Implications of international drug approval systems on confidentiality of business secrets in the U.S. pharmaceutical industry

Food and Drug Law Journal

Volumn 53, Issue 1, 1998, Pages 123-132

  O'Reilly, James T ^a  

^a PROCTER AND GAMBLE COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONFIDENTIALITY; DEVICE; DRUG APPROVAL; DRUG INDUSTRY; DRUG INFORMATION; DRUG LEGISLATION; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; INTERNATIONAL COOPERATION; REVIEW; UNITED STATES;

CONFIDENTIALITY; DEVICE APPROVAL; DRUG APPROVAL; DRUG EVALUATION; DRUG INDUSTRY; EUROPE; EUROPEAN UNION; HUMANS; PATENTS; RESEARCH; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0031949910     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (57)

1. Agreement on Mutual Recognition Between the United States of America and the European Community, June 20, 1997.
2. As the D.C. Circuit Court stated, "[f]ree riding is too high a price to pay for vigorous competition." Contact Lens Mfrs. Ass'n v. FDA, 766 F.2d 592 (D.C. Cir. 1985).
3. 21 U.S.C. § 355 (1994); 21 C.F.R. pt. 314 (1997).
4. Pub. L. No. 89-487, 80 Stat. 250 (1966) (codified at 5 U.S.C. § 552 (1994)). See also 21 C.F.R. § 20.61.
5. Current Developments on the International Regulatory Scene, FDLI Seminar, Washington, D.C. (Sept. 25, 1997).
6. At a minimum, FDA must consider its international obligations when disclosure of foreign-transferred confidential business data is sought by a FOIA requester. See 21 C.F.R. § 20.111. The legal issue for future courts will be whether an MRA, like a treaty, can itself have exemptive effect under FOIA (5 U.S.C. § 552(b)(3)). The argument can be asserted, but FDA is likely to pursue the broadest discretionary powers.
7. 5 U.S.C. § 552(b)(4).
8. 21 US.C. § 331(j) (FDCA § 301(j)); 18 U.S.C. § 1905 (1994).
9. A very detailed exposition on this history is found in 2 JAMES O'REILLY, FOOD AND DRUG ADMINISTRATION ch. 2 (1993, 1997 Supp.).
10. See 21 U.S.C. §§ 355, 360j(g) (FDCA §§ 505, 520(g)).
11. Public Citizen Health Research Group v. FDA, 953 F. Supp. 400 (D.D.C. 1996).
12. Id.
13. 21 C.F.R. § 20.45.
14. Exec. Order No. 12,600, 52 Fed. Reg. 23,781 (Feb. 25, 1989).
15. 21 C.F.R. § 20.89.
16. While there is a theoretical cause of action to remedy FDA's arbitrariness under administrative adjudication principles, see Chrysler Corp. v. Brown, 441 U.S. 281 (1979), in practice this is very unlikely to be employed successfully.
17. Bartholdi Cable Co., Inc. v. FCC, 114 F.2d 274 (D.C. Cir. 1997).
18. Id. at 282-83.
19. Ruckelshaus v. Monsanto Corp., 467 U.S. 986 (1984).
20. 21 C.F.R. pt. 20; 39 Fed. Reg. 44,614 (Dec. 24, 1974).
21. United States v. California Canners & Growers, 9 Cl. Ct. (1986).
22. 21 US.C. § 331(j) (FDCA § 301(j)) has not been employed against an FDA employee in any reported decisions.
23. 21 U.S.C. § 355(1) (FDCA § 505(1)).
24. Id.
25. FOIA does not compel an agency to utilize an exemption from disclosure, such as that found in 5 U.S.C. § 552(b)(4).
26. Peter Barton Hutt, Public Information and Public Participation in the Food and Drug Administration, 36 Q. BULL. ASS'N FOOD & DRUG OFFICIALS 212 (1972), quoted in RICHARD A. MERRILL & PETER BARTON HUTT, FOOD AND DRUG LAW: CASES AND MATERIALS 919-20 (1st ed. 1980).
27. Peter Barton Hutt, Public Information and Public Participation in the Food and Drug Administration, 36 Q. BULL. ASS'N FOOD & DRUG OFFICIALS 212 (1972), quoted in RICHARD A. MERRILL & PETER BARTON HUTT, FOOD AND DRUG LAW: CASES AND MATERIALS 919-20 (1st ed. 1980).
28. 21 C.F.R. pt. 20; 39 Fed. Reg. 44,614 (Dec. 24, 1974).
29. 21 C.F.R. § 20.61.
30. 37 Fed. Reg. 9130 (May 5, 1972).
31. FDA's summary of the adverse comments is found at 42 Fed. Reg. 3094 (Jan. 14, 1977).
32. 21 C.F.R. pt. 20, especially section 20.61, presumes disclosure unless the submitting party can substantiate its case for confidential handling.
33. 21 C.F.R. § 812.38.
34. Id. § 514.11.
35. U.S. DEP'T OF HEALTH EDUC. AND WELFARE, REPORT BY THE COMMISSIONER OF FOOD AND DRUGS ON FINDINGS AND RECOMMENDATIONS OF THE REVIEW PANEL ON NEW DRUG REGULATION 24-26 (1978), cited in Jane Fisher, Disclosure of Safety and Effectiveness Data under the Drug Price Competition and Patent Term Restoration Act, 41 FOOD DRUG COSM. L.J. 268 n.5 (1986).
36. U.S. DEP'T OF HEALTH EDUC. AND WELFARE, REPORT BY THE COMMISSIONER OF FOOD AND DRUGS ON FINDINGS AND RECOMMENDATIONS OF THE REVIEW PANEL ON NEW DRUG REGULATION 24-26 (1978), cited in Jane Fisher, Disclosure of Safety and Effectiveness Data under the Drug Price Competition and Patent Term Restoration Act, 41 FOOD DRUG COSM. L.J. 268 n.5 (1986).
37. S. 2397, 96th Cong., 1st Sess. (1979), discussed in James O'Reilly, Regaining a Confidence: Protection of Business Confidential Data Through Reform of the Freedom of Information Act, 34 ADMIN. L. REV. 263, 272 (1982).
38. FDA'S policy decision to narrow the scope of trade secret coverage was expressed in its brief in Public Citizen Health Research Group v. FDA, 704 F.2d 1280 (D.C. Cir. 1983).
39. The plaintiff won an appellate decision that testing data were not "trade secrets," but since the submitter had demonstrated CBI status by adequate proof, the court denied disclosure. Id.
40. Anderson v. Dep't of Health and Human Servs., 907 F.2d 936 (10th Cir. 1990); Teich v. FDA, [1985-90 Transfer Binder] Med. Device Rep. (CCH) 15,133 (D.D.C. 1990).
41. The best statement of policy in favor of disclosure was written by former FDA Associate Chief Counsel, Gary Yingling, Veterinary Drugs: The Impact of the Laws of Confidentiality on International Communications, 38 FOOD DRUG COSM. L.J. 35 (1983). For an extended view of FDA policy evolution, see O'REILLY, supra note 9, § 22.03 (1997 Supp.).
42. 21 U.S.C. § 355(j) (FDCA § 505 (j)).
43. Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585.
44. 130 CONG. REC. S10,989 (Sept. 12, 1984).
45. 21 U.S.C. § 355(1)(5) (FDCA § 505(1)(5)).
46. James O'Reilly, Knowledge is Power: Legislative Control of Drug Industry Trade Secrets, 54 U. CIN. L. REV. 1 (1985).
47. The challenge would assert that FDA had acted arbitrarily in its decision to disclose data, in breach of the property rights of the submitter. Chrysler v. Brown, 441 U.S. 281 (1979).
48. Exec. Order No. 12,600, supra note 14.
49. 21 C.F.R. § 20.45. FDA's antipathy extended also to presubmission requests for confidential handling. Id. § 20.111. See also Carson Prods., Inc. v. Califano, 594 F.2d 453 (5th Cir. 1979).
50. WILLIAM CASEY, JOHN MARTHINSEN, & LAWRENCE MOSS, PRODUCTIVITY, ENTREPRENEURSHIP AND THE FREEDOM OF INFORMATION ACT (1982).
51. 5 U.S.C. § 552.
52. U.S. Dep't of Justice, President and Attorney General Issue New FOIA Policy Memoranda, 14 FOIA UPDATE 5 (1993) (discussing President William J. Clinton, Memorandum for Heads of Departments and Agencies (Oct. 4, 1993)).
53. 21 C.F.R. § 20.89.
54. Id.
55. Id.
56. Id.
57. FDA Export Reform and Enhancement Act of 1996, Pub. L. No. 104-134, 110 Stat. 1321 (codified at 21 U.S.C. § 382(b)(4) (FDCA § 802(b)(4))).