In the news release, K-V Pharmaceutical Comments on ACOG and SMFM Information Update Regarding Hydroxyprogesterone Caproate - FDA-Approved Makena™ and Compounded 17P, issued
Oct. 13, 2011
by K-V Pharmaceutical Company over PR Newswire, we are advised by a representative of the company that there have been updates to the release. Please disregard the original transmission. The complete, updated release follows:
K-V Pharmaceutical Comments on ACOG and SMFM Information Update Regarding 17-Alpha Hydroxyprogesterone Caproate - FDA-Approved Makena™ and Compounded 17P
Oct. 13, 2011
/PRNewswire/ -- K-V Pharmaceutical Company (the "Company") (NYSE: KV.A/KV.B) appreciates that the American College of Obstetricians and Gynecologists (ACOG) and Society for Maternal-Fetal Medicine (SMFM) have issued an information update that ensures healthcare providers, patients, and the payer community have the facts regarding FDA-approved Makena™. The information update emphasizes that previous ACOG and SMFM statements regarding Makena were not intended to be used by private or public payers as a basis for interfering with the medical judgment of healthcare providers or denying patient access to Makena. It also states that physicians should understand the inherent differences between an FDA-approved manufactured product and a compounded preparation, and that ACOG and SMFM's previous statements were not meant to suggest that Makena and compounded 17P are identical products.
Healthcare providers understand that evidence-based medicine is the foundation of clinical practice. Evidence from the NICHD MFMU Network study (Meis, et al.) supporting the use of hydroxyprogesterone caproate (17P) was based on drug manufactured under FDA's Good Manufacturing Practices (GMP) conditions, and not on drug made using compounding processes or obtained from compounding pharmacies. The drug used in the NICHD study is available today as FDA-approved Makena.
Access to FDA-approved Makena for clinically-indicated patients is an important public health priority. Certain payer coverage policies have been influenced by a belief that unapproved compounded 17P formulations are the same as Makena. These policies should be modified to ensure that clinically-indicated patients have unencumbered access to FDA-approved Makena, consistent with their healthcare provider's medical judgment.