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H.R. 2315 (113th): Preserving Access to Orphan Drugs Act of 2013

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The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.


6/11/2013--Introduced. Preserving Access to Orphan Drugs Act of 2013 - Amends the Patient Protection and Affordable Care Act (PPACA) to exclude any drug or biological product which is approved or licensed by the Food and Drug Administration (FDA) for marketing solely for one or more rare diseases or conditions (orphan drug) from the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million.

Makes this Act effective as if included in PPACA.