Rep. Diana DeGette Op-Ed: 20 years later, the FDA must lift restrictions on medication abortion care
Over the years, there have been numerous challenges in the way the United States has approached reproductive health. We rely on our public health institutions to make decisions using the best data to get the best outcomes. Twenty years ago, the Food and Drug Administration (FDA) approved mifepristone, the pill for medication abortion with numerous restrictions on who could prescribe the medication, where it could be taken and where it could be dispensed.
Now, 20 years later, medication abortion care has been used by more than 4 million women and has proven to be a safe and effective option to end an early pregnancy. Mifepristone has long had the potential to transform health care access — yet, the same restrictions the FDA first placed on medication abortion needlessly remain in place to this day. This must change.
On this year’s anniversary of the FDA’s approval of mifepristone, we face a pandemic that has strained our health care system, restricted travel, and necessitated physical distancing — all of which could make doctors’ visits and getting to an abortion clinic more difficult. We know that this disproportionately impacts low-income women and women of color. With nearly all health services becoming available remotely through telehealth during the pandemic, it’s crucial for people to also have timely access to medication abortion care and the ability to meet with their providers over the phone or on video.
The Trump administration is fighting hard to keep in place the onerous, outdated restrictions on medication abortion care. Through 20 years of use and research, all evidence indicates the medication is safe, with a 99 percent safety rate. Yet they have appealed to the Supreme Court to make it more difficult to provide medication abortion care during the pandemic — endangering the well-being of patients and health care providers alike.
Removing barriers to medication abortion care is now more urgent than ever. As access to medication abortion remains obstructed by medically unnecessary restrictions and barriers, we are needlessly putting people at risk. The requirement for providers to be physically present when the medication is given to the patient isn’t just unnecessary — this restriction can also be harmful by pushing abortion care out of reach for patients altogether. This is especially true for those who live in rural areas and may face more economic or physical barriers to visit a health care provider. Amid one of the most pressing health crises of our time, the fact that medication abortion remains inaccessible is simply unacceptable.
We must do more to ensure everyone can safely reach the care they need. And we need to start by listening to scientists and medical experts, who are calling on FDA to revisit its Risk Evaluation and Mitigation Strategy (REMS) that currently impedes access to mifepristone.
Even prior to this pandemic, the American Medical Association, American College of Obstetricians and Gynecologists (ACOG), and American Academy of Family Physicians (AAFP) have been clear: it’s time to lift restrictions and ensure medication abortion is available for all. In a statement, ACOG has called restrictions on mifepristone “inconsistent with those for other medications with similar or greater risks,” and stated that lifting restrictions “would allow more women the option of medical management for early pregnancy loss, and improve access for first trimester medication-induced abortion.” In a letter to FDA from 2019, the AAFP expressed concern that women “in rural and medically-underserved areas who typically lack health care options” could face significant delays in reaching abortion care as a result of REMS.
In this critical moment, the pandemic and the economic crisis it has caused have created even more barriers to access abortion care in this country. Unemployment, wage loss, loss of insurance coverage, travel restrictions, and new political attacks on abortion access have created an even more urgent need for change to ensure everyone can access the reproductive care they need to plan their families, lives and futures.
It’s been 20 years since the FDA approved mifepristone. Its use and testing have shown time and again that it is safe and effective. It shouldn’t be this hard to get medication abortion care. It’s past time to ease the burden on patients and fix these outdated restrictions. FDA must suspend the in-person distribution requirement for mifepristone immediately.