Many Tissue Banks Go Unregulated
Many tissue banks in the United States operate without federal oversight, raising the possibility of contaminated or diseased tissue being given to recipients, the Hartford Courant reports. In a hearing before Congress yesterday, federal investigators said that of an estimated 350 tissue banks in operation across the country, the FDA has conducted only 188 inspections, some of which were repeat examinations. The investigators said that "at least half" of U.S. tissue banks have never been inspected by the federal government. Although donated tissue is supposed to comply with "strict federal standards" to prevent the spread of communicable diseases such as HIV and hepatitis, investigators found that some tissue banks have engaged in "questionable practices." Valerie Rao, chief medical examiner in Lake County, Fla., said that Regeneration Technologies Inc. accepted donors with malignant tumors of the breast, colon, cervix and lung, and that the company did not perform routine blood or bone marrow tests to detect possible diseases (MacDonald, Hartford Courant, 5/25).
The AP/Richmond Times-Dispatch reports that the banks' practices may stem from their competition with not-for-profits to control part of the donation market. This competition can result in the use of "medically questionable tissue by firms that have a financial interest in producing as much material as they can," experts told Congress yesterday. Members of the Senate Government Affairs investigations subcommittee yesterday called on the FDA to "drastically increase" its inspections and said that the agency might want to consider drafting new rules that "go beyond" those now under review by the FDA. Those rules, which are not final, give the FDA the power to shut down tissue banks that do not meet standards (AP/Richmond Times-Dispatch, 5/25). However, FDA officials say they do not have enough funds to inspect tissue banks "as often as [they] would like," ideally every two years. Kathryn Zoon, director of research at the FDA, said that the agency instead focuses on banks which had "problems" in the past. The agency said it will spend an additional $4.35 million on inspections this year (Hartford Courant, 5/25).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.