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? pharmaceuticalonline.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmaceuticalonline.com Daily Mail and Mail on Sunday newspapers.
Jacksonville, FL (PRWEB) May 25, 2021 TrippBio, Inc. (TrippBio), a clinical development-stage company developing antiviral treatments with an initial focus
Patrish Jackson/Shutterstock
As the United States continues the fight against COVID-19, officials are leveraging pharmacies to help administer vaccinations. This is excellent news for anybody who doesn t live near a hospital or clinic. But for 15 million Americans, getting their shots at a pharmacy still puts the vaccination out of reach.
Health Affairs found that 1 out of 3 urban neighborhoods is in a pharmacy desert. Initially coined in 2014 by Dima M. Qato, PharmD, associate professor at the University of Southern California School of Pharmacy in Los Angeles and senior author of this study, a pharmacy desert is an urban neighborhood that is more than a mile away from the nearest pharmacy. The distance is reduced to half a mile for neighborhoods with at least 100 households with no vehicle access or 20 percent of households below the federal poverty level.