Affordable Care Act
Implementation Of The Biosimilars Provisions Of The ACA — Where Are We Now?
By Billy Wynne | December 14, 2015
Despite the passage of a 2010 law addressing such medicines, the Food and Drug Administration’s (FDA) approval this year of the first biosimilar has prompted a flurry of regulatory activity aimed at filling gaps left by the statute. For a helpful primer on the issue, see a recent Health Affairs Health Policy Brief. This post will address key concerns raised by recent FDA guidance, as well as other widely anticipated but yet-to-be released regulatory activity, such as the pivotal interchangeability standard....+ Read More
Travels In Hyperreality: What If Bipartisan ACA Fixes Were Possible?
By Billy Wynne | April 23, 2014
Since enactment of the Affordable Care Act in March 2010, a strange, relatively unnoticed phenomenon has occurred: Congress has passed bipartisan changes to it. These amendments were generally to such esoteric components of the law that they dodged the political block-aid that otherwise surrounds it. But what would happen if things were different?...+ Read More
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