Tuesday, October 21, 2014
Inquirer Daily News

FDA reverses course on Makena, a costly drug for pre-term pregancies

On Wednesday, U.S. officials said they won't stop special pharmacies from making a cheaper version of a new expensive drug called Makena that prevents preterm labor. That comes after critics who accused the drug's maker of price gouging for raising the price 100 times.

FDA reverses course on Makena, a costly drug for pre-term pregancies

On Wednesday, U.S. officials said they won’t stop special pharmacies from making a cheaper version of a new expensive drug called Makena that prevents preterm labor.
   The Food and Drug Administration’s rare decision means that pharmacies can undersell the recently approved Makena, which went on sale this month at $1,500 per dose.
    The decision was a victory for doctors and others, including Penn's Alexander Friedman, who have objected to the high price, because special compounding pharmacies have been making the drug for high-risk pregnant women for decades. The recent cost was $10 to $20 a dose and it is considered the standard of care for women in danger of delivering early.
    In February, the drug’s maker warned pharmacies to stop making the cheaper version or they could face FDA enforcement. But the FDA said Wednesday that the pharmacies can continue making the cheaper version.

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Check Up covers major health events in our region and offers everything from personal health advice to an expert look at health reform. Read about some of our bloggers here.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section

Michael R. Cohen, R.Ph. President, Institute for Safe Medication Practices
Daniel R. Hoffman, Ph.D. President, Pharmaceutical Business Research Associates
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