Health Reproductive Rights

FDA Expands Access to Medication Abortion

The federal Food and Drug Administration (FDA) made mifepristone (the early option of abortion by pills, or medication abortion) more accessible to women, but still kept in place unnecessary regulations.

The FDA announced changes yesterday to the label for mifepristone, one of the drugs in a two-drug regimen used to induce early abortion. It lowered the required dosage from 600 to 200 milligrams, and increased the length of time a woman could use mifepristone from 49 to 70 days from the beginning of her last menstrual period (LMP). This is significant, since an estimated 30 percent of women seeking abortions do so between 49 and 70 days from LMP. According to Guttmacher Institute, medication abortion was used by nearly 25% of women who sought abortions in 2011.

The FDA also relaxed requirements for people who can provide medication abortions. The new labeling language allows that both physicians’ assistants and nurse practitioners to dispense the medication. Previously only doctors could provide the medication. Moreover, the FDA reduced the number of in-office visits for mifepristone from two visits to one.

The previous requirements were based on clinical trials from the 1990s, and healthcare providers had long been following off-label, evidence-based protocols that differed from the now-changed FDA requirements. In at least three states, however, doctors are forced by law to follow FDA protocol (regardless of changing medical practice). Now, however, providers’ methods and the FDA’s labeling line up.

The FDA, however, missed an opportunity to expand access to mifepristone for purposes beyond abortion.“Tragically, the FDA was silent about allowing mifepristone to be prescribed off-label for many serious illnesses, primarily affecting women that have exhausted all other remedies,” explained Eleanor Smeal, President of the Feminist Majority Foundation. “The Feminist Majority Foundation has administered, with the permission of the FDA, the only ‘Mifepristone Compassionate Use’ program for patients with such illnesses. Today, we’ve assisted nearly 150 desperately ill patients with various kinds of hormone dependent tumors or endocrinopathies and we still hope this change will be made in the future. This lifeline for many people should be more accessible,” concluded Eleanor Smeal.

“Tragically, the FDA was silent about allowing mifepristone to be prescribed off-label for many serious illnesses, primarily affecting women that have exhausted all other remedies,” explained Eleanor Smeal, President of the Feminist Majority Foundation. “The Feminist Majority Foundation has administered, with the permission of the FDA, the only ‘Mifepristone Compassionate Use’ program for patients with such illnesses. Today, we’ve assisted nearly 150 desperately ill patients with various kinds of hormone dependent tumors or endocrinopathies and we still hope this change will be made in the future. This lifeline for many people should be more accessible,” concluded Eleanor Smeal.Even though not complete, the FDA label change is still a victory for women’s health. Mark S. DeFrancesco, president of the American Congress of Obstetricians and Gynecologists (ACOG), praised the change. “The evidence-based regimen for medication abortion has been shown to improve efficacy, reduce adverse effects, and even lower the cost of medication abortion,” said DeFrancesco,

Even though not complete, the FDA label change is still a victory for women’s health. Mark S. DeFrancesco, president of the American Congress of Obstetricians and Gynecologists (ACOG), praised the change. “The evidence-based regimen for medication abortion has been shown to improve efficacy, reduce adverse effects, and even lower the cost of medication abortion,” said DeFrancesco, in a statement. “And by allowing more qualified healthcare providers to prescribe and administer mifepristone, and removing the in-person follow-up appointment, the updated label will also make medication abortion accessible to more women, including previously underserved and rural women.”

The changes are of particular importance in states such as Texas, North Dakota and Ohio, where legislators have successfully restricted women’s access to medication abortion by requiring doctors to abide by the FDA’s previous outmoded standards. In these states many women have been unable to obtain medication abortions.

Dr. Nancy Stanwood, board chair of Physicians for Reproductive Health, said in a statement released today, “Millions of women in the United States and Europe have used [mifepristone] to safely end pregnancies, and it was profoundly disappointing to see it restricted in some states for political reasons.” She added, “I hope that today marks a new chapter in expanding rather than restricting access to safe abortion, providing women with access to the best modern medical care for their reproductive health needs.”Mifepristone was approved by the FDA in 2000 for

Mifepristone was approved by the FDA in 2000 for early pregnancy termination. Taken in a regimen with misoprostol, mifepristone blocks progesterone, a hormone that prepares the uterus to carry a pregnancy; misoprostol then induces uterine cramping to help end the pregnancy.