March 31, 2011 — FDA will not take enforcement action against pharmacists who continue to produce a cheaper version of Makena, an injectable treatment that prevents premature labor, according to an FDA statement issued Wednesday, the Wall Street Journal's "Health Blog" reports (Dooren, "Health Blog," Wall Street Journal, 3/30).
Last month, FDA approved Makena, a synthetic form of the hormone progesterone, for the reduction of the risk of certain preterm births. Because no commercial product was previously available, the drug had been dispensed by compounding pharmacies, which made the drug to order and charged about $10 to $20 per shot. After the approval, K-V Pharmaceutical, Makena's maker, listed the price at $1,500 and sent letters to compounding pharmacies warning them of potential FDA action if they continued to make the treatment.
Makena, recommended once weekly beginning in the 16th week of pregnancy, could cost as much as $30,000 over the course of a pregnancy. Ther-Rx, a K-V Pharmaceutical subsidiary that will market Makena, said it would provide the drug to uninsured women with incomes less than $100,000 per year for a copayment of $20 or less. The drugmaker defended the price, saying that it spent more than $200 million to develop the drug and conduct post-market studies. However, critics pointed out that the main study used to show Makena's effectiveness was conducted by the National Institutes of Health and paid for by taxpayers (Women's Health Policy Report, 3/29).
HHS Secretary Kathleen Sebelius announced the decision on Wednesday while testifying at the Senate Appropriations Subcommittee on Labor, Health and Human Services. She said FDA is prohibited from considering the price of drugs during the approval process but wanted to put pressure on K-V Pharmaceutical to lower Makena's price (Adams, CQ HealthBeat, 3/30).
FDA generally exercises enforcement discretion to prevent pharmacies from compounding once a drug is approved, according to the "Health Blog." However, in order to ensure all women have access to needed treatments to prevent early labor, FDA does not intend to take enforcement action against pharmacies that compound a cheaper version of the drug unless the compounded products are unsafe or of poor quality, according to an agency spokesperson ("Health Blog," Wall Street Journal, 3/30).
"FDA understands that ... the manufacturer of Makena has sent letters to pharmacists indicating that FDA will no longer exercise enforcement discretion with regard to compounded versions of Makena. This is not correct," the agency wrote in the letter to pharmacies. "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 agency said (Fox, National Journal, 3/30).
"K-V Pharmaceuticals is taking advantage of the law to achieve a monopoly and outrageous price hike at the expense of American families, American taxpayers and our health care system," Sen. Tom Harkin (D-Iowa) -- chair of the Senate Appropriations Subcommittee on Labor, Health and Human Services -- said, adding "K-V’s behavior has been outrageous, and I credit the secretary and FDA with taking timely action to address this important public health issue. This sort of conduct simply cannot be tolerated. KV must lower the price of Makena immediately" (CQ HealthBeat, 3/30).
According to the Chicago Tribune, K-V Pharmaceutical said it would take steps to make the drug more affordable but did not indicate if it would lower the price (Zajac, Chicago Tribune, 3/31).