In 2007, Congress created a fast-track review voucher at the US Food and Drug Administration (FDA) as a reward for approval of a drug for a neglected disease. The developer of a neglected-disease drug receives a transferable voucher for faster review of any other drug. Similar fast-track...

U.S. federal and state governments rarely regulate healthcare price levels, but do regulate price changes for pharmaceuticals, hospitals, and health insurance. Previous research showed that limiting price increases can raise launch prices and reduce both profit and social welfare, assuming...

U.S. federal and state governments rarely regulate healthcare price levels, but do regulate price changes for pharmaceuticals, hospitals, and health insurance. Previous research showed that limiting price increases can raise launch prices and reduce both profit and social welfare, assuming...

The Biologics Price Competition and Innovation Act (BPCIA) was enacted in March 2010 as part of the Affordable Care Act (ACA). The objective of the BPCIA, like the Hatch-Waxman Amendments of 1984 for generic copies of non-biological drugs, was to increase price competition and generate cost...