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Sen. Cruz, Others Hammer FDA on Relaxed Standards for Abortion Drug

75 members of Congress demand answers from FDA Commissioner

April 26, 2016

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202-228-7561

WASHINGTON, D.C. – U.S. Sen. Ted Cruz (R-Texas) on Monday joined 74 members of Congress in sending a bicameral letter to Food and Drug Administration (FDA) Commissioner Robert Califf, expressing serious concerns about the FDA’s decision to loosen standards governing use of the abortion drug mifepristone and demanding answers regarding the recent changes.

“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,” the letter states. “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.

 “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.”

In addition to Sen. Cruz, the following members of Congress also signed onto the letter: Sen. Roy Blunt (R-Mo.), Sen. Steve Daines (R-Mont.), Sen. Joni Ernst (R-Iowa), Sen. James Lankford (R-Okla.), Sen. Mike Lee (R-Utah), Sen. Jerry Moran (R-Kan.), Sen. James Risch (R-Idaho), Sen. David Vitter (R-La.), Rep. Rick Allen (R-Ga.), Rep. Brian Babin (R-Texas), Rep. Dan Benishek (R-Mich.), Rep. Diane Black (R-Tenn.), Rep. Charles Boustany (R-La.), Rep. Kevin Brady (R-Texas), Rep. Dave Brat (R-Va.), Rep. Earl ‘Buddy’ Carter (R-Ga.), Rep. Steve Chabot (R-Ohio), Rep. Tom Cole (R-Okla.), Rep. Sean Duffy (R-Wis.), Rep. Jeff Duncan (R-S.C.), Rep. Blake Farenthold (R-Texas), Rep. John Fleming (R-La.), Rep. Bill Flores (R-Texas), Rep. Randy Forbes (R-Va.), Rep. Jeff Fortenberry (R-Neb.), Rep. Virginia Foxx (R-N.C.), Rep. Trent Franks (R-Ariz.), Rep. Bob Gibbs (R-Ohio), Rep. Bob Goodlatte (R-Va.), Rep. Gregg Harper (R-Miss.), Rep. Vicky Hartzler (R-Mo.), Rep. Jeb Hensarling (R-Texas), Rep. Jody Hice (R-Ga.), Rep. Richard Hudson (R-N.C.), Rep. Tim Huelskamp (R-Kan.), Rep. Bill Huizenga (R-Mich.), Rep. Bill Johnson (R-Ohio), Rep. Sam Johnson (R-Texas), Rep. Walter Jones (R-N.C.), Rep. David Joyce (R-Ohio), Rep. Mike Kelly (R-Pa.), Rep. Trent Kelly (R-Miss.), Rep. Steve King (R-Iowa), Rep. Doug LaMalfa (R-Calif.), Rep. Doug Lamborn (R-Colo.), Rep. Daniel Lipinski (D-Ill.), Rep. Barry Loudermilk (R-Ga.), Rep. Blaine Luetkemeyer (R-Mo.), Rep. Mark Meadows (R-N.C.), Rep. Jeff Miller (R-Fla.), Rep. Alex Mooney (R-W.Va.), Rep. Markwayne Mullin (R-Okla.), Rep. Tim Murphy (R-Pa.), Rep. Randy Neugebauer (R-Texas), Rep. Pete Olson (R-Texas), Rep. Steve Pearce (R-N.M.), Rep. Robert Pittenger (R-N.C.), Rep. Joe Pitts (R-Pa.), Rep. Mike Pompeo (R-Kan.), Rep. John Ratcliffe (R-Texas), Rep. Phil Roe (R-Tenn.), Rep. Todd Rokita (R-Ind.), Rep. Keith Rothfus (R-Pa.), Rep. David Rouzer (R-N.C.), Rep. Steve Russell (R-Okla.), Rep. Matt Salmon (R-Ariz.), Rep. Chris Smith (R-N.J.), Rep. Chris Stewart (R-Utah), Rep. Ann Wagner (R-Mo.), Rep. Tim Walberg (R-Mich.), Rep. Mark Walker (R-N.C.), Rep. Randy Weber (R-Texas), Rep. Daniel Webster (R-Fla.), and Rep. Kevin Yoder (R-Kan.).

Read the letter in its entirety here and below:

April 25, 2016

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 of mifepristone. 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 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 mifepristone, Mifeprex, RU-486 or “medication abortion.”

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.

Sincerely,

Representative Chris Smith
Senator James Lankford
Senator Roy Blunt
Senator Ted Cruz
Senator Mike Lee
Senator Jerry Moran
Senator David Vitter
Senator James Risch
Senator Joni Ernst
Senator Steve Daines
Representative Diane Black
Representative Virginia Foxx
Representative Vicky Hartzler
Representative Ann Wagner
Representative Kevin Brady
Representative Tom Cole
Representative Daniel Lipinski
Representative Tim Murphy
Representative Tim Walberg
Representative Randy Forbes
Representative Pete Olson
Representative Sean Duffy
Representative Todd Rokita
Representative John Fleming
Representative Steve King
Representative Jeb Hensarling
Representative Sam Johnson
Representative Bob Goodlatte
Representative Walter Jones
Representative Matt Salmon
Representative Steve Chabot
Representative Doug Lamborn
Representative Steve Pearce
Representative Trent Franks
Representative Blaine Luetkemeyer
Representative Barry Loudermilk
Representative Jeff Duncan
Representative Steve Russell
Representative Robert Pittenger
Representative Gregg Harper
Representative Brian Babin
Representative Doug LaMalfa
Representative Jeff Miller
Representative Phil Roe
Representative David Rouzer
Representative Richard Hudson
Representative Earl ‘Buddy’ Carter
Representative Randy Weber
Representative Rick Allen
Representative Dan Benishek
Representative Mark Meadows
Representative Blake Farenthold
Representative Bill Flores
Representative Daniel Webster
Representative Tim Huelskamp
Representative Markwayne Mullin
Representative Keith Rothfus
Representative Bill Huizenga
Representative Alex Mooney
Representative Randy Neugebauer
Representative Trent Kelly
Representative Charles Boustany
Representative Jeff Fortenberry
Representative Bill Johnson
Representative Kevin Yoder
Representative Mark Walker
Representative Chris Stewart
Representative John Ratcliffe
Representative Bob Gibbs
Representative Dave Brat
Representative Mike Pompeo
Representative David Joyce
Representative Jody Hice
Representative Mike Kelly
Representative Joe Pitts

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