Reputation, gatekeeping and the politics of post-marketing drug regulation

Virtual Mentor

Volumn 8, Issue 6, 2006, Pages 403-406

  Carpenter, Daniel ^a  

^a HARVARD UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84866002235     PISSN: 19377010     EISSN: None     Source Type: Journal    
DOI: 10.1001/virtualmentor.2006.8.6.pfor1-0606     Document Type: Review

References (14)

1. US General Accounting Office. Drug Safety: Improvement Needed in FDA’s Postmarket Decision-making and Oversight Process. Washington, DC: US General Accounting Office; 2006:36. GAO-06-402.
2. Carpenter DP, Ting MM. The political logic of regulatory error. Nature Reviews—Drug Discovery. 2005;4:819-823.
3. Avorn J. Powerful Medicines. New York, NY: Knopf; 2004.
4. Fontanarosa PB, Rennie D, DeAngelis CD. Postmarketing surveillance—lack of vigilance, lack of trust. JAMA, 2004;292:2647-2650.
5. Frantz S. How to avoid another Vioxx. Nature Reviews—Drug Discovery. 2004;4:5-7. Available at: http://www.nature.com/news/2004/041220/pf/nrd1629_pf.html Accessed July 7, 2005.
6. Wood AJ, Stein CM, Woolsey R. Making medicines safer: the need for an independent drug safety board. N Engl J Med. 1998;339:1851-1854.
7. U.S. Congress, Office of Technology Assessment. Postmarketing Surveillance of Prescription Drugs. Washington, DC: US Government Publishing Office; 1982.
8. Appendix B of the OTA Report, Postmarketing Surveillance of Prescription Drugs, Conclusions and Recommendations of the Joint Commission on Prescription Drug Use. Jan. 23, 1980.
9. U.S. Congress, Office of Technology Assessment. Washington, DC: US Government Publishing Office; 1982.
10. US General Accounting Office. Drug Safety. 2006:19.
11. United States Senate Committee on Finance Web page. Testimony of David J. Graham, MD, MPH, November 18, 2004. Available at: http://finance.senate.gov/hearings/testimony/2004test/111804dgtest.pdf. Accessed May 1, 2006.
12. Interagency Coordination in Drug Research and Regulation. Hearings Before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations. Part 3, The Bureau of Medicine in the Food and Drug Administration. US Senate, 89th Congress, 1st Sess, (March 20, 1963):783, 790.
13. Federal Register 70 (33) February 18, 2005: 8030.
14. Comments of Consumers Union before the Food and Drug Administration Science Board. April 15, 2005: 8-9. Available at: http://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4136OPH_02_01_Consumer's%20Union.pdf. Accessed September 8, 2005.