Why the FDA’s Breakthrough Therapy Designation Creates a Two-Tier Drug Market

In July 2012, the FDA approved Stribild, an HIV combination therapy. It was among the first drugs to receive something called Breakthrough Therapy Designation—a new pathway created by the FDA Safety and Innovation Act, signed into law just two months earlier. The idea was simple enough: speed up development for drugs targeting serious or life-threatening […] The post Why the FDA’s Breakthrough…