-- 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
participate in 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.
Contact Information: Contact: Jill Farrell 202-646-5188