New FDA Documents Reveal Abortion Pill RU-486 Made in Substandard Chinese Plant When Approved
WASHINGTON, D.C, October 17, 2007 (LifeSiteNews.com) – Evidence is mounting that the US Food and Drug Administration (FDA) participated in coverups of health and safety violations and breaches of ethics in approving the abortion drug, RU-486, that has caused the death of at least six women in the US.
Yesterday, the public interest group Judicial Watch announced that newly acquired FDA documents, previously withheld by the FDA, show that the agency knew that the facilities owned by China’s Hua Lian Pharmaceutical Company to manufacture RU-486 were sub-standard at the time they were approved for use in August 2000.
The documents further reveal that the clinical trial results used to gain federal approval of the drug were, in at least two cases, published by active members of the abortion lobby. At least one of the trials was conducted by Dr. Suzanne Poppema, President of the National Abortion Federation. Another was performed by Dr. Daniel Mishell, a senior scientist for RU-486’s patent holder, the Population Council.
The documents also reveal that the FDA knowingly participated in the “off label” use of Cytotec, the drug that is used in conjunction with RU-486. The agency helped that drug’s manufacturer, Searle, write a letter protecting the company from legal liability for the unauthorized use of Cytotec.
In July this year, US Congressman Chris Smith (R-New Jersey) cited the failure of Hua Lian to pass FDA safety inspections as he called on the Agency to investigate Danco, a company established in the Cayman Islands solely for the purpose of selling its only product, RU-486, in the United States.
Smith’s call came as Chinese state authorities were recalling stocks of another drug used as an abortifacient, Methotrexate, also manufactured by Hua Lian, a company that has been regularly found in violation of US health regulations.
The head of the Chinese State Food and Drug Administration (SFDA), Zheng Xiaoyu, was found guilty and executed earlier this year on corruption charges, and many of the drugs approved under his administration are being recalled.
Read the FDA documents from Judicial Watch (PDF 6.7 MB)
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Massive Chinese Recalls, but FDA Silent Over RU-486 Chinese Manufacturers
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