According to MSNBC, doctors nationwide fear a price hike of a premature labor drug Makena may lead to more premature births and deter low-income women from getting the medically necessary treatment. Recently, KV Pharmaceutical of suburban St. Louis won government approval to exclusively sell the drug. The March of Dimes, health charity committed to improvement of the health of babies by preventing birth defects and premature births, supported the approval because it hoped it would mean consistent quality of the drug and availability. However, no one expected the dramatic price spike, where a Makena went from $10 to $1,500 per injection. KV Pharmaceutical defended Makena’s cost saying it was justified to avoid the mental and physical disabilities that can come with a premature birth. The cost of care for a preemie baby is estimated at $51,000 in the first year alone. The company reportedly spent hundreds of millions of dollars in research, including international studies, in order to receive FDA approval. The U.S. Food and Drug Administration approves drugs but is not involved in setting prices. The American College of Obstetricians and Gynecologists recommended Makena as a generic. Makena is a synthetic form of the hormone progesterone. A publication in 2003 reported benefits of preventing early births in women who had a history of spontaneous preterm deliveries. The exact cause of a preterm birth is not known, however preemie babies, if they survive, need intensive care and often suffer disabilities and development issues. The hormone progesterone calms the uterus. One study found 36 percent of women at risk given the progesterone treatment had preterm births, compared with 55 percent among those at risk who did not receive the drug. The March of Dimes website reports that hormone progesterone Makena shots may be paid for by a woman’s health insurance company and state Medicaid programs, as the treatment has been approved by the FDA. The recent price change of Makena worries experts as it is unclear if health insurance companies will have to raise premiums or other costs to customers in order to pay the higher price. Some fear that state Medicair programs may be forced to stop paying for the drug or enroll fewer women. Ther-Rx Corp will market Makena. After the public outcry over price spikes, Ther-Rx announced a patient assistance program designed to help uninsured and low income women get the preterm labor drug. The lawmakers state this is not enough to protect the public from a sharp cost increase for a treatment that prevents preterm labor in pregnant women. Two senators sent Federal Trade Commission Chairman a letter asking the regular to investigate KV Pharmaceutical’s behavior. Senators Sherrod Brown and Amy Klobchar say the price increase will diminish access to the drug and urged the FTC to investigate potential anti-competitive conduct by the drug maker, they charge the company is price gouging.
Written by: Brianna
March 21, 2011
Premature Pregnancy Prevention Drug Sky Rockets in Price
Publisher: Salient News
arch of Dimes Makena KV Pharmaceutical Premature birth drug Senator Amy Klobchar Senator Sherrod Brown