Partners Lee Rosebush and Andrew Grossman have been the driving force behind a lawsuit filed by the Outsourcing Facilities Association – of which Rosebush is chairman – against the FDA for removing the drugs Mounjaro and Zepbound from the FDA’s “drug shortage list,” which blocked pharmacies and outsourcing facilities from manufacturing compounded versions of the drug. The lawsuit pressed several novel theories challenging the FDA’s action, including that it failed to comply with required notice-and-comment procedures and acted arbitrarily in failing to consider market supply provided by compounders. Rosebush stated that the FDA’s action will not only affect the compounding industry, but also have serious consequences for both patients and physicians who rely on the compounded medications.
After the OFA moved for emergency relief, the FDA folded. In a settlement negotiated by Grossman, as lead litigation counsel, the agency agreed to reconsider its decision and, meanwhile, permit OFA’s members to continue producing compounded version of the drug. U.S. District Judge Mark Pittman in Fort Worth, Texas, moved quickly to approve that outcome, sending the matter back to the agency and providing instant relief for OFA’s members.
In a statement, Rosebush said the group was “greatly relieved, for our members and the many patients that they serve, that the FDA has agreed to reconsider its decision.”
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