Regulation of the Human Tissue Industry: A Call for Fast-Track Regulations
| Author | Michael Leachman |
| Position | J.D./B.C.L. Candidate, May 2005, Paul M. Hebert Law Center, Louisiana State University |
| Pages | 444-471 |
J.D./B.C.L. Candidate, May 2005, Paul M. Hebert Law Center, Louisiana State University. I would like to thank Professor Michael Malinowski for his guidance and assistance in the drafting of this article.
Self-regulation by an industry-dominated accrediting body will, in our opinion, never be as rigorous nor as aggressive as Government regulation and consequently will not . . . as effectively protect the patients.
-Steven Anderson, President of Cryolife, before the Subcommittee on Regulation, Business Opportunities, and Technology, 103rd Congress, 1993.1
Page 444
Twenty-three-year-old Brian Lykins arrived at St. Cloud Hospital in St. Cloud, Minnesota for a routine cartilage transplant to repair a damaged knee.2 Three days following surgery, Brian was dead. Scientists from the Centers for Disease Control (CDC) later determined the cause of death to be Clostridium Sordellii, a rare and toxic bacteria that lives in soil and human intestines.3 The CDC's investigation traced the source of infection to the donor of the transplanted tissue-a dead human body.4 The transplanted tissue was processed by Cryolife, one of the largest human tissue banks in the United States.
Conventional tissue banks process human tissues from cadavers and distribute the tissues to surgeons for transplantation.5 These products serve a crucial role in medicine, and they have the potential for providing important new therapies.6 The tissue bank industry hasPage 445 experienced rapid growth over the past two decades. In 1990, surgeons performed 350,000 tissue transplants.7 Today, more than 800,000 tissues are transplanted every year.8 However, all human cellular and tissue-based products pose a potential risk of transmitting communicable diseases because of their nature as derivatives of the human body.9 The risk of infection can be marginalized if proper testing and sterilization procedures are followed.10
Although transplantation was generally thought to be a safe and effective surgical procedure, investigational reports conducted by the CDC following Brian Lykins' death exposed grave deficiencies within the tissue industry.11 Some banks ran multiple tests on recovered tissue in hopes that the second test would find material healthy when the first did not;12 accepted donors with nonmetastasizing malignant tumors;13 and pooled material from multiple donors, risking contamination of the entire batch.14 The investigational report documented fifty-four bacterial infections resulting from tissue transplants.15 The death of Brian LykinsPage 446 combined with the shocking report issued by the CDC left the question, "How could a medical industry in the United States of America be allowed to operate like this?"16
Though organs and blood have long been subjected to extensive FDA oversight, human tissues have fallen between the cracks of federal regulation.17 While "normally, when something [is] a matter of public health and safety, the federal government acts far more quickly," the implementation of a federal regulatory scheme governing human tissues has been a lethargic process.18 The FDA first acknowledged the need for extensive government oversight in its 1993 Interim Rule.19 However, the FDA did not propose a comprehensive regulatory approach to the regulation of human tissues until February of 1997.20 Still, seven years later, the FDA still has not finalized all of the proposed regulations.21
In contrast, other countries have exercised government oversight over the human tissue industry for many years. Belgium enacted a comprehensive regulatory system in 1988.22 In 1994, France enactedPage 447 comprehensive regulatory legislation.23 Even two states-New York and Florida-have developed comprehensive human tissue programs.24The absence of a federal comprehensive regulatory system has concerned many leaders within the tissue industry as well as members of Congress.25 In a hearing before the Senate Governmental Affairs Committee, Chairwoman Susan Collins sharply criticized the FDA for its failure to exercise any substantial oversight. She stated, "The FDA still has not kept its commitment to addressing this public health risk. The result of bureaucratic inertia has been tragedy."26
The FDA presented its comprehensive regulatory plan approximately seven years ago. The long delay in FDA enactment of human tissue regulations is illustrative of a serious problem afflicting all administrative agencies: "ossification" of the rulemaking process.27 Today, the minimum time period between the proposal of major regulations and the final enactment is five years. While ossification affects every administrative agency in the United States government, it has been particularly detrimental to FDA regulation of the human tissue industry. This article contends that the dynamic nature of science and technology requires Congress to consider implementing a fast-track program for FDA regulations.
Section II will trace the evolution of human tissue regulation. Section III will look at recent developments on Capitol Hill concerning human tissue regulation. Section IV analyzes the threat of contaminated human tissues and the support for federal oversight. Section V will discuss the informal rulemaking procedure, noting the benefits as well as the drawback of the current rulemaking system. Section VI proposes the creation of a fast-track rulemaking system that will function to streamline the FDA rulemaking process.
During the late 1980s and early 1990s, reports surfaced concerning the spread of communicable diseases through tissue transplants. The most infamous report occurred in 1991. Lifenet, aPage 448 human tissue bank, mistakenly distributed five organs and fifty-four tissue products taken from a HIV-positive donor.28 Three organ recipients died, and at least another three of the patients contracted HIV from tissue transplants.29
Public concern over the transmission of HIV and other communicable diseases forced the federal government to address the growing concerns. "The Assistant Secretary for Health 'convened a Public Health Service Work Group to evaluate the need for, and type of, federal oversight that should be developed for human tissue.'"30The Work Group recommended that an investigation into the needed level of mandatory oversight for tissue transplantation should take place.31 The Work Group suggested that the FDA should assert jurisdiction.32
Growing public concern over the transmission of communicable diseases through tissue transplants did not escape attention from Congress. Senator Paul Simon (D-IL) introduced the Human Tissue Transplantation Act of 1992 amid the growing concerns of human tissue contamination.33 The bill established a National Council on Tissue Transplantation which would develop a record keeping system to facilitate the tracking of potentially contaminated tissue and publish voluntary standards governing the procurement, processing, and distribution of human tissue. The bill also required all tissue banks to register with the Department of Health and Human Services (HHS). Tissue banks would have to obtain a license and pay license fees to fund the regulatory program. Furthermore, the Secretary of HHS was directed to issue mandatory professional standards if the voluntary standards published by the Council were not adequately protecting the public health.
The bill received a cold reception by the human tissue industry. The American Association of Tissue Banks (AATB) and the American Red Cross agreed that tissue transplantation must be federally regulated.34 The registration of human tissue banks,Page 449 establishment of donor screening and testing procedures, and the establishment of a tracking system were widely supported. However, the AATB and the Red Cross opposed the bill. They argued that mandatory standards-rather than the proposed voluntary professional standards-were needed. 35
The Human Tissue Transplantation Act of 1992 did not become law. However, Senator Simon made a second attempt the following year. Abandoning the National Council on Tissue Transplantation, the Human Tissue for Transplantation Act of 1993 centralized rulemaking authority in the Secretary of DHHS.36 The 1993 Act required the Secretary to enact regulations concerning donor screening, donor testing, record keeping, and good tissue practices. Tissue banks would be required to register with the Secretary.
Unlike the 1992 Act, the 1993 Act was popular. The American Academy of Orthopaedic Surgeons stated, "[This] legislation takes necessary steps to ensure the safe screening of human tissue without impeding with undue regulation the scientific...
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