The Biden administration has pledged to “follow the science” when approving drugs. It will also vigorously safeguard reproductive rights.
FDA career scientists have raised concerns about the drug’s safety and efficacy, even as the agency and the White House are under pressure to expand contraceptive options in a highly charged political environment around abortion, which has dramatically shrunk since the Supreme Court overturned Roe v. Wade last year.
“I’m very aware [that] in this exact moment in time… we have just spent months… screaming ‘the FDA is a scientific authority,’ over and over again,” said Greer Donley, an associate professor at the University of Pittsburgh law school who supports abortion access. It makes it tougher to criticize the FDA when we think their conclusion has serious problems.
Two expert panels may approve the FDA’s first non-prescription birth control pill this week
The agency’s independent advisors met Tuesday and will meet Wednesday to evaluate data from the pill’s producer to propose the FDA approve Opill for over-the-counter sale. FDA approval would advance the decades-long drive to make hormonal contraception available without a prescription in the U.S. Summer will bring a decision.
HRA Pharma, the pill’s maker, and many health care providers and abortion-rights supporters argue that the Biden administration should approve the pill given the rapid erosion of abortion access after Roe v. Wade last summer and the urgent need to help patients avoid unwanted pregnancies.
In briefing notes for the two-day conference released Friday, FDA officials warned that customers may not comprehend and follow the pill’s instructions, which include taking it at the same time every day, potentially reducing its efficacy. The FDA also questioned the pill’s manufacturer’s use of 50-year-old data from its 1973 prescription approval.
Ibis Reproductive Health and the American College of Obstetricians and Gynecologists, which are pushing the Biden administration to approve Opill, told reporters Monday that the FDA’s analysis was “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 groups were confident that this week’s advisory panels would resolve the agency’s worries.
Other analysts say the Biden administration and the FDA confront a difficult dilemma and will be criticized and accused of political involvement whether the tablet is allowed over FDA employee objections or refused.
“We’re between a rock and a hard place,” Donley remarked.
The FDA and White House declined comment
The Catholic Medical Association, National Association of Catholic Nurses, and American Association of Pro-Life Obstetricians and Gynecologists are also exerting political pressure. They want the FDA to deny Opill OTC clearance.
Students for Life Action president Kristan Hawkins said she is “offended” that the FDA is considering the pill’s over-the-counter approval given the nation’s record rate of sexually transmitted infections.
Carolyn Sufrin, an associate professor of gynecology and obstetrics at Johns Hopkins University School of Medicine, said that Plan B, the “morning after” pill, was approved for over-the-counter sale a decade ago, but promiscuity has not increased.
The FDA advisory council met Tuesday to discuss how HRA Pharma trial data may be utilized by U.S. consumers. HRA Pharma presented study data to the FDA on how effectively people could utilize Opill without medical assistance. They asked more than 1,700 people to decide if the tablet was right for them and then tracked roughly 900 participants, who electronically logged daily pill use.
HRA Pharma found that everyone, even teenagers and those with low health literacy, could take the tablet correctly.
However, FDA experts identified major data concerns. The business didn’t submit the research protocol to the government, and a “substantial portion” of study participants stated they took more tablets than they were given, casting doubt on the new study’s rigor.
The experts also questioned whether the company’s evidence used to certify Opill for prescription usage would still apply now, when obesity has skyrocketed and become a major health concern.
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Senate tax head claims billionaire Crow “stonewalling” on perks for Clarence Thomas On Monday, supporters of a non-prescription birth control pill demonstrated outside the White House with medical experts and teenagers who have faced birth control access barriers, as well as an obstacle course to represent what patients must go through to get a prescription. Rally organizers said that researchers have had decades to assess the tablets’ safety and efficacy and have not raised concerns, highlighting that the public health advantages of avoiding unplanned births exceed the dangers.
“More than 50 years of research and science speaks for itself on birth control pill safety and efficacy,” said Free the Pill Youth Council manager Angela Maske. The statistics suggest that consumers can self-screen for contraindications and utilize the drug properly without a doctor.
Advocates worry that decades of social discomfort and heated debates over sexually active youth will influence the FDA’s decision to approve non-prescription Opill.
“There always seems to be a lot more government involvement and control of what they can and cannot have easy access to,” said Sufrin. Non-political drugs are simpler to get. Ibuprofen is significantly riskier than the medicine under consideration for over-the-counter classification.
Mara Gandal-Powers, director of birth control access and senior counsel at the National Women’s Law Center, sees the yearslong regulatory and legal battle to get Plan B emergency contraception approved over-the-counter as a cautionary tale.
Gandal-Powers said lawsuit revealed political influence. The age limit was unscientific. It was ideological—young people shouldn’t have easy access to contraception.”
No matter the FDA’s decision, litigation and citizen petitions are likely due to Plan B’s approval history and the political battle for reproductive rights.
“We can’t pretend that this is happening in a vacuum outside of politics,” Donley added at day’s conclusion. “All decisions are political.”