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The United States Federal Drug Administration (FDA) and Clinical Research

  • Stephen P. Glasser
  • Carol M. Ashton
  • Nelda P. Wray

Abstract

The USFDA is an agency of the US Department of Health and Human Services and is the nation’s oldest consumer protection agency whose function it is to review drugs before marketing, monitor marketed drugs, monitor drug manufacturing and advertising, protect drug quality, and to conduct applied research. It is charged with overseeing of not only human drugs and biologics, but also veterinary drugs, foods, medical devices, and radiopharmaceuticals, and as such serves as a watch dog over industry. This chapter discusses the historical development of the FDA, and what the FDA is today. The phases of research development leading to the marketing of a new drug, the role of the FDA in surgical interventions, and the FDA’s role in advertising and adverse event reporting are discussed.

Keywords

Carotid Endarterectomy Sham Procedure Lung Volume Reduction Surgery Federal Drug Administration North American Symptomatic Carotid Endarterectomy 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. 1.
    Lewis S, Baird P, Evans RG, et al. Dancing with the porcupine: rules for governing the university-industry relationship. CMAJ. Sept 18, 2001; 165(6):783–785.PubMedGoogle Scholar
  2. 2.
    The Historical Guide to American Government. New York: Oxford Press; 1998.Google Scholar
  3. 3.
  4. 4.
    Swann R. History of the FDA. www.fda.gov/oc/history. Accessed May 9, 2007.
  5. 5.
    Guidance for Industry. www.fda.gov/cber/guidelines.
  6. 6.
    Thelithromycin. Wikipedia.Google Scholar
  7. 7.
    FDA Amendment Act of 2007; 2007.Google Scholar
  8. 8.
    The Mission Statement of the ICH. http://www.ich.org/
  9. 9.
    Coronary Drug Project. www.fda.gov
  10. 10.
    Suntharalingam G, Perry MR, Ward S, et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med. Sept 7, 2006; 355(10):1018–1028.PubMedCrossRefGoogle Scholar
  11. 11.
    European Medicines Agency (EMEA). http.www.emea.europa.
  12. 12.
    O’Donnell P. Not yet the last word on first-in-man. Appl Clin Trials. 2007; 16:34–38.Google Scholar
  13. 13.
    Palesch YY, Tilley BC, Sackett DL, Johnston KC, Woolson R. Applying a phase II futility study design to therapeutic stroke trials. Stroke. Nov 2005; 36(11):2410–2414.PubMedCrossRefGoogle Scholar
  14. 14.
    Henderson L. The long arm of the FDA. Appl Clin Trials. 2007.Google Scholar
  15. 15.
    Ramsey SD, Sullivan SD. Evidence, economics, and emphysema: medicare’s long journey with lung volume reduction surgery. Health Aff (Millwood). Jan–Feb 2005; 24(1):55–66.CrossRefGoogle Scholar
  16. 16.
    Brantigan OC, Mueller E. Surgical treatment of pulmonary emphysema. Am Surg. Sept 1957; 23(9):789–804.PubMedGoogle Scholar
  17. 17.
    Cooper JD, Trulock EP, Triantafillou AN, et al. Bilateral pneumectomy (volume reduction) for chronic obstructive pulmonary disease. J Thorac Cardiovasc Surg. Jan 1995; 109(1): 106–116; discussion 116–109.PubMedCrossRefGoogle Scholar
  18. 18.
    Tunis SR, Pearson SD. Coverage options for promising technologies: medicare’s ‘coverage with evidence development’. Health Aff (Millwood). Sept–Oct 2006; 25(5):1218–1230.CrossRefGoogle Scholar
  19. 19.
    Fishman A, Martinez F, Naunheim K, et al. A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema. N Engl J Med. May 22, 2003; 348(21):2059–2073.PubMedCrossRefGoogle Scholar
  20. 20.
    Kolata G. Medicare says it will pay, but patients say ‘no thanks’. New York Times. March 3, 2006, 2006; C:1.Google Scholar
  21. 21.
    Al-Naaman YD, Carton CA, Cooley DA. Surgical treatment of arteriosclerotic occlusion of common carotid artery. J Neurosurg. Sept 1956; 13(5):500–506.PubMedCrossRefGoogle Scholar
  22. 22.
    Winslow CM, Solomon DH, Chassin MR, Kosecoff J, Merrick NJ, Brook RH. The appropriateness of carotid endarterectomy. N Engl J Med. Mar 24, 1988; 318(12):721–727.PubMedCrossRefGoogle Scholar
  23. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. North American Symptomatic Carotid Endarterectomy Trial Collaborators. N Engl J Med. Aug 15, 1991; 325(7):445–453.Google Scholar
  24. 24.
    Endarterectomy for asymptomatic carotid artery stenosis. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. JAMA. May 10, 1995; 273(18):1421–1428.CrossRefGoogle Scholar
  25. 25.
    Barnett HJ, Taylor DW, Eliasziw M, et al. Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. North American Symptomatic Carotid Endarterectomy Trial Collaborators. N Engl J Med. Nov 12, 1998; 339(20):1415–1425.PubMedCrossRefGoogle Scholar
  26. 26.
    Halm EA, Tuhrim S, Wang JJ, Rojas M, Hannan EL, Chassin MR. Has evidence changed practice?: appropriateness of carotid endarterectomy after the clinical trials. Neurology. Jan 16, 2007; 68(3):187–194.PubMedCrossRefGoogle Scholar
  27. 27.
    Moseley JB, O’Malley K, Petersen NJ, et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. July 11, 2002; 347(2):81–88.PubMedCrossRefGoogle Scholar
  28. 28.
    Weinstein JN, Tosteson TD, Lurie JD, et al. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA. Nov 22, 2006; 296(20):2441–2450.PubMedCrossRefGoogle Scholar
  29. 29.
    Horng S, Miller FG. Ethical framework for the use of sham procedures in clinical trials. Crit Care Med. Mar 2003; 31(3 Suppl):S126–130.CrossRefGoogle Scholar
  30. 30.
    Macklin R. The ethical problems with sham surgery in clinical research. N Engl J Med. Sept 23, 1999; 341(13):992–996.PubMedCrossRefGoogle Scholar
  31. 31.
    Freed CR, Greene PE, Breeze RE, et al. Transplantation of embryonic dopamine neurons for severe Parkinson’s disease. N Engl J Med. Mar 8, 2001; 344(10):710–719.PubMedCrossRefGoogle Scholar
  32. 32.
    Brody BA. The Ethics of Biomedical Research: An International Perspective. New York: Oxford University Press; 1998.Google Scholar
  33. 33.
    Wennberg JE. An apple a day? N Engl J Med. Sept 22, 1994, 1994; 331(12):815–816.PubMedCrossRefGoogle Scholar
  34. 34.
  35. 35.
    Division of Drug Marketing, Advertising, and Communications, Food and Drug Administration. 5/31/07; http://www.fda.gov/cder/ddmac
  36. 36.
    21 CFR Part 310 section 502(a) of the Food and Drug Administration Modernization Act of 1997. In: Department of Health and Human Services FaDA, ed. Vol 21 U.S.C. 352(a).Google Scholar
  37. 37.
    Baylor-Henry M, Drezin N. Regulation of prescription drug promotion: direct-to consumer advertising. Clin Ther. 1998; 20(C):C86–C95.CrossRefGoogle Scholar
  38. 38.
    Section 502(n) of the Food Drug and Cosmetics Act, and Title 21 Code of Federal Regulations. Vol 202.1(1)(1).Google Scholar
  39. 39.
    Kessler DA, Pines WL. The federal regulation of prescription drug advertising and promotion. JAMA. Nov 14, 1990; 264(18):2409–2415.PubMedCrossRefGoogle Scholar
  40. 40.
    21 CFR Part 310 section 502(a) of the Food and Drug Administration Modernization Act of 1997 (Modernization Act).. In: Department of Health and Human Services FaDA, ed. Vol 21 U.S.C. 352 (n).Google Scholar
  41. 41.
    Section 502(n) of the Food Drug and Cosmetics Act, and Title 21 Code of Federal Regulations. Vol 202.1(j)(1).Google Scholar
  42. 42.
    Section 502 (n) of the Food Drug and Cosmetics Act, and Title 21 Code of Federal Regulations. Vol 202.1.Google Scholar
  43. 43.
    21 CFR Part 310 section 502(a) of the Food and Drug Administration Modernization Act of 1997 (Modernization Act). Vol 21 314.81(b)(3).Google Scholar
  44. 44.
    Woodcock J. Statement by Janet Woodcock, MSD Director, Center of Drug Evaluation and Research. US Drug Administration. Rockville, MD: Department of Health and Human Services; 2003.Google Scholar
  45. 45.
    Gahart MT, Duhamel LM, Dievler A, Price R. Examining the FDA’s oversight of direct to consumer advertising. Health Affairs. 2003; W3:120–123.Google Scholar
  46. 46.
    Waxman HA. Ensuring that consumers receive appropriate information from drug ads: what is the FDA’s role? Health Affairs. 2004; W4:256–258.Google Scholar
  47. 47.
    Waxman RHA. Letter from Rep. Henry A. Waxman to the Honorable Tommy G. Thompson. http://oversight.house.gov/story.asp?ID=441. Accessed June 1, 2007.
  48. 48.
    Food and Drug Administration. http://www.fda.gov/opacom/backgrounders/miles.html. Accessed October 6, 2007.

Copyright information

© Springer Science + Business Media B.V 2008

Authors and Affiliations

  • Stephen P. Glasser
    • 1
  • Carol M. Ashton
    • 2
  • Nelda P. Wray
    • 2
  1. 1.Univesity of Alabama at Birmingham, Birmingham, AlabamaBirmingham
  2. 2.Division of Preventive Medicine, Department of Internal MedicineUnivesity of Alabama at BirminghamBirmingham

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