Restrictions surrounding an abortion pill should be lifted, which would provide easier access for pregnant women, because the benefits of mifepristone greatly outweigh the risks, according to a group of medical experts.
Although mifepristone, also known as RU-486, was approved in 2000, it is subject to a Risk Evaluation and Mitigation Strategy (REMS), a set of strict regulations placed on a drug believed to have a limited safety record or that may have serious risks to patients.
But a group of 10 doctors, public health and legal experts, writing in the New England Journal of Medicine, say that decades of experience with mifepristone, both here and abroad, indicate the burdensome regulations are unnecessary and the drug should be made more readily available. They say the REMS should be lifted, given the drug’s track record of very few adverse events.
The drug is available today, but it can only be given to a patient at a clinic or hospital by a certified provider. However, since the number of abortion providers has declined, many women must travel long distances to get the drug.
In addition, the women must be given a medication guide and sign an agreement that they understand mifepristone’s risk. While other drugs, such as antibiotics, insulin and high blood-pressure medication, can cause immediate, serious reactions, they are not subject to the kind of restrictions mifepristone is. The group wants the drug treated like most other FDA-approved medications, so it is available to women with a prescription through a pharmacy.
“The reasons for the REMS are just no longer tenable,” Paul Blumenthal, MD, a professor of obstetrics and gynecology at Stanford School of Medicine who is a member of the group, told Stanford’s Scope Blog. “The drug has proven itself. It can be regulated just like any other drug… If this were Viagra, men would not stand for it.”