Implications of FDA's proposal to include foreign marketing experience in the over-the-counter drug review process

Food and Drug Law Journal

Volumn 53, Issue 1, 1998, Pages 105-122

  Pinco, Robert G ^a  

^a Akin Gump Strauss Hauer & Feld LLP   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COSMETIC; FOOD ADDITIVE; HERBACEOUS AGENT; NEW DRUG; NON PRESCRIPTION DRUG; SUNSCREEN;

CULTURAL FACTOR; DRUG APPROVAL; DRUG LABELING; DRUG LEGISLATION; DRUG MARKETING; DRUG SURVEILLANCE PROGRAM; EUROPEAN UNION; FOOD; FOOD AND DRUG ADMINISTRATION; HEREDITY; REVIEW; UNITED STATES;

COSMETICS; DIETARY SUPPLEMENTS; DRUG APPROVAL; DRUG EVALUATION; DRUGS, NON-PRESCRIPTION; EUROPE; EUROPEAN UNION; FOOD; FOOD ADDITIVES; HUMANS; MARKETING OF HEALTH SERVICES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0031947839     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (82)

1. Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System; Request for Information and Comments, 61 Fed. Reg. 51,625 (Oct. 3, 1996).
2. Id.
3. See Procedures for Classification of Over-the-Counter Drugs, 37 Fed. Reg. 9464 (May 11, 1972).
4. Over-the-Counter Drugs, Proposal Establishing Rule Making Procedures for Classification, 37 Fed. Reg. 85, 86 (Jan. 5, 1972).
5. See Rosemarie Kanusky, Symposium: Intellectual Property: Comment: Pharmaceutical Harmonization: Standardizing Regulations Among the United States, The European Economic Community, and Japan, 16 HOUS. J. INT'L L. 665, 674 (1994).
6. See generally 37 Fed. Reg. at 85.
7. 61 Fed. Reg. at 51, 627.
8. See EUROPEAN-AMERICAN PHYTOMEDICINES COALITION, CITIZEN PETITION TO AMEND FDA'S OVER-THE-COUNTER DRUG REVIEW POLICY REGARDING FOREIGN INGREDIENTS (July 24, 1992) [hereinafter EAPC CITIZEN PETITION].
9. 61 Fed. Reg. at 51,625.
10. See 37 Fed. Reg. at 9464.
11. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended 21 U.S.C. §§ 301 et seq. (1994)).
12. 21 U.S.C. § 355 (FDCA § 505).
13. Id.
14. Id. § 321 (p) (FDCA § 201(p)).
15. See generally 37 Fed. Reg. at 85.
16. Id.
17. Id.
18. Id.
19. See Unified Agenda, Food and Drug Administration, Over-the-Counter Drug Review, 62 Fed. Reg. 57,474 (Oct. 27, 1997).
20. See generally 37 Fed. Reg. at 85.
21. 21 C.F.R. § 330.13 (1997).
22. This date was originally May 11, 1972, but later was extended informally to 1975. See Warning Letter from Daniel L. Michels, Center for Drug Evaluation and Research, FDA, to Richard D. Frazer, Pres., Crescent Mfg. (Sept. 9, 1991).
23. See, e.g., 21 C.F.R. § 330.13; McNeilab, Inc. v. American Home Prods. Corp., 501F. Supp. 540 (S.D.N.Y. 1980); FDA May Take "Anti-Plaque" Oral Rinse Marketers to Court, F-D-C REP. ("The Rose Sheet"), Feb. 19, 1996, at 1.
24. 61 Fed. Reg. at 51,627.
25. See, e.g., Weinberger v. Hynson, Wescott and Dunning, Inc., 412 U.S. 609, 631 (1973); Prerno Pharm. Labs., Inc. v. United States, 629 F.2d 795, 801-02 (2d Cir. 1980).
26. 61 Fed. Reg. at 51,626.
27. Octyl Triazone Inclusion in Sunscreen Monograph Sought by BASF AG, F-D-C REP. ("The Rose Sheet"), Dec. 2, 1996, at 8.
28. See EAPC CITIZEN PETITION, supra note 8.
29. 61 Fed. Reg. at 51,627.
30. The FDCA defines cosmetic as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance." 21 U.S.C. § 321(i) (FDCA § 201 (i)). The European Cosmetic Directive defines a cosmetic product as "any substance or preparation intended to be placed in contact with the various external parts of the human body . . . or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them or keeping them in good condition." Council Directive 93/35/EEC, art. 1, 1993 O.J. (L 151) 32, 33 (amending Council Directive 76/768/EEC).
31. See National Nutritional Foods Ass'n v. Mathews, 557 F.2d 325, 333, 335 (2d Cir. 1977); United States v. An Article . . . "Sudden Change," 409 F.2d 734 (2d Cir. 1969).
32. See Comment to Dkt. No. 96N-0277, Coalition of European Sunscreen Manufacturers (Dec. 26, 1996).
33. Sunscreen Products for Over-the-Counter Human Use, Establishment of a Monograph, 43 Fed. Reg. 38,206, 38,209 (Aug. 25, 1978).
34. 21 C.F.R. § 314.106.
35. See FDA's Proposed Sunscreen Definition Excludes Some Category I Ingredients, F-D-C REP. ("The Rose Sheet"), Apr. 4, 1994, at 6.
36. 61 Fed. Reg. at 51,625.
37. Food and Drug Administration Modernization Act, Pub. L. No. 105-115, § 129, 111 Stat. 2296 (1997).
38. Phytomedicines, also referred to as herbal medications, consist of crude plants having medicinal properties. These plants include 13,000 species that have been used for centuries as traditional medicines by various cultures around the world. The terms "phytomedicines," "herbal medications," and "natural medications" are used interchangeably throughout this article.
39. See generally EAPC CITIZENS PETITION, supra note 8.
40. Id. at 7. The EU currently is composed of the following member states: Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, and the United Kingdom.
41. The first Directive, 65/65/EEC, provides basic definitions. Council Directive 65/65/EEC, art. 1, 1965 O.J. (22) 369. The second Directive, 75/318/EEC, specifies the requirements for the quality, safety, and efficacy documentation for all drugs. Council Directive 75/318/EEC, 1975 O.J. (L147) 1. The third Directive, 75/319/ EEC, outlines the application procedure whereby market authorization in a Member State can lead to multistate acceptance. Council Directive 75/319/EEC, 1975 O.J. (L147) 13.
42. Directives 65/65/EEC, 75/318/EEC, supra note 41.
43. COMMISSION OF THE EUROPEAN COMMUNITIES, Quality of Herbal Remedies, in THE RULES GOVERNING MEDICINAL PRODUCTS IN THE EUROPEAN COMMUNITY (1986).
44. 21 U.S.C. § 321 (FDCA § 201).
45. Id. § 342 (FDCA § 402); United States v. Lexington Mill & Elevator Co., 232 U.S. 399 (1914).
46. 21 U.S.C. § 321(s) (FDCA § 201(s)); see also National Nutritional Foods Ass'n v. Kennedy, 572 F.2d 377, 391 (2d Cir. 1978) (stating materials qualifying as foods are not precluded from also being food additives).
47. The excluded categories consist of substances that 1) are generally recognized as safe; 2) were approved or sanctioned under the FDCA, the Meat Inspection Act, or the Poultry Products Inspection Act before 1958 (referred to as "prior sanction"); of 3) fall within specific exceptions for pesticides, color additives, dietary supplements, and new animal drugs. 21 U.S.C. § 321(s) (FDCA § 201(s)). See also PETER B. HUTT & RICHARD A. MERRILL, FOOD AND DRUG LAW: CASES AND MATERIALS 12 (2d ed. 1991).
48. See 21 U.S.C. § 321(s)(6) (FDCA § 201(s)(6)).
49. See United States v. Two Plastic Drums . . . Black Currant Oil, 984 F.2d 814 (7th Cir. 1993).
50. 21 U.S.C. § 321(ff)(1) (FDCA § 201(ff)(1)).
51. Id. § 343(r)(6) (FDCA § 403(r)(6)).
52. Pub. L. No. 103-417, 108 Stat. 4325 (1994).
53. NDA approval costs an average of $50,000,000 to $100,000,000 per product. To the small-sized herbal medicine manufacturer, the cost is an absolute deterrent to applying for NDA approval.
54. EAPC CITIZEN PETITION, supra note 8.
55. Id. The EAPC is an association of manufacturers and marketers of phytomedicines, whose members operate in France, Germany, Israel, Italy, The Netherlands, Switzerland, and the United Kingdom, as well as the United States.
56. Id. at 4.
57. Id. The Petition discusses the possibility of limiting geographic eligibility to the countries identified in the FDA Export Reform and Enhancement Act of 1996, Pub. L. No. 104-134, 110 Stat. 1321 (codified in scattered sections of 21 U.S.C. and 42 U.S.C. § 262 (1994)). These are Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, and members of the EU.
58. 61 Fed. Reg. at 51,625.
59. Id.
60. Id. at 51,627.
61. Id. at 51,628.
62. See Sunscreen Drug Products for Over-the-Counter Human Use; Marketing Status of Products Containing Avobenzone; Enforcement Policy, 62 Fed. Reg. 23,350 (Apr. 30, 1997).
63. See, e.g., International Conference on Harmonisation; Guideline on Impurities in New Drug Products, 62 Fed. Reg. 27,453, 27,454 (May 19, 1997).
64. 21 C.F.R. § 314.106; New Drug and Antibiotic Regulations, 50 Fed. Reg. 7452, 7493 (Feb. 22, 1985).
65. See. e.g., International Accord on Drug Testing Standards Will Delete LD50 Animal Testing Requirements, F-D-C REP. ("The Blue Sheet"), Nov. 20, 1991, at 9.
66. See FDA Modernization Act, Pub. L. No. 105-115, 111 Stat. at 2296.
67. 715 F.2d 185 (9th Cir. 1983)
68. EAPC CITIZEN PETITION, supra note 8.
69. Id.
70. 61 Fed. Reg. at 51,629.
71. Id.
72. EU Directive 76/768/EEC, 1976 O.J. (L262) 169, as amended in Council Directive 93/35/EEC, supra note 30, art. 7a.
73. Council Directive 93/35/EEC, supra note 30, art. 7a.
74. 61 Fed. Reg. at 51,628.
75. Id. at 51,629.
76. Pub. L. No. 104-134, tit. II, 110 Stat. at 1321-1313.
77. Id.
78. 21 C.F.R. § 330.13
79. 61 Fed. Reg. at 51,625.
80. 21 U.S.C. § 321(p)(2) (FDCA § 201(p)(2)).
81. 61 Fed. Reg. at 51,630.
82. See supra pt. V.A.3.