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Makena Drug for Pre-term Labor Out of Financial Reach for Many Pregnant Women


In early February, we cheered the announcement of the FDA’s approval of Makena, the brand name of hydroxyprogesterone caproate injection, commonly known as 17P, which is a synthetic form of a hormone produced during pregnancy used to help prevent preterm births. According to a published study by the March of Dimes, the National Institutes for Health, and the Centers for Disease Control and Prevention, nearly 10,000 spontaneous premature births might be prevented annually if all women eligible for the progesterone injections received them. Hydroxyprogesterone caproate has previously been used off-label (and manufactured by compounding pharmacies) to treat women at risk for pre-term labor.

Since the initial approval of Makena however, KV Pharmaceutical, the company that owns Makena, released the drug’s list price, which jumped from about $10 to $20 per shot when obtained from a compounding pharmacy to a jaw-dropping $1,500 per dose. For an expectant mother in need of weekly injections for about 20 weeks, it could cost a whopping $30,000 to help keep her baby safe from preterm birth. Expectant women, medical professionals, women’s advocates, and lawmakers protested loudly in the press and through social media like Facebook, where a page was created entitled, “Shame on you, KV Pharmaceutical and CEO Greg Divis.
Plus: Ways to Prevent Preterm Labor

The list price was particularly shocking because the company had received federal assistance in the drug’s development by relying on research funded by the National Institutes of Health to demonstrate the drug’s efficacy (paid for by $5 million in taxpayers’ money), and it had been granted a monopoly for 7 years by the FDA under the Orphan Drug Act, which would allow KV Pharmaceutical to exclude from the market any drugs (not just similar ones) that treat the same condition. The drug maker defended its pricing and said that it was spending more than $200 million to develop the drug and conduct FDA-required follow-up studies, and had started a financial assistance program to help women who couldn’t afford the drug. (For a full rundown of the Makena pricing fiasco, check out this report in the Washington Post.)
Plus: Parents’ Survival Guide for Leaving a Preemie in the NICU

Adding insult to injury, KV Pharmaceutical also sent letters to compounding pharmacies that had continued to provide the life-saving drug to pregnant women at the much lower price point, stating they could no longer sell their versions of the drug and implying that the FDA would start cracking down on compounding pharmacists who did not stop making individual batches of the drug. Subsequently, the FDA released a statement on March 30th, indicating that there would be no FDA crackdown on compounding pharmacists, unless there was reason to believe that the drug being produced in pharmacies was unsafe or of substandard quality. The Washington Post also reports that an FDA official told the newspaper that, “if requested, the agency could approve a lower-priced generic version of the drug for another use that doctors could prescribe ‘off label,’” in order to help maintain women’s access to this life-saving treatment.
Plus: Bonding with Your Preemie

Last Friday, KV Pharmaceutical announced it was dropping the price by more than half to $690 per dose. Hours after the company’s announcement, the March of Dimes (which had accepted about $1 million in donations since 2006 from a subsidiary of the drug company, Ther-Rx Corporation, and allowed it to use the March of Dimes logo on its website) released a statement in which the charity terminated its relationship with Ther-Rx Corp., stating that the “company's handling of the launch of Makena, and the initial list price, were highly unsatisfactory and unacceptable to the March of Dimes and the families we represent.” Other groups like the American College of Obstetricians and Gynecologists (ACOG) voiced their disappointment in the “woefully inadequate” price reduction as well.

Do you think this lower cost is enough? Are you disgusted at pharmaceutical price-gouging when a baby’s life is at risk?