FRC urging justices to grill FDA over mifepristone

FRC urging justices to grill FDA over mifepristone

FRC urging justices to grill FDA over mifepristone

Now that a date has been set for the U.S. Supreme Court to hear arguments from the FDA over the abortion pill mifepristone, the Family Research Council is getting involved.

The nation's top court is set to hear arguments March 26. The goal of FRC is to urge the justices to focus on the lack of safeguards now that the abortion drug is becoming more accessible. 

Drugstore giants Walgreens and CVS announced last week they intend to begin providing the drug in their stores in a matter of weeks.

Mifepristone, known by the trade name Mifeprex, can end a pregnancy through seven weeks gestation. It was first approved by the FDA in 2000.

The pill, which breaks down the lining of the uterus, is taken first followed by a second pill, misoprostol, which empties the uterus of the fetus. 

The FRC and post-abortion expert Dr. Martha Shuping have submitted an amicus brief for the Supreme Court on this upcoming case.

“In 2000, when the drug was approved, the original approval was inadequate in terms of the safeguards put in place by the FDA. We’ve never backed off of that,” Chris Gacek, FRC’s senior fellow for regulatory affairs, said on Washington Watch Monday.

Gacek, who led the drafting and arguments of the brief, said Democrat administrations under Barak Obama and now Joe Biden have made it their mission to advance mifepristone. Both administrations did so, he alleges, at the same time they "weakened" medical safeguards that protect the women who take it. 

The Mayo Clinic lists 30 potential side effects. Abdominal pain, back pain, diarrhea, dizziness, headache and nausea are the most common, it says.

"I think the goal is to get it to the point where it’s essentially dispensed at a pharmacy without any supervision," Gacek said. "So like Walgreens and CVS are probably going to be giving it out in their clinics, where you go and meet someone there, and you have to sign some forms." 

Doctors have been removed from the process. It’s also not required that the drugs be taken in the presence of the prescriber.

“That allows the possibility that the pills can be used in other ways,” Gacek said.

The National Institutes of Health in 2016 said that requiring physicians to dispense Mifepristone was an unnecessary limit on safety and access to medical abortion.

Gacek, Chris Gacek

The FRC and Shuping disagree. 

 FRC research predicts thousands of women may make emergency room visits associated with mifepristone usage.

In addition to the absence of supervision, the FDA also no longer requires non-fatal adverse event reporting.

“In other words, if you had a really bad reaction but didn’t die, you didn’t have to report it," Gacek warned. "The FDA was just covering its own tracks in this thing. It’s really horrible."