As the principal agency regulating food, drugs, medical devices, and biological products used by Americans, the U.S. Food and Drug Administration (FDA) serves one of the most critical consumer protection functions of the federal government. The FDA's reach is enormous, regulating products that represent roughly 25 percent of all consumer spending in the United States. Since 1992, however, federal funding for the agency has diminished, and the FDA's Center for Drug Evaluation and Research (CDER) currently relies on the fees it receives from the industry it regulates to fund the majority of its drug regulation functions. Prescription drug safety is receiving heightened press coverage and congressional scrutiny as a result of recent, highly publicized events, such as the recall of Vioxx because of its link to heart attacks, and the link between certain antidepressants (selective serotonin reuptake inhibitors, or SSRIs) and an increased risk of suicidal ideation in children.
Table of Contents
|2 Addressing the FDA's Resource Challenges||13-18|
|3 Strengthening the Scientific Base of the Agency||19-25|
|4 Integrating Pre- and Postmarket Review||26-31|
|5 Enhancing Postmarket Safety Monitoring||32-48|
|6 Conducting Confirmatory Drug Safety and Efficacy Studies||49-53|
|7 Enhancing the Value of Clinical Trial Registration||54-57|
|8 Enhancing Postmarket Regulation and Enforcement||58-69|
|9 Looking to the Future||70-77|
|Appendix A Workshop Agenda||81-92|
|Appendix B Speaker Biographies||93-110|
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