WASHINGTON – A piece of fruit coming into the United States is more likely to get government attention than a ligament or heart valve taken from a cadaver and destined for transplant.
While demand for donor tissue is booming, government inspections have fallen. In 2001, the Food and Drug Administration inspected 1 in 3 registered tissue companies; now it is 1 in 8. Over the same period, the tissue enforcement staff has shrunk from 252 to 227.
Meanwhile, the list of companies or individuals handling tissue has quintupled in that time frame from 406 to 2,030.
"Anytime you've got a growing industry with high profits to be made and the cops are not on the beat and they know it, it opens the door to mischief," said William Hubbard, an FDA associate commissioner from 1991-2005.
The Bush Administration's proposed budget for the FDA warns of dire consequences if it doesn't get an extra $2.5 million and more inspectors: "Without this initiative, the American public risks an increase in preventable transmission of new and emerging infectious diseases."
With limited resources, the FDA targets companies it views as most risky to patients' health — those that are high-volume and less reputable. FDA spokeswoman Julie Zawisza called it "the smartest way to do inspections."
But the agency didn't jump on the signs it saw at Biomedical Tissue Services in 2003. An inspector found problems with the way the New Jersey company kept records on how it disposed of "unsuitable" tissue. After BTS' chief promised the problems had been fixed, the FDA said it would verify that "during our next inspection."
The next inspection came too late — after investigators found evidence the firm was shipping out thousands of unsuitable body parts with faked health records.
"FDA used to have a presence so that people thought, 'We ought to follow the rules because you know they'll be back,'" said Hubbard. "Now they know we're not likely to come the first time."
U.S. Rep. Frank Pallone (news, bio, voting record), D-N.J., has co-authored a bill to regulate tissue banks further. "I don't think there's much protection (for consumers) because there really isn't much government involvement ... It's a crisis."
FDA officials contend tissues are adequately safe, tested and free of disease because of new flexible rules that went into force a year ago. Zawisza said the agency can't prevent "bad people" from breaking the law.
She and others point to the guidelines of the industry trade group, the American Association of Tissue Banks. But those guidelines are voluntary and the scandalized New Jersey company wasn't a member of that group.
James Forsell, the president of the tissue bank association, says the organization tries to keep the industry clean "through peer pressure."
"We don't have the ability to force anybody to do it," he said.