role in assuring the safety and efficacy of prescription drugs now and in the future. Also, PDUFA reauthorization is just months away, and major legislation addressing drug regulation has been prepared and considered.15 These circumstances make this a golden moment of opportunity to improve fundamentally the way FDA regulation considers and responds to the evolving understanding of risks and benefits of drugs, and the way all stakeholders in the drug safety system perceive, study, and communicate about those risks and benefits. As described in Chapter 1, there have been many commissions and reports addressing issues similar to those contained in this report. It is the committee’s fervent hope that Congress, FDA, and the other stakeholders will seize the gathering momentum to invigorate the drug safety system. The agency’s credibility and its ability to protect and promote optimally the health of the American people cannot wait another year or another decade.

REFERENCES

Carpenter D, Ting MM. 2004. A Theory of Approval Regulation. [Online]. Available: http://people.hmdc.harvard.edu/~dcarpent/endosub-20040214.pdf [accessed October 10, 2005].

DHHS (Department of Health and Human Services), OIG (Office of Inspector General). 2003. FDA’s Review Process for New Drug Applications: a Management Review. OEI-01-01-00590. Washington, DC: OIG, FDA.

FDA (Food and Drug Administration). 2003. PDUFA III Five Year Plan. [Online]. Available: http://www.fda.gov/oc/pdufa3/2003plan/default.htm [accessed October 10, 2005].

FDA. 2005a. Center for Drug Evaluation and Research—Activities and Level of Effort Devoted to Drug Safety. Submitted to the Institute of Medicine Committee on the Assessment of the US Drug Safety System by FDA.

FDA. 2005b. White Paper, Prescription Drug User Fee Act (PDUFA): Adding Resources and Improving Performance in FDA Review of New Drug Applications. [Online]. Available: http://www.fda.gov/oc/pdufa/PDUFAWhitePaper.pdf [accessed December 5, 2005].

Federal News Service. 2000. Prepared Testimony of Richard Platt, MD, MSC, Professor of Ambulatory Care and Prevention Harvard Medical School Director of Research Harvard Pilgrim Health Care.

GAO. 2002. Food and Drug Administration: Effect of User Fees on Drug Approval Times, Withdrawals, and Other Agency Activities. GAO-02-958. Washington, DC: GAO.

GAO. 2006. Drug Safety: Improvement Needed in FDA’s Postmarket Decision-Making and Oversight Process. GAO-06-402. Washington, DC: GAO.

Goldhammer A. 2005 (June 8). Statement of the Pharmaceutical Research and Manufacturers of America to Institute of Medicine. Presentation to the Institute of Medicine Committee on the Assessment of the US Drug Safety System. Washington, DC: IOM.

Laffont J, Tirole J. 1991. The politics of government decision-making: a theory of regulatory capture. Quart J Econ 106(4):1089-1127.

Stigler G. 1971. The theory of economic regulation. Bell J Econ Manage Sci 2:2-21.

Thompson L. 2000. User fees for faster drug reviews. Are they helping or hurting the public health? FDA Consum 34(5):25-29.

15

The Enhancing Drug Safety and Innovation Act of 2006, http://help.senate.gov/S___.pdf.



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