Makena™ Price Reduction Is Inadequate

Main Category: Pregnancy / Obstetrics
Also Included In: Pharma Industry / Biotech Industry;  Regulatory Affairs / Drug Approvals
Article Date: 04 Apr 2011 - 0:00 PDT


Today K-V Pharmaceutical Company announced that it is reducing the cost of its drug Makena™ from $1,500 per dose to $690 per dose, clearly acknowledging the negative impact of their original pricing strategy. Although this may seem like a relatively significant price reduction, unfortunately it remains a woefully inadequate response. This 'lower' price still remains prohibitively high for a safe and effective treatment that is currently available at a much lower price in the form of compounded 17 hydroxyprogesterone caproate (17P).

The American College of Obstetricians and Gynecologists (The College) applauds the US Food and Drug Administration's (FDA) statement that it will not prevent compounding pharmacies from continuing to produce valid prescriptions for 17P, a medication that has been safely used for years to help prevent preterm labor in certain high-risk pregnant women. Although there are clear benefits to having an FDA-approved version of 17P, there is no evidence that Makena™ is more effective or safer than the currently used compounded version. In fact, the evidence used to obtain FDA approval for Makena™ relied primarily on data obtained using the compounded product.

The College, along with the Society for Maternal-Fetal Medicine, American Academy of Pediatrics, American College of Osteopathic Obstetricians & Gynecologists, National Medical Association, American Academy of Family Physicians, American College of Nurse-Midwives, and the Association of Women's Health and Obstetric and Neonatal Nurses, will continue to collaborate to ensure that this medication is accessible and affordable to every pregnant woman who needs it. The US health care system simply cannot be expected to absorb the cost of Makena™ at its current prohibitive price without significant negative repercussions.

Source:
American College of Obstetricians and Gynecologists

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