House members write FDA to warn against relaxing restrictions on the use of the abortifacient mifepristone

By Dave Andrusko

Fifty-three members of the House of Representatives have sent a letter to the FDA warning against acceding to Planned Parenthood’s request to remove restrictions on the use of the abortifacient, mifepristone, the first of two drugs that make up “medication [chemical] abortions” technique.

There is added urgency not only because of pressure from Planned Parenthood and other pro-abortion officials, but also because the FDA has approved a generic version of mifepristone marked by GenBioPro. Previously, mifepristone has only been marketed by Danco under the brand named Mifeprex.

As NRL News Today has written in dozens of posts and the 53 Members of the House highlighted in their letter to Norman Sharpless, M.D., FDA’s Acting Commissioner, “The use of mifepristone as a method to kill unborn babies has increased despite its proven health risks to women, and we are concerned that having this drug more readily available will have deeply troubling results.”

The object in Planned Parenthood’s cross-hairs is the requirement that mifepristone is subject to a Risk Evaluation and Mitigation Strategy. REMS are imposed by the Food and Drug Administration “for medications with seriously health concerns.”

Anna North, writing for Vox explained, “Under the REMS, the drug can’t be dispensed at a pharmacy like other medications (including its counterpart, misoprostol). It can only be provided by a doctor or other clinician who has gone through a special certification process.”

Planned Parenthood, of course, ignores all the evidence of thousands of complications and at least 24 deaths (just in the U.S.) in their haste to expand its use and eliminate the REMS for mifepristone. Here’s more from North’s story:

Abortion-rights advocates agree that the FDA requirements could limit the impact the GenBioPro pill will have. “While the generic form of mifepristone is important and long overdue, the real barrier to accessing medication abortion, especially for those living in rural and medically underserved areas, is the FDA’s unnecessary restrictions on how mifepristone is dispensed,” said June Gupta, director of medical standards at Planned Parenthood Federation of America, in a statement to Vox.

But the letter from the 53 Members of the House makes clear

“We vigorously opposed calls by Planned Parenthood and other pro-abortion advocates to remove the REMS for mifepristone. Allowing the drug to be available without medical supervision will have dire consequences for women and children.”

Here is the section of the letter that outlines the dangers and is very important to read:

According to one study, women who have chemical abortions experience roughly four times the rate of adverse events as women whose babies are surgically aborted. Although complete data is not available, the FDA reports the rate of adverse events that, since mifepristone was first approved on September 28, 2000, twenty-four women have died and thousands of women have experienced adverse events. These include hospitalization, blood loss requiring a transfusion, severe or fatal infection, or ruptured ectopic pregnancies.

Even though the REMS requires a provider who dispenses mifepristone to test for ectopic pregnancy, the FDA reports that at least 97 women with ectopic pregnancies have been given mifepristone; at least two women died from ruptured ectopic pregnancy. According to one study, an incomplete abortion can happen at least up to 10 percent of the time during chemical abortions and the risk increases after the 9th week of pregnancy.

The lawmakers have asked for a meeting with Acting FDA Commissioner Sharpless to discuss the matter further by October 1.