Congressmen Question FDA on Loosening of Abortion-Inducing Drug Standards

Lauretta Brown | April 26, 2016 | 4:53pm EDT
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RU-46 (AP Photo)

( – Rep. Chris Smith (R-N.J.) and Sen. James Lankford (R-Okla.) sent a letter Monday, together with 73 of their colleagues to Food and Drug Administration (FDA) Commissioner Robert Califf, expressing concern and seeking information regarding the recent loosening of regulation of the abortion-inducing drug Mifeprex or RU-486.

The FDA announced a change in their guidelines for Mifeprex in March. The new guidelines reduce the dosage from 600 milligrams to 200 milligrams, decrease the number of required doctor’s visits from three to two, and allow the pill to be taken later in pregnancy, at 10 weeks of pregnancy from 7 weeks.

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

“The Obama Administration’s gift to the abortion industry disregards the safety and lives of women. Not only is mifepristone used to kill babies, it is a poison that has harmed and even killed women.” Rep. Chris Smith told

“Yet even with this record, in the last months of his term, President Obama has bowed to pressure from his abortion cronies and has further expanded the use of the abortion pill, putting the health and lives of even more women and children at risk,” Smith added. “Abortion advocates are celebrating FDA’s expansion of ‘medication abortion,’ but women who have suffered the trauma of a mifepristone abortion know that it is not ‘medication’– this chemical poison is not designed to heal, or cure, or mitigate pain.”

The letter pointed out that the original approval process for the drug 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,” the letter stated.

“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,” according to the letter. “Finally, the drug was pushed through the approval process in the final months of the Clinton administration.”

The congressmen said that in light of the pill’s history, they 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.”

The letter requested more information regarding the drug and its adverse effects no later than May 20, 2016, including “any reported deaths associated with mifepristone through December 2015” since “current available data on Adverse Events has only been updated through April 2011.”

The letter also requested that the FDA Commissioner provide “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” and “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.’”

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