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FDA’s Nonenforcement Actions Are Not Reviewable, Agency Argues In KV’s Makena Suit

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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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.

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.

FDA Helps Makena With Statement Against High-Volume Compounding

Agency says it could take enforcement action against pharmacies producing large quantities of the preterm birth drug and physicians should prescribe an approved drug before a compounded version.

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