“We generally saw no unsafe or deceptive practices,” said FDA enforcement director David Elder.
The agency hopes to inspect 484 companies by the end of this year, including processing plants, said Dr. Jesse Goodman, director of the FDA’s Center for Biologics Evaluation and Research. “That’s quite an uptick” since 2003-04, when fewer than 300 were inspected both years, he said.
One of the chief complaints about the FDA’s oversight by critics like Sen. Charles E. Schumer, New York Democrat, is that certification and specific training of tissue-recovery operators isn’t required.
“Barbers are required to go to school and pass a test, but someone who does [tissue] recovery doesn’t have to do anything but say where they live,” Miss Kupchyk said. “I think that’s appalling.”
Dr. Witten said the FDA rules require “proper education and training.” Those rules, however, do not spell out what that is.
The issue of who cuts body parts out of cadavers made headlines in late 2005 with the investigation of Biomedical Tissue Services (BTS) of New Jersey, accused of plundering corpses for body parts that were sold as tissues for transplant. Among the plundered bodies was that of Mr. Cooke, the 95-year-old PBS-TV host who died of cancer in New York.
Seven funeral home directors have pleaded guilty, and tens of thousands of body parts removed by BTS were recalled. About 10,000 people are believed to have received tissues from the company.