Report Details Effect of Mifepristone Labeling Change
By Rebecca Bowers
EXECUTIVE SUMMARY
New research indicates that for Texas providers and patients, the 2016 Food and Drug Administration’s (FDA) new labeling for the abortion drug mifepristone increased access options and brought the proportion of medication abortions in the state into alignment with national data.
- Texas abortion rights advocates have fought an uphill battle in the state since legislative measures were implemented to hobble access. In 2013, legislators passed House Bill 2 (HB 2), which imposed restrictions on medication abortion and required providers to follow the original mifepristone label.
- Data indicate that medication abortion comprised 28% of all abortions before the 2013 legislation, 10% after HB 2’s implementation, and 33% after the FDA label change.
In 2016, the Food and Drug Administration (FDA) issued new labeling for the abortion drug mifepristone, which lowered the recommended dosage, extended the time frame for when a woman could take the pill, and reduced the required number of provider visits.
New research indicates that for Texas providers and patients, the labeling change increased access options and brought the proportion of medication abortions in the state into alignment with national data.1
Texas abortion rights advocates have fought an uphill battle in the state since legislative measures were implemented to hobble access. In 2013, legislators passed House Bill 2 (HB 2), which imposed restrictions on medication abortion and required providers to follow the original mifepristone label. The bill also decreased the gestational age limit to 49 days and required four provider visits. Figures indicate that medication abortions decreased 70% in the first six months following the law’s implementation, primarily because of the new legislation, clinic closures, and confusion regarding the legality of abortion.2
With the issuance of the new drug labeling, the restrictions set forth by HB 2 were nullified. According to the new research conducted by the Texas Policy Evaluation Project (TxPEP), medication abortion comprised 28% of all abortions before the 2013 legislation, 10% after HB 2’s implementation, and 33% after the FDA label change. To perform the analyses, researchers collected data directly from licensed non-hospital abortion facilities at three time points and supplemented the data with abortion statistics publicly available from the Texas Department of State Health Services.
“The new FDA label has allowed Texas providers to offer medication abortion in a way that is consistent with the best medical evidence, rather than being forced to comply with an outdated label imposed by HB 2,” says Sarah Baum, MPH, TxPEP investigator, associate at Ibis Reproductive Health, and lead author of the study. “This has increased options for Texas women and brought the proportion of medication abortions in the state in alignment with national data.”
The Texas Policy Evaluation Project is an effort to document and analyze the effects of the reproductive health-related measures passed by the Texas legislature. The project team involves researchers at the University of Texas at Austin Population Research Center, the University of California San Francisco, Ibis Reproductive Health, and the University of Alabama at Birmingham.
The label change also brought the medication abortion prescribing guidelines in Texas in line with evidence-based practice, lowering the number of required provider visits from four to two and extending the period when patients can take the abortion medication from seven weeks to 10 weeks of pregnancy.
“With the label change, many Texas women have regained access to medication abortion, a method some women prefer,” said Kari White, PhD, MPH, a TxPEP investigator. “However, the smaller network of open facilities in Texas following HB 2 means that some women still need to travel considerable distances just to take a pill that is established to be safe and effective.”
Advocates Push for Access
Although the FDA labeling change made an impact on access to medication abortion for women in Texas, barriers still remain. In Texas, about 900,000 reproductive-age women live more than 150 miles from an abortion clinic, in part because of clinic closures brought about by HB 2, according to TxPEP statistics. Currently, 20 clinics provide abortion services in Texas, down from more than 40 prior to the 2013 legislation. Although medication abortion may be available in the state, a ban on providing medication abortion via telemedicine remains. Also, women must undergo a mandatory ultrasound exam during a visit at least 24 hours before taking the first pill. Insurance is prohibited from covering abortion in the state.
A 2014 practice bulletin from the American College of Obstetricians and Gynecologists states that medication abortion can be provided safely and effectively via telemedicine with a high level of patient satisfaction.3 According to the Guttmacher Institute, routine ultrasound is not considered to be medically necessary as part of a first-trimester abortion, and it can add significantly to the procedure’s cost.
The dosing regimen for mifepristone calls for 200 mg (one tablet) to be taken by mouth on day one. At 24-48 hours after taking mifepristone, 800 mcg (four tablets) of misoprostol is taken buccally (in the cheek pouch) at a location that is appropriate for the patient. About seven to 14 days after taking mifepristone, the patient is advised to follow up with her healthcare provider.
REFERENCES
- Baum SE, White K, Hopkins K, et al. Rebound of medication abortion in Texas following updated mifepristone label. Contraception 2019 Jan. 23. doi: 10.1016/j.contraception.2019.01.001. [Epub ahead of print].
- Grossman D, Baum S, Fuentes L, et al. Change in abortion services after implementation of a restrictive law in Texas. Contraception 2014;90:496-501.
- American College of Obstetricians and Gynecologists. Practice bulletin no. 143: Medical management of first-trimester abortion. Obstet Gynecol 2014;123:676-692.
New research indicates that for Texas providers and patients, the 2016 Food and Drug Administration’s (FDA) new labeling for the abortion drug mifepristone increased access options and brought the proportion of medication abortions in the state into alignment with national data.
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