Price of Premature Birth Drug Rises 15,000 Percent After F.D.A. Grants Exclusive Manufacturing Rights

The cost of progesterone, an intravenous drug to prevent premature birth in high-risk pregnancies, was raised $1,500 per shot after the Food and Drug Administration granted exclusive production rights to K-V Pharmaceuticals in February. The firm’s announcement prompted in a lobbying campaign by patients, physicians, and maternity advocates urging the drug manufacturer to reconsider the increase. Progesterone is very inexpensive to manufacture, and has been available for just $10 at specialty pharmacies for several years. Under the brand name Makena, the shots will now cost an estimated $30,000 over the course of a pregnancy.

Physicians argue that the high price is not justified since K-V Pharmaceuticals did not invest significantly in development and clinical trials. The company has said that it plans to offer financial aid to help low-income families obtain the drug at a lower cost.

[N]o program providing short-term financial assistance to some patients will mitigate the harm that this new cost will cause to publicly funded programs, including Medicaid, and the women who rely on them. Nor will it mitigate the cost to employers and individuals who purchase insurance coverage and therefore directly bear all increases in health care costs,

wrote Dr. Joanne Armstrong in an article published in the New England Journal of Medicine.

 

Read more here – “Maternity Advocates Challenge High Cost of Preterm Birth Drug,” (Courtney Hutchison, ABC News)

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