This article serves to address the statutory disconnect in the healthcare industry regarding generic products. There has been marked success in the generics market pertaining to pharmaceutical drugs, but the same cannot be said for medical devices and, in more recent times, biosimilars. The end result for consumers is higher product prices, limited access of care, and a more burdensome healthcare system. This article explores the statutory history of drug and medical device approval and production. It also explores differences between modern regulation of generic drugs and generic medical devices, focusing on key issues of FDA approval, consumer safety and risk, and liability. The article concludes with a recommendation geared towards consolidating generic healthcare product regulation under one statutory scheme, one that will promote and advance more generic product choice in the healthcare market.
George Encarnacion Jr.,
The Future of Healthcare is Generic: Expanding Hatch-Waxman to Equitably Regulate the Healthcare Products Industry,
DePaul J. Health Care L.
Available at: https://via.library.depaul.edu/jhcl/vol24/iss2/2