In September 2000, the Food and Drug Administration (FDA) — of which one of us was commissioner at the time — approved mifepristone, one of two medications used to end early unwanted pregnancies. At that time, because of limited clinical trial data from the United States, the FDA simultaneously imposed various restrictions — including a limited distribution system — to ensure that the benefits outweighed the risks of the newly approved drug. Now, after nearly two decades of actual use, additional research, and a comprehensive review conducted by the National Academies of Science, Engineering, and Medicine (NASEM) — which the other one of us cochaired — all of which clearly demonstrate that mifepristone is extremely safe and effective, we believe that the distribution restrictions may no longer be appropriate.

Mifepristone is a antagonist that blocks progesterone, a hormone that is essential to pregnancy, and along with another medication (misoprostol) enables the body to terminate pregnancy. When the FDA approved mifepristone, data from its use in Europe — primarily, but not limited to, France, where it had been used for more than a decade — were used to support the approval. There were questions about its use, however, such as whether the rate and severity of adverse events would be similar or greater with mifepristone than with surgical abortions in the United States. Furthermore, the health care delivery systems in France and other European countries differ greatly from that in the United States. In recognition of these issues, the FDA restricted the distribution of mifepristone to certified health care providers and limited dispensing to patients, who could receive it only at qualified clinics and hospitals. In addition, extensive record keeping by these health care providers was required. Thus, a pregnant person would not be able to be treated by her own physician unless her doctor was among those certified. Given the available scientific evidence at the time, we believe that the decision to approve mifepristone was the right one, as was the FDA’s judgment with regard to initially limiting its distribution system.

Since its approval in 2000, more than 3.7 million women have used mifepristone to end an early pregnancy in the United States — it is approved for use up to 70 days into a pregnancy.1 Nearly two decades of data on its use and effects on patients provide significant new insights into its safety and efficacy.2 Mifepristone is more than 97% effective. Most adverse effects are mild, such as cramping or abdominal pain, and the rate of severe adverse events is very low: such events occur in less than 0.5% of patients, according to the FDA. Many drugs marketed in the United States have higher adverse event rates and are not subject to restricted distribution. A 2018 review conducted for the NASEM by a committee of leading medical and research experts (which one of us cochaired) concluded that both surgical and medication abortion in the United States are extremely safe.3

The accumulated knowledge about mifepristone strongly suggests that the current restricted distribution system is not aligned with the limited risks that are now known to be posed by the drug. A recent study of mifepristone in Ireland and Northern Ireland showed that medication abortions can be done at home as safely as treatments can be administered in a clinic, confirming that there is no advantage to special dispensing restrictions.4 Countries with regulatory bodies similar to the FDA have minimal restrictions on mifepristone. For example, Australia and Canada allow it to be dispensed in pharmacies, and Canada recently removed restrictions that require that an ultrasound be performed to determine gestational age before medication for an abortion is provided.

Removing access barriers to this medication has a significant effect on the ability to obtain safe abortion care. In fact, the World Health Organization has included mifepristone on its List of Essential Medicines, noting that it “has revolutionized access to safe and effective abortion care globally.”5 The NASEM report notes that state restrictions that require multiple visits or impose waiting periods may delay access to care and “by doing so, may increase the clinical risks and costs of care.” To mitigate inequities in access, NASEM experts recommended that the FDA reconsider the distribution restrictions placed on mifepristone, given “the extensive body of research demonstrating its safety and effectiveness.” In fact, the FDA has approved clinical trials for alternative distribution models for mifepristone in the United States.

Recent media reports indicate that, as access to clinics that satisfy the FDA restrictions shrinks, people are increasingly turning to the Internet to source mifepristone on their own from foreign manufacturers. The FDA cannot effectively control Internet sales, which are likely to grow further, nor can the safety of these foreign-sourced products be ensured.

Women should have access to FDA-approved products whose safety and effectiveness are confirmed. Since the evidence available today indicates that the current restrictions are overly prescriptive, we urge the FDA to reevaluate whether they are still necessary.

Disclosure forms provided by the authors are available at

This article was published on June 26, 2019, at

Author Affiliations

From the National Academy of Medicine, Washington, DC (J.E.H.); and the Chicago Community Trust, Chicago (H.D.G.).