Women in the United States are often unable to get ready, affordable access to mifepristone, a drug used to induce abortion, because of burdensome federal regulations, a Stanford researcher and his colleagues write in the New England Journal of Medicine.
Since its approval in 2000, the drug has been subject to a federal Food and Drug Administration regulation known as a Risk Evaluation and Mitigation Strategy, designed for medications that have a limited safety record or pose a potentially serious risk to patients. But the drug, taken as a single pill, has years of experience in the marketplace and does not fit this profile, said Paul Blumenthal, MD, professor of obstetrics and gynecology.
“The drug has been on the market for 17 years and has proven itself to be very safe and effective. It’s as safe as surgical abortion,” Blumenthal told me. He is among a group of 10 clinicians, public health and legal experts who argue in the commentary in favor of lifting the restrictions.
The authors say a third of the eligible women in the United States seeking abortions turn to the drug, which has been used by 2.8 million patients since its introduction. Of these, 17 women died of problems potentially related to the drug, a mortality rate of .0006 percent. By comparison, among pregnant women who give birth, the mortality rate is 14 times greater, they note.
“The fact that women are choosing the drug tells us it is well-accepted by the patients and by the provider population and yet there are all these hoops they have to jump through to get access to this medication. The evidence and experience doesn’t justify that kind of regulatory oversight anymore,” Blumenthal said.
Under the federal restrictions, applied to just 74 of the roughly 1,750 prescription drugs available in the United States, the drug cannot be prescribed but has to be given to patients at a clinic or hospital by a certified provider. The number of abortion providers in the country has declined, meaning many women have to travel long distances to obtain the drug, Blumenthal said. To be certified, providers have to sign a form attesting to their ability to manage certain complications, including providing surgical intervention, if needed – a requirement that may make some reticent to offer the pill, he said.
Women who use the drug also must be given a medication guide and sign an FDA-approved agreement that outlines the drug’s potential risks. Other commonly used drugs, such as antibiotics, insulin and high blood pressure medications, can cause immediate serious or fatal reactions but they are not subject to these same restrictions, the authors note. It’s time mifepristone is treated by the FDA as any other medication, the authors say.
“The reasons for the REMS are just no longer tenable,” Blumenthal said. “The drug has proven itself. It can be regulated just like any other drug… If this were Viagra, men would not stand for it.”
Previously: New device improves contraceptive options for women in the developing world, New ban on U.S. aid to family planning groups could have unintended consequences and Stanford law expert weighs in on Supreme Court's abortion ruling
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