For now FDA will continue to allow pharmacies to provide compounded hydroxyprogesterone caproate

April 1, 2011

FDA "...does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products," according to a statement.

Key Points

FDA "...does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products," according to a statement.

This is in response to events initiated by the agency's accelerated approval of the synthetic progestin, hydroxyprogesterone caproate (Makena, KV Pharmaceutical and Ther-Rx) to reduce the risk of preterm birth in women with a singleton pregnancy that have a history of at least 1 spontaneous preterm birth.

Shortly after the drug's approval, KV Pharmaceutical originally announced the price of a dose of hydroxyprogesterone caproate to be $1,440 (wholesale acquisition cost), making the cost of a typical 20-week course of therapy approximately $29,000 per patient.

FDA stated: "In order to support access to this important drug," they will not take enforcement action against pharmacies compounding hydroxyprogesterone caproate at this time. They noted, "As always, FDA may at any time revisit a decision to exercise enforcement discretion."

Perhaps in defense of their ruling, in what the agency is calling a "unique situation," officials reminded those reading the press release that, "KV Pharmaceutical, the drug's owner, received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by the National Institutes of Health to demonstrate the drug's effectiveness."

In response to multiple parties' concerns regarding the cost of branded hydroxyprogesterone caproate, the drug's manufacturer announced the creation of a patient financial assistance program to reduce the out-of-pocket cost of the drug. However, according to a New England Journal of Medicine editorial by Joanne Armstrong, MD, from the Women's Health Division at Aetna, "...no 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."

Recently, the drug's manufacturer said that they will be taking steps to make Makena more affordable. This includes reducing the list price by nearly 55%, to $690 per injection; offering of supplemental rebates; capping the cost of a full course of therapy to a maximum of 3 vials; and removing income caps to qualify for financial assistance.