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March 31, 2011

Fiscal and Public Health Safety and Sanity Prevailing

[Page: H2050]  GPO's PDF 

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(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 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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