FDA committee votes on over-the-counter capsule
Opill oral contraception
A panel of experts advising the Food and Drug Administration unanimously recommended on Wednesday that the agency, for the first time, allow women to obtain birth control pills without a prescription.
The panel had been asked whether the benefits of selling HRA Pharma’s birth control pill Opill outweigh the risks of improper use of the drug leading to an unwanted pregnancy.
The FDA is not required to follow the recommendations of its independent advisors, all 17 of whom voted “yes” to the proposal after a two-day hearing.
However, HRA Pharma expects a final decision from the FDA this summer on its application to sell Opill, commonly referred to as norgestrel, over-the-counter. The Paris-based drugmaker is owned by Perrigoa manufacturer of over-the-counter medicines.
Since they were approved in the United States more than 60 years ago, oral contraceptives have only been available to women with a prescription. If the FDA approves HRA Pharma’s application, women could receive Opill without first having to see a doctor or other healthcare provider.
“The history of female contraception is a struggle for women’s control over their reproduction, and we have to trust women,” said Dr. Katalin Roth, FDA Advisory Board Member and Professor of Medicine at George Washington University
“I urge the FDA to approve the over-the-counter availability of Opill,” Roth said in justifying her vote in HRA Pharma’s application.
The FDA originally approved norgestrel as a prescription drug in 1973. But the company halted U.S. sales of the pill in 2005 for business reasons, the agency said.
HRA Pharma updated the pill’s label in 2017 in hopes of reintroducing the drug to the US market, explicitly as an over-the-counter drug.
Medical groups like the American College of Obstetricians and Gynecologists have been pushing for years to allow birth control pills to be sold over-the-counter
In March 2022, more than 50 members of Congress called on FDA Commissioner Dr. Robert Califf to ensure that the agency reviews applications for over-the-counter birth control pills promptly.
“This is a critical issue for reproductive health, rights and justice,” lawmakers wrote in a letter to Califf.
“Despite decades of proven safety and effectiveness, people still face immense barriers to access contraception due to systemic inequalities in our healthcare system.”
According to a study published in 2016 by the New England Journal of Medicine, nearly half of all pregnancies in the United States in 2011 were unintended.
And according to this study, 75% of all pregnancies in girls between the ages of 15 and 19 were unwanted.
HRA Pharma filed its application with the FDA last summer, two weeks after the Supreme Court abolished state abortion rights by overturning its landmark Roe v. Wade from 1973.
The case of Roe v. Wade led some states to ban abortion or place severe restrictions on the procedure. It also led to legal efforts to take abortion drugs off the US market.
Shrinking access to abortion in the US, in turn, prompted renewed calls for expanded access to birth control to prevent unwanted pregnancies.
FDA questions company data
Norgestrel contains a hormone called progestin that prevents pregnancy by thickening cervical mucus to prevent sperm from reaching and fertilizing an egg. The pill should be taken at the same time each day.
Progestogen-only pills are typically used by women who, for health reasons, do not want to take the more common combination pills that contain progestin and estrogen.
Progestogen-only pills are an effective method of birth control, but according to the American College of Obstetricians and Gynecologists, it’s important to take the pill at the same time each day.
According to the medical association, with typical real-world use, around 9 out of 100 women become pregnant in the first year of taking the pill. If the patient never forgets to take a pill, less than 1 in 100 women will become pregnant in the first year.
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However, FDA scientists have raised concerns about whether the general public, particularly adolescents and those with lower literacy levels, will understand norgestrel’s drug labeling and use the drug properly.
The FDA also found that one-third of the participants in HRA Pharma’s study reported taking more norgestrel pills than were actually dispensed.
dr Theresa Michele, head of the FDA’s Nonprescription Drugs Division, said these errors questioned whether other data in the study were reliable.
“I can’t think of any study that has 30% invalid data,” Michele told the committee on Wednesday. “It really doesn’t come up in any study, let alone a consumer study of this kind – so it’s really quite extraordinary.”
“We went back and asked the sponsor to look for the root cause of this, but they couldn’t find it,” Michele said.
dr Karen Murry, deputy director of the FDA’s Office of Non-Prescription Drugs, said the agency understands the importance of improving women’s access to effective birth control. But Murry said HRA Pharma presented a study that was difficult to interpret.
“And so the FDA has been put in a very difficult position to determine whether it’s likely that women will safely and effectively use this product in the non-prescription setting,” Murry said.
Kathryn Curtis, a research scientist at the Centers for Disease Control and Prevention and a member of the FDA committee, said that despite the study’s data problems, the benefits of over-the-counter birth control clearly outweigh the risks.
“Let’s not take women hostage”
The FDA was also concerned that some women with a history of breast cancer in HRA Pharma’s Drug Label Comprehension study chose to take norgestrel despite being warned not to do so. Progestin can increase the risk of breast cancer coming back.
The agency’s scientists were also concerned that some women with unexplained vaginal bleeding between menstrual cycles were taking norgestrel without first consulting a doctor.
dr Pamela Goodwin, an oncologist at the University of Toronto, told the committee Tuesday that most women diagnosed with breast cancer are older than 50 and beyond reproductive age.
There is a small population of women of childbearing age who have been diagnosed with breast cancer who may want to use oral contraceptives, but they are in constant contact with their doctor and are unlikely to take medications that would increase their risk of the cancer coming back said Goodwin.
“The breast cancer population is very concerned about avoiding recurrence,” said Goodwin, speaking for HRA Pharma. “They have been warned by their doctors and are warned again on the label not to use this if they have ever had breast cancer.”
dr Anna Glasier, an expert in reproductive medicine, told the committee on Tuesday that most women don’t see a doctor about unexplained vaginal bleeding because these episodes are common and usually resolve spontaneously. Glasier also testified on behalf of HRA Pharma.
“Let’s not hold women hostage because they need to see a doctor to get this extremely safe and effective POP,” Glasier said, referring to progestogen-only birth control pills like norgestrel.
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