Medication Abortion Is Now More Accessible Than Ever
This morning, doctors and reproductive-health advocates welcomed a rare positive announcement: Danco Laboratories finally won FDA approval for updating the Mifeprex® (mifepristone) label to reduce barriers to accessing medication abortion. As a result, those seeking a first-trimester abortion will now have increased access in underserved areas.
Mifepristone, in tandem with misoprostol, has been used safely for ending pregnancy more than 2.75 million times since its approval in the U.S. in 2000, but has remained unnecessarily regulated and restricted. While the new FDA approval has not done away with the requirement to visit the office of an advanced practice clinician, it ushers in significant changes. The label no longer mandates that the prescriber be a doctor; the pill may now be administered through 70 days gestation (i.e., since the last menstrual period) rather than only through 49 days; and the need for an office visit to administer misoprostol, the second of the two medications, has been eliminated.
“Today’s FDA announcement of a label change to mifepristone is a significant advancement for women in the United States. All of us at Whole Woman’s Health (WWH) are thrilled that the updated FDA labeling reflects evidence-based care that is best for women,” said WWH president and CEO Amy Hagstrom Miller in announcing the news. “People who visit our clinics deserve options for abortion care without worrying about medically unnecessary obstacles, and this change allows more women to get the care they deserve.”
Despite the previous unnecessary time constraints, ridiculous laws requiring mifepristone to be taken at an ambulatory surgical center, and bans on telemedicine that allow counseling to be done remotely, early medication abortions increased from 6% of all abortions in 2001 to 23% in 2011. Medication abortion is a popular choice because it can be administered as soon as the patient confirms pregnancy, and the induced miscarriage is completed in the comfort of one’s home.
Since the wave of abortion restrictions at the state level began in 2011, however, some states are seeing that trend reverse. In Texas, for example, the passage of HB2 in 2013 has greatly increased the burden for accessing medication abortion.
“Prior to HB2, 40 to 50% of our patients at Whole Woman’s Health chose medication abortion. Since HB2 [currently before the Supreme Court] went into effect, that figure has decreased dramatically,” said Hagstrom Miller. “For the past two years, only about 5% of the women we serve in Texas have been able to get the medication abortion care they wanted because HB2’s barriers were insurmountable. This label change will dramatically expand access for women not only in Texas, but throughout our clinics nationwide.”
One reason for the decrease in medication abortion in Texas and other states besieged by a myriad of unnecessary abortion restrictions is the extensive wait time just to get an initial appointment at a clinic. Those in Texas who have transportation access, money, and the time to travel face 20 to 30 day waits to be seen by a physician; many are beyond the previous gestation limit for mifepristone by the time they walk in the door. With only one clinic south of San Antonio — the WWH in McAllen — and no clinics in the 600-mile stretch from San Antonio to the WWH in Las Cruces, New Mexico, expanding the gestation limit by 21 days is huge.
Ohio is one of the other states dealing with funding reductions, shuttered clinics, multiple TRAP (“Targeted Regulation of Abortion Providers”) laws, and a state house hostile to reproductive rights. Chrisse France, executive director of Cleveland-based reproductive health group Preterm, welcomed today’s news. “The label change for medication abortion will mean that it will once again be a real option for Preterm’s patients and women across the state,” said France, whose clinic was part of the clinical trials in the 1990s which lead to the original FDA approval. “We will no longer be forced to practice medicine mandated by politicians whose ultimate goal is to shut us down. The updated label is more aligned with evidence-based medicine and has the potential to expand abortion access for Ohio women.”
While physicians in most states have been able to alter protocol without waiting for the updated label approval from the FDA — a routine medical practice commonly referred to as “off-label” prescribing — legislators in Arizona, Arkansas, North Dakota, Ohio, and Oklahoma passed laws to specifically require adherence to the outdated mifepristone label.
“In 2011, in an attempt to decrease access to abortion, politicians forced Ohio abortion providers to follow an outdated and less effective FDA protocol, under the guise of protecting women’s health,” said France. “In reality, this law simply made medication abortion unnecessarily costly and nearly impossible to access.”
Due to the 24-hour waiting period and law requiring an office visit to administer misoprostol, patients in Ohio were forced to obtain four separate office visits — an expensive and time-consuming burden that has now been reduced by one visit.
Nancy Northup, president and CEO of the Center for Reproductive Rights — the organization representing Planned Parenthood, Whole Woman’s Health, and other independent providers in the fight against TRAP laws around the country — applauded the label change while highlighting the motivation of those who resisted the update.
“This label change underscores just how medically unnecessary and politically motivated restrictions on medication abortion in states like Texas and Oklahoma truly are, and demonstrates the lengths politicians will go to single out reproductive health care to restrict women’s rights,” Northrup said. “It’s time to put an end to laws that let politics trump science and use underhanded means to attack a woman’s constitutionally guaranteed right to safe, legal abortion.”
These attacks are ongoing and unprecedented. Including the 57 abortion restrictions enacted in 2015, states have adopted 288 abortion restrictions just since the 2010 midterm election — introducing a record 514 provisions last year. While states that specifically mandate a doctor prescribe and administer Mifeprex® have not as of yet had those laws overturned, the language change on the label to allow any “healthcare provider who prescribes” to do so under FDA guidelines has the potential to vastly expand access to abortion in most corners of the country. California passed a law in 2014 to specifically allow advanced practice clinicians — e.g. nurse practitioners and others who routinely prescribe other medications — to perform first trimester abortion procedures and administer mifepristone, thus addressing the provider shortage by increasing the pool of qualified medical personnel. The hope is that this label change could lead to this type of expansion in more states.
“This does pave the way for progressive policies in other states that recognize the value of allowing advanced practice clinicians to provide a broader range of medical services, not just abortion,” said Janet Crepps, senior counsel for the Center for Reproductive Rights. “This really recognizes that there’s no reason to treat Mifeprex® differently than other medications.”
Vicki Saporta, president and CEO of the National Abortion Federation (NAF), sees a possible abortion provider expansion through this label change as well.
“NAF and Clinicians For Choice have long advocated for advanced practice clinicians to provide first trimester abortion care — both medical and surgical,” said Saporta. “In the states where they’re not prohibited from doing so, I think that expansion will take place fairly quickly. We’re hoping that will open access for women in areas where there isn’t an abortion provider.
Ideally, today’s announcement won’t be the final step in increasing access to medication abortion.
“The situation isn’t perfect. Medication abortion is still being treated more restrictively than other medications,” said France. “That said, we are pleased to announce that as of today we will be offering medication abortion to more women with fewer required visits.”
Plenty of evidence exists to support the efficacy and safety of mifepristone minus the exceptional regulations. Gynuity Health Projects has performed dozens of studies in more than 60 countries over the past two decades. Gynuity president Beverly Winikoff, M.D., M.P.H., sees no medically-supported reason why it can’t be available in pharmacies like most other medication.
“The good news is that the approved regimen has finally caught up with medical practice and evidence. The bad news is mifepristone remains overly regulated and is still not available in pharmacies,” Winikoff said. “While these changes will help many women, additional regulatory changes are essential to maximize access to this important medication. Mifepristone holds untapped potential for improving the availability and affordability of abortion in the U.S.”
Lead image: flickr/Jonas Tana