Pressure mounts on drug makers to move birth control over the counter

Drug makers are facing growing pressure to sell contraception without a prescription. And this weekend, the nation’s largest physicians group could join in the chorus calling to expand access to birth control.

At the American Medical Association’s annual meeting in Chicago, delegates will vote on a resolution to encourage contraceptive makers to submit applications to the Food and Drug Administration to switch the status of their pills from prescription to over the counter. If it passes, the new policy would be directed more squarely at drug makers than the AMA’s current policy, which focuses on the FDA’s role.

“This isn’t just a contraception issue. This is a women’s health issue,” said Dr. Katherine Tynus, who introduced the resolution and works as an internal medicine physician at Northwestern Medical Group in Chicago.

More than 100 countries already offer contraception over the counter — but the U.S. doesn’t, aside from the emergency contraceptive often known by the brand name Plan B. Experts who support OTC contraception say it will lower the rate of unplanned pregnancies in the U.S., which are linked to higher health costs and increased risk of negative outcomes for both pregnant women and infants. An estimated 45 percent of pregnancies in the U.S. are unplanned.

Two companies are working to apply for OTC status for contraceptives, but nothing is likely to happen anytime soon. The contraceptive coverage mandate rolled out by the Obama administration — and later relaxed by the Trump administration — requires insurers to cover prescribed contraceptives without a copay, with some exceptions. If contraceptives do move over the counter, it’s possible that some women will end up paying more, because insurers generally don’t cover OTC drugs.

But advocates of making birth control more accessible say that it’s possible to have low-cost, OTC contraception. And they argue that the time is ripe for drug makers to put the wheels in motion.

That’s because for years, researchers and medical groups have been laying the groundwork, running studies to gauge the safety and efficacy of OTC birth control — and show there’s a market for it. Much of that work has been spurred by the Oral Contraceptives Over-the-Counter Working Group, a coalition of clinicians, advocacy groups, and health organizations formed in 2004 and supported by a slew of medical groups.

The findings have been encouraging: Research has shown that women can use checklists to determine whether they might have potential problems with contraceptives, such as interactions with other drugs. And research has suggested that removing the prescription requirement might actually make women more likely to use an oral contraceptive correctly.

“I feel very confident that women can understand their need for birth control pills, and there’s good evidence women can understand the contraindications,” said Dr. Krishna Updhya, a physician at Children’s National Health System in Washington, D.C., who specializes in young adult health.

The studies have helped pave the way for two drug companies to start the process of applying for FDA approval. In 2016, the European drug company HRA Pharma announced it was partnering with the nonprofit Ibis Reproductive Health to work to bring an OTC oral contraceptive to the U.S. market. And another company, Cadence Health, is hoping to bring a different oral contraceptive over-the-counter, promising to “liberate the pill.”

“All of that research has kind of helped to push pharma to move forward,” said Dr. Daniel Grossman, director of the Advancing New Standards in Reproductive Health program at the University of California, San Francisco. “They realized that from a business perspective, there’s a large potential market.”

Up until now, the drug industry has steered clear of asking the FDA to move contraceptives over the counter. In part, experts say that’s because of the drawn-out battle to do so with Plan B. That work — and later, the movement to make it available OTC for girls under age 17 — ran into one political roadblock after another.

An FDA advisory committee voted 23-to-4 to grant Plan B OTC status in 2003, but the agency’s leaders rejected the initial request amid a heated debate among health officials about whether making Plan B more accessible would encourage risky sexual behaviors. Plan B was eventually cleared for OTC sale to women 18 and older in 2006, but there was another battle to change the age restriction. It wasn’t lowered to 15 until 2013.

“That gave pharma companies cold feet,” Grossman said. But armed with new evidence and the support of a growing number of medical groups, drug makers are eyeing the option.

Drug companies looking to bring oral contraceptives over the counter might face a similar fight. Anti-abortion groups that also oppose contraception lobbied fiercely to block Plan B from going over the counter — and they might do the same with legislation that would require insurers to cover OTC contraceptives without a prescription.

And the White House isn’t likely to champion the cause. In 2017, the Trump administration moved to make it easier for employers to exclude contraception from insurance coverage offered to their workers.

Grossman, who has advised HRA and previously worked for Ibis, said the company will likely file an application to bring a progestin-only contraceptive over the counter in the next two years, which the FDA would then review.

“I doubt we’ll see an OTC pill in this administration,” he said.

Experts agree that if and when the first OTC contraceptive is approved — however long that might take — others are likely to follow. And supporters of the movement to bring birth control over the counter are hopeful that statements from the AMA and other leading medical groups will help make the case.

If it passes, the AMA resolution would also make clear that the organization supports full insurance coverage of contraception without any cost to patients — whether it’s obtained with or without a prescription.

“It doesn’t have to be that OTC medications aren’t covered by insurance. That’s not a universal truth that can’t be changed,” Upadhya said. There’s more than one way that could happen: Insurers could opt to cover all birth control without charging patients, or state or federal lawmakers could force them to do so.

Experts say insurers would likely save money by covering OTC contraception. In its report on the proposed resolution, the AMA Board of Trustees said full insurance coverage would likely curb unintended pregnancies — which in theory, would also cut health costs.

“It makes sense from a cost-benefit perspective,” Grossman said.