo Nordisk. The FDA had declared the semaglutide shortage resolved, allowing enforcement against unauthorized production.
The ruling affects both small 503A pharmacies, which must cease production immediately, and larger 503B facilities, given until May 22 to comply. This decision supports the FDA's position that Novo Nordisk's supply meets U.S. demand.
Industry Response and Legal Actions
Novo Nordisk criticized the production of compounded semaglutide as unsafe, citing legal actions against over 100 entities in 32 states to protect patient safety and uphold FDA regulations.
The Outsourcing Facilities Association expressed disappointment, claiming the court overlooked evidence of ongoing shortages. They plan to revisit this evidence in future legal processes and discussions with the FDA.