Human Tissue Transplants : Cost

by Food and Drug Administration (FDA)

(Page 3 of 3)

FDA's interim rules are designed as a "temporary measure" until FDA "can complete its evaluation of whether additional regulations are necessary," says Steven Falter, director of FDA's division of bioresearch monitoring and regulation. FDA has provided technical advice to congressional officials on bills introduced by Wyden and Simon. Among other things, Falter says, legislation would require tissue banks to register with FDA. This would put to rest lingering questions about just how many U.S. tissue banks exist. With no previous federal oversight of tissue facilities and only sporadic state supervision of tissue banks, such numbers have been impossible to produce accurately.

Other provisions in the bills involve labeling all banked tissue and requiring that strict written procedures be followed in tissue recovery, processing, storage, and distribution. A law regulating tissue products has widespread support in the tissue- banking industry. AATB assisted Wyden and Simon in formulating their bills, each of which contained elements already part of AATB's standards and accreditation program. Likewise, EBAA advocates "well-drafted legislation." In congressional testimony, Ellen Heck of the eye-bank trade group said, "The legislation must take care to seek out and not delay in applying regulation to those [tissue banks] most likely to linger undetected and, therefore, unregulated and noncompliant." The American Red Cross agreed that enforceable federal standards are needed.

Who Will Pay the Bills?

FDA, Congress and industry agree on one critical aspect about pending legislation: Regulating human tissues requires resources. As Kathryn Zoon, Ph.D., director of FDA's Center for Biologics Evaluation and Research, says, "It will do little good to enact a statute or launch a [tissue-regulation] program without the resources to establish the program and sustain the program over time."

Where will these funds come from? Key players in the legislation are brainstorming possibilities. One is to levy user fees on the tissue-banking industry. Such a program, says Zoon, "would provide real value to the tissue-banking community in terms of public credibility and a level playing field, and it is fair to ask that community to bear the cost." But she warns that user-fee costs would likely be passed on to consumers. Legislation, she says, should be "thoroughly examined" for its impact on health-care reform.

Industry sources express mixed feelings about user fees. The AATB, says spokesman Weixel, would likely support such fees, provided they were fair and "dedicated to accomplishing regulation, not to underwriting budget difficulties." He says user fees probably could not fund an entire regulation program, only parts such as tissue-bank registration and some inspections. Other resources, such as federal seed money or a value-added tax on transplants, might be needed to finance compliance, research, and other critical elements, Weixel adds.

Though officials are wrestling with how to fund legislation, many express confidence that the issue will be resolved. "As a society," says FDA's Zoon, "we must balance the benefits that would clearly accrue from allocating resources to tissue regulation against using the resources to address other issues."

Until further measures take shape, FDA is relying on the interim rule to safeguard tissue transplants. For the moment, says FDA Commissioner David A. Kessler, M.D., the rule "will ensure that the public is protected, and protected well."

FDA's Interim Rules

Tissue banks covered under FDA's interim rules now must test blood specimens from all donors using laboratories regulated under the Clinical Laboratories Improvement Act of 1988. Blood samples must test negative for antibodies to HIV (types 1 and 2), hepatitis B surface antigen, and antibodies to hepatitis C virus.

Some of the other interim rule conditions provide for:

Screening — Tissue banks are required to obtain a medical history for each donor to help rule out risk factors.

Record keeping — Banks must keep written or electronic records for 10 years that document donor testing and screening. All banked tissue must be either quarantined or accompanied by proper records.

Inspections — FDA can inspect tissue-banking facilities to ensure compliance with the new rules.

Recall — FDA may order the recall or destruction of any tissue not meeting interim-rule requirements.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.