Sometimes the silence can be like the thunder: Access to pharmaceutical data at the FDA

Law and Contemporary Problems

Volumn 69, Issue 3, 2006, Pages 85-98

  Lurie, Peter ^a   Zieve, Allison ^b  

^a Public Citizen Health Research Group   (United States)

^b Public Citizen Litigation Group   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 33750118709     PISSN: 00239186     EISSN: 00239186     Source Type: Journal    
DOI: None     Document Type: Article

References (52)

1. Bob Dylan, Lovesick, on Time Out of Mind (Columbia Records 1997).
2. An-Wen Chan et al., Empirical Evidence for Selective Reporting of Outcomes in Randomized Trials: Comparison of Protocols to Published Articles, 291 J. Am. Med. Ass'n 2457, 2462-64 (2004);
3. An-Wen Chan & Douglas G. Altman, Identifying Outcome Reporting Bias in Randomized Trials on PubMed: Review of Publications and Survey of Authors, 330 Brit. Med. J. 753, 756-57 (2005).
4. Drummond Rennie, Thyroid Storm, 277 J. Am. Med. Ass'n 1238, 1239-40 (1997).
5. Elizabeth Barbehenn et al., Alosetron for Irritable Bowel Syndrome, 356 Lancet 2009 (2000).
6. Jon N. Jureidini et al., Efficacy and Safety of Antidepressants for Children and Adolescents, 328 Brit. Med. J. 879, 882 (2004).
7. Barry Meier, Contracts Keep Drug Research Out of Reach, N.Y. Times, Nov. 29, 2004, at A1.
8. Craig J. Whittington et al., Selective Serotonin Reuptake Inhibitors in Childhood Depression: Systematic Review of Published versus Unpublished Data, 363 Lancet 1341, 1344-45 (2004).
9. Food & Drug Admin., Patient Information Sheet: Celecoxib (Apr. 7, 2005), http://www.fda.gov/cder/drug/infopage/celebrex/Celebrex-ptsk.pdf.
10. Fred E. Silverstein et al., Gastrointestinal Toxicity with Celecoxib vs Nonsteroidal Anti-Inflammatory Drugs for Osteoarthritis and Rheumatoid Arthritis: The CLASS Study: A Randomized Controlled Trial, 284 J. Am. Med. Ass'n 1247 (2000).
11. Susan Okie, Missing Data on Celebrex; Full Study Altered Picture of Drug, Wash. Post, Aug. 5, 2001, at A11.
12. Dep't of Health and Human Servs., Office of Inspector General, Report No. OEI-01-01-00590, FDA's Review Process for New Drug Applications: A Management Review 42 (2003).
13. Larry D. Sasich et al., The Drug Industry's Performance in Finishing Postmarketing Research (Phase IV) Studies (Apr. 13, 2000), http:// www.citizen.org/publications/release.cfm?ID=6721.
14. See 21 C.F.R. § 314.430(b)-(d).
15. Federal Advisory Committee Act, 5 U.S.C. app. II §§ 1-15 (2000).
16. Freedom of Information Act, 5 U.S.C. § 552 (2000).
17. 5 U.S.C. app. II §§ 10-11.
18. 5 U.S.C. § 552(b) (2000).
19. Food and Drug Administration. Annual Freedom of Information Act (FOIA) Report, Fiscal Year (FY) 2004, available at http://www.fda.gov/foi/ annual2004.html.
20. Id. at III(B)(6).
21. The cases reviewed below were obtained by searching the Westlaw database for published cases and from unpublished cases litigated by the Public Citizen Litigation Group. The timeframe of each case relative to the FDA review process described above is indicated in Figure 1. The authors also reviewed law review articles regarding FDA and the Freedom of Information Act (FOIA). The most relevant article mounts a general critique of the trade secret status of health and safety information and suggests that FDA has erred in its nearly unlimited granting of trade secret status to such information. See Thomas O. McGarity & Sidney A. Shapiro, The Trade Secret Status of Health and Safety Testing Information: Reforming Agency Disclosure Policies, 93 Harv. L. Rev. 837 (1980).
22. Pub. Citizen Health Research Group v. Food & Drug Admin. (Schering), 185 F.3d 898 (D.C. Cir. 1999).
23. 21 U.S.C. § 355(1) (2000)
24. Schering, 185 F.3d at 901.
25. Id. at 904.
26. Id. at 906.
27. Pub. Citizen Health Research Group v. Food & Drug Admin. (Searle), Civ. A. No. 94-0017 (RMU) (D.D.C. April 10, 1995)
28. The drug had never been approved for use in any condition.
29. Pub. Citizen Health Research Group v. FDA, 2000 WL 34262802 (D.D.C. 2000).
30. These same materials are often provided to the drug's sponsor well before the advisory committee meeting, but the FDA says that additional time is needed to redact exempted material before disclosure to the public.
31. Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat. 2296 (1997).
32. 21 U.S.C. § 355(n)(4) (2000).
33. Food and Drug Administration. Draft guidance on disclosure of conflicts of interest for special government employees participating in FDA product specific advisory committees (2002), available at http:// www.fda.gov/oc/guidance/advisorycommittee.html.
34. Stephen E. Daniels et al., The Analgesic Efficacy of Valdecoxib vs. Oxycodone/Acetaminophen After Oral Surgery, 133 J. Am. Dental Ass'n 611 (2002).
35. Melody Petersen, Madison Ave. Has Growing Role in the Business of Drug Research, N.Y. Times, Nov. 22, 2002, at A1.
36. Companies, particularly start-ups hungry for venture capital, now use their mandatory reports to the Securities and Exchange Commission to tout each step in the drug development process, further distorting the public record.
37. Public Citizen Health Research Group v. Food & Drug Admin., No. 04-304 (D.D.C. filed Feb. 26, 2004);
38. See Public Citizen Health Research Group, Complaint for Declaratory and Injunctive Relief (Feb. 26, 2004), available at http://www.citizen.org/ documents/ACF5CF.pdf
39. Bextra package insert, Pfizer, Inc. (2004), available at http://www.pfizer.com/download/uspi_bextra.pdf.
40. Dawn Jennings-Peterson & Sidney M. Wolfe, Petition to Remove the Cox-2 Inhibitors Celecoxib (Celebrex) and Valdecoxib (Bextra) from the Market (Jan. 24, 2005), http://www.citizen.org/publications /release.cfm?ID=7358.
41. Davis v. Food & Drug Admin., No. 01-982 (D.D.C. filed May 9, 2001).
42. Pub. Citizen Health Research Group v. Food & Drug Admin. (Glucophage Study), 964 F. Supp. 413 (D.D.C. 1997).
43. Id. at 414.
44. Nat'l Parks & Conservation Ass'n v. Morton, 498 F.2d 765, 770 (D.C. Cir. 1974).
45. Glucophage Study, 964 F. Supp. at 415.
46. Id.
47. Robert Steinbrook, Public Registration of Clinical Trials, 351 NEW ENG. J. MED. 315 (2004).
48. Catherine A. De Angelis et al., Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors, 141 Annals Internal Med. 477 (2004).
49. Fair Access to Clinical Trials Act, H.R. 5252, 108th Cong. (2004);
50. Fair Access to Clinical Trials Act, S. 2933, 108th Cong. (2004).
51. Availability of Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Human Gene Therapy or Xenotransplantation, 66 Fed. Reg. 4688 (Jan. 18, 2001).
52. Unified Agenda of Federal Regulatory and Deregulatory Actions, 67 Fed. Reg 3304-01 (May 13, 2002).