Judicial Watch Obtains New FDA Documents Re: Abortion Pill RU-486

(Washington, DC) — Judicial Watch, the public interest group that investigates and prosecutes government corruption, announced today that it recently received 175 pages of new documents pertaining to the abortion pill RU-486 that had previously been withheld by the Food and Drug Administration (Judicial Watch, Inc. v. Food and Drug Administration, et al. (on remand 00-2973)). According to the documents uncovered by Judicial Watch:

• Despite the FDA’s refusal to disclose where the abortion pill is manufactured, these documents confirm that the China-based Hua Lian Pharmaceutical Company manufactured RU-486 at the time of approval. This seems to be the first official document confirming that the abortion drug has been manufactured in China.
• The documents indicate that not only did Hua Lian fail its first FDA safety inspection, but that the company was not in compliance with safety requirements at the time the FDA approved the facility for manufacturing on August 15, 2000.
• The documents also show the extent to which the pro-abortion lobby was involved in the approval process. For example, one of the trials used by the FDA to justify its decision was conducted by Dr. Suzanne Poppema, President of the National Abortion Federation. Another trial was performed by Dr. Daniel Mishell, a senior scientist for RU-486’s patent holder, the Population Council.
• RU-486 must be used in conjunction with another drug (Cytotec) that is not approved as an abortifacient. According to FDA internal communications obtained by Judicial Watch, the agency knowingly participated in the “off label” use of Cytotec and helped the drug’s manufacturer, Searle, craft a letter designed to protect the company from legal liability for the unauthorized use of the drug.

“These documents show the reckless and politicized nature of the FDA’s decision to approve the abortion pill,” said Judicial Watch President Tom Fitton. “The FDA certainly has a lot of explaining to do. For starters, why has the FDA previously refused to disclose the Chinese connection and the related safety issues? And why did the FDA allow the abortion lobby to control the clinical trial process? The American people deserve answers.”

Through the Freedom of Information Act and litigation against the FDA, Judicial Watch previously discovered that RU-486 was approved under the “Accelerated Approval of New Drugs for Serious or Life-threatening Illnesses,” a measure that was adopted for use in rare cases to encourage the manufacture and importation of drugs designed to treat life-threatening diseases such as cancer or heart disease. Judicial Watch also uncovered clinical trials and other documents that revealed serious health complications resulting from the use of the drug. These documents resulted in calls to recall RU-486 from the market.

These recently released documents and others pertaining to Judicial Watch’s RU-486 investigation and litigation, and its special report, “The Clinton RU-486 Files,” can be found at www.judicialwatch.org.

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