- The Washington Times - Friday, March 1, 2024

The lawyer representing a group of pro-life doctors in a challenge to the abortion pill said the Supreme Court case isn’t about abortion but about product safety laws, arguing the Food and Drug Administration ran afoul of federal law in easing the distribution of mifepristone.

Erin Hawley, senior counsel with the Alliance Defending Freedom, said the FDA eased restrictions on the abortion pill’s distribution in violation of the Administrative Procedure Act.

The FDA had moved to limit the number of in-person doctor visits needed to obtain the drug and also allow it to be used longer into pregnancy. The changes have led to more women ending up in emergency rooms, according to Ms. Hawley’s client, Dr. Christina Francis, CEO of the American Association of Pro-Life Obstetricians and Gynecologists.

“This particular case is not about access, but just making sure that if women are going to take these drugs, that there is some minimum requirement of safety,” said Ms. Hawley.

Dr. Francis said, “Women, regardless of the fact of whether they are seeking an abortion or not, deserve excellent health care and that’s not what they are seeing right now because of the FDA’s actions.”

SEE ALSO: Trump ponders 15 or 16 weeks as abortion limit

Mifepristone is used with misoprostol to terminate a pregnancy.

The abortion pill accounts for more than half of abortions in the United States. More than 5 million women have used it since 2000.

Alliance Defending Freedom cites studies showing that 1 out of 25 women who take the pill end up in emergency rooms, arguing it is not as safe as Advil — or other pain relief drugs — as the FDA has claimed.

“Not 1 in roughly 25 women who take Advil end up in the emergency room. There is simply no comparison,” Ms. Hawley said.

The legal battle will come before the justices on March 26 and it is one of the most closely watched battles from the Justice Department, which appealed a lower court ruling restricting the use of mifepristone.

The feds say the drug has been used throughout five presidential administrations and more than half of American women who choose to end pregnancies use mifepristone.

“Study after study has shown that when mifepristone is taken in accordance with its approved conditions of use, serious adverse events are exceedingly rare,” the Justice Department argued in its high court filing.

A district court ruled the drug should not have had FDA approval at all but the 5th U.S. Circuit Court of Appeals did not go that far. Instead, the appeals panel said the drug could still be dispensed but not through the mail as regulators had begun to allow in 2016, and only up to seven weeks into pregnancy.

The abortion pill has been available for at least two decades, but in recent years the FDA has moved to reduce the number of in-person doctor visits women would need to obtain the pill and alter the gestation period for which it could be dispensed.

The justices will consider how long the pill can be prescribed during pregnancy and whether it can be mailed as federal officials had proposed in recent administrative changes.

However, the court rejected another case from the same group of pro-life doctors who asked the justices to review the pill’s initial FDA approval during the Clinton administration.

The drug was approved in 2000 for up to seven weeks of pregnancy, but its administration required three steps: first, a visit with a doctor to receive mifepristone, then another one to get the drug misoprostol, and finally a follow-up to address complications.

The pill has remained available during the appellate process after the Supreme Court placed the lower court ruling on hold.

Danco Laboratories, a producer of mifepristone, petitioned the high court over its production of the pill, challenging the lower court’s restrictions on its distribution.

• Alex Swoyer can be reached at aswoyer@washingtontimes.com.

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