The country’s top health official said Monday during a visit to Georgia that he will be “vigorous” in defending the availability of a key drug after a court ruling threatened access to the most commonly used method of abortion in the U.S.
“We’re going to be vigorous in defending the Food and Drug Administration’s approval process,” Xavier Becerra, U.S. Department of Health and Human Services Secretary, told reporters after a Monday event with U.S. Sen. Jon Ossoff in Norcross. “We don’t believe it is in anyone’s interest to have the sound, tested, proven approval process that FDA goes through before it lets any drug on the market be overturned, and be turned upside down.”
Becerra’s remarks came the same day the Justice Department urged an appeals court to reject a Texas court ruling that would reverse the longstanding approval of mifepristone. The filing described the Texas judge’s ruling imperiling access to a drug widely available for decades as “extraordinary and unprecedented.” Becerra stressed that for now women still have access to mifepristone.
Becerra’s comments came following a panel discussion with Ossoff to promote a newly enacted law that lowers the cost of some prescription drugs. Meanwhile, in Atlanta, FDA Commissioner Robert Califf said the science that supported the drug’s approval hasn’t changed.
Califf was attending a conference, and spoke to reporters at a hotel next to Centennial Olympic Park. His visit was scheduled before two contradictory court rulings came down on Friday, and he declined to directly comment due to the ongoing litigation.
“We made a decision 23 years ago. I obviously wasn’t there,” Califf said of his position at the FDA, but “the decision was made and we stand by it.”
U.S. District Judge Matthew Kacsmaryk, a Donald Trump appointee, issued his decision to invalidate FDA’s approval of the drug on Friday but ruled it wouldn’t take effect for seven days.
Mifepristone is one of two drugs used in medication abortions and was approved in 2000 by the FDA, which is overseen by the Health and Human Services Department headed by Becerra. The Texas decision came at nearly the same time that U.S. District Judge Thomas O. Rice, an appointee of Barack Obama, essentially ordered the opposite.
He directed U.S. authorities not to make any changes that would restrict access to the drug in at least 17 states where Democrats sued in an effort to protect availability. The confusion surrounding the conflicting decisions will likely put the issue on the front burner for the Supreme Court.
In 2019, Georgia passed a law that bans most abortions once a doctor can detect fetal cardiac activity, typically about six weeks into a pregnancy. The Georgia Supreme Court will soon decide whether that abortion law should remain in effect — or if it was illegal from the start.
It’s unclear how last week’s court rulings could potentially impact Georgians who are seeking a medical abortion, and are legally allowed to do so. Right now, Georgia patients are required to undergo an ultrasound exam with a physician before obtaining a prescription for abortion medicine.
Becerra called the Texas judge’s decision “extreme,” and said he is confident the Biden administration will prevail in court. There is essentially no precedent for a lone judge overruling the FDA’s medical decisions.
“That’s FDA’s charge — to make sure that no drug is on the market unless it is safe and effective. That’s what they did with mifepristone more than 20 years ago. And then to have one judge in one court in one state say for everyone in America, ‘No.’ That’s extreme.”
Mifepristone has been widely used in the U.S. since it was approved by the FDA. For medication abortions in the U.S., mifepristone is used in conjunction with a second drug —misoprostol — to end a pregnancy.
Credit: Natrice Miller / Natrice.Miller@ajc.com
Credit: Natrice Miller / Natrice.Miller@ajc.com
“Mifepristone is still legal for use. Mifepristone is still available today. And we are going to do everything we can within the legal process to ensure that that doesn’t change,” said Becerra, adding: “One way or the other, the president’s made the commitment. We’re going to use every available resource to protect a woman’s right to reproductive health.”
If the New Orleans-based federal appeals court upholds Kacsmaryk’s ruling, it’s uncertain how the two conflicting court orders could play out. Such a situation could increase pressure on the Biden administration to tell the FDA to ignore Kacsmaryk’s decision.
According to KFF (Kaiser Family Foundation), a nonprofit organization providing information on health issues to the nation, it is too soon to tell what the impact of the conflicting court rulings will be on the availability of medication abortion. The FDA approves drugs for the whole country and does not vary its approval by state.
If the FDA is forced to suspend its approval of mifepristone, some clinics may respond to this ruling by switching from the two-drug mifepristone-misoprostol regimen to using a higher dose of misoprostol alone.
-- Staff writer Ariel Hart and the Associated Press contributed to this report.
HOW DO ABORTION DRUGS WORK?
A medication abortion differs from a surgical abortion in that it is achieved with the use of drugs. In the U.S., a medication abortion is typically done in two steps: A patient first takes one mifepristone pill, which terminates the pregnancy. About 24 hours later, the patient takes a four-pill dose of misoprostol to soften the cervix and prompt contractions that expel the embryo or fetus.
Mifepristone is taken first, swallowed by mouth. The drug dilates the cervix and blocks the effects of the hormone progesterone, which is needed to sustain a pregnancy.
Misoprostol is taken 24 to 48 hours later. The pill causes the uterus to cramp and contract, causing bleeding and expelling pregnancy tissue.
While the two-drug combination is slightly more effective, misoprostol is sometimes used alone for abortions. That practice is more common in countries where mifepristone is banned, but U.S. clinics are preparing to switch to the single drug if the lawsuit prevails.
Source: The Associated Press
