Drug safety proposals and the intrusion of federal regulation into patient freedom and medical practice

Health Affairs

Volumn 26, Issue 3, 2007, Pages 664-677

  Gottlieb, Scott ^a  

^a AMERICAN ENTERPRISE INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL PRACTICE; DRUG APPROVAL; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HUMAN; LEGAL ASPECT; METHODOLOGY; ORGANIZATION; PATIENT RIGHT; PHYSICIAN ATTITUDE; REVIEW; RISK MANAGEMENT; UNITED STATES;

DRUG APPROVAL; DRUG INDUSTRY; GOVERNMENT REGULATION; HUMANS; INSTITUTE OF MEDICINE (U.S.); PATIENT RIGHTS; PHYSICIAN'S PRACTICE PATTERNS; PHYSICIAN'S ROLE; RISK MANAGEMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 34248594707     PISSN: 02782715     EISSN: 02782715     Source Type: Journal    
DOI: 10.1377/hlthaff.26.3.664     Document Type: Review

References (24)

1. B. Meier, "Dispute Puts a Medical Journal under Fire," New York Times, 17 January 2005;
2. and A. Berenson, "Trial Lawyers Now Take Aim at Drug Makers," New York Times, 18 May 2003.
3. "First-Cycle Approvals May Rise for Second Consecutive Year-Parexel Report," FDC Reports (Pink Sheet), 19 June 2006, 21;
4. "CDER's 2005 Performance by the Numbers," FDC Reports (Pink Sheet), 28 August 2006, 4;
5. "Pharmaceutical Approvals Monthly: Total NDA/BLA, New Use Approvals Recovered s NMEs Slowed - CDER," FDA Reports, 15 September 2006;
6. G. Chacko, P. Tufano, and G. Verter, "Taking Risk Management Theory Seriously," NBER Working Paper no. 7748 (Cambridge, Mass.: National Bureau of Economic Research, June 2000);
7. and E.M. Perfetto et al., "Evidence-Based Risk Management: How Can We Succeed? Deliberations from a Risk Management Advisory Council," Drug Information Journal 37 (2003): 127-134.
8. K. Uhl and P. Honig, "Risk Management of Marketed Drugs: FDA and the Interface with the Practice of Medicine," Pharmacoepidemiology and Drug Safety 10, no. 3 (2001): 205-208;
9. and D.J. Grahamet al., "Liver Enzyme Monitoring in Patients Treated with Troglitazone," Journal of the American Medical Association 286, no. 7 (2001): 831-833.
10. J.M. Alvir et al., "Clozapine-Induced Agranulocytosis: Incidence and Risk Factors in the United States," New England Journal of Medicine 329, no. 3 (1993): 162-167.
11. G. Steidle and S.E. Hodges, "The United States Food and Drug Administration's Risk Management Framework," Drug Information Journal 36 (2002): 333-341;
12. Scott Gottlieb, deputy commissioner for medical and scientific affairs, Food and Drug Administration, speech at the American Medical Association Annual Meeting, Chicago, Illinois, 12 June 2006;
13. and FDA, "Guidance for Industry: Development and Use of Risk Minimization Action Plans," March 2005, http://www.fda.gov/cber/gdlns/ riskminim.pdf (accessed 23 February 2007).
14. FDA, "Guidance for Industry."
15. Gottlieb, speech before AMA Annual Meeting.
16. FDA, "FDA Issues Final Risk Minimization Guidances," Press Release, 24 March 2005, http://www.fda.gov/bbs/topics/news/2005/NEW01169.html (accessed 23 February 2007).
17. FDA, "Guidance for Industry."
18. Ibid.
19. "FDA's Risk Communication Committee Puts Promotion in Center of NDA Review," FDC Reports (Pink Sheet), 12 February 2007, 5-7.
20. A. Baciu, K. Stratton, and S.P. Burke, eds., The Future of Drug Safety: Promoting and Protecting the Health of the Public (Washington: National Academies Press, 2006);
21. and Enhancing Drug Safety and Innovation Act of 2006, introduced by Sen. Mike Enzi and Sen. Edward M. Kennedy 3 August 2006. The bill contains four titles: drug safety; establishment of the Reagan-Udall Institute for Applied Biomedical Research; clinical trials registry and results databases; and reform of conflicts of interest on FDA advisory committees.
22. Enhancing Drug Safety and Innovation Act of 2007, S. 484, sponsored by senators Enzi and Kennedy, introduced 1 February 2007 (bill summary released by Senator Kennedy's office).
23. Baciu et al., eds., The Future of Drug Safety, Section 5.1
24. L. Noah, "Ambivalent Commitments to Federalism in Controlling the Practice of Medicine" (Unpublished paper, University of Florida, 3 August 2003).