A copy of all documents, studies and other evidence used to assess the safety and efficacy of the Mifeprex (mifepristone) changes announced on March 30, 2016.ĥ. Governing the use of the abortion drug, Mifeprex (mifepristone) including any review by the Bone, Reproductive and Urologic Drugs Advisory Committee (formerly the Reproductive Health Drugs Advisory Committee.)Ĥ. A timeline of FDA actions associated with Danco's application to loosen standards A list of all applications submitted to the FDA since 2000 by Danco Laboratories, including but not limited to the recently approved application to loosen standards governing the use of the abortion drug, Mifeprex (mifepristone).ģ. The current available data on Adverse Events 1 has only been updated through April 2011.Ģ. A thoroughly updated "Postmarketing Adverse Events Summary" including any reported deaths associated with mifepristone through December 2015. We respectfully request that you provide the following information within a month (no later than May 20, 2016):ġ. In light of this history, we are concerned about the recent changes to the FDA-Approved Regimen and the Risk Evaluation and Mitigation Strategy (REMS) for Mifeprex (mifepristone) announced on March 30, 2016. Finally, the drug was pushed through the approval process in the final months of the Clinton administration. States, abortion proponents created Danco Laboratories for the sole purpose of distributing the abortion drug in the United States. When mainstream drug manufacturers refused to bring this baby-killing drug to the United Then-FDA Commissioner Kessler even urged the European patent-holder, Roussel Uclaf, to submit an application for approval ofmifepristone. At the start of the Clinton Administration, President Clinton issued an Executive Order instructing the FDA to reevaluate the status of the abortion drug. This powerful abortion drug has been associated with serious adverse events including hemorrhaging, severe infections and even deaths of mothers who have taken it.įurthermore, the drug's original approval process was extremely controversial. We are deeply disappointed to learn that you have loosened FDA standards governing use of the abortion drug mifepristone, also referred to as Mifeprex or RU-486.
Smith food and drugs baby formal pdf#
Headquartered in the Cayman Islands, DANCO had the abortion drug manufactured in China and packaged in New Jersey.Ī PDF of the letter is available here, and the full text is below: When mainstream drug manufacturers refused to bring this baby-killing drug to the United States, the Population Council licensed the drug and abortion proponents created a corporation, DANCO, for one purpose and one purpose only: to distribute mifepristone in the United States. Then-FDA Commissioner Kessler even urged the European patent-holder, Roussel Uclaf, to submit an application for approval of mifepristone. At the beginning of the Clinton Administration, Clinton issued an executive order instructing the FDA to re-evaluate the status mifepristone, also known as RU-486.
In the letter the lawmakers seek additional information in light of the controversial origins of the original approval of mifepristone in the United States.
WASHINGTON, DC – Senator James Lankford (R-OK) and Representative Chris Smith (NJ-04) today led a bicameral letter to the US Food and Drug Administration (FDA) to express concern and request information about the agency’s recent decision to change policies regarding the abortion drug mifepristone. Smith Demand Information From FDA About Loosening of Abortion Drug Rules