Letter to the Honorable Jon Leibowitz, Chairman, Federal Trade Commission

Letter

U.S. Senators Amy Klobuchar (D-MN) and Sherrod Brown (D-OH) today sent Federal Trade Commission Chairman Jon Leibowitz a letter urging the agency to launch an investigation into potentially anti-competitive behavior after a drug treatment used for high-risk pregnancies dramatically increased in cost. The drug, commonly known as Makena, is a weekly injection of progesterone meant to prevent pre-term labor in pregnant women and has been safely administered by U.S. pharmacies in the past at a cost of between $10 and $20 per injection. After the Missouri-based drug company KV Pharmaceutical was granted orphan status for its version of the drug, the cost reportedly rose to $1,500 per injection -- 150 times the original cost.

"This is a proven and affordable drug that has been around for over 50 years. It's critical that we make sure this company isn't taking advantage of its orphan-drug determination to monopolize the market and engage in price gouging at the expense of pregnant women," Klobuchar said. "At a time when rising prices for prescription drugs are stretching the budgets of middle-class families, we must be vigilant in stopping practices that would limit access to vital medicines."

"KV created an overnight monopoly for this lifesaving drug -- and then proposed raising the price by 14,900 percent," Brown said. "Last week, 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. Families deserve an investigation."

Last week, Brown sent a letter to KV Pharmaceutical urging the company to reverse course on the price increase for Makena. Brown called on the company to maintain access to the critical drug to stem an increase in premature births.

The drug first came to the market over 50 years ago and it has recently been used to help prevent early births in women who have a history of spontaneous pre-term deliveries. The price increase not only threatens to restrict individual access to the drug, it also places a heavy burden on state Medicaid programs, which cover a majority of high-risk pregnancies in this country.

The full text of the letter is pasted below:

March 17, 2011

The Honorable Jon Leibowitz
Chairman
U.S. Federal Trade Commission
600 Pennsylvania Ave. N.W.
Washington, D.C. 20580

Dear Chairman:

I am writing to request that the Federal Trade Commission initiate a formal investigation into any potential anticompetitive conduct arising out of KV Pharmaceutical's actions regarding a dramatic 150-fold increase in price that the company has applied to a proven progesterone treatment.

17-hydroxyprogesterone caproate, sold by KV Pharmaceutical under the name Makena, is a weekly injection of a form of progesterone meant to prevent preterm labor in high-risk pregnant women. This drug, which first came to market over 50 years ago, has recently been used to help prevent early births to women who had a history of spontaneous preterm deliveries. Prior to KV Pharmaceutical's actions, this product was mixed by compound pharmacies and administered safely for $10 to $20 per injection. Due to the product being given orphan drug status, KV Pharmaceutical has potentially created an anticompetitive market and has indicated they will dramatically increase the cost per injection to $1,500.

While I understand the Food and Drug Administration (FDA) is working to ensure that drugs marketed and sold in the United States are safe and effective, I am concerned that KV Pharmaceutical is taking advantage of FDA's approval of Makena and orphan drug determination to achieve rights as the sole source for this limited use of progesterone, leading to a monopolization of treatments to address preterm labors.

I appreciate KV Pharmaceutical's attempt to provide financial assistance to help purchase Makena. However, the financial assistance is not sufficient and does not extend to certain groups of women. In additional to significant costs to individuals, this price increase will place a heavy burden on state Medicaid programs, which cover a majority of high-risk pregnancies. I am extremely concerned that KV Pharmaceutical's actions will result in diminished access to appropriate health care for women and result in increased preterm births.

Thank you for your attention to my request.

Sincerely,

Amy Klobuchar
Sherrod Brown

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