EXECUTIVE SUMMARY

The risk evaluation and mitigation strategy (REMS) restriction on mifepristone has been burdensome for providers and patients, researchers noted.

  • Mifepristone has been shown to be safe and effective, while drugs under REMS restriction are supposed to be risky.
  • The REMS restriction exacerbates the stigma around abortion care, which already disproportionately affects communities of color and young people.
  • Since the pandemic, the FDA has begun to ease REMS restrictions, which will help advance equity to timely healthcare and increase the number of providers willing to provide medication abortion care.

There is no medical reason mifepristone should carry the risk evaluation and mitigation strategy (REMS) restriction, according to the authors of recent paper.1

The commentary explains that REMS restrictions are supposed to be reserved for medications that are risky, such as opioids and other drugs that are addictive, says Jenny Ma, JD, MA, co-author of the commentary, senior staff attorney at the Center for Reproductive Rights, lecturer in law at Columbia Law School, and lecturer for the Sexuality and Gender Law Clinic in New York City.

Since 2004, mifepristone for abortion care in the first 10 weeks of pregnancy has been restricted by the FDA. “Mifepristone cannot be picked up in a pharmacy,” Ma says. “You have to go to a certified healthcare provider and pick up the medication in person. Under the REMS, the provider has to be registered with the drug manufacturer.”

This process is burdensome for providers, who have a lot of upfront costs and time constraints. “This drug is effective and safe. There are mountains of data on this,” Ma adds.

It does not make sense for providers to encounter so many barriers to giving the pill to patients, she says.

“Because of the REMS and these restrictions, mifepristone is only available to certain providers, including those who want to be certified and have a system in place to allay some of these burdens,” Ma explains. All of this means it is difficult for patients to access mifepristone, she adds.

Advocates and others who want the FDA to lift the REMS from prescribing mifepristone have seen some positive movement in that direction during the COVID-19 pandemic. The FDA decided there is no reason to require a person to visit a clinic to pick up the pill from their healthcare provider when they could obtain the pill safely through a mail order, just as they would with other drugs, Ma explains.

In May, the FDA said that it would undertake a full review of mifepristone restrictions. “That’s incredibly exciting,” Ma says.

The easing of restrictions during the pandemic is sensible because there are no scientific or medical reasons to require people to visit a clinic to take mifepristone home. “Of more than 20,000 FDA-approved drugs, mifepristone is the only one the FDA requires people to pick up in a clinical setting, even though they don’t have to take it under clinical supervision,” Ma notes. The FDA’s announcement that it would review REMS for mifepristone is a positive sign, she adds.

State governments have continued to hinder access to abortion and miscarriage management, disproportionately affecting communities of color and young people. “We contend in our article that lifting the REMS is key to advancing equity to access to timely healthcare,” she says. “When you look at who accesses abortion care in this country, 75% of those who access it are low-income, and six out of 10 are Black, Indigenous, or people of color.”

Placing the REMS layer on top of existing barriers exacerbates discriminatory practices and creates a punitive landscape of abortion care, which is already heavily stigmatized. “The burdens land on communities that already have trouble accessing healthcare,” Ma notes.

Lifting REMS would be a huge step in improving access for reproductive health patients. “In the pandemic, from our clients alone (and we represent individual abortion care providers), we have seen the impact this has made where state law allows,” she explains. “The idea that people don’t have to come pick up pills unnecessarily when they can be mailed to their home is incredible.”

Even if REMS is eliminated for mifepristone, it will not mean that all barriers to the medication are gone. There are many different state laws that restrict access to this type of care. For instance, some states make an ultrasound and/or counseling mandatory before an abortion. Some states require abortion care patients to be counseled with debunked information, such as a correlation between abortion and oppression, or abortion and breast cancer.

“Lifting REMS on mifepristone would make it less of a barrier. But, unfortunately, it wouldn’t be as seamless in those [abortion-restrictive] parts of the country, as in other areas where such state laws are not in place,” Ma adds.

If REMS is lifted for mifepristone, it would have a huge effect on family planning clinic providers. “You wouldn’t have to be certified anymore; you could have 10 pills in your small doctor’s office,” she explains. “If your patient is experiencing a miscarriage or desires an abortion, then you can provide this type of care without sending them to a different provider, as is currently happening in various places because of the burden of being certified.”

Lifting REMS would increase the number of providers willing to provide medication abortion care. “If REMS is lifted, patients can pick these up like any other pills at a pharmacy and they can be mailed like any other medication,” Ma says.

Also, providers could implement more flexible delivery models, especially in areas with healthcare access issues, she says.

Mifepristone is only available to patients for a limited window of time. Sometimes, the barriers of patients living hundreds of miles from a clinic severely affect their ability to use the abortion drug.

“Sometimes multiple weeks go by before a person can make it back to the clinic, and a lot of things happen in their lives,” Ma explains. “Lifting REMS would be a huge step forward.”

REFERENCE

  1. Thompson A, Singh D, Ghorashi AR, et al. The disproportionate burdens of the mifepristone REMS. Contraception 2021;104:16-19.