FDA Weighs Oversight of Body Parts Trade

This file photo taken from a May 12, 2005 video image, provided by a source that requested anonymity, shows Philip Joe Guyett Jr., owner of Donor Referral Services of Raleigh, N.C., speaking during an educational seminar at a retirement community in Cary, N.C. Federal officials shut Guyett's body tissue operation down in August 2006, saying his products pose a public health danger. (AP Photo, File) (AP)

A three-month investigation by The Associated Press, published in June, documented the potential risks to the public from this little-regulated industry.

The FDA relies on broad, catchall language for much of its regulation. An industry group, the American Association of Tissue Banks, has more specific and strict rules, but tissue businesses are not required to seek the association's accreditation or comply with its standards.

The FDA's task force will be an internal review involving agency employees _ no outside experts, said Robert Rigney, executive director of the association, who was briefed on the plans.

"We have not been asked to participate, although we would welcome an opportunity," he said.

An FDA spokesman could not immediately say why the task force didn't include anyone from outside the agency.

Earlier this month, the tissue bank association adopted a new rule requiring its members to provide a list of all tissue businesses they work with, including tissue procurers. It also allows the association to inspect and audit those businesses even if they are not association members themselves. The action was recommended by a task force the association formed in the wake of the scandal involving the New Jersey company. That company was not an association member.

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AP medical writer Marilynn Marchione contributed to this report.

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Food and Drug Administration: http://www.fda.gov/