New FDA Rules Require Registration of Tissue and Cell Products
Fulfilling her promise to tighten regulations on the human body part trade, HHS Secretary Donna Shalala yesterday released final regulations requiring all establishments that manufacture human cells, tissues and cellular- and tissue-based products to register and list their products with the FDA, the Orange County Register reports. In August, Shalala said HHS would step up efforts to oversee the growing industry (Heisel, Orange County Register, 1/19). The new requirements will create for the first time a "complete base of information on the tissue bank industry," and will include tissues and cells not previously regulated. The rules also establish a tiered system of regulation, under which certain tissues and cells will be "subject only to regulations aimed at preventing the spread of communicable disease," while other tissue-related products will be "required to obtain premarket approval in addition to following the communicable disease requirements." FDA Commissioner Jane Henney said, "This rule will give the FDA the information it needs to implement the agency's risk-based approach to tissue regulation" (FDA release, 1/18).
Earlier this month, an HHS report found that many U.S. tissue banks have "never been inspected by federal authorities, leaving tissue recipients potentially vulnerable to infection from HIV, hepatitis and other pathogens" (California Healthline, 1/8). The new FDA regulations cover a "broad array" of cells and tissues, including skin, tendons, bone, heart valves and corneas, and encompass tissues that have not been previously subjected to regulation, including reproductive tissues and stem cells derived from "umbilical cord blood and other blood sources." The rules also apply to "novel uses" under development for human cells and tissues, such as the use of "manipulated human cells" to treat viral infections, Parkinson's disease and diabetes. The FDA has proposed two other related rules concerning tissue regulation. A 1999 guideline focuses on donor screening and testing measures for infectious diseases, and a guideline issued Jan. 8 aims to create "good tissue practice standards" for the methods, facilities and controls used to manufacture cellular and
tissue-based products (FDA release, 1/18).
Although the new regulations are part of Shalala's "legacy", the Orange County Register reports that implementation of the rules will fall to Shalala's likely successor Wisconsin Gov. Tommy Thompson (R), who has seen "firsthand" how the industry can be "prone to abuses." Last year, the director of the University of Wisconsin-Madison Hospital organ procurement organization resigned after admitting he accepted more than $86,000 for sending tissue to banks associated with a for-profit company. Sources familiar with the situation said that Thompson "worried the scandal might mar the public's perception of organ donation" (Orange County Register, 1/19).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.