A federal decision to ease restrictions on an abortion pill has reignited the debate about safety versus access to the nonsurgical option for abortion.
The Food and Drug Administration on Wednesday approved a label change to the abortion pill Mifeprex, which is used to end a pregnancy. The change will enable women to get the drug at a later date, with it now being able to end a pregnancy through 70 days or less of gestation, a couple of weeks later than the prior restriction.
The change also lowers the recommended dose of the drug and provides a different way for patients to take the drug.
Pro-life advocates responded to the decision by playing up what they say are rampant safety problems with Mifeprex.
“Despite a record of at least 14 known deaths, and thousands of women suffering significant adverse events, the FDA relaxed safety standards,” said Randall O’Bannon, director of education and research for National Right to Life.
Another anti-abortion group, the March for Life, demanded the FDA release “the latest adverse event reports” related to Mifeprex.
The group said the FDA was putting “access to abortion over and above women’s health.”
However, the FDA has said it is not uncommon for the agency to learn about adverse events associated with any prescription drug after it is approved.
From the drug’s approval in September 2000 to April 2015, the FDA received 3,724 reports of adverse events, according to an agency response to a citizen’s petition from pro-life groups asking for more adverse event data. The agency told the Washington Examiner that it could not provide the total number of prescriptions of Mifeprex over that period.
The agency has received notice of several cases of a severe infection called sepsis. Some of the cases were fatal, with a single case of a non-fatal heart attack.
As of July 2015, 17 people had died since the drug was approved in 2000.
The FDA disagreed with the groups’ assertion that the adverse event reporting on the abortion drug has been “spotty,” but did acknowledge that the reporting program is voluntary.
The potential for underreporting of adverse events is low because “of the restricted distribution of the product and because healthcare providers have agreed in writing to report any hospitalizations, transfusions or other serious adverse events associated with the drug to the sponsor, which is required under FDA’s regulations to report all adverse events.”
Pro-choice advocates, meanwhile, cheered Wednesday’s decision and said it could lead to more women getting access to the drug. The decision will allow lower doses of the drug, which many doctors have been prescribing “off-label” since they have found that the lower doses are effective.
Three states require the drug to be provided in accordance with FDA labeling. The laws effectively outlaw the “off-label” use in which a doctor can administer or prescribe a drug in a way that differs from the FDA-approved label, according to the pro-choice think tank Guttmacher Institute.
Such laws in North Dakota, Ohio and Texas prevented doctors from going “off-label” in how they prescribe the drugs. Abortion rights advocates have said that evidence-based standards over the years have called for a lower dose of the drug, which the labeling now reflects.
“It is high time to put medicine back in the hands of medical professionals and take it out of politicians’ hands,” said Ilyse Hogue, president of NARAL Pro-Choice America.
The agency’s decision comes as advocates on both sides are waiting for a highly anticipated Supreme Court decision this summer on different abortion restrictions.
The Supreme Court is expected to rule this summer on a challenge to Texas’ 2013 law that abortion clinics meet ambulatory surgical center requirements and providers have admitting privileges in a local hospital.
While state lawmakers say the measures are to ensure the health of the woman, pro-choice advocates charge it is an attempt to undermine abortion rights.
