Political pressure is also coming from anti-abortion and religious groups, including the Catholic Medical Association and the National Association of Catholic Nurses. The FDA and the White House did not respond to requests for comment. “We’re caught between a rock and a hard place,” said Donley. The groups voiced confidence that the agency’s questions and concerns would be put to rest after this week’s advisory committees’ deliberations.īut 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. Groups pushing the Biden administration to approve Opill, including Ibis Reproductive Health and the American College of Obstetricians and Gynecologists, told reporters Monday the FDA’s analysis is “surprising” and “disappointing,” and “absolutely did not reflect what we know about the strong body of evidence on safety and effectiveness” of the pill. The FDA also raised concerns about the pill’s manufacturer relying on 50-year-old data from when the pill was approved for prescription use in 1973. However, in briefing documents for the two-day meeting made public Friday, FDA staff warned that consumers may not be able to understand and follow the pill’s instructions, which include taking it at the same time every day, potentially lowering its effectiveness. This illustration provided by Perrigo depicts proposed packaging for Opill, the company's birth control medication. Wade last summer and the pressing need to help patients avoid unwanted pregnancies. HRA Pharma, the pill’s maker - backed by many health care providers and abortion-rights supporters - argue it’s especially incumbent upon the Biden administration to grant approval given the swift erosion of abortion access after the fall of Roe v. A decision is expected sometime this summer. join dozens of other countries where hormonal contraceptives are available without a prescription. FDA approval would be a major step forward for the decadeslong campaign to have the U.S. 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. “It makes it harder for us to criticize when we think there are legitimate flaws with their decision.” “I’m very aware in this exact moment in time … we have just spent months … screaming ‘the FDA is a scientific authority,’ over and over and over again,” said Greer Donley, an associate professor at the University of Pittsburgh law school who favors increased abortion access.
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