Politicized Medicine

FDA approved RU-486 under questionable circumstances, group charges


The approval process of the RU-486 abortion pill faced new charges of political favoritism, poor oversight, and lax production safety standards in a release from Judicial Watch on Tuesday.

Judicial Watch, a public interest group that investigates and prosecutes government corruption, recently received 175 pages of new documents pertaining to the RU-486 abortion pill that had previously been withheld by the Food and Drug Administration.

According to Judicial Watch, the documents confirm that the drug was manufactured by the China-based Hua Lian Pharmaceutical Company at the time of approval.  Hua Lian failed its first FDA inspection and was not in compliance with FDA standards at the time the FDA approved its manufacturing facility in August of 2000.  This is the first official documentation confirming that the drug was manufactured in China. 

The documents also highlight conflicts of interest in the testing of the abortion drug.  One of the drug trials 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,” 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.”

Previous Judicial Watch investigations have revealed serious health complications resulting from the use of the drug, resulting in some calls to recall RU-486 from the market.  Many of the drugs approved under the former head of the Chinese State Food and Drug Administration are being recalled.  The former head was recently convicted on corruption charges and executed.

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