The Government's role in advancing regenerative medicine and tissue engineering - Science, safety, and ethics

Periodontology 2000

Volumn 41, Issue 1, 2006, Pages 16-29

  Smith, David S ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

APPARATUS, EQUIPMENT AND SUPPLIES; ARTICLE; ETHICS; EUROPE; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HUMAN; LEGAL ASPECT; MARKETING; REGENERATIVE MEDICINE; SAFETY; TISSUE ENGINEERING; UNITED STATES;

CONSUMER PRODUCT SAFETY; EQUIPMENT AND SUPPLIES; ETHICS; EUROPE; EUROPEAN UNION; GOVERNMENT REGULATION; HUMANS; MARKETING; REGENERATIVE MEDICINE; SAFETY; TISSUE ENGINEERING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33745316101     PISSN: 09066713     EISSN: 16000757     Source Type: Journal    
DOI: 10.1111/j.1600-0757.2006.00177.x     Document Type: Review

References (28)

1. U.S. Department of Health and Human Services, ''2020: A New Vision - A Future for Regenerative Medicine'', http://www.hhs.gov/reference/newfuture. shtml.
2. Statement by President George Bush, 9 August 2001.
3. U.S. Senate, S.658, A Bill to Amend the Public Health Service Act to Prohibit Human Cloning, (Sponsor: Brownback, S.), introduced 17 March 2005.
4. FD&C Act §201(g)(1).
5. FD&C Act, §201(h) (emphasis added).
6. PHS Act, §351(a).
7. See, FDA Notice of Public Hearing: Products Comprised of Living Autologous Cells Manipulated ex vivo and Intended for Implantation for Structural Repair or Reconstruction (60 FR 36808; 18 July 1995).
8. 21 U.S.C. Section 360c(a)(1)(C); 21 CFR Section 860.3(c).
9. 21 U.S.C. Section 360c(c)(2)(C); 21 CFR Section 860.93.
10. Title 21, U.S. Code of Federal Regulations, Section 860.7(d).
11. PHS Act, §361(a).
12. Title 21, U.S. Code of Federal Regulations, Section 127.3(d).
13. FDA Notice: Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products (58 FR 53248; 14 October 1993).
14. FDA Notice of Interim Rule: Human Tissue Intended for Transplantation (58 FR 65514; 14 December 1993).
15. With the exception of Document #1, each document listed here can be obtained through the FDA web site ( http://www.fda.gov/cber) or from the author. While the provisions of the FD&C and PHS Acts and the Final Rules [codified as part of the Code of Federal Regulations (CFR)] promulgated thereunder by the FDA have the force of law and are binding on the Agency, FDA Guidance documents are not. Nevertheless, Guidances are clearly helpful in anticipating the Agency's response to particular marketing approval and other regulatory issues.
16. Title 21, U.S. Code of Federal Regulations, Section 127.3(f).
17. Directive 2004/23/EC of the European Parliament and of the Council of March 31, 2004; Directive 2006/17/EC of the European Commission of 6 February 2006.
18. Proposal 2005/0227(COD) for a Regulation of the European Parliament and of the Council of 16 November 2005.
19. U.S. Constitution, Article VI, cl. 2.
20. 21 U.S.C. Section 360k.
21. 518 U.S. 470, 116 S.CA 2240 (1996).
22. 42 U.S.C. sects. 273, et. seq.
23. Uniform Anatomical Gift Act (1987), Section 10, reproduced at 8A Uniform Laws Annotated 58 (Master Edition, 1993).
24. Moore v. Regents of University of California, 202 Cal. App.3d 1405, 249 Cal.Rptr. 494 (1988), affirmed in part and reversed in part, 51 Cal.3d 120, 271 Cal.Rptr. 146, 793 P.2d 479 (1990).
25. 51 Cal.3d at 148 (Arabian, J. concurring).
26. 51 Cal.3d at 140-41.
27. 51 Cal. 3d at 141-42. The Court observed that federal law permits the patenting of those organisms that represent the product of ''human ingenuity'', but not those that are naturally occurring. Id., quoting Diamond v. Chakrabarty, 447 U.S. 303, 309-10, 100 S.Ct. 2204, 65 L.Ed.2d 144 (1980).
28. 51 Cal. 3d at 174, quoting Danforth, Cells, Sales, & Royalties: The Patient's Right to a Portion of the Profits, 6 Yale L. & Pol'y Rev. 179, 190 (1988).