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FDA Steps Up Oversight of Body Parts Companies
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Page: << Prev | 1 | 2 | 3 | Next >> To date the FDA has inspected 153 major human tissue recovery firms and plans on inspecting an additional 300 companies, Elder said. "What our investigators found was encouraging for tissue safety," he said during the teleconference. "Although we identified some deviations from regulations, we generally saw no unsafe or deceptive practices that could put tissue recipients at risk for disease."
The biggest company involved in illegally harvesting body parts was Biomedical Tissue Services of New Jersey. The company faces trial, along with a former New York state funeral home director, on charges they stole bodies and dissected them unlawfully, the Associated Press reported.
In addition, seven funeral home directors have already pleaded guilty and tens of thousands of body parts removed by the company have been recalled. About 10,000 people are believed to have received tissues from the company, according to the AP.
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The FDA task force is also recommending:
- Increased education and outreach. The FDA should sponsor a workshop on tissue processing and microbiology for industry, surgeons and academics, to develop and share best practices for reducing the risk of disease transmission.
- Research regulations and guidance. In September 2006, the FDA issued a "guidance document" that emphasized responsibilities for ensuring tissue safety between establishments and their contractors. The FDA will issue guidance on "current good tissue practices" to encourage tissue manufacturers to seek the best methods to further reduce the risk of infection transmission.
The FDA's Center for Biologics Evaluation and Research has strengthened its collaboration with the U.S. Centers for Disease Control and Prevention, to oversee tissue-safety surveillance and adverse reaction investigations, according to the report.
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Copyright © 2007 ScoutNews, LLC. All rights reserved.
Last updated 6/12/2007
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SOURCES: June 12, 2007, teleconference with Celia Witten, M.D., Ph.D., director, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration; David Elder, director, Office of Enforcement, Office of Regulatory Affairs, U.S. Food and Drug Administration; Associated Press; June 12, 2007, prepared statement, Sen. Charles Schumer, D-N.Y.
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