Gaps, Tensions, and Conflicts in the FDA Approval Process: Implications for Clinical Practice

References

1. ↵
   Lipsky MS, Sharp LK. From idea to market: the drug approval process. J Am Board Fam Pract 2001; 14: 362–7.

   OpenUrlAbstract
2. ↵
   Lasser KE, Allen PD, Woolhandler SJ, Himmelstein DU, Wolfe SM, Bor DH. Timing of new black box warnings and withdrawals for prescription medications. JAMA 2002; 287: 2215–20.

   OpenUrlCrossRefPubMedWeb of Science
3. ↵
   Friedman MA, Woodcock J, Lumpkin MM, Shuren JE, Hass AE, Thompson LJ. The safety of newly approved medicines: do recent market removals mean there is a problem? JAMA 1999; 281: 1728–34.

   OpenUrlCrossRefPubMedWeb of Science
4. ↵
   Maisel WH, Sweeney MO, Stevenson WG, Ellison KE, Epstein LM. Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator devices. JAMA 2001; 286: 793–9.

   OpenUrlCrossRefPubMedWeb of Science
5. ↵
   Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. JAMA 2002; 288: 321–33.

   OpenUrlCrossRefPubMedWeb of Science
6. ↵
   Grady D, Herrington D, Bittner V, et al. Cardiovascular disease outcomes during 68 years of hormone therapy: Heart and Estrogen/progestin Replacement Study Follow-up (HERS II). JAMA 2002; 288: 49–57.

   OpenUrlCrossRefPubMedWeb of Science
7. ↵
   ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA 2002; 288: 2981–97.

   OpenUrlCrossRefPubMedWeb of Science
8. ↵
   Echt DS, Liebson PR, Mitchell LB, et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med 1991; 324: 781–8.

   OpenUrlCrossRefPubMedWeb of Science
9. ↵
   Moore TJ. Deadly medicine: why tens of thousands of heart patients died in America’s worst drug disaster. New York: Simon and Schuster; 1995.
10. ↵
    Petersen M. Diuretics’ value drowned out by trumpeting of newer drugs. The New York Times 2002 Dec 18;Sect A:32.
11. ↵
    Gorelick PB, Richardson D, Kelly M, et al. Aspirin and ticlopidine for prevention of recurrent stroke in black patients: a randomized trial. JAMA 2003; 289: 2947–57.

    OpenUrlCrossRefPubMedWeb of Science
12. ↵
    Gahart MT, Duhamel LM, Dievler A, Price R. Examining the FDA’s oversight of direct-to-consumer advertising. Health Aff (Millwood) 2003; Suppl W3 120–3.

    OpenUrl
13. ↵
    Ramsey SD, Luce BR, Deyo R, Franklin G. The limited state of technology assessment for medical devices: facing the issues. Am J Manag Care 1998; 4 Spec No: SP188–99.
14. ↵
    Merrill RA. Modernizing the FDA: an incremental revolution. Health Aff (Millwood) 1999; 18: 96–111.

    OpenUrlAbstract/FREE Full Text
15. ↵
    Milestones in US food and drug law history. United States Food and Drug Administration. http://www.fda.gov/opacom/backgrounders/miles.html, accessed 8/19/02.
16. ↵
    Handelsman H. Intermittent positive pressure breathing (IPPB) therapy. Health Technol Assess Rep 1991; (1): 1–9.
17. ↵
    FDA Center for Devices and Radiological Health. Office of Device Evaluation annual report 2002. Available at: URL: http://www.fda.gov/cdrh/annual/fy2002/ode/index.html.
18. ↵
    Willman D. How a new policy led to seven deadly drugs. The Los Angeles Times 2000 Dec 20;Sect. A:1.
19. ↵
    Adams C, Hensley S. Health and Technology: drug makers want FDA to move quicker. Wall Street Journal 2002 Jan 29;Sect. B:12.
20. ↵
    Adams C. FDA may start assessing fees on makers of medical devices. The Wall Street Journal 2002 May 21;Sect. D:6.
21. ↵
    Angell M, Relman AS. Prescription for profit. The Washington Post 2001 Jun 20;Sect. A:27.
22. ↵
    Adams C. FDA searches for an elixir for agency’s attrition rate. The Wall Street Journal 2002 Aug 19;Sect. A:4.
23. ↵
    Goldberg R. FDA needs a dose of reform. The Wall Street Journal 2002 Sep 30;Sect. A:16. Available at: URL: http://www.aei.brookings.org/policy/page.php?id=113
24. ↵
    Moore TJ, Psaty BM, Furberg CD. Time to act on drug safety. JAMA 1998; 279: 1571–3.

    OpenUrlCrossRefPubMedWeb of Science
25. ↵
    Ahmad SR. Adverse drug event monitoring at the Food and Drug Administration: your report can make a difference. J Gen Intern Med 2003; 18: 57–60.

    OpenUrlCrossRefPubMedWeb of Science
26. ↵
    Wood AJJ. The safety of new medicines: the importance of asking the right questions. JAMA 1999; 281: 1753–54.

    OpenUrlCrossRefPubMedWeb of Science
27. ↵
    Cauchon D. FDA advisers tied to industry. USA Today 2000 Sep 25;Sect. A:1.
28. ↵
    Cauchon, D. Number of drug experts available is limited. Many waivers granted for those who have conflicts of interest. USA Today 2000 Sep 25;Sect. A:10.
29. ↵
    Gribbin A. House investigates panels involved with drug safety. Mismanagement claims spur action. The Washington Times 2001 Jun 18;Sect. A:1.