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Why Should We Rescue The Legislative Intent Of The BPCIA?


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. ....

United States , France General , Wayne Winegarden , Peterj Pitts , Robert Popovian , Public Health Service , University Of Southern California School Pharmacy , Global Healthy Living Foundation , Drug Administration , Pacific Research Institute , University Of Paris School Medicine , Biologics Price Competition , Innovation Act , Public Health Service Act , Public Interest , Paris School , Senior Health Policy Fellow , Progressive Policy Institute , Southern California School , Senior Fellow , Medical Economics , Pacific Research , ஒன்றுபட்டது மாநிலங்களில் , வேன் ஒயின் கார்டன் , பொது ஆரோக்கியம் சேவை , பல்கலைக்கழகம் ஆஃப் தெற்கு கலிஃபோர்னியா பள்ளி மருந்தகம் ,