FDA questions proposal to make birth control pill available over the counter
WASHINGTON — U.S. health regulators are weighing the first request to make a birth control pill available without a prescription.
But in an initial review posted Friday, the Food and Drug Administration raised numerous concerns about drugmaker Perrigo’s application to sell its decades-old pill over the counter.
The FDA said there were problems with the reliability of some of the company’s data on the drug, Opill, and questioned whether women with certain medical conditions would correctly opt out of taking it. The agency also noted that study participants appeared to have trouble understanding the labeling instructions.
Advisors to the FDA will meet next week to review drugmaker Perrigo‘s application. The two-day public meeting is one of the last steps before a final FDA decision.
If the agency grants the company’s request, Opill will become the first contraceptive pill in the United States to be moved out from behind the pharmacy counter onto store shelves, or available online without a prescription.
A drug company is seeking U.S. approval for the first birth control pill that women could buy without a prescription
Friday’s FDA review suggests regulators have serious reservations about allowing such broad access to the drug, including whether younger teenagers will be able to correctly follow the directions for using it.
On Wednesday, at the end of the meeting, the FDA advisory panel will hold a nonbinding vote on whether the benefits of making the pill more widely available outweigh the potential risks. The FDA is expected to make its final decision on the pill this summer.
Perrigo executives say Opill could be an important new option for the estimated 15 million U.S. women and teens, or one-fifth of those of child-bearing age, who currently use no birth control or less-effective methods such as condoms.
“We have no doubt that our data clearly shows that women of all ages can safely use Opill in the over-the-counter setting,” Frederique Welgryn, the company’s global vice president for women’s health, said this week.
The company’s application has no relation to the ongoing lawsuits over the abortion pill mifepristone, which is not a contraceptive. Research for over-the-counter sales of the pill began nearly a decade ago.
Hormone-based pills like Opill have long been the most common form of birth control in the U.S., used by tens of millions of women since the 1960s.
Opill was first approved in the U.S. 50 years ago. Perrigo acquired rights to the drug last year with its buyout of Paris-based HRA Pharma, which bought the pill from Pfizer in 2014. Opill is not currently marketed in the U.S., but is sold without a prescription in the United Kingdom.
The FDA’s decision on Opill won’t apply to other birth control pills, although advocates hope that a decision to approve it might push other pill makers to seek over-the-counter sales. Birth control pills are available without a prescription across much of South America, Asia and Africa.
A new law in California allows women to pick up birth control pills from pharmacies without a doctor’s prescription.
Many common medications have made the over-the-counter switch, including drugs for pain relief, heartburn and allergies. Generally, drugmakers must show that consumers can accurately understand and follow labeling instructions to safely and effectively use the drug.
Nonprescription medicines are usually cheaper, but generally aren’t covered by insurance. Forcing insurers to cover over-the-counter birth control would require a regulatory change by the federal Department of Health and Human Services.
Perrigo’s main study tracked nearly 900 U.S. women and teens taking its pill without professional supervision for up to six months. The group included people of different races and educational and cultural backgrounds.
Study participants were paid to track and record their use of the pill, including whether they followed instructions to take it during the same 3-hour window each day. That consistency is key to the drug’s ability to block pregnancy.
But after Perrigo wrapped up its study, the FDA identified a problem: Nearly 30% of women erroneously reported taking more pills than they were actually supplied.
The FDA said Friday these cases of “improbable dosing” call into question the company’s results.
If Congress fails to revoke the FDA’s power to require a prescription to buy contraceptives, the FDA should make them available over the counter.
Perrigo plans to present a reanalysis of its data that excludes the participants who overreported their use of Opill. The company says the new analysis shows the study still demonstrated that most women used the pill correctly.
Participants reported taking the pill on a daily basis 92% of the time during the study, and data show there would be about two pregnancies for every 100 women who take its pill for a year, the company says. But the FDA called this figure “an imprecise estimate” because the number of people in the study was significantly smaller than in typical studies used to evaluate contraceptive effectiveness.
The most popular birth control pills today contain a combination of the synthetic hormone progestin, which helps block pregnancy, plus estrogen — which can help make periods lighter and more regular but it also carries the risk of rare blood clots.
Opill contains only progestin, making it a safer option and, according to experts, an easier regulatory switch to over-the-counter status. But progestin-only pills have downsides, including reduced effectiveness if they’re not taken at the same time daily.
The forces fighting against legal abortion have already shown their hand: Contraception is the next target.
The FDA review also flagged concerns over whether women with certain health risks will appropriately avoid taking the drug.
Women with a history of breast cancer should not take the pill, though a few participants in preliminary research incorrectly said they thought they could. And women who have unusual vaginal bleeding are instructed to talk to a doctor first, because it could indicate a medical problem. But the FDA noted that Perrigo had found that half of those who had unexplained bleeding incorrectly said Opill would be appropriate for them.
Several major U.S. medical groups, including the American Medical Assn., support making such medication available over the counter. The 60-year history of birth control pills shows “the benefits of widespread, nonprescription availability far outweigh the limited risk,” the group said in comments submitted to the FDA.
Roman Catholic groups, including the United States Conference of Catholic Bishops, are opposing Opill’s application, saying women should be evaluated by a doctor before getting it. The church officially opposes any “artificial” means of birth control as immoral.
