U.S. ART practitioners soon to begin their forced march into a regulated future

Journal of Assisted Reproduction and Genetics

Volumn 20, Issue 7, 2003, Pages 265-270

  Katayama, Alyce C ^a  

^a Health Law Group   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL PRACTICE; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HEALTH CARE PERSONNEL; HUMAN; INFERTILITY THERAPY; PRIORITY JOURNAL; REGISTER; REGULATORY MECHANISM; REVIEW; UNITED STATES;

HUMANS; INFERTILITY; REPRODUCTIVE TECHNIQUES, ASSISTED; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0043169712     PISSN: 10580468     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1024506419990     Document Type: Review

References (42)

1. Consumer Protection Issues Involving In Vitro Fertilization Clinics: Hearing Before the Sub-Committee on Regulation & Business Opportunities of the House Committee on Small Business, 100th Cong., 2d Sess. (1988).
2. Consumer Protection Issues Involving In Vitro Fertilization Clinics: Hearing before the Sub-Committee on Regulation, Business Opportunities & Energy of the House Committee on Small Business, 101st Cong. (1989)
3. Pub. L. No. 102-493 (codified at 42 U.S.C. §§ 263a-1 to 263a-7) (Oct. 24, 1992)
4. 42 U.S.C. § 263a-2(i)(1), 2003
5. 42 U.S.C. § 263a-2(i)(2), 2003
6. Application of Current Statutory Authorities to Human Somatic Cell Therapy Products, and Gene Therapy Products, 58 Fed. Reg. 53248 (Oct. 14, 1993)
7. Human Tissue for Transplantation; Interim Rule, 58 Fed. Reg. 65514 or 53248 (Oct. 14, 1993) (codified at 21 C.F.R. Pt. 1270)
8. A Proposed Approach to the Regulation of Cellular and Tissue-Based Products, 62 Fed. Reg. 9271 (March 4, 1997)
9. 42 U.S.C. § 264, 2003
10. 62 Fed. Reg. 9721 (March 4, 1997)
11. The Establishment Registration Rule (Human Cells, Tissue, and Cellular and Tissue-Based Products; Establishment Registration and Listing) was published in proposed form on May 14, 1998 (63 Fed. Reg. 26744), and in final form on January 19, 2001 (66 Fed. Reg. 5447)
12. The Donor Suitability Rule (Suitability Determination for Donors of Human Cellular and Tissue-Based Products) was published in proposed form on Sept. 30, 1999 (64 Fed. Reg. 52696)
13. The GTP Rule (Current Good Tissue Practices for Manufacturers of Human Cellular and Tissue-Based Products; Inspection and Enforcement) was published in proposed form on January 8, 2000 (66 Fed. Reg. 1508)
14. 68 Fed. Reg. 2689 (2003)
15. 21 C.F.R. § 1271.21 April 1, 2002
16. 21 C.F.R. § 1271.26 April 1, 2002
17. 21 C.F.R. § 1271.1(b) April 1, 2002
18. Presentation of Martha A. Wells of FDA's Center for Biologics, Evaluation and Research, University of Kentucky Workshop, Nov. 9, 2002
19. FDA has indicated that examples of acceptable sterilizing, preserving, and storage agents would include cryoprotectants (e.g., DMSO); chemicals used for sterilization (e.g. ethylene oxide); and storage solutions. 66 Fed. Reg. at 5459. Comment 30
20. FDA Workshop on Evidenced Based Assisted Reproductive Technologies, Sept. 18, 2002
21. www.fda.gov/cber/minutes/asrm041601.htm
22. The written comments are discussed in detail in the Preamble to the final Establishment Registration Rule, supra note 11
23. 21 C.F.R. § 1271.3(e) (April 1, 2002)
24. 21 C.F.R. § 1271.15 (April 1, 2002)
25. 68 Fed. Reg. 2689, 2690 (Jan. 21, 2003)
26. 42 U.S.C. § 271, 2003
27. 18 U.S.C. §§ 3559 and 3571 (c) 2000
28. See specifically the enforcement regulations contained in the proposed GTP Rule
29. Form FDA 3356 can be found on FDA's website at http://forms.psc.gov/forms/FDA/FDA-3356.pdf
30. 66 Fed. Reg. 5457. "By "immediate use," we mean that the reproductive materials are used promptly enough that cryopreservation is not necessary and is not performed. This exception is intended to cover an establishment that recovers semen for use in the artificial insemination of the donor's sexually intimate partner. We believe that this situation raises few new infectious disease concerns. For this reason, we are excepting these establishments from registering and from the other requirements will be contained in part 1271. The exception does not extend to the recovery of cells or tissues from close relative who are not sexually intimate partners, since an increased risk of communicable disease transmission exists in this situation."
31. See minutes of Workshop on Evidence Based Assisted Reproductive Technologies. Sept. 18, 2002. (Remarks of Jill H. Warner)
32. www.cdc.gov/nccdphp/drh/art.htm. The website includes the 2000 pregnancy success rate report as well as the five earlier reports published under the Fertility Clinic Success Rate and Certification Act
33. Data presented to FDA by SART
34. 66 Fed. Reg. 5452 (Jan. 19, 2001)
35. www.fda.gov/cber/ltr/cytotrans070601
36. 58 Fed. Reg. 53248 (Oct. 14, 1993)
37. Washington Post, July 11, 2001, A2. Weiss noted that this assertion of authority "differs in that it relates to fertility procedures. Medical procedures generally fall under the category of 'the practice of medicine,' which the FDA does not usually oversee out of respect for doctors' freedom to treat their patients as they see fit."
38. www.fda.gov/cber/ltr/humemb (March 2002)
39. 63 Fed. Reg. 5450 (Jan. 19, 2001)
40. Proposed Approach to Regulation of Cellular and Tissue Based Products, Docket Number 97N-0068 at p. 17
41. 66 Fed. Reg. 5462 (emphasis added) (Jan. 19, 2001)
42. See, e.g., Linder v. United States, 268 U.S. 5 (1925) (the direct control of medical practice is beyond the power of the federal government); Federal Trade Commission v. Simeon Management Corp., 391 F. Supp. 697 (N.D. Cal. 1975) (discussing the congressional intent as reflected in the legislative history of the 1938 Food, Drug and Cosmetic Act and the 1962 amendments to it - repeated statements that Congress did not intend the FDA to interfere with the medical practice); United States v. Evers, 453 E Supp. 114 (M.D. Ala. 1978); aff'd 643 F.2d 1043 (5th Cir. 1981); Washington Legal Foundation v. Henney, 202 E3d 331 (D.C. Cir. 2000). See also Rokosz, G.J., Human Cloning; Is the Reach of FDA Authority Too Far a Stretch, 30 Seton Hall L. Rev. 464 (2000)