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
