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FDA revises rules for drug-induced abortions

Texas women will be able to obtain medical abortions later into their pregnancies under newly approved changes by the federal Food and Drug Administration. (Image credit: MGN Online)

Texas women will be able to obtain medical abortions later into their pregnancies under newly approved changes by the federal Food and Drug Administration.

The FDA on Wednesday announced revised rules for drug-induced abortions a method used early in a pregnancy that will increase the number of days women can take medication to induce abortions from 49 days of gestation to 70 days. Other revisions to the original FDA label for medication that induces abortions include a lower dosage of the drug, known as mifepristone.

First approved in 2000, mifepristone, when taken with another drug called misoprostol, is used to terminate early pregnancies.

Doctors in many states already followed common, evidence-based protocols that strayed from the FDA's previous label for the drug, but Texas doctors were prohibited from doing so by state law. Among the provisions of the 2013 abortion law known as House Bill 2, Texas doctors were required to follow the FDA's protocol for drug-induced abortions rather than evidence-based protocols.

Texas abortion providers unsuccessfully challenged that requirement in court, but a federal appeals court sided with the state and deemed it constitutional.

The rule revisions are a win for abortion rights advocates, bringing Texas practices in line with dozens of other states.

Abortion providers and representatives of the medical community had long asked for an update to the FDA rules, arguing the original FDA label for mifepristone was based on outdated evidence from the 1990s.

"Today, science has prevailed where the state legislature has failed," said Yvonne Gutierrez, executive director of Planned Parenthood Texas Votes, the organization's political arm in the state.

While the medication to end a pregnancy must still be administered in Texas by a physician, the FDA revisions also say the second drug can now be taken "at a location appropriate for the patient." It's unclear what that means for Texas women who under state law must take the pill in front of a doctor.

Representatives for the Texas Department of State Health Services and the Texas Medical Board did not immediately respond to requests for clarification on the impact of the FDA's revisions to that requirement.

The U.S. Supreme Court is currently weighing the constitutionality of other provisions in HB 2. Those include a requirement that doctors performing abortions must have admitting privileges at hospitals within 30 miles of an abortion clinic. A separate provision, which hasn't gone into effect, requires clinics to maintain the same standards as hospital-like ambulatory surgical centers.

During oral arguments earlier this month, Justice Anthony Kennedy, considered the swing vote in that case, pressed the state's solicitor general on figures showing the share of drug-induced abortions on the rise nationwide but dropping in Texas while the number of surgical abortions are increasing in the state.

"This may not be medically wise," he said after his colleagues questioned why Texas would require women to obtain abortion-inducing medication in an ambulatory surgical center under HB 2.

State-reported figures show drug-induced abortions in Texas decreased from 19,081 medical abortions in 2012 to 16,756 in 2013. Data on medical abortions performed in 2014 the first full year since HB 2 took effect is not yet available. But state officials did note that the overall number of abortions performed in Texas dropped significantly in 2014 with almost 9,000 fewer procedures compared to the year before.

This article originally appeared in The Texas Tribune at http://www.texastribune.org/2016/03/30/fda-revises-rules-medical-abortions/.

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