By KATHERINE ELLEN FOLEY, DAVID LIM, MEGAN MESSERLY and ALICE MIRANDA OLLSTEIN 04/10/2023 03:39 PM EDT
A Texas judge’s decision to rescind the FDA’s approval of the abortion pill could jeopardize access to the most popular method of terminating a pregnancy.
And many in government and inside the pharmaceutical industry fear that it could also undermine the agency’s broader authority to regulate medicines, opening the door for courts to question approvals of anything from birth control pills to new treatments for debilitating diseases. HHS Secretary Xavier Becerra suggested insulin, vaccines and new Alzheimer’s drugs could conceivably all come under scrutiny if U.S. District Court Judge Matthew Kacsmaryk’s ruling is upheld.
While Kacsmaryk stayed his decision until Friday and the Biden administration has already appealed to the 5th U.S. Circuit Court of Appeals, the ramifications from Friday’s decision for the FDA and the drug industry could be felt for decades regardless of how this case is ultimately decided.
Here’s what we know:
Will the decision turn the FDA approval process “upside down”? Experts disagree. Kacsmaryk’s ruling focused on the procedures around mifepristone’s approval and the FDA’s delayed response to petitions from anti-abortion organizations asking the agency to reconsider. It did not directly address FDA’s approval authority, said Greer Donley, an associate professor at the University of Pittsburgh law school.
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