A cure worse than the disease
When FDA oversight falters, tissue implants can do more harm than good
Ironically, it was fear about transmission of infectious diseases that initially got the FDA interested in the tissue-bank industry. In the early 1990s, HIV was spread through organ and tissue donations to transplant recipients. FDA inspectors also found that tissue from foreign countries that had not been screened for diseases was being sold to U.S. suppliers. In response, the agency required that tissue banks test and screen donors for HIV and hepatitis B and C. The rules allowed the FDA to inspect tissue banks and to recall and destroy tissue that didn't meet the hepatitis and HIV standards.
But the industry was growing rapidly. By last year, as many as 200 organizations--some for profit, others nonprofit--were recovering, processing, and distributing tissue products to hospitals across the country. The FDA left it to the American Association of Tissue Banks, an industry group, to ensure practices that would avoid tissue contamination. The AATB set up a strict accreditation program that involves on-site inspections and a detailed review of operating procedures. The organization hired ex-FDA officials, including one former head of compliance at the FDA's Center for Biologics Evaluation and Review, to conduct inspections and application reviews. Currently, 74 tissue banks are accredited by the AATB.
But participation in the program is voluntary (and costly), and many companies opt not to join in. And the AATB cannot close down tissue banks for selling contaminated products. So, when circumstances appear dire enough, or when cases like Brian Lykins's come to light, the agency invokes its authority to prevent infectious disease. For instance, AlloSource of Centennial, Colo., fully accredited by the AATB, received a lengthy letter from the FDA on July 2 warning of numerous processing deficiencies and record-keeping problems. AlloSource has spent $1 million trying to address the FDA's concerns, a spokesperson said.
Action plan. Back in 1998, the FDA proposed new regulations that would greatly increase its authority over the tissue-bank industry. The "tissue action plan" has three key components: One requires tissue banks to register with the FDA. Another says donors must be screened for disease. The third, and perhaps the most needed, would establish "good tissue practices," akin to the high standards set for the manufacturing of pharmaceuticals. Only the first of these has been put into effect. The others are still open for public comment.
This has irked Sen. Susan Collins no end. "The FDA's action against CryoLife does not solve the underlying problem of a lack of regulation of this entire industry," says the Maine Republican. Since last December, Collins has sent two letters to the FDA urging the agency to set a deadline for putting the new rules into effect. She was told the FDA could not provide a date. "I am extremely frustrated," she says. "It is a case of bureaucratic inertia at its worst." Sen. Richard Durbin, an Illinois Democrat, wrote to the FDA in January 2001, asking the agency to outline the financial resources it would need from congressional appropriators to implement the expanded authority. He has received no response. Says Philip Noguchi, acting director of the FDA's new Office of Cellular Tissue and Gene Therapies, "We recognize that we need to finish this. It's a top priority in the next fiscal year."
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