Makena Update: FDA Opens Up Competition, KV Pharmaceuticals Improves Access

Amid the media frenzy regarding KV Pharmaceutical's decision to sell the FDA-approved drug Makena (hydroxyprogesterone caproate injection) at up to $1500 per injection, the pharmaceutical company as well as the FDA took steps last week to ensure that the medication, which is recommended for women at high risk for premature birth, is more accessible to patients.

Although in letters to pharmacies KV warned that the FDA would take action against compounded versions of the drug, the FDA issued a statement asserting, "This is not correct." The release went on to clarify:

"In order to support access to this important drug, at this time and under this unique situation, 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. As always, FDA may at any time revisit a decision to exercise enforcement discretion."

Still, the Administration did note that KV "received considerable assistance from the federal government" to develop the drug and that it relied on "research funded by the National Institutes of Health to demonstrate the drug's effectiveness." The statement also mentioned the drug's "greater assurance of safety" given that it is an approved sterile injectable product. Under the Orphan Drug Act, Makena has 7 years to market the drug exclusively.

A day after the FDA's statement, Ther-Rx (a branded marketing subsidiary of KV Pharmaceuticals) issued its own statement to announce the expansion of the company's Patient Assistance Program for Makena. Revisions to the assistance program include:

• An almost 55% reduction in price to $690 per injection
• Supplemental rebates to use in conjunction with the standard Medicaid rebate of 23.1%
• Capped costs for a full course of therapy (maximum of 3 vials or 15 injections) for contracted health insurance plans and state Medicaid agencies
• An expansion of the assistance program by removing income caps to qualify for financial assistance

The press release went on to discuss the importance of FDA-approved medication (specifically, the fact that Makena is manufactured in an FDA-regulated and FDA-compliant sterile facility) and its investment (more than a quarter of a billion dollars, including over $60 million in research and clinical trial costs).

Do you think the FDA's plan to turn the other cheek toward pharmacies who compound the drug for an "individually identified patient" is a good one? And has KV Pharmaceuticals finally done enough to make sure Makena is accessible to all patients?