The agency is slated to make a decision on approval of the daily hormonal pill by this summer.
The Biden administration has long vowed to “follow the science” on drug approvals. But it has also pledged to aggressively defend reproductive rights.
The agency’s independent advisers met Tuesday and will meet Wednesday to review data from the pill’s maker to decide whether to recommend the FDA approve the drug, Opill, for over-the-counter sale. FDA approval would be a major step forward for the decadeslong campaign to have the U.S. join dozens of other countries where hormonal contraceptives are available without a prescription. A decision is expected sometime this summer.
But other experts say the Biden administration and the FDA face a difficult decision — and they’re likely to be excoriated and accused of political interference whether the pill is approved over the objections of FDA staff or rejected.The FDA and the White House did not respond to requests for comment.
Given Plan B’s approval history and the current political tug-of-war over reproductive rights access, lawsuits and citizen petitions are possible no matter what decision the FDA makes. | Justin Sullivan/Getty Images Advocates in favor of a non-prescription birth control pill held a demonstration outside the White House on Monday, featuring testimony from medical experts and teenagers who have encountered barriers to birth control access, as well as an obstacle course to symbolize what patients currently have to go through to get a prescription.
“When it comes to people being able to control their own reproductive destinies and desires, there always seems to be a lot more government involvement and control of what they can and cannot have easy access to,” said Sufrin. “There tends to be much easier access to less politically charged medications. Something as common as ibuprofen carries much higher risks of complications and high-risk events than the drug up for consideration for over-the-counter status.
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