© Reuters. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly
NEW YORK (Reuters) -The U.S. Food and Drug Administration on Thursday said that it would permanently ease some restrictions on a pill used to terminate early pregnancies, removing a requirement that it be dispensed in person and making it easier to obtain by mail.
The decision comes as the right to obtain an abortion, established in the 1973 Supreme Court ruling Roe v. Wade, hangs in the balance.
The drug, generically known as mifepristone, is approved for use to up to 10 weeks of pregnancy and is also sometimes prescribed to treat women who are having miscarriages.
“The FDA’s decision will come as a tremendous relief for countless abortion and miscarriage patients,” said Georgeanne Usova, senior legislative counsel at the ACLU.
The restrictions on the pill had been in place since the FDA approved the drug in 2000 and were lifted temporarily by the government earlier this year due to the pandemic. The FDA’s decision makes that temporary change permanent.
As a result of the FDA rule change, many patients will no longer need to go to a clinic, medical office or hospital in person to receive the medication, but can opt to receive the pill through the mail from a certified prescriber or pharmacy.
Removing the requirement for in-person dispensing will increase access to medication abortion for some women in remote and rural areas without providers nearby.
Low-income women who face obstacles reaching clinics such as lack of transportation and inability to take time off work will also gain greater access to the drug.
However, 19 states have laws that supersede the FDA decision, barring telehealth consultations or mailing of abortion pills. Women in those states will not be able to take advantage of the FDA’s decision on Thursday.
The change is likely to add to the intense U.S. political debate over abortion. Conservative Supreme Court justices indicated https://www.reuters.com/world/us/us-supreme-court-consider-rolling-back-abortion-rights-2021-12-01 in Dec. 1 oral arguments over an abortion ban in Mississippi at 15-weeks of pregnancy that they are open to either gutting Roe or overturning it entirely. A decision is due by the end of June.
SOME RESTRICTIONS REMAIN
The FDA left in place some of the restrictions, such as the need to use a certified pharmacy and requiring the prescribers to be certified. The ACLU said it was “disappointing that the FDA fell short of repealing all of its medically unnecessary restrictions on mifepristone and these remaining obstacles should also be lifted.”
The organization sued the U.S. government on behalf of a
Hawaii doctor and several professional health care associations in 2017 challenging the restrictions that it said limited access to medication abortion.
Medication abortion involves two drugs, taken over a day or two. The first, mifepristone, blocks the pregnancy-sustaining hormone progesterone. The second, misoprostol, induces uterine contractions.
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