FDA finalizes human tissue, cell donor rule

In an effort to tighten the regulation of transplanted tissue and cells such as skin or reproductive material, the Food and Drug Administration announced its final rule on donor eligibility last month.

The rule requires testing and screening for communicable diseases and excludes donors based on the actual presence of an infectious agent. Donors also are excluded for behavioral risk factors that would put them at higher risk for disease, such as injection drug use. But reproductive tissue from donors who are intimate or otherwise known by the recipient are exempt.

Overall, the FDA's system is much like the one used to keep the blood supply safe.

"Transplanted human tissues and cells have the potential to treat or cure a wide range of health conditions," said acting FDA Commissioner Lester M. Crawford, DVM, PhD. "Our comprehensive approach helps make these novel products as safe as possible while still encouraging innovation."

Infections from tissue transplantation are unusual, but the industry has come under increasing scrutiny because of several high-profile adverse events, including the 2001 death of a 23-year-old college student after knee surgery. Also that year, a report by the Health and Human Services Office of Inspector General found that the industry was poorly policed by the FDA. To improve regulation, the agency has expanded inspections, created a database of all tissue banks and launched an Office of Cellular, Tissue and Gene Therapies.

Industry insiders praised the recent activity but said many banks already had taken steps similar to those proposed by the FDA.

"What this is doing is formalizing practices that have been in existence for years and adding some more detail, some more mechanisms, some more definitions and some tighter regulatory schemes," said Bob Rigney, CEO of the American Assn. of Tissue Banks, a group that represents about three-quarters of the industry.