HRA Pharma expects a final decision by the FDA this summer on its application for nonprescription sales of Opill, which is generically called norgestrel.
Source: Perrigo
A panel of experts who advise the U.S. Food and Drug Administration unanimously beneficial Wednesday that the agency for the primary time allow women to acquire a contraception pill and not using a prescription.
The panel had been asked whether the advantages of selling HRA Pharma’s contraception pill Opill outweighed the risks of consumers improperly using the medication leading to unintended pregnancy.
The FDA will not be obligated to follow the recommendations of its independent advisors, all 17 of whom voted “yes” on the proposal after a two-day hearing.
But HRA Pharma expects a final decision by the FDA this summer on its application for nonprescription sales of Opill, which is generically called norgestrel. The Paris-based drugmaker is owned by Perrigo, a manufacturer of over-the-counter drugs.
Since they were approved in the US greater than 60 years ago, oral contraceptives have only been available to women with a prescription for his or her use. If the FDA approves HRA Pharma’s application, women could obtain Opill without first having to go to a health care provider or other health-care provider.
“The history of girls’s contraception is a struggle for ladies’s control over their reproduction and we’d like to trust women,” said Dr. Katalin Roth, a member of the FDA advisory panel and a professor of drugs at George Washington University.
“I urge the FDA to approve over-the-counter availability of Opill,” Roth said, in explaining her vote in favor of HRA Pharma’s application.
The FDA originally approved norgestrel in 1973 as a prescription drug, but the corporate stopped U.S. sales of the pill in 2005 for business reasons, based on the agency.
HRA Pharma updated the pill’s label in 2017 in hopes of reintroducing the medication to the U.S. market, explicitly as an over-the-counter drug.
Medical associations equivalent to the American College of Obstetricians and Gynecologists for years have urged over-the-counter sales of contraception pills be allowed.
Greater than 50 members of Congress in March 2022 called on FDA Commissioner Dr. Robert Califf to make sure the agency reviewed applications for over-the-counter contraception pills directly.
“This can be a critical issue for reproductive health, rights, and justice,” the lawmakers wrote in a letter to Califf.
“Despite a long time of proven safety and effectiveness, people still face immense barriers to getting contraception on account of systemic inequities in our healthcare system.”
Nearly half of all pregnancies within the U.S. were unintended in 2011, based on a Latest England Journal of Medicine study published in 2016.
In response to that study, 75% of all pregnancies amongst girls 15 to 19 years old were unintended.
HRA Pharma submitted its application to the FDA last summer, two weeks after the Supreme Court abolished federal abortion rights by overturning its landmark 1973 Roe v. Wade decision.
The autumn of Roe v. Wade led some states to ban abortion or place tight restrictions on the procedure. It also led to legal efforts to tug abortion medication from the U.S. market.
Shrinking access to abortion across the U.S. in turn sparked renewed calls for expanded access to contraception to stop unwanted pregnancies.
FDA questions company data
Norgestrel comprises a hormone called progestin that stops pregnancy by thickening the cervix mucus to dam sperm from reaching and fertilizing an egg. The pill is supposed to be taken at the identical time every day.
Progestin-only pills typically are utilized by women who don’t want to take the more common combination pills that contain progestin and estrogen for health reasons.
Progestin-only pills are an efficient contraception method, however it’s crucial to take the pill at the identical time daily, based on the American College of Obstetricians and Gynecologists.
In typical real-word use, about 9 in 100 women will get pregnant in the primary 12 months taking the pill, based on the medical association. When the patient never forgets to take a pill, fewer than 1 in 100 women get pregnant throughout the first 12 months.
But FDA scientists raised concerns about whether the general public, particularly adolescents and folks with lower literacy levels, will understand norgestrel’s drug label and use the medication the precise way.
The FDA also found one-third of participants in HRA Pharma’s study reported taking more norgestrel pills than were actually allotted.
Dr. Theresa Michele, head of the FDA’s nonprescription drug division, said these errors call into query whether other data within the study is reliable.
“I am unable to consider a study that has 30% invalid data,” Michele told the committee Wednesday. “That actually just doesn’t occur in any sort of a study, much less a consumer study of this nature, so it’s really very extraordinary.”
“We went back and asked the sponsor to search for a root reason for this they usually didn’t find one,” Michele said.
Dr. Karen Murry, a deputy director of the FDA’s nonprescription drug office, said the agency understands the importance of increased access to effective contraception for ladies. But Murry said HRA Pharma submitted a study that was difficult to interpret.
“And so, the FDA has been put in a really difficult position of trying to find out whether it is probably going that ladies will use this product safely and effectively within the nonprescription setting,” Murry said.Â
Kathryn Curtis, a scientist on the Centers for Disease Control and Prevention and an FDA committee member, said even with the study’s data problems, the advantages of over-the-counter contraception clearly outweigh the risks.
‘Let’s not hold women hostage’
The FDA was also frightened some women with a history of breast cancer in HRA Pharma’s drug label comprehension study selected to take norgestrel despite a warning they shouldn’t. Progestin can increase the danger of breast cancer returning.
The agency’s scientists were also concerned some women with unexplained vaginal bleeding between menstrual cycles selected to take norgestrel without consulting a health care provider first.
Dr. Pamela Goodwin, an oncologist on the University of Toronto, told the committee Tuesday most girls diagnosed with breast cancer are older than 50 and beyond reproductive age.
There is a small population of reproductive-age women diagnosed with breast cancer who should want to use oral contraception, but they’re in constant contact with their doctor and are unlikely to make use of a medicine that might increase their risk of cancer coming back, Goodwin said.
“The breast cancer population could be very focused on avoiding reoccurrence,” said Goodwin, who presented for HRA Pharma. “They’ve been cautioned by their physicians and will likely be cautioned again by the label not to make use of this in the event that they’ve ever had breast cancer.”
Dr. Anna Glasier, an authority on reproductive medicine, told the committee Tuesday most girls don’t seek the advice of a health care provider about unexplained vaginal bleeding because these episodes are common and typically resolve spontaneously. Glasier also testified on behalf of HRA Pharma.
“Let’s not hold women hostage to having to see a health care provider to get this extremely protected and effective POP,” Glasier said, referring to progestin-only contraception pills equivalent to norgestrel.