Tissue Bank Industry Needs Greater FDA Regulation

The FDA has not done enough to regulate the procedures and safety practices of human tissue banks, which themselves have often not adequately disclosed the distribution and use of tissues in an increasingly "profit-driven industry," according to a new report issued by the HHS inspector general. The Chicago Tribune reports that the six-month, two-part study found that of the 154 tissue banks the FDA has identified, it has never inspected 36 of them and inspected 68 only once. Furthermore, there "may exist" tissue banks that the agency does not know about, according to the report. The number of tissue donations, which includes "anything from the human body that is not a vital organ," reached 20,000 in 1999, up from 6,000 in 1994. The FDA's only regulation governing such donations, however, is that tissue banks "screen donors and tissue for the AIDS virus and hepatitis." Although the report states that no cases of disease transmission are known to have occurred since the regulation took effect in 1993, "inspectors have found serious deficiencies in tissue banks' screening and testing practices," including instances where "diseased tissue" was distributed and where tissue from overseas "was accepted without proper medical information." To remedy this situation, the report makes the following recommendations:

The FDA should finalize a "long-proposed" rule requiring that all tissue banks be registered and subject to "regular inspections."
The FDA should enact "new safety standards to prevent the transfer of disease through tissue," including "enhanced donor screening" (Hedges, Chicago Tribune, 1/6).
Congress should increase the FDA's funding so that it can more effectively regulate the tissue bank industry (AP/Washington Post, 1/7).

HHS Secretary Donna Shalala said, "As a result of the public attention that has been drawn to this area, important steps are already under way toward making improvements" (AP/Nando Times, 1/6).

A Growing Industry

Addressing the industry's role, the report also noted a growing "tension" between families donating deceased relatives' tissue "in hope of helping someone else" and the increasing commercialization of the industry, the Chicago Tribune reports. A Tribune examination in June found that tissue donation has become a "near billion-dollar-a year national industry" in which some banks were found to have charged "exorbitant prices for donated tissue," while others "openly" bought and sold it in violation of a federal law that "makes the sale of body parts illegal." Some of the commercial uses for human tissue include skin for cosmetic surgery and knee tendons for athletes' surgeries The HHS report found that no standards exist to guide how tissue banks should request donations from families, which are often unaware that tissue could be used for commercial purposes (Chicago Tribune, 1/7). "When this is driven by money instead of for humanitarian reasons, you have to worry," Sen. Richard Durbin (D-Ill.), who requested the investigation, said (AP/Washington Post, 1/7). The report makes the following recommendations to the tissue bank industry:

Tissue banks should provide written disclosure to families outlining the intended use of the donated tissue.
Tissue processors and distributors "should ensure that information accompanying their products clearly indicate it is derived from donated human tissue."
The industry should work with groups representing donor families "to explore public disclosure of tissue banks' finances."

George Grob, the deputy inspector general who ran the investigation, said, "What we have here is a very special commodity, given by people with the expectation that it will save or enhance another life. I think it's not unreasonable to expect a much greater disclosure of how that product is obtained, what the costs of it are, what the transactions are that created it and what happens to it." The American Association of Tissue Banks, which represents roughly 70 tissue organizations, "welcome[d] the report," which noted that the association's accreditation program is "more stringent" than FDA standards (Chicago Tribune, 1/6). To download the HHS report, go to http://oig.hhs.gov/new.html. (Note: You will need Adobe Acrobat Reader to view the report).
This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.