Why Should We Rescue The Legislative Intent Of The BPCIA?
By Peter J. Pitts, Robert Popovian, and Wayne Winegarden
What happens when regulatory ambiguity displaces sound scientific guidance, deterring the legislative intent of Congress? This is precisely the situation regarding the FDA changing the regulatory rules of the road regarding a biosimilar’s strength versus its potency. It is a distinction with a difference – with the potential unintended consequence of disincentivizing both the development and uptake of biosimilars. It is also important to consider the implications of the legislative intent of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and how it can be improved.
Why Should We Rescue The Legislative Intent Of The BPCIA?
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