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Ѻا : 7/03/2018
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  Klobuchar wants KV drug investigation 2
  22 չҤ 2554 ǹŴ͡éѺ

March 17, 2011
The Honorable Jon Leibowitz
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 Pharmaceuticals 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 Pharmaceuticals 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 FDAs 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 Pharmaceuticals 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 Pharmaceuticals 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.
Amy Klobuchar
Sherrod Brown