FDA: Pharmacies Can Still Make Preterm Birth Drug

March 30, 2011 -- Pharmacies can continue to make and sell inexpensive, generic versions of the premature birth drug Makena, the FDA said today.

KV Pharmaceuticals recently won FDA approval of its brand-name Makena (hydroxyprogesterone caproate), a synthetic form of the hormone progesterone. The drug is approved to lower the risk of some preterm births in women who have already had at least one previous preterm birth.

The approval seemed to be good news -- until KV announced that Makena would cost $1,500 a shot -- up from the $10 to $15 that compounding pharmacies charge.

After getting the approval, KV sent a letter to compounding pharmacies telling them that the FDA would enforce the company's exclusive right to make the drug.

"This is not correct," the FDA said today.

"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," the FDA announced.

The FDA noted that KV's approval for Makena was based on research funded by the federal government.

The FDA approval -- under the Orphan Drug Act -- granted KV the exclusive right to sell Makena for seven years. The intent of the law is to give manufacturers a financial incentive to make important drugs for which there is only a small market.

For years, compounding pharmacies have made their own versions of synthetic progestin, commonly under the generic name 17P. Because it is a sterile injectable drug, the FDA felt that an approved product, made under FDA guidelines, would provide "greater assurance of safety."

On March 8, KV announced that it had launched a patient assistance program to make Makena available to women who cannot afford the drug:

• Uninsured women with annual household incomes under $60,000 would get the drug at no cost.
• Uninsured women with annual household incomes of $60,00 to $100,000 would get the drug at a cost comparable to the average copay assigned by insurance companies.
• Insured women with annual household incomes up to $100,000 who apply for assistance will get Makena at a copay cost of $20 or less per injection.

KV Pharmaceuticals sells Makena through its branded marketing subsidiary, Ther-Rx Corp.