The U.S. Food and Drug Administration (FDA) has approved the first over-the counter (OTC) oral contraceptive in the United States.
The decision on July 13 came after a panel of advisors gave the go-ahead to approve the sale of Perrigo’s Opill, an orally taken hormone-based birth control drug that currently requires a prescription from a physician.
The panel came to its nonbinding conclusion in May after two days of deliberation over whether the pill is safe and effective for women to take without consulting a medical professional.
“Nonprescription availability of Opill may reduce barriers to access by allowing individuals to obtain an oral contraceptive without the need to first see a health care provider. Almost half of the 6.1 million pregnancies in the U.S. each year are unintended,” stated an FDA news release.
In its news release, Perrigo did not say when OTC sales will begin.
The FDA’s approval of an OTC oral contraceptive applies only to Opill, though it could set the bar for other drug makers to apply for over-the-counter availability.
Questions About Safety, Effectiveness
The panel’s unanimous recommendation came despite pushback on multiple fronts from FDA scientists who reviewed the company’s 880-patient study of Opill’s safety and effectiveness.
“We have an application with many complicated issues and uncertainties, including questionable reliability,” FDA’s Pamela Horn, M.D., told the panelists.
The panelists raised concerns about study participants’ inability to understand and follow the instructions on the product’s label. The labeling says the drug is contraindicated for use by women who may be pregnant or may have breast cancer or undiagnosed abnormal uterine bleeding, and that other medications could interact with Opill’s effectiveness. The labeling advises users to take the pill at the same time every day and to discuss menstrual bleeding patterns “with a health care provider.”
An especially alarming problem was that 68 percent of women who had unexplained vaginal bleeding incorrectly said Opill would be safe to take. Some women with breast cancer also mistakenly told researchers they could take the pill.
Another problem identified was that close to 30 percent of participants reported taking more pills than they were given.
The panel sidestepped those issues in making its recommendation to the FDA, prioritizing the benefit of having more effective birth control available to more people, particularly young and low-income groups.
‘Plan B’ Already OTC
The science is on the side of approving Opill for over-the-counter sales, says Jeffrey A. Singer, M.D., a senior fellow in health policy at the Cato Institute.
“The American College of Obstetricians and Gynecologists, the American Academy of Family Physicians, and the American Medical Association believe it is safe for females of all ages,” said Singer. “The worst that can happen is some premenstrual bleeding. The panel has called for it to be available for women of all ages, just like the more potent Plan B is.”
The “Plan B” or “morning after” pill, an emergency contraceptive that prevents fertilization, underwent fierce debates in the 1990s before being approved for over-the-counter status.
“The government should get out of the way of medically proven harm-reduction strategies—particularly one like this, that is available OTC in many countries around the world and has been advocated by medical experts for decades,” said Singer.
Singer writes in a Reason op-ed coauthored by Josh Bloom that there are far more dangerous medications already available over the counter, including Tylenol and Benadryl.
“And if we have fewer young girls with unwanted pregnancies, we will have fewer abortions,” Singer told Health Care News.
Medical Issues Set Aside
Not everyone agrees with making Opill more accessible or with the role of government in determining who can use it. Catholic organizations, including the U.S. Conference of Catholic Bishops, have spoken out against approving its availability without the supervision of a medical professional, arguing it violates the medical ethic of “first, do no harm.”
The FDA should not let alleged social benefits override medical safety consideration, says David Gortler, Pharm.D., a fellow at the Ethics and Public Policy Center.
“The bottom line here is that these products are not completely safe and shouldn’t be OTC,” Gortler told Health Care News.
Gortler says the proposal to make Opill available over the counter is driven more by politics than sound science.
“The FDA is only supposed to consider safety in its decisions, not convenience or access or abortion-type politics,” said Gortler.
Compliance, Cost Concerns
In a recent editorial for the Brownstone Institute, Gortler notes the synthetic progestin used in birth control pills can lead to increased risk of breast cancer, cervical cancer, STDs, and mood disorders.
There are also compliance concerns. If Opill is sold over the counter, there is no professional monitor.
“Oral contraceptives require discipline and self-control, something which minors tend to not have,” Gortler wrote.
It is not clear how much Opill will cost. Making it OTC means insurers do not have to pay for it, unlike prescription oral contraceptives under the Affordable Care Act.
Anticipating Opill’s approval, Senate Democrats introduced legislation that would force insurers to cover OTC oral contraception.
Behind-the-Counter Option
An alternative the FDA could have considered is selling Opill “behind the counter,” whereby a pharmacist would have to interact with the consumer before purchase.
The GoodRx.com website explains why some drugs are sold only behind the counter.
“Some are kept there for safety purposes,” GoodRx states. “That’s because they can cause harm if they aren’t used exactly as directed (like insulin). Other medications are behind the counter because they carry a risk of misuse or dependency. And in other cases, they can be used illegally to make highly addictive drugs.”
Harry Painter (harry@harrypainter.com) writes from Oklahoma.