US Congress Moves to Expand FDA Powers in Monitoring Drug Safety

The US Senate has voted 93 to 1 to pass Bill S-1082, and renew the Prescription Drug User Fees Act (PDUFA), which would otherwise expire on September 30, 2007. Similar legislation is expected to be passed by the House of Representatives and become law, re-authorizing and extending the PDFUA until 2012. Under the PDUFA, the Food and Drug Administration (FDA) is granted authority to collect fees from drug manufacturers to expedite the review of drug submissions. Bill S-1082 increases the quantum of fees the FDA may collect and introduces a number of significant measures intended to increase drug safety. One such measure is the creation of a "Postmarket Risk Identification and Analysis System", which will collect information from health data systems in an attempt to expedite the recognition of drug safety concerns which arise after initial FDA approval of a drug. It is forecast that the initiative will collect data from 100 million patients by 2012. The Bill also introduces civil monetary penalties, as high as $2 million, for a drug manufacturer which knowingly violates an accepted risk evaluation and mitigation strategy. Pharmaceutical manufacturers praised the legislation, despite the new requirements. The Pharmaceutical Research and Manufacturers of America (PhRMA), the industry's largest lobby group, commented that the bill "will preserve – and even strengthen – the FDA's ability to do its job" and "make a good system even better." Observers speculate that industry support may have stemmed in part from what was left out of the final version, namely the legalization of drug imports from Canada and a system to approve bio-generic drugs. For the full text of Bill S-1082, visit: http://thomas.loc.gov/ For the PhRMA comments, see: http://tinyurl.com/yoc823 For further commentary, see: http://tinyurl.com/28xd23 Summary by: Michael Migus