With the U.S. Supreme Court’s overturn of Roe V. Wade ending the constitutional right to abortion on June 24, attention is on how the ruling will impact prescriptions of abortion-inducing medications.
Roe v. Wade was a landmark decision by the U.S. Supreme Court in 1973 that recognized women’s “right to privacy” in the Fourteenth Amendment, which protected a pregnant woman’s right to an abortion until the fetus can survive on its own outside the womb.
However, the Supreme Court overturned its own decision after 49 years, causing a social uproar in the U.S. The latest ruling will make abortion illegal in 26 out of 50 U.S. states.
The Roe overturn is likely to affect the use of abortion drugs in states that prohibit ending a pregnancy because the conflict over the abortion right is spreading to the problems of remote prescriptions and mail delivery of abortion medications.
The FDA used to mandate a doctor’s prescription to use an abortion drug but temporarily eased the rule due to the Covid-19 pandemic. Then, the FDA deleted the rule in December last year.
States that ban abortion plan to restrict the supply of abortion medicines. However, a controversy erupted over whether a state government could restrict or prohibit an FDA-authorized medicine.
After the Supreme Court’s June 24 ruling, the FDA said mifepristone, a drug ingredient for a medical abortion, was regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and that the drug would be supplied to patients who need it.
In states where abortion is legal, women can get prescriptions for abortion pills. Thus, observers said that more women living in states banning abortion are expected to purchase abortion drugs in other states that allow abortion.
The American Medical Association issued a statement criticizing the overturn of Roe v. Wade.
“The American Medical Association is deeply disturbed by the U.S. Supreme Court’s decision to overturn nearly a half-century of precedent protecting patients’ right to critical reproductive health care,” the AMA said.
The decision was an “egregious allowance of government intrusion into the medical examination room, a direct attack on the practice of medicine and the patient-physician relationship, and a brazen violation of patients’ rights to evidence-based reproductive health services,” it added.
For a medication abortion, mifepristone, which blocks the action of progesterone, should be used in combination with misoprostol, which induces a uterine contraction.
According to the U.S. Centers for Disease Control and Prevention (CDC), 42 percent of American abortions are carried out through medications.
In Korea, no abortion pill has received approval from the Ministry of Food and Drug Safety. Plus, there is no local law that supports medication abortion. Although the Constitutional Court decided to make abortion legal in 2019, lawmakers have yet to amend the related laws.
Hyundai Pharm, a Korean drugmaker, said last year that it would introduce Mifegymiso (mifepristone, misoprostol), an oral treatment for abortion, in the local market.
However, the plan has failed to make progress because the MFDS has yet to conclude whether to waiver a bridging trial. The MFDS requested the company to submit additional data for approval review.
How the U.S. overturning the abortion right will affect discussions about introducing an abortion pill to Korea is drawing attention.