April 1, 2011 -- Bowing to heavy pressure from the medical community and the Food and Drug Administration, KV Pharmaceuticals slashed the cost of its pricey drug to prevent premature births, Makena, today by half.
KV cut the price of a dose of Makena, its branded version of a progesterone shot that previously sold for $20 a pop, from $1,500 per dose to $690. The company also announced an expanded financial assistance program for obtaining the drug.
But many advocates and organizations working on behalf of maternal health -- such as the March of Dimes, the American College of Obstetrics and Gynecology, the American Academy of Pediatrics and the Society for Maternal Fetal Medicine -- say this pricing Band-Aid won't cut it.
The March of Dimes, which has had a corporate relationship with KV for years, announced it would sever all ties with the pharmaceutical company over the Makena ordeal.
"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," the organization said in a press release.
But a recent move by the FDA could open a low-cost way to obtain the progesterone shot.
Under FDA exclusivity rules, production of the cheaper version of the drug by specialty compounding pharmacies would ordinarily have to cease. Following the public outcry over KV's pricing, however, the FDA announced Wednesday that it had no intention of enforcing its own rules, reopening the doors for women to continue to obtain an affordable version of the drug, known clinically as 17P
KV had sent cease-and-desist letters to compounding pharmacies regarding 17P in error, the FDA said Wednesday, saying it would only step in to halt production when the safety of the product was in question.
The FDA granted KV approval to produce this already-in-use drug in February, a move many maternity experts hoped would offer a more regulated and readily available version of the shot. When KV announced it would charge about hundred times what patients were paying at compounding pharmacies, a firestorm of criticism ensued, and the pharmaceutical company has backpedaled on its pricing.
Maternity Advocates Challenge High Cost of Preterm Birth Drug
Even if doctors continue to use compounding pharmacies to get 17-P for their patients, Medicaid and health insurance providers will have to contend with the high price of Makena, leaving maternity care experts asking about patients' access to this important drug, said Dr. M. Kathryn Menard, director of the Center for Maternal and Infant Health at the University of North Carolina School of Medicine
"This is the only evidence-based approach we have, medication, to prevent preterm birth," she said.
Several letters were sent to the company in past weeks by leading maternity advocates and public officials, voicing concerns that the price would prevent many women in need from receiving the drug and put a heavy burden on the health care system as a whole, especially Medicaid.
"KV wanted to listen to our concerns. They apologized sincerely for the way this was handled, said they were working with incomplete information. Basically, they're going to take all that listening and go back to the board and make a decision," Menard reported from a meeting with KV.
ABC News' Lisa Stark contributed on this report.