Nearly every GOP senator on Thursday urged the Food and Drug Administration to revisit its decision to approve a new generic form of the abortion pill mifepristone.
Fifty-one senators said they were pleased to see Health and Human Services Secretary Robert F. Kennedy Jr. commit to a general safety review of the drug, “given the recent studies raising concerns about the drug’s safety.”
“Given this commitment, however, we are deeply concerned about the FDA’s approval of a new generic version of mifepristone,” they wrote in a letter to Mr. Kennedy and Food and Drug Commissioner Marty Makary. “While we recognize the FDA’s statutory responsibility in evaluating drug applications, the timing of this approval appears inconsistent with the comprehensive safety reassessment your agencies have prioritized.”
The White House said the recent decision to approve a version of mifepristone by Evita Solutions had been required by law because it demonstrated the same effects as the brand-name version.
“It’s not an endorsement of this drug by any means. They are just simply following the law,” White House press secretary Karoline Leavitt said earlier this month.
Every Senate Republican signed the letter, except Sens. Susan Collins of Maine and Lisa Murkowski of Alaska, who’ve historically been more pro-choice than fellow GOP lawmakers.
Democrats and blue states have pushed to broaden access to abortion pills, and Evita Solutions has defended the safety of its drug.
“Medical abortion with mifepristone is an effective, safe way to terminate early pregnancy,” it says on its website.
Mifepristone was first approved in 2000, and the Biden administration expanded access to versions through online prescribing and mail-order, angering conservatives.
The pill is approved to end pregnancies through 10 weeks.
Pro-life groups were upset to learn about the recent generic approval under Mr. Kennedy, because the Trump administration had pledged to push back on abortion.
In their letter, senators asked the administration to suspend any approvals of generic versions of mifepristone pending its review of prior Risk Evaluation and Mitigation Strategies (REMS) approvals.
The senators pointed to data and studies that suggest the risks from the pill are higher than what’s stated on the drug label.
They also said the issue is a matter of state autonomy, pointing to the Supreme Court’s “Dobbs” decision that eliminated the broad nationwide right to abortion and reverted the issue to the states.
“Unrestricted access to abortion pills is systematically undermining states’ rights and violating pro-life state laws,” the senators wrote. “Every month, thousands of abortion drugs are shipped into states that have otherwise limited access to abortion after Dobbs, degrading pro-life laws at the state level across the country.”
• Tom Howell Jr. can be reached at thowell@washingtontimes.com.