Chairman Collins to FDA: Why Haven’t Much-Needed Tissue Bank Regulations Been Issued?

WASHINGTON, D.C.—Senate Governmental Affairs Committee Chairman Susan Collins (R-ME) today demanded that the Food and Drug Administration (FDA) produce information related to its proposed regulations governing tissue banks, regulations that the FDA has yet to finalize.

“This is an issue of longstanding interest—and frustration—to me,” Collins wrote in her letter to the FDA. “For more than two years, I have pressed the FDA to act on an issue that it first identified as a public health risk some six years ago.”

In May 2001, following an investigation conducted by the Permanent Subcommittee on Investigations, then chaired by Collins, the FDA claimed at a committee hearing that it was “committed” to establishing a regulatory framework that would help ensure the safe use of human tissue for transplantation. Since that time, and after repeated requests from Collins for more information and a timeline for issuing the regulations, the FDA and Health and Human Services Secretary Thompson stated that the regulations would be published by early 2003. In July 2003, the FDA acknowledged that it did not have “a precise target date for publication of the final rules.”

“The repeated delays, combined with the FDA’s failure to articulate a coherent rationale for its inaction, are baffling and unacceptable,” wrote Collins.

Specifically, Collins is seeking records related to the promulgation of the two rules that have not been finalized—“Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products; Inspection and Enforcement” (66 Fed. Reg. 1508) and “Suitability Determination for Donors of Human Cellular and Tissue-Based Products” (64 Fed. Reg. 52696), and the one rule that was issued, “Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P)—Registered Establishments,” as a point of comparison. Collins has asked for documents that should show why the FDA refuses to issue these two important rules.

In 1997, the FDA acknowledged the health risks involved with tissue transplants and the need for better federal oversight of the industry. Similar to blood transfusions and organ transplants, tissue transplants can transmit communicable diseases such as HIV and hepatitis. Unlike the government’s stringent oversight of the nation’s blood banks and organ donor programs, there are scant federal regulations governing how transplant tissues are processed and distributed.