On July 10, 2014, the U.S. House of Representatives overwhelmingly passed legislation intended to speed the approval of drugs and medical devices and increase funding for medical research. The central aim of H.R. 6, the “21st Century Cures Act” (Cures bill), is to accelerate the drug development process by reducing or removing regulatory obstacles. Specifically, … Continue Reading
The trade coalition representing pharmacy benefit managers is raising concerns about major bipartisan legislation aimed at streamlining the approval of new medicines and medical devices. However, the Pharmaceutical Care Management Association’s (PCMA) opposition to the legislation is not about the content of the bill but rather how Congress intends to pay for it. The 21st … Continue Reading
The House Energy and Commerce Committee unanimously approved H.R. 6, the “21st Century Cures Act,” on May 21, 2015, after reaching a bipartisan agreement to fund the legislation (Cures bill). Often described as a “landmark medical innovation” bill, key provisions of the Cures bill are intended to speed marketing approval of drugs and medical devices. … Continue Reading