FDA restrictions make mifepristone—one of two medications used to end early pregnancy—hard to access for off-label use and drug companies have declined to develop mifepristone for other uses. As a result, this critical medicine remains hostage to anti-abortion politics, and women’s health has suffered.
In 2000, the U.S. Federal Drug Administration (FDA) approved mifepristone for abortion during the first seven weeks of pregnancy, later extending allowable use to ten weeks in 2016. While widely known as an abortion pill, mifepristone is very effective for treating fibroids and may also be effective for treating endometriosis and depression.
Yet the drug is not available to use for these serious conditions because the FDA tightly restricts the medication due to intense anti-abortion pressure. The politicization around mifepristone has made research on its usefulness in treating these conditions difficult to conduct, preventing its development for treatments that could significantly enhance women’s health.
The FDA restricts mifepristone in a drug safety program called the Risk and Evaluation Mitigation Strategy (REMS). Despite unequivocal evidence of its safety and efficacy, the FDA REMS blocks pharmacies from distributing the medication and requires medical providers to register with the drug manufacturer and dispense the pills themselves directly to their patients in person. These restrictions have limited availability of this medication for research and off-label uses for other conditions. But that may soon change.
The Biden administration recently lifted the in-person distribution requirement for the duration of the public health emergency in order to protect against the spread of COVID-19, and the FDA is now reviewing the necessity of its restrictions on mifepristone. While the focus is on the safety of using mifepristone for abortion, lifting the FDA restrictions would free up the drug for development and use in treating fibroids and possibly other conditions.
Extensive research has shown that mifepristone is an effective treatment for fibroid tumors—which are noncancerous growths of the uterus that often appear during childbearing years. This common condition, afflicting 26 million women in the U.S., can cause heavy periods, severe pain and difficulty conceiving.
Fibroids are often treated with surgery to remove the fibroids or even hysterectomies—removal of the uterus. Approximately 600,000 hysterectomies are performed annually in the United States, which the National Women’s Health Networks contends are often unnecessary and put women’s health at needless risk.
Some research suggests that mifepristone may also be helpful in treating endometriosis, where tissue that normally lines the inside of the uterus—called the endometrium—grows outside the uterus. Endometriosis afflicts an estimated 10 percent of reproductive-age women. Common treatments include laparoscopic surgery—involving the cutting and removing endometrial tissue or destroying it with a laser beam or electric current—and hysterectomies.
Mifepristone is a non-surgical alternative for treating fibroids and possibly endometriosis as well, with the potential to reduce unnecessary hysterectomies. Research has shown that the medication reduces menstrual bleeding, relieves pain, improves quality of life and can enhance fertility.
Other research indicates that mifepristone may be effective in treating depression, including postpartum depression, which affects one in nine new mothers each year. It is also an effective form of contraception and is an emergency contraceptive.
Yet, despite mifepristone’s promise to provide women with health-enhancing treatments, development of the medication for these uses is stymied. “Most new applications of existing drugs are discovered and even developed by physicians using drugs off-label, but that path is not easily accessible because of the REMS,” said Francine Coeytaux, co-director and co-founder of Plan C Pills, which educates the public about abortion pills and advocates for greater access.
Meanwhile, drug companies won’t invest in research and development of the medication for fear of long-standing threats of anti-abortion boycotts. As a result, this important medication remains inaccessible to many women who could benefit tremendously from it.
How Anti-Abortion Politics Blocked Access to a Vital Medication
The French company Roussel-Uclaf first developed mifepristone, known as RU-486, in 1980. After extensive testing, the company applied for and obtained the French government’s approval in 1988 for the drug to be used for abortion.
The same year, anti-abortion protests in France caused Rousel-Uclaf’s owner Hoechst AG of Germany to stop distributing mifepristone. The French government responded by ordering Roussel-Uclaf to resume selling the medication in the interest of public health.
French Health Minister Claude Évin famously explained at the time, “I could not permit the abortion debate to deprive women of a product that represents medical progress. From the moment government approval for the drug was granted, RU-486 became the moral property of women, not just the property of a drug company.”
Great Britain approved mifepristone for abortion 1991 and Sweden in 1992. But due to pressure from anti-abortion groups, including the U.S. National Right to Life Committee, Roussel-Uclaf and Hoechst AG declined to bring the drug to the U.S. market for fear of boycotts and lost profits. Instead, the company donated all rights for medical uses of mifepristone in the U.S. to the Population Council—a nonprofit that conducts international research on reproductive health.
The Population Council then tried to find a large drug company willing to develop the drug for the U.S. market. After threatened boycotts from anti-abortion groups, large drug companies refused, so in 1995, the Population Council gave the rights to distribute mifepristone to a small company named Danco Laboratories, formed specifically for this purpose. Danco sought and obtained FDA approval of the drug for abortion in 2000, with support of the Clinton administration.
But in a concession to anti-abortion groups, the FDA restricted the drug, despite strong evidence of its safety. Citing fear of anti-abortion violence, the FDA at the time refused to reveal the names of the manufacturer or the FDA employees involved in approving the drug. The threats were so serious the agency had to increase security at its offices.
After research showed that mifepristone was effective in treating brain tumors and providing palliative care for several forms of cancer, including breast and ovarian cancer, the FDA in 2009 approved the use of the drug under a highly restrictive and hard-to-access compassionate use program, where the FDA allows patients to use medications for conditions for which it has not yet been approved. But few doctors and patients know about this option and accessing the medication under this program is very cumbersome.
Then in 2012, enterprising physicians at Stanford Medical School won FDA approval of mifepristone for treatment of Cushing’s disease. The Silicon Valley-based drug company Corcept Therapeutics now markets mifepristone as the medication Korlyn to control high blood sugar in patients with Cushing’s.
But the drug is not available for any further uses—including for fibroids—despite strong evidence that the medication is effective for treating this condition. The FDA REMS make the drug hard to obtain for research and drug companies have declined to develop the drug for the treatment of any other diseases. As a result, this critical medicine remains hostage to anti-abortion politics, and women’s health has suffered.
More than 40 years after the development of mifepristone, this medication is still not yet “the moral property of women.” The FDA’s current reconsideration of its restrictions on mifepristone is an opportunity for the agency to finally value women’s health and lives over anti-abortion politics. The FDA should not only make this important medication widely available for abortion but also open the door for research and development of mifepristone for other life- and health-saving treatments for women it might provide.
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