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FDA to study oversight of body parts industry

/ Source: The Associated Press

The second body parts scandal in a year has federal health officials asking if they need to strengthen their oversight of the trade in human tissues and organs.

The Food and Drug Administration said Wednesday it has formed a task force to study its regulation of the industry, including the effectiveness of new rules implemented just last year. Since then, investigators have discovered at least two companies that collected human body parts for medical use without following federal guidelines.

“The primary goal of the new task force is to identify whether any additional steps are needed to further protect the public health while assuring the availability of safe products,” said Dr. Jesse Goodman, director of the FDA center that oversees human tissue.

Earlier this month, the FDA shut down Donor Referral Services of Raleigh, N.C., saying the company had “serious deficiencies” in its processing, donor screening and record-keeping. The FDA said the records on at least five donors did not match their death certificates, some of which listed cancer and drug use that might have made them ineligible as tissue sources. Company owner Philip Guyett has denied any wrongdoing.

The closure came after Biomedical Tissue Services, a now-defunct New Jersey company, was accused of failing to gain consent to take bones, tendons, ligaments, skin and other tissue from cadavers. The company’s owner and three others have pleaded not guilty to the charges against them.

Most tissue companies follow the law, the FDA said. But the regulatory agency wants to study whether it needs to step up its oversight to ensure all companies act to protect recipients of donated tissue from communicable diseases.

Improper testing or treatment of donated tissues can lead to infections like hepatitis.

Donated cadaver tissue is used in more than 1.3 million medical procedures a year, ranging from knee repairs and spine surgeries to burn care and even dental work.

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.