WASHINGTON (OSV News) -- The Food and Drug Administration recently approved a new generic form of mifepristone -- a pill commonly, but not exclusively, used for early abortion -- drawing criticism from pro-life advocates. It marks the second time a Trump administration has approved a generic form of the pill.
On Sept. 30, the FDA notified Evita Solutions that its generic version of mifepristone was approved, despite previous suggestions from FDA and Department of Health and Human Services officials that mifepristone would undergo a review.
The move was met with condemnation by former Vice President Mike Pence, who wrote in a post on X, "The Trump Administration's approval of a generic chemical abortion drug is a complete betrayal of the pro-life movement that elected President Trump."
Pence previously advocated for the Senate to reject Trump's nomination of Robert F. Kennedy Jr., a Catholic and scion of the famous Kennedy political clan, as HHS secretary in part due to his views supporting legal abortion. Kennedy was ultimately confirmed to the role.
Pence argued the approval of the drug should prompt Kennedy's resignation.
"Earlier this year, I opposed RFK's nomination because he was unfit for the role and particularly over the concern that he would expand access to abortion, as he has done today," Pence wrote.
"President Trump must immediately reverse this decision. RFK must resign and give President Trump the opportunity to appoint a new Secretary of HHS who will protect the sanctity of life," he said. "The fight for life continues."
Sen. Josh Hawley, R-Mo., a close ally of Trump, also expressed surprise in his own comments on X.
"FDA had promised to do a top-to-bottom safety review of the chemical abortion drug, but instead they've just greenlighted new versions of it for distribution," he said. "I have lost confidence in the leadership at FDA."
Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, which works to elect pro-life candidates to public office, said in a statement, "This reckless decision by the FDA to expand the availability of abortion drugs is unconscionable."
"These dangerous drugs take the lives of unborn children, place women and underage girls at serious risk, empower abusers, and trample the pro-life laws enacted by states across the nation," she said.
Dannenfelser, who is also Catholic, argued that "Secretary Kennedy said the Biden administration 'twisted the data to bury one of the safety signals.' Secretary Kennedy and FDA Commissioner Makary assured Congress and the American people they would conduct a thorough review given credible evidence of the harm inflicted by these drugs. The prompt completion of the review is made more urgent given this approval to flood the market with a cheap abortion drug."
"The FDA must, at a minimum, immediately reinstate the commonsense safeguards that were in place during President Trump's first term," she said.
Kristan Hawkins, president of Students for Life of America and Students for Life Action, and a Catholic, argued in a statement the drug's approval was "a stain on the Trump Presidency and another sign that the deep state at the FDA must go."
However, the Evita Solutions generic is actually the second approved generic pill for mifepristone. The first generic pill for abortion -- from GenBioPro -- was approved in 2019, during the first Trump presidency.
Prior to Evita Solutions' announcement, GenBioPro claimed to have cornered two-thirds of the U.S. market for mifepristone.
In comments posted on X, Kennedy said, "The Biden administration removed mifepristone’s in-person dispensing rule without studying the safety risks. We are filling that gap."
Kennedy said he and FDA Commissioner Martin Makary last month sent a letter to state attorneys general "pledging to review all the evidence -- including real-world outcomes -- on the safety of this drug. Recent studies already point to serious risks when mifepristone is used without proper medical oversight."
Kennedy claimed the FDA "only approved a second generic mifepristone tablet because federal law requires approval when an application proves the generic is identical to the brand-name drug."
The Drug Price Competition and Patent Term Restoration Act of 1984, sometimes called the Hatch-Waxman Act, streamlined the approval process for generic drugs but still requires them to undergo a review to ensure they are "bioequivalent" to their name-brand counterparts and meet the FDA's safety standards.
The Catholic Church teaches that all human life is sacred from conception to natural death, and as such, opposes direct abortion.
Approved by the FDA for early abortion in 2000, mifepristone -- the first of two drugs used in a medication-based abortion -- gained the moniker "the abortion pill." However, the same drug combination has become used sometimes in recent years for miscarriage care, where an unborn child has already passed, a situation that Catholic teaching would hold as morally licit use.
