FDA Amendments

U.S. Food and Drug Administration. 2002. FDA Amends Its Regulations to Provide for Approval of Certain New Pharmaceutical Products Based on Animal Efficacy Data, FDA News, P02-17, Department of Health and Human Services, May 30. Available online at . 

The early phases of these efforts laid both the intellectual basis for the signing of the Drug Safety Law, namely the FDA Amendments Act (FDAAA), by President Bush on September 27, 2007, and the timing requirements for implementation under that Act. On March 4,2008, Senate Finance Committee member, Chuck Grassley (R-Iowa), called for a General Accountability Office investigation into how the FDA monitors safety and efficacy of approved drugs. 

Various stakeholders have recognized the need to improve current pharmacovigilance practice and the opportunities that exist to expand the use of observational data in that pursuit (Berlin 2008). In 2007, the U.S. Congress passed the FDA Amendment Act, which in part mandated the "establishment of a postmarket risk identification and analysis system" that leverages observational health-care data, including administrative claims and electronic health records (EHRs), to monitor approved medicines on a periodic basis. In response, FDA established the Sentinel Initiative, an effort to create and implement a national, integrated, electronic system for monitoring medical product safety (Platt et al. 2009). 

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