Fifty-one Republican senators are pressing Health and Human Services Secretary Robert F. Kennedy Jr. and Food and Drug Administration Commissioner Marty Makary to take mifepristone, one of the drugs used in medication abortions, off the market.
"Your agencies have all the information they need to bring an end to previous Democrat administrations' abortion drug regulations while a comprehensive review is conducted," they wrote in a letter Thursday to Kennedy and Makary.
The lawmakers recommended that the agencies suspend approval of any new generic versions of mifepristone pending the outcome of the risk evaluation and mitigation strategies, or REMS, review.
They also asked HHS and the FDA to commit to ensuring that all such versions are included in the ongoing reevaluation of prior REMS approvals, and reinstate the in-person dispensing requirement for mifepristone and its generic versions.
Further, they pressed the agencies to suspend the distribution of mifepristone and all generic versions as an "imminent hazard" under Section 505(e) of the Federal Food, Drug, and Cosmetic Act and withdraw FDA guidance permitting pharmacy distribution of mifepristone and all its generic versions.
Mifepristone was approved by the FDA in 2000.
In 2021, the FDA under President Joe Biden permitted online prescribing and mail-order delivery of the drug, greatly expanding access. Abortion opponents have been fighting the change ever since.
Just two days ago, the FDA approved a second generic version of the drug, a move that drew criticism from anti-abortion voices.
Former Vice President Mike Pence called it a "a complete betrayal of the pro-life movement that elected President Trump" and called for Kennedy's resignation.
Sen. Josh Hawley, R-Mo., said he had "lost confidence in the leadership at FDA."
"This is shocking. FDA has just approved ANOTHER chemical abortion drug, when the evidence shows chemical abortion drugs are dangerous and even deadly for the mother. And of course 100% lethal to the child," he wrote on X on Thursday afternoon.
"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. I have lost confidence in the leadership at FDA," Hawley added.
HHS spokesman Andrew Nixon said in a statement that "the FDA has very limited discretion in deciding whether to approve a generic drug. By law, the Secretary of Health and Human Services must approve an application if it demonstrates that the generic drug is identical to the brand-name drug."
In a letter to Republican attorneys general last month, Kennedy and Makary pledged to conduct a full review of the drug's safety.
Access to mifepristone is restricted across large sections of the country because of state laws that ban abortion — including drug-induced abortion — or impose separate restrictions on the drug's use.
Those laws are subject to a number of ongoing lawsuits that are winding their way through the legal system.
Newsmax wires contributed to this report.
Solange Reyner ✉
Solange Reyner is a writer and editor for Newsmax. She has more than 15 years in the journalism industry reporting and covering news, sports and politics.
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