[Congressional Record (Bound Edition), Volume 157 (2011), Part 4]
[House]
[Pages 4685-4686]
[From the U.S. Government Publishing Office, www.gpo.gov]




         FISCAL AND PUBLIC HEALTH SAFETY AND SANITY PREVAILING

  (Mr. COURTNEY asked and was given permission to address the House for 
1 minute and to revise and extend his remarks.)
  Mr. COURTNEY. Madam Speaker, a few hours ago, fiscal and public 
health safety and sanity prevailed when the Food and Drug 
Administration clarified an order on February 3 approving the drug 
Makena, which is an injectable medication for women at risk of preterm 
birth, one of the biggest health care challenges that our country 
faces. There are a half million premature births in this country. They 
cost the health care system $29 billion. They are the leading cause of 
infant mortality.
  This new medication which the FDA approved on February 3 is 
promising, but it costs $1,500 per injection, $30,000 per pregnancy. At 
the same time, OB-GYNs in this country have been prescribing a compound 
alternative that costs only $20 per treatment per medication. And yet 
the order on February

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3 indicated that there would only be exclusive treatments under the 
$1,500 medication.
  The order this morning clarifies that there will be no exclusivity, 
that OB-GYNs will continue to be able to prescribe the cheaper 
alternative, but FDA retains its power to still require exclusivity.
  For the sake of taxpayers and patients, Congress must keep a close 
eye on the FDA to not take away this option to OB-GYNs all across 
America.

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