Final Report (all chapters)

As an infrastructure of quality assurance and monitoring, the model program has one glaring
limitation: It does not reach all laboratories involved in the use and manipulation of embryos.
Laboratories that create embryos for purposes other than reproduction do not fall under FCSRCA
jurisdiction. Nor is FCSRCA’s emphasis to protect the health and safety of the patients, establish
appropriate personnel qualifications, or ensure consistency in the quality of medical procedures
of any relevance to conducting research. Other elements of the model program, such as recordkeeping
requirements for reproductive tissues, could, however, be extended to research labs at
biotech companies and university hospitals.
In addition to its inability to reach any of the controversial reproductive procedures or
research protocols, the model program includes only weak sanctions. HHS, through the CDC,
makes inspection results public and has the authority to revoke the certification of third-party
inspectors. 13 This approach may be described as enforcement by disclosure, and under certain
circumstances it can indeed be effective – for example, when disclosed information negatively
affects an organization’s public image. Bad publicity is often associated with negative economic
consequences, reason enough for an organization to stay in compliance with applicable laws and
regulations. In the present case, however, neither ART clinics nor third-party inspectors are
likely to suffer significant financial losses from a poor inspection record. Neither one of these
types of organizations has enough public visibility to fear the negative consequences of bad
publicity.
5.1.2 Public Health Service Act
The use and manipulation of reproductive tissues, including embryos, is not entirely beyond
the reach of the FDA. Section 361 of the Public Health Service Act (PHSA) gives the FDA the
authority to promulgate rules and regulations to prevent the introduction, transmission, and
spread of communicable diseases between the states or from foreign countries into the United
States. In this area, the FDA has exercised its authority selectively. While blood and bloodrelated
products have traditionally received considerable scrutiny, other biological products have
remained essentially unregulated. In response to the rapid growth in the commercial trade of
human tissues, the agency announced in 1997 its plans to implement a comprehensive regulatory
system aimed at minimizing health risks involved in the transplantation of human tissues,
improving understanding of the human tissue bank industry, monitoring new developments, and
institutionalizing communication and information exchange with industry members. These plans
are set out in two documents: “A Proposed Approach to the Regulation of Cellular and Tissue-
Based Products” and “Reinventing the Regulation of Human Tissue.” 14 The new regulatory
framework consists of three main rules: an “establishment registration and listing” rule, a “donor
13
14
See 42 USC 263a-3(c).
See http://www.fda.gov/cber/gdlns/celltissue.pdf and http://www.fda.gov/cber/tissue/rego.htm, respectively.
Programmatic documents and proposed interim and final rules can be found at
http://www.fda.gov/cber/tissue/docs.htm. See also Martha A. Wells, "Overview of FDA Regulation of Human
Cellular and Tissue-Based Products," Food and Drug Law Journal 52 (1997).
120