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FDA in the Twenty-First CenturyThe Challenges of Regulating Drugs and New Technologies$
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Holly Fernandez Lynch and I. Glenn Cohen

Print publication date: 2015

Print ISBN-13: 9780231171182

Published to Columbia Scholarship Online: May 2016

DOI: 10.7312/columbia/9780231171182.001.0001

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From “Recycled Molecule” to Orphan Drug

From “Recycled Molecule” to Orphan Drug

Lessons from Makena

(p.366) Chapter Nineteen From “Recycled Molecule” to Orphan Drug
FDA in the Twenty-First Century

Kate Greenwood

Columbia University Press

In 2011, the Food and Drug Administration made the controversial decision not to enforce the Orphan Drug Act’s period of market exclusivity for Makena (hydroxyprogesterone caproate injection), clearing the way for patients to continue to access the drug in compounded form. This chapter situates the FDA's decision in the context of rising concern about the price of orphan drugs and evaluates a number of policy levers that Congress could deploy in response, including shortening the Act's exclusivity period, allowing for limited competition during the exclusivity period, and implementing a cap on drug prices.

Keywords:   Makena, rare diseases, Orphan Drug Act, drug prices, market exclusivity, enforcement discretion

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