FDA expresses concern about providers who offer abortion medications before pregnancy, reports say

By Jen Christensen, CNN

Although health-care providers are not authorized to offer a medication abortion before a patient gets pregnant, some are doing so, a spokesperson for the US Food and Drug Administration told Politico. The FDA is concerned that the practice could be dangerous.

Medication abortion, also known as medical abortion, is a method by which someone ends their pregnancy by taking two pills, rather than having a surgical procedure. The first pill is mifepristone, sold under the brand names Mifeprex (formerly RU 486) or Korlym. The second pill is misoprostol.

Medication abortion now accounts for more than half of all US abortions, according to the Guttmacher Institute, a research and policy organization focused on sexual and reproductive health.

When mifepristone was approved by the FDA in 2000, it was restricted for use only to end a pregnancy 10 weeks or less after the first day of the person’s last menstrual period.

The FDA told Politico that it was concerned that providers who gave medication for an abortion before they were pregnant wouldn’t be able to properly oversee their patient’s care, including telling how far along the pregnancy is or whether it’s inside the uterus (intrauterine) or outside the uterus (ectopic). Mifepristone’s labeling says it should not be used in cases of ectopic pregnancy.

The FDA did not have a direct response to the report when CNN asked for comment.

“They’re not acknowledging people’s ability to understand their own bodies and know what’s right for them,” said Ushma Upadhyay, a professor in the Department of Obstetrics, Gynecology and Reproductive Science in the University of California, San Francisco’s Bixby Center for Global Reproductive Health.

The FDA’s concern about provider oversight is not based on evidence, Upadhyay said. Some studies she’s worked on have found that people are generally capable of determining how far along they are in their pregnancy. Several other studies have also shown that self-management — proceeding without direct medical supervision — with this kind of medication is safe and effective.

“Patients should also be trusted to know when it is appropriate for them and when it is not to seek help from a provider,” Upadhyay said.

The FDA relaxed certain federal regulations around medication abortion during the Covid-19 pandemic.

Since 2011, mifepristone has been the subject of a type of restricted program the FDA uses to make sure the benefit of certain drugs outweighs any risk.

There are 62 drugs in these programs, including some medications to treat cancer or MS, antipsychotics, opioids and testosterone. These medicines usually have some kind of contraindications, and the program requires a provider to be certified to administer them. For some, the provider must follow a specific plan to educate the patient about how the drug works.

In December, the FDA allowed medication abortion pills to be sent by mail and said it would no longer enforce a rule that required people to get the first of the two pills in person at a clinic or hospital.

Organizations like Choix, a California-based telehealth organization for reproductive and sexual health, have been prescribing mifepristone to people who aren’t pregnant as a way to expand access and to give the patient the power to access care when they need it with the support they deserve, Choix CEO Cindy Adam said.

“Providing abortion care via telehealth, including advance provision, allows us to decrease the multitude of barriers to care that patients face and provides patients peace of mind,” Adam said in an email to CNN. “For some people, the time between finding out they’re pregnant and receiving abortion pills in the mail can be extremely stressful, and presents a range of challenges related to privacy, logistics, finances, their health, and more.”

Someone who uses Choix is counseled on what precautions they need to take when they get the medicine and screened for risk factors like a previous ectopic pregnancy, abdominal surgery or sexually transmitted infection, Adam said. They’re told to seek additional care if they become pregnant and get a referral for in-person care if they need it.

“We’re also proud to offer ongoing, supportive abortion care from our providers as part of our advance provision service to support patients throughout the process,” she said.

Politico said the FDA would not comment on whether it is considering any changes to its restrictions or if it planned to enforce its regulations by fining doctors or companies that prescribe mifepristone in a way that is not approved.

“Providers are fully able to prescribe medications off-label, and in fact, some prescribe mifepristone up to 12 weeks” into a pregnancy, Upadhyay said. “Providers should be able to prescribe this medication as they see fit. This is very safe, very effective.”

Given the current political climate and the significantly restricted access to abortion in the US, Upadhyay said the FDA needs to take more of a public health approach to abortion to make sure people are able to access these medications.

The American College of Obstetricians and Gynecologists has called for the FDA to remove access issues to medication abortion, although the organization has no policy on advanced prescription of these drugs.

“I think that oftentimes, people think that just because the FDA says something means that it’s right,” said Dr. Jen Villavicencio, the organization’s lead for equity transformation. “They are not infallible.”

Villavicencio said “excellent data” shows that the extra steps providers must take are “really inappropriate” based on the safety profile of the drugs.

To prescribe the abortion medication, providers have to be certified, and the patient must sign paperwork that says they understand that there is a risk of complications. These steps serve as a barrier to access, she said, rather than enhancing safety.

“There have been more deaths related to ibuprofen and Tylenol, which are over-the-counter and able to be bought by anybody. There are more deaths related to those over the 22 years since mifepristone has been approved by the FDA that have been attributed to mifepristone or medication abortion,” Villavicencio said.

“That is not evidence-based,” she added. “Mifepristone is one of the safest medications that somebody can take.”

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