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America's Health Insurance Plans, which represents health insurers, also welcomed the FDA's announcement. And the news was quickly spread in a memo to states from the Centers for Medicare and Medicaid Services, the federal agency over government insurance programs for the elderly and poor.
Experts say the Makena situation is unusual. More commonly, pharmaceutical companies develop a new drug and -- after it comes on the market -- some pharmacies may try to make a version of the licensed drug. But in this instance, pharmacies were making it before KV.
What's more, the FDA's regulation of special pharmacies is "a gray area" based on agency policies, not laws, noted Alvin J. Lorman, a respected Washington, D.C.-based food and drug lawyer.
KV, based in suburban St. Louis, previously announced a patient assistance program that would discount the price for women who met certain guidelines. The company said Wednesday it was "exploring additional ways to help provide affordable access for all patients who are prescribed Makena."
Makena is a synthetic form of the hormone progesterone. An earlier version first came on the market more than 50 years ago to treat other problems; it was withdrawn in the 1990s, though not for safety reasons.
The drug got a new life in 2003, when a study showed it helps prevent premature birth in women who previously delivered early. Doctors started prescribing it, and pharmacies mixed it.
FDA statement: http://tinyurl.com/fdastatement
Copyright 2011 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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