New protocol

New abortion protocol could thwart anti-abortion laws

The agency updated the label requirements for mifepristone, the pill used in a medication abortion, so that some doses can be taken at home.

By Jennifer Haberkorn

The FDA on Wednesday waded into abortion politics by expanding its approval of a drug used for medication abortions, a decision that could make the procedure more easily available in at least three states where it was tightly controlled.

The agency updated the label requirements for mifepristone, the pill used in a medication abortion, so that some doses can be taken at home. Fewer doctor visits and a lower dosage will make the procedure cheaper; the new protocol also extends from 49 days to 70 days the period of pregnancy during which a woman can use the drug.

Health care providers have used the protocol approved Wednesday for years because scientific evidence showed it to be safe and effective. But in at least three states — Texas, Ohio and North Dakota — anti-abortion laws required health care providers to use only FDA-approved processes.

In those states, medication abortions could be nearly impossible to obtain because of the added expense and doctor visits required. Typically, providers in the three states recommended more invasive surgical abortions, even when a woman was not far along into a pregnancy.

Three other states — Arizona, Arkansas and Oklahoma — had passed similarly strict laws that were enjoined by the courts prior to the FDA announcement.

Health care providers in each of the states were now expected to begin offering medication abortions within days.

"Today, medication abortion care is once again a real option for Ohio women," said NARAL Pro-Choice Ohio Executive Director Kellie Copeland. "Ohio physicians no longer have to follow an outdated, draconian protocol enacted by anti-choice politicians, which forces women to take more medication and make more trips to the clinic than is medically necessary."

The changes were backed by the American College of Obstetricians and Gynecologists, National Abortion Federation, Planned Parenthood, the Center for Reproductive Rights and other groups that support abortion rights.

The protocol approved Wednesday has been in place at Planned Parenthood for some time, said Raegan McDonald-Mosley, chief medical officer at Planned Parenthood Federation of America. “But given the restrictions on medication abortion enacted at the state level in recent years, updating the label to reflect best medical practice represents a significant step forward for science, for women, and for health care providers who want to give our patients the highest quality care.”

The increasing availability of telemedicine abortions — in which doctors at a remote location instruct a woman in a clinic by video on how to use mifepristone — could also expand use of the drug in the many areas of the country where clinics have been closing.

Physicians routinely use off-label protocols for other drugs, and it was only political opposition to abortion that led to the restrictions of mifepristone’s use in the three states.

National Right to Life, which opposes abortion, said that the FDA underplayed the health risks of a medication abortion.

“It is obvious that the FDA's new protocol serves only the interests of the abortion industry by expanding their base of potential customers, increasing their profit margin, and reducing the level of staff and amount of resources they have to devote to the patient,” said National Right to Life Director of Education and Research Randall K. O’Bannon. “It is clear whose interests it is the FDA is serving. It isn't the women, and it isn't the babies.”

The only benefit for the company that makes the drug, Danco Laboratories, is that it can now advertise the updated protocols, which won't change much since health providers in most places were already using them.

Abortion rights supporters and researchers had encouraged Danco to ask the FDA for the new label for many years because of the restrictions, which limited providers from using “the evidence-based regimes, so women in those states have been virtually denied care,” said Vicki Saporta, president and CEO of the National Abortion Federation.

Danco first asked for a new label last May, said Beverly Winikoff, president of Gynuity Health Projects, which has extensively studied mifepristone. She cited the extensive fees required. “It has taken this long for them to feel like it was worth” the cost, she said.