FDA and CMS Issue Important Updates on Makena; FDA Emphasizes That it is Applying its Normal Enforcement Policies for Compounded Drugs

K-V Pharmaceutical Company KV announced today that the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) both issued updated statements on Makena® that affirm the importance of the only FDA-approved drug for treatment of women with a history of preterm birth. Prior statements by both agencies had been cited by some payers as the basis for denying patients' access to FDA-approved Makena in favor of unapproved compounded hydroxyprogesterone caproate (17P) formulations. In a related statement, CMS also issued an update, which reiterated FDA's comments that approved drug products, such as Makena, provide a greater assurance of safety and effectiveness compared to compounded products, and also that the compounding of any drug, including hydroxyprogesterone caproate, should not exceed the scope of traditional pharmacy compounding. Additionally, in its June 15 update, CMS: Reminded States of their "…responsibility to cover FDA-approved products, such as Makena, that qualify as covered outpatient drugs under the Medicaid drug rebate program." Pointed out with regard to drug coverage policies for their insured beneficiaries that …"Any prior authorization procedures for such drugs must be administered in accordance with Section 1927(d) of the Social Security Act, without imposing unreasonable conditions."