Advocates face tough path to OTC birth control

Drug companies are facing increasing pressure to make birth control pills available for over-the-counter sale, but that situation is still years away from reality. 

Leading medical organizations and experts have said for years that the birth control pill is safe enough to sell without a prescription requirement in the U.S. And supporters of the idea say it could make the pills more accessible and potentially lower costs.

{mosads}But a complex drug regulatory system and financial considerations have kept companies from seeking approval from the Food and Drug Administration (FDA) to sell their birth control products over the counter. 

“Because of the time and money that it would take, the pharmaceutical companies are treading very carefully,” said Dr. Daniel Grossman, director of Advancing New Standards in Reproductive Health at the University of California, San Francisco . 

“The reality is also I think that women’s health in general [is] deprioritized in the pharmaceutical industry and they don’t see the potential of a blockbuster drug happening in the contraceptive space,” Grossman added.

The American College of Obstetricians and Gynecologists endorsed over-the-counter birth control in 2012, arguing that it could improve access and reduce unintended pregnancies. More than 100 other health organizations, including the American Medical Association and the American Academy of Family Physicians have also endorsed the idea. 

And the Oral Contraceptives Over-the-Counter Working Group has been pushing the issue since 2004. 

In the U.S., a birth control prescription usually requires a trip to the doctor at least once a year, but experts say that poses unnecessary barriers to people who don’t have insurance or can’t take time off from work. 

The pill is as safe to use without permission from a doctor as other over-the-counter drugs like ibuprofen, experts say.

But for drug companies there are competing financial and political factors at play.

One reason drug companies might be moving cautiously is because of the long contentious political fight over Plan B, which is used as emergency contraception after unprotected sex.

The FDA approved the drug for over-the-counter sale in 2006 after years of fighting, despite evidence showing that it was safe. 

“I think that [experience] made pharmaceutical companies reticent to do this,” Grossman said.

Also, birth control pills are rarely a big moneymaker for drug companies. And they could potentially lose money if they moved their products over the counter, because insurance companies are only required to cover birth control when it is prescribed by a doctor.

Moving drugs over the counter subjects the products to more competition and typically reduces prices. And taking a drug from prescription-only to over the counter involves years of research and investment.

For many companies, that means beginning the process to sell birth control over the counter may not be worth the effort.

“Contraception is not a billion-dollar blockbuster drug, and so I think for many companies looking at their bottom line, moving a birth control pill over the counter doesn’t necessarily rise to the top when it comes to profit-making efforts,” said Kelly Blanchard, president of Ibis Reproductive Health, a research and advocacy group.

Two European drug companies, however, are taking a gamble and applying for FDA approval. But the process could take years.

HRA Pharma announced in 2016 a partnership with Ibis to bring an over-the-counter progestin-only birth control pill to the U.S. market. 

Blanchard said HRA Pharma hopes to submit its application to the FDA in two to five years. If that effort is successful, she hopes other drug companies might follow suit. 

“We hope that once one company has shown that there’s FDA support for this and that it’s feasible, and there’s interest in it. We hope that other companies will put in a switch for their pills as well,” she said. 

In the meantime, several state governments have found creative ways to make birth control more accessible. 

Six states, including California and Maryland, have passed laws allowing pharmacists to prescribe birth control, meaning patients won’t have to make a separate trip to the doctor. 

The issue received attention from members of Congress earlier this year when Rep. Alexandria Ocasio-Cortez (D-N.Y.) tweeted that all birth control pills should be available over the counter. 

She partnered with Rep. Ayanna Pressley (D-Mass.) and Sen. Patty Murray (D-Wash.) to introduce a bill earlier this year that would require insurance companies to cover over-the-counter birth control, should it become available in the U.S. in the future. But the legislation is unlikely to go anywhere while Republicans control the Senate.

Advocates for over-the-counter birth control worry that cost concerns could defeat their objectives. Without legislation requiring insurance coverage, they worry over-the-counter birth control could end up still being inaccessible to many.

“We feel if the pill were to go over the counter, and it’s not available at an accessible price or covered by insurance, and therefore not accessible by the population that faces barriers accessing contraception, that it really wouldn’t be a success,” Grossman said.