by Steven Ertelt
October 18, 2007
Washington, DC (LifeNews.com) — A public interest group has obtained copies of Food and Drug Administration records showing that agency knew the dangerous abortion drug RU 486 was made in China before it was approved for use in the U.S. at the end of the Clinton administration. The drug has killed several women in the U.S. and more than a dozen worldwide.
Judicial Watch told LifeNews.com it has obtained 175 pages of new documents pertaining to the abortion pill that had previously been withheld by the FDA.
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 group said.
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.
"These documents show the reckless and politicized nature of the FDA’s decision to approve the abortion pill," Judicial Watch President Tom Fitton told LifeNews.com.
"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?" he asked.
"And why did the FDA allow the abortion lobby to participate in the clinical trial process? The American people deserve answers," Fitton said.
Meanwhile, RU 486 must be used in conjunction with another drug (Cytotec) that is not approved for abortions and is normally for treating ulcers.
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.
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."
That is a system 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.