Currents in contemporary ethics the implications of expanding access to unapproved drugs

Journal of Law, Medicine and Ethics

Volumn 35, Issue 2, 2007, Pages 316-319

  Talbott, Meghan K ^a  

^a University of Louisville School of Medicine   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

ARTICLE; CLINICAL TRIAL; ETHICS; FOOD AND DRUG ADMINISTRATION; HUMAN; LEGAL ASPECT; PATIENT RIGHT; UNITED STATES;

CLINICAL TRIALS; DRUGS, INVESTIGATIONAL; HUMANS; PATIENT RIGHTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 34249074032     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2007.00141.x     Document Type: Article

References (57)

1. 21 C.F.R. § 312.34 (2006).
2. Id. § 312.34(c).
3. FDA News Release FDA News Release available at http://www.fda.gov/bbs/ topics/NEWS/2006/NEW01520.html? last visited March 6, 2007).
4. Expanded Access to Investigational Drugs for Treatment Use, 71 Fed. Reg. 75147-75168 (December 14, 2006) (to be codified at 21 C.F.R. pt. 312).
5. Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 445 F.3d 470, 473 (D.C. Circuit 2006) (vacated for rehearing en banc) [hereinafter cited as Abigail Alliance] S. Okie Access before Approval - A Right to Take Experimental Drugs," New England Journal of Medicine 355, no. 5 (2006): 437-440; Marti Nelson Cancer Foundation/CancerActionNow. org, "Expanded Access: Our Efforts available at http://www.canceractionnow.org/ advocacy/expandedaccess.php last visited March 5, 2007).
6. Abigail Alliance, 445 F.3d 470.
7. Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, No. 04-5350, 2006 U.S. App. LEXIS 28974 (D.C. Circuit November 21, 2006).
8. See Expanded Access to Investigational Drugs for Treatment Use, 71 Fed. Reg. at 75,150.
9. Id.
10. Id., at 75,148.
11. Id.
12. 21 C.F.R. § 312.34(a).
13. T. Class Expanded Access to Unapproved Medical Products: Compassionate Use Regulatory Affairs Focus magazine, May 2006, available at http://www.raps.org/s_raps/rafocus_article.asp?TRACKID=&CID=61&DID=2720 last visited March 8, 2007).
14. 21 C.F.R. § 312.34(b)(1)(iv).
15. Id. § 312.34(b)(2)-(3).
16. Id. § 312.34(a).
17. Id.
18. Id. § 312.34(b)(3).
19. Id. § 312.34(b)(2).
20. See Okie, supra note 5.
21. Id.
22. Abigail Alliance, 445 F.3d at 473.
23. Id.
24. Id., at 473-474.
25. Id., at 475.
26. Id., at 475-487.
27. Id., at 484, 486.
28. Id., at 480-483.
29. Id., at 484-485.
30. Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, No. 04-5350, 2006 U.S. App. LEXIS 28974 (D.C. Circuit November 21, 2006).
31. Expanded Access to Investigational Drugs for Treatment Use, 71 Fed. Reg. 75,147, 75,150 December 14, 2006 to be codified at 21 C.F.R. pt. 312).
32. Id.
33. Id., at 75,166.
34. Id., at 75,151.
35. Id., at 75,151.
36. Abigail Alliance, 445 F.3d at 473.
37. Expanded Access to Investigational Drugs for Treatment Use, 71 Fed. Reg. at 75,166-75,167.
38. Id., at 75,167.
39. Id., at 75,166.
40. Id.
41. R. Milligan and B. Bailey Physician Participation in Clinical Trials: The Rewards Are Obvious, but Risks Are Real April 1, 2005, available at http://www.hg.org/articles/article_1080.html last visited March 6, 2007).
42. 21 C.F.R §§ 56.109, 56.111.
43. Abney v. Amgen, Inc., 443 F.3d 540 (6th Circuit 2006 see Milligan, supra note 40.
44. Expanded Access to Investigational Drugs for Treatment Use, 71 Fed. Reg. at 75,150.
45. Id.
46. See Milligan and Bailey, supra note 41.
47. E. Nichols and the Institute of Medicine, Expanding Access to Investigational Therapies for HIV Infection and AIDS, March 12-13, 1990 Conference Summary (Washington, D.C. : National Academy Press 1991 at 50.
48. Id.
49. Id.
50. Id.
51. Id.
52. Expanded Access to Investigational Drugs for Treatment Use, 71 Fed. Reg. 75,147, 75,158 Dec. 14, 2006 to be codified at 21 C.F.R. pt. 312).
53. M. Mello, D. Studdert, and T. Brennan The Rise of Litigation in Human Subjects Research Annals of Internal Medicine 139 (2003 40-45, at 41.
54. Class, supra note 13.
55. See Expanded Access to Investigational Drugs for Treatment Use, 71 Fed. Reg. at 75,166.
56. Charging for Investigational Drugs, 71 Fed. Reg. 75,168, 75,170 Dec. 14, 2006 to be codified at 21 C.F.R. pt. 312).
57. Id., at 75,170.