“I know very well [that] Greer Donley, an associate professor at the University of Pittsburgh Law School and an advocate for increased access to abortion, said: “It becomes difficult to criticize [the FDA] When we think their decisions are justifiably flawed. “
The agency’s independent advisors will meet on Tuesday and Wednesday to review data from the tablet manufacturers and decide whether to recommend that the FDA approve the drug Opill for over-the-counter marketing. FDA approval would be a major step forward in a decades-long campaign to join the United States in joining dozens of other countries where hormonal contraceptives are available without a prescription. A decision is expected later this summer.
Pill maker HRA Pharma is backed by many health care providers and abortion rights advocates, and given the rapid loss of access to abortion after the collapse of the United States, the Biden administration has It claims that giving approval is particularly compulsory. Law vs Wade Last summer and the patient’s pressing need to avoid unwanted pregnancies.
however, Explanatory material At a two-day meeting published Friday, FDA staff warned that consumers may not be able to understand and follow the instructions on the pill. The FDA has also raised concerns about pill manufacturers relying on data dating back 50 years, from when the drug was approved for prescription use in 1973.
Groups urging the Biden administration to approve opil, including Ibis Reproductive Health and the American College of Obstetricians and Gynecologists, told reporters on Monday that the FDA’s analysis was “surprising” and “disappointing” and that “strong body It doesn’t reflect anything we know.” Evidence on the Safety and Effectiveness of the Pill”. The group expressed confidence that the agency’s questions and concerns would be resolved after deliberations by its advisory committee this week.
But other experts say the Biden administration and the FDA face tough decisions. Whether the pill is approved or rejected over the objections of FDA staff, they say they will likely be accused and accused of political interference.
“We’re caught between a rock and a hard place,” says Donley.
The FDA and White House did not respond to requests for comment.
Political pressure also comes from anti-abortion and religious groups such as the Catholic Medical Association, the National Catholic Nurses Association, and the American Association of Professional-Life Obstetricians and Gynecologists.they are Request to FDA Block OTC approval of Opill.
Kristan Hawkins, chairman of the advocacy group Students for Life Action, said he fears lifting restrictions on oral contraceptives would increase unprotected sex, prompting FDA approval of the pill over-the-counter. He added that he was “offended” that he was considering Given the country’s current record rate of sexually transmitted infections.
Similar predictions about an increase in promiscuity were made when Plan B, the so-called “morning after” pill, was sought over-the-counter approval, a decade after it was approved for sale without a prescription. but it hasn’t happened yet. said Carolyn Sufrin, associate professor of gynecology and obstetrics at the Johns Hopkins University School of Medicine.
The FDA’s advisory committee meeting on Tuesday focused on how trial data from HRA Pharma translates into real-world use among US consumers. In filing with the FDA, HRA Pharma submitted the results of recent research into how successfully consumers can use her Opill without the help of a healthcare provider. More than 1,700 participants were asked to determine if the pill was appropriate, and nearly 900 participants were tracked and electronically recorded daily whether they took the pill.
HRA Pharma concluded that the study showed that the general population, including adolescents and those with limited health literacy, could take the pill correctly.
But FDA scientists have raised serious questions about the data in general. They noted that although they submitted protocols for studies to determine whether participants correctly followed the instructions on the pill, the company had not previously submitted protocols for some ancillary studies to the agency. Scientists at the institution flagged that a “significant portion” of the study’s participants said they took more pills than they received, questioning its rigor. also noted that obesity has risen dramatically in recent decades and has become a far greater health problem than it was in the early 1970s, so much so that the company’s submission data used to approve prescription use of Opil is not today. I also questioned whether it would apply.
Proponents of non-prescription oral contraceptives marched outside the White House on Monday to hear testimony from medical professionals and teens who have encountered barriers to access to contraceptives, as well as testimonials from patients who have encountered barriers to access. We’ve taken an obstacle course to represent what you have to do now. I will go pick up my prescription. The organizers of the rally argued that researchers had spent decades evaluating the pill’s safety and efficacy and had never raised any concerns, arguing that the public could benefit from avoiding unwanted pregnancies. He emphasized that the health benefits outweigh the risks.
Free The Pill Youth Council Manager Angela Muske said: “The data show that people can self-screen for contraindications and use drugs appropriately, whether they are under medical supervision or not.”
No matter how robust the data presented to the FDA, no matter how much the Biden administration promised to “follow the science” in its decisions, many advocates are skeptical about decades of social stigma and sexual harassment. I fear that the fierce battle over the ideas of the active youth will play a role.Whether nonprescription Opill is approved.
“When it comes to people being able to control their own reproductive destinies and desires, there seems to be constant government involvement and control over what they can and cannot easily access,” Sufrin said. “Politically less burdensome medicines tend to be much easier to access. of events are much higher.”
When it comes to contraceptive access, the previous conflict between science and politics has greatly overshadowed this debate. In particular, the years of regulatory and legal battles to get over-the-counter approval for Plan B’s emergency contraceptive pills by Mara Gandal Powers, head of contraceptive access. and senior attorneys at the National Center for Women’s Law consider it a didactic story.
“Through the lawsuit, it became clear that it was an act of political interference,” said Gandhar Powers. “There was no science to back up the age limit. It was based on the ideological belief that young people shouldn’t have easy access to contraception.”
Given the history of Plan B approvals and the current political tug-of-war over access to reproductive rights, lawsuits and public petitions are possible no matter what the FDA decides.
After all, “you can’t pretend this is happening in a vacuum outside of politics,” said Donley. “All of these decisions are also political.”
