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Sen. Lankford and Rep. Smith Demand Information From FDA About Loosening of Abortion Drug Rules

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. The letter was joined by 73 lawmakers.

In the letter the lawmakers seek additional information in light of the controversial origins of the original approval of mifepristone in the United States. 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. Then-FDA Commissioner Kessler even urged the European patent-holder, Roussel Uclaf, to submit an application for approval of mifepristone. 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. Headquartered in the Cayman Islands, DANCO had the abortion drug manufactured in China and packaged in New Jersey.

A PDF of the letter is available here, and the full text is below:

Dr. Robert M. Califf, M.D. Commissioner

Food and Drug Administration  (FDA)

10903 New Hampshire Ave

Silver Spring, MD 20993

Dear Commissioner  Califf,

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.  This powerful abortion drug has been associated with serious adverse events including hemorrhaging, severe infections and even deaths of mothers who have taken it.

Furthermore, the drug’s  original approval process was extremely controversial.   At the start of the Clinton Administration,  President Clinton issued an Executive Order instructing the FDA to reevaluate the status of the abortion drug.  Then-FDA Commissioner  Kessler even urged the European patent-holder,  Roussel Uclaf, to submit an application for approval ofmifepristone. When mainstream drug manufacturers refused to bring this baby-killing drug to the United

States, abortion proponents created Danco Laboratories for the sole purpose of distributing the abortion drug in the United States.  Finally, the drug was pushed through the approval process in the final months of the Clinton administration. 

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. We respectfully request that you provide the following information within a month (no later than May 20, 2016):

1.  A thoroughly updated “Postmarketing Adverse Events Summary” including any reported deaths associated with mifepristone through December 2015.  The current available data on Adverse Events 1 has only been updated through April 2011.

2.   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).

3.   A timeline of FDA actions associated with Danco’s  application to loosen standards

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.)

4.   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.

5.   A copy of any transcripts or notes from consideration  of Danco applications  by the Bone, Reproductive and Urologic Drugs Advisory Committee.

6.   The locations where mifepristone  is manufactured  and/or packaged and a list of all FDA safety reviews of these locations in the past 15 years including any site visits conducted by the FDA or at the request of the FDA.

7.   A copy of all communications between you, or any member of the FDA staff, and the White House and/or the Office of the Secretary of HHS, regarding mifepristone, Mifeprex, RU-486 or “medication  abortion.”

8.   A copy of all communications between you, or any member of the FDA staff, and any nongovernmental  entity (such as Planned Parenthood,  ACOG, Gynuity) regarding mifpristone. 

Thank you for your prompt response to these requests within a month (no later than May 20, 2016).  In addition please provide documents as they become available, rather than holding all responses until all documents are collected. If you have any questions about this request, please contact Autumn Christensen with Rep. Chris Smith at 202-225-3765. 

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