In Wake of Price Hike from $10 per Dose to $1,500 per Dose for Drug that Prevents Pre-Term Labor, Brown Joins Obstetricians and New Mother to Call on Company to Rethink Decision

Press Release

Starting this month, the price of a critical drug used to prevent pregnant women from delivering premature babies increased from $10-20 per dose to $1,500 per dose. U.S. Sen. Sherrod Brown (D-OH) joined Dr. Brian Mercer and Dr. Jennifer Bailit of the Department of Obstetrics & Gynecology at MetroHealth, and a new mother, Jillian Burnett, to call on KV Pharmaceutical to reverse course on the outrageous price increases of a drug to prevent preterm pregnancy. Dr. Mercer serves on the Board of Directors of The Society for Maternal Fetal Medicine. The Society has also sent a letter to KV Pharmaceutical and is actively engaged in the effort to maintain affordable access to the drug.

"The diagnosis of a complicated pregnancy is worrisome enough. This anxiety shouldn't be heightened by the worry of how to pay for a once-affordable treatment," Brown said. "Since KV Pharmaceuticals announced the intended price hike, I called on KV Pharmaceuticals to immediately reconsider their decision, but to this date the company continues to defend this astronomical price increase. Price-gouging is never acceptable, particularly not when it undermines public health and fleeces taxpayers. Parents-to-be deserve an investigation."

At the news conference, Brown called for an investigation by the Federal Trade Commission (FTC) to determine if the actions of KV--which has been sending cease and desist letters to pharmacies that sell a different, compounded version of the drug--violate antitrust rules. The drug for high-risk pregnant women, which KV Pharmaceutical plans to sell under the brand name Makena, has been produced by compounding pharmacies for years and typically costs between $10-20. Last month, KV Pharmaceutical became the first company to receive FDA approval to sell the product and plans to raise the cost to $1,500 per dosage.

"Makena is not a new drug, but a potential replacement for a cheaper medication that is already widely available. While 17-hydroxyprogesterone can save up to $2 billion each year in the USA at its current price, the proposed cost of Makena will add expense without substantially improving outcomes further," said Dr. Bailit.

"Obstetricians across the country are concerned that the proposed pricing of Makena could limit access to treatment for women in need," said Dr. Mercer. "If insurers and governments have to pay such a high price for Makena, it could cause them to cut other important services to make ends meet. An alternative to reduced pricing of Makena would be to allow continued production of the currently available compounded 17-hydroxyprogesterone."

"The Society for Maternal-Fetal Medicine strongly supports Senator Sherrod Brown in his effort to ensure access to this important treatment. The Society urges KV to reconsider their pricing of Makena so that patients who can potentially benefit have timely and efficient access to treatment, and so that financial resources do not need to be diverted away from other important healthcare services," Dr. Mercer continued.

Brown sent a letter to the CEO of KV Pharmaceuticals urging the company to reverse course on the price hike, and last week, he sent a letter requesting an antitrust investigation of KV's practices by the Federal Trade Commission (FTC).

Taxpayer dollars actually helped finance the research and development of this product. Tax dollars funded the first clinical trial in 2003 through the National Institute of Child Health and Human Development (NICHD) at the National Institutes of Health (NIH), as well as subsequent trials in the years following.

MetroHealth played an important role in the development of Makena, also known as hydroxyprogesterone caproate, having participated in the multicenter NICHD-funded study that found that pregnant women who had previously delivered a preterm baby had fewer preterm and low birth-weight babies, and their babies had fewer complications of prematurity, if they were treated with weekly injections of hydroxyprogesterone caproate throughout pregnancy. Dr. Bailit authored a 2007 study that showed that weekly injections of compounds similar to Makena, given to at-risk pregnant women, would dramatically decrease the rate of premature births and could save the United States public health system at least $2 billion per year.

According to Drs. Mercer and Bailit, preterm birth affects 1 in 8 babies, and is responsible for serious complications, including infant death. Among survivors, infants delivering preterm are at increased risk of suffering serious long-term complications, including delays in development, cerebral palsy, hearing and vision problems, and chronic lung disease. Higher costs of a drug like Makena mean that health insurance companies could either stop coverage of the treatment or impose higher premiums on consumers, and those who are uninsured could have limited access to the treatment. Already stretched state Medicaid programs would be forced to deal with the financial repercussions of the company's decision unless pricing is changed or less expensive compounded alternatives remain available.

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