How did REMS come about?
The Prescription Drug User Fee Act (PDUFA) is a law that authorizes FDA to collect fees from drug companies that submit marketing applications for certain human drug and biological products. The original PDUFA (PDUFA I) was enacted in 1992 and had a five-year life. When PDUFA I expired in 1997, Congress passed the FDA Modernization Act (FDAMA, Public Law 105–115) which extended PDUFA (PDUFA II) for an additional five years. Then, in 2002, Congress extended PDUFA again through fiscal year 2007 (PDUFA III) through the Public Health Security and Bioterrorism Preparedness and Response Act (Public Law 107–188). Most recently, Title I of the Food and Drug Administration Amendments Act of 2007 (FDAAA, Public Law 110–85) reauthorized PDUFA through fiscal year 2012 (PDUFA IV). PDUFA’s intent has been to provide additional revenues so that FDA could hire more staff, improve systems and establish a better managed human drug review process to make important therapies available to the public more q
