Bankrupt KV Pharma’s Hopes For Makena Rest With Skeptical Judge
During a hearing in the company’s lawsuit against FDA, a federal judge repeatedly questions her authority to require the agency take enforcement action against compounding pharmacies; KV filed for bankruptcy protection three days earlier, citing its inability to realize full value of the pre-term birth drug due to competition from cheaper compounded versions of 17-P.
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FDA Compounding Statements Beyond Judicial Review; Court Tosses Makena Suit
The agency’s public statements about compounded versions of the pre-term birth drug are exempt from judicial review under a 1985 Supreme Court decision, U.S. Judge Amy Berman Jackson said.
FDA’s Nonenforcement Actions Are Not Reviewable, Agency Argues In KV’s Makena Suit
The agency says its decisions not to take enforcement action against pharmacies compounding hydroxyprogesterone are discretionary and that KV has not shown that payers are likely to change their reimbursement policies if the court follows its request.
Makena’s Orphan Exclusivity Is “Nullified” By FDA’s Compounding Policy, KV Suit Says
KV seeks a court order requiring FDA to desist from permitting importation of unapproved API for compounded hydroxyprogesterone and to state its intent to take enforcement action against compounders.