The U.S. Food and Drug Administration has approved a new label for a common abortion-inducing drug.
The change undermines restrictions on medication abortions passed by several states, allowing women to take the drug later in a pregnancy and with fewer required office visits.
The FDA notified the manufacturer of the drug Mifeprex in a letter Tuesday that the drug is safe and effective for terminating a pregnancy in accordance with the new label. Also known as mifepristone, the drug is used in combination with another drug, misoprostol, to end a pregnancy.
Laws in states such as North Dakota, Ohio and Texas have required providers to follow the requirements on the original FDA labels for the drug when conducting abortions by medication. Many doctors have said those labels, based on clinical evidence from the 1990s, were outdated and that the state laws went against accepted medical practice and made it harder for women to get abortions.
In Arkansas, Act 577 was passed by the Legislature last year, requiring doctors to follow FDA protocols when administering the drug and requiring doctors performing abortions to contract with a physician who has admitting privileges at a designated hospital to handle any complications.
The state's Abortion-Inducing Drugs Safety Act was to go into effect Jan. 1, but its enforcement has been blocked while a lawsuit challenging the law makes its way through the legal system.
Under the new FDA-approved label, mifepristone can be used up to 70 days after the beginning of a woman's last menstrual period, instead of the 49-day limit in effect under the old label.
Mifepristone blocks the production of progesterone, a hormone that prepares the lining of the uterus for a fertilized egg. A day or two after taking that drug, the woman takes the second drug, misoprostol, which causes the uterus to contract and expel the pregnancy.
Under the new label, the second drug can be taken by a woman at home and is not required to be administered at a clinic, which would reduce the number of trips women have to make to a doctor for a medication-induced abortion from three to two in most states, experts said.
The new label also reduces the dosage of mifepristone from 600 milligrams to 200 milligrams. Medical experts had said the previous dosage was too high, and abortion-rights advocates said it increased the cost and the side effects of the procedure.
The label also relaxes prescriber guidelines to allow, for example, a nurse practitioner to administer the drugs rather than a physician.
In most states, doctors had been following this medically accepted regimen, despite the fact that the former FDA-approved mifepristone label advised otherwise. That is fairly common in medical practice and is known as off-label use.
The FDA's label change "is a huge step in increasing access to medication abortion, and it comports with the scientific evidence," said Elizabeth Nash, a senior state issues associate at the Guttmacher Institute, which tracks women's reproductive-health matters. She said medication abortions accounted for about a quarter of all abortions in 2011, the last year measured by the institute.
Arkansas' law restricting medication abortions was challenged in a December lawsuit filed by Planned Parenthood of the Heartland and Dr. Stephanie Ho.
The plaintiffs said in a court filing in February that "with no medical justification, Arkansas has enacted a law that will prevent all Arkansas women from accessing medication abortion, an extremely safe and effective method of terminating an early pregnancy that has been used by over two million women in the United States alone."
Planned Parenthood of the Heartland spokesman Ashley Wright said when the lawsuit was filed in December that medication abortions are safer than surgical ones and that many women prefer the chemical method.
"They feel it is much more comfortable being in their homes and it's less invasive," Wright said. "Taking away that option is severely limiting the health care they have chosen to receive. One in four women choose medication abortions over surgical ones when it is available."
In 2015, Planned Parenthood performed 500 medication abortions in Arkansas -- 300 in its Fayetteville clinic and 200 in its Little Rock location. Planned Parenthood of the Heartland provides only medication abortions.
The only other clinic in the state that provides abortions is Little Rock Family Planning Services, which can provide either surgical or medication abortions but had agreed to provide only surgical abortions after the law was passed.
Attorneys for Arkansas said in court filings last month that the law protects women by requiring doctors to perform medication abortions in a way that has been approved by the FDA and by forbidding doctors from abandoning their patients when complications or emergencies arise.
The state said the plaintiffs "would prefer to send the women on their way to take the drug wherever they would like and then fend for themselves, rather than give the women that drug at the clinic and then care for them as they endure the drug-induced miscarriage."
If any problems arise during a medication abortion, the attorneys representing Arkansas said, the plaintiffs would have the women call the Planned Parenthood hot line or go to an emergency room, which they say "does not ensure continuity of care."
They said the state Legislature had enacted the law to protect women from "the dangerous and potentially deadly off-label use of abortion-inducing drugs."
Judd Deere, a spokesman for Arkansas Attorney General Leslie Rutledge, said Wednesday that "Attorney General Rutledge is evaluating today's announcement from the FDA and the impact it will have on ongoing litigation, but has no further comment at this time."
Planned Parenthood of the Heartland said on its website, "Multiple states have tried to restrict access to safe, legal abortion by writing outdated medical regulations into law. Today, the FDA updated medication abortion guidelines to reflect the latest research, which means patients everywhere will get the higher standard of health care they deserve. This is great news!"
The FDA initially approved Mifeprex in September 2000. The protocol it approved then required the ingestion of three 200-milligram tablets of mifepristone, followed by two 200-microgram tablets of misoprostol, up to 49 days from the beginning of the woman's previous menstrual period, with the patient to return for a follow-up visit to confirm that a "complete termination of pregnancy" has occurred.
In addition, the Arkansas law requires any physician who performs a medication abortion to have "a signed contract with a physician who agrees to handle complications" and who has "active admitting privileges and gynecological/surgical privileges at a hospital designated to handle any emergencies associated with the use or ingestion" of the drugs.
The FDA said when it approved Mifeprex that cramping and vaginal bleeding are possible side effects of medication abortions and that in some cases surgery would be needed to stop heavy bleeding. Other potential side effects, the FDA said, include headache, diarrhea, dizziness and nausea.
Anti-abortion groups on Wednesday noted that the new FDA-approved label carries over the old label's warnings of some of the dangers associated with the drug -- including the rare possibility of infection or death.
"The new label affirms the deadly realities of chemical abortion and underscores the need for in-person patient examination and follow-up care as well as the fact that the abortion drug regimen presents serious risks to women's health," Anna Paprocki, staff attorney for Americans United for Life, said in a statement.
Randall O'Bannon, director of research for the anti-abortion group National Right to Life, said medication abortions still are dangerous and have led to at least 14 deaths and thousands of injuries.
He said the new protocols serve mostly the interests of the abortion industry, increasing its profit margin by requiring a smaller dose of the drug and reducing the level of staffing devoted to the patient.
"It looks like this benefits the abortion industry and increases their potential customer base and revenues, but it's not clear that anything here makes it safer for women in the long run, and certainly nothing about a chemical abortion makes it any safer for the unborn child," O'Bannon said.
But the American Congress of Obstetricians and Gynecologists, a nonprofit organization of women's health care physicians, said in a statement that it was "pleased that the updated FDA-approved regimen for mifepristone reflects the current available scientific evidence and best practices."
The group added that "medication abortion has been subject to legislative attacks in various states across the country, including mandated regimens that do not reflect the current scientific evidence. We hope that these states take the FDA label into account."
Abortion-rights supporters said they expect providers in North Dakota, Ohio and Texas to begin administering the drugs in accordance with the new label within the next few days.
Chris France, executive director of Preterm, Ohio's largest abortion provider, said Wednesday: "We will be implementing the new protocol today."
France said that before Ohio's law prohibiting off-label use of the drugs went into effect, between 10 percent and 15 percent of patients elected for a medication abortion. That number dropped to less than 2 percent after the law took effect.
"Combined with other restrictions in our state, medication abortion has required four in-person clinic visits, making this method too costly and cumbersome for most people," France said. "Now, our providers will no longer be forced to practice medicine mandated by politicians whose goal is to shut us down."
Similar restrictions on medication abortion have passed but have been blocked by court order in Oklahoma and Arizona. In addition, Arizona legislators have passed another measure that tries to maintain the original FDA protocol, but it has not yet been signed into law.
Information for this article was contributed by Sean Murphy of The Associated Press; by Sabrina Tavernise and Jan Hoffman of The New York Times; by Sandhya Somashekhar and Laurie McGinley of The Washington Post; and by Linda Satter, Jake Sandlin and Jeannie Roberts of the Arkansas Democrat-Gazette.
Metro on 03/31/2016