Image via WikipediaThe bill would strengthen manufacturer quality standards, enhance the FDA’s ability to protect Americans through improved tracking of foreign manufacturing sites, and give the FDA much-needed authority to recall potentially dangerous drugs.Return Home: http://drughealth.blogspot.com/
I was really surprised to find out that biosimilars are included in the recently passed healthcare bill, Patient Protection and Affordable Care Act. I learned about this while reading Kevin O'Donnell's post on his blog (Where cooler heads prevail), "New U.S. Healthcare Bill Includes Pathway for Biosimilars and 12 Year Patent Exclusivity."
Kevin writes:
"This provision, Title VII- Providing Access to Innovative Medical Therapies, "prohibits the approval of an application as either biosimilar or interchangeable until 12 years from the date on which the reference product is first approved. In addition, it stipulates an additional 6 months of exclusivity for the use of reference products "in the pediatric population.""References:
My hat is off to Matt Hotz, on the Pharma Compliance Blog, for writing this succinct and consumable post that even I can understand, Preemption and the Distinction between Drugs and Devices. I'm not a lawyer, so I've found this particular topic difficult to digest. Hotz' post got me up to speed quickly and expanded my understanding of the touchpoints to local, state, vs. federal law; and to the distinctions and nuances between drugs vs. medical devices. Now I feel that I can follow breaking preemption news with some basic foundational understanding. Thanks Matt!
Updated Dec 9, 2016:
Links in the original post didn't age well. You might also be interested in:
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