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“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 makes it harder for us 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 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.
But in a briefing document for the two-day meeting released Friday, FDA staff warned that consumers may not be able to understand and follow instructions on the pill. The FDA has also raised concerns about pill manufacturers relying on data that goes 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 asking the FDA to 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 while the company submitted protocols for studies on whether participants followed pill instructions correctly, it did not submit protocols for some supporting studies to government agencies beforehand. The agency’s scientists questioned its rigor, noting that a “substantial portion” of the study’s participants said they took more than they received. The scientists also said the data submitted by the company to approve prescription use of Opil is now a far greater health problem than it was in the early 1970s, with the dramatic rise in obesity over recent decades. I also doubt if it applies.
Proponents of non-prescription contraceptives held a demonstration outside the White House on Monday, highlighting testimonies from medical professionals and teens who have encountered barriers to access to contraception and what patients currently have to do. He presented an obstacle course that symbolizes what must be done. Please go to get a prescription. Organizers of the rally argued that researchers had spent decades evaluating the pill’s safety and efficacy but had so far raised no concerns about avoiding unwanted pregnancies. He stressed that the public health benefits of HIV outweigh the risks.
“More than 50 years of research and science tell us about the safety and efficacy of oral contraceptives,” said Angela Muske, manager of the Free The Pill Youth Council. “The data show that people can self-screen for contraindications and use drugs appropriately, whether they are under medical supervision or not.”
Many proponents remain skeptical of the numbers around the concept of sexually active youth, no matter how solid the data submitted to the FDA, or how the Biden administration vows to “follow science” in its decisions. I fear that a decade of social discomfort and bitter fighting will have an impact. Whether Opill without a prescription is approved.
“When it comes to allowing people to control their reproductive destinies and desires, there always seems to be more government involvement and control over what people can and cannot easily access. ,” says Suffrin. “Politically less burdensome medicines tend to be much easier to access. much higher.”
The previous clash of science and politics on contraceptive access looms large over the debate — particularly the multi-year call for over-the-counter approval of Plan B emergency contraceptives proposed by Mara Gandal-Powers, Director of Contraceptive Access. Especially in regulation and legal battles. 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, any decision by the FDA could result in lawsuits and public petitions.
After all, “you can’t pretend this is happening in a vacuum outside of politics,” said Donley. “All of these decisions are also political.”
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