The Food and Drug Administration has announced that women will no longer have to pick up the abortion pill mifepristone (Mifeprex) in person at certain certified locations and will be able to get a prescription through online advice and delivery by mail.
In April 2021, the FDA lifted the obligation to dispense mifepristone in person for the duration of the COVID-19 pandemic, and in December the agency made that decision final.
As reported by this news outlet on April 12, 2021, Acting Commissioner for Food and Medicines Janet Woodcock, MD stated that the FDA “would allow mifepristone to be mailed by or under the supervision of a certified prescriber; or via a mail order pharmacy under the supervision of a certified prescribing doctor. “
This decision was made following the suspension of in-person clinic visits in response to COVID-19 safety concerns for patients and providers related to in-person clinic visits.
Decision will be made amid the debate over the Supreme Court
The FDA’s decision comes as the Supreme Court nears a decision on whether to deliver its 1973 ruling on Roe v. Should pick up calf.
Additionally, the Supreme Court dismissed a Texas abortion ban lawsuit after 6 weeks in a federal appeals court that let the law go into effect twice instead of a district judge trying to block it.
Alexis McGill Johnson, President and CEO of the Planned Parenthood Federation of America, said in a statement, “Abortion is a time-sensitive, essential health care service and this decision will remove a sometimes insurmountable barrier for patients seeking an abortion. With abortion rights under threat like never before, the FDA’s decision is long overdue to expand people’s access to safe medication abortion. “
Georgeanne Usova, senior legal counsel at the American Civil Liberties Union, told CNBC News, “The FDA’s decision will be a tremendous relief to countless abortions and miscarriages.”
Catherine D. Cansino, MD, MPH, Associate Clinical Professor in the Department of Obstetrics and Gynecology at the University of California, Davis, and member of the editorial board of ObGyn News, said in an interview: It’s a long time coming and suggests that Science counts and medicine takes precedence over politics. We have to protect health rights first! “
Others expressed doubts or indignation.
Fidelma Rigby, MD, professor in the Department of Obstetrics and Gynecology, Department of Maternal Fetal Medicine, Virginia Commonwealth University Medical Center, Richmond, said in an interview, “My concern is, what if there is an ectopic pregnancy? I’m not as excited about this announcement as some of my partners would. “
“Today’s FDA decision puts women at risk,” said Carol Tobias, president of the National Right to Life Committee. “These changes don’t make this abortion process any safer for women. These changes simplify the process for the abortion industry. “
The anti-abortion groups Charlotte Lozier Institute and the Susan B. Anthony List were among other organizations that have issued statements against the FDA’s December 16 decision.
The FDA stated that mifepristone prescribers still need certification and training. In addition, the dispensing pharmacies must be certified.
The FDA said in an updated guide on its website that after a review of the risk assessment and mitigation strategy for mifepristone, it “found that the data support changing the REMS to ease the burden on patient access and the health care system, and to ensure that” the benefits of the product outweigh the risks. “
The modifications include:
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“Removal of the requirement that mifepristone only has to be dispensed in certain health care facilities, in particular in clinics, medical practices and hospitals (referred to as the” requirement for personal dispensing “).”
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Added a requirement that pharmacies must be certified to dispense the drug.
The FDA said the repeal of the in-person dispensing rule will allow mifepristone to be delivered by mail through certified prescribers or pharmacies in addition to in-person dispensing at clinics, doctor’s offices, and hospitals.
In 2018, a panel of experts from the National Academies of Science, Engineering, and Medicine concluded that the requirement that drug abortions should only be performed in specified facilities, solely by a doctor or in the physical presence of certain providers, was not safe or secure improves the quality of care.
Mifepristone is used with misoprostol to stop early pregnancy. The FDA first approved Mifeprex for use up to 10 weeks of pregnancy in 2000. According to the FDA, mifepristone is approved in more than 60 other countries.
Many states prohibit the shipping of abortion pills
However, according to the Guttmacher Institute, there are laws in 19 states that prohibit telemedicine consultations or the shipping of abortion pills.
Reuters reported that women in these states would not be able to use the rule change to get the drug delivered to their homes, but could potentially travel to other states to have an abortion from drugs.
“States like California and New York that have tried to improve access to abortion may make the drug available to women from other states,” Reuters reported.
Jessica Arons, senior advocacy and policy counsel for reproductive freedom at ACLU, told CBS News, “Drug abortion is another lens through which we see that we are witnessing a history of two countries. Half of the states protect access to abortion and the other half try in every possible way to prevent access to abortion care. “
Positive results when Canada lifted restrictions
As this news organization reported, a study found positive results when Canada lifted restrictions on access to abortion pills and a good safety profile for mifepristone.
A study in the New England Journal of Medicine found that abortion rates remained stable and adverse events were rare after prescribing restrictions on mifepristone were lifted in Canada.
Senior author Wendy V. Norman, MD, a professor in the Department of Family Practice at the University of British Columbia, Vancouver, said in a statement, “Our study is a signal to other countries that restrictions are not necessary to ensure patient safety guarantee.”
Another recent study in the JAMA Network Open (2021 August 24th doi: 10.1001 / jamanetworkopen.2021.22320) found that abortions via telemedical prescriptions can be just as safe and effective as personal care.
The study’s investigators said that “Of the 110 women from whom the researchers collected data on remote abortion outcomes, 95% had a full abortion with no additional medical interventions such as aspiration or surgery, and no adverse events occurred. The researchers said this effectiveness rate is similar to that of face-to-face visits. “
This story originally appeared on MDedge.com, part of the Medscape Professional Network.
