21 State AGs, Led by Rob Bonta, Call for FDA to Approve Over-the-Counter Birth Control

Birth control pills are already available over the counter in over 100 countries worldwide, according to the American Academy of Family Physicians.

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California Attorney General Rob Bonta, along with 20 other AGs in a multi-state coalition, submitted a letter on Friday to the Food and Drug Administration, urging the agency to approve over-the-counter birth control pills.

If the FDA approves the pill for purchase and use without a doctor's prescription, the AGs argue, there will be fewer barriers in the way of people getting the safe and effective reproductive care they need.

Along with California AG Bonta, AGs from "Colorado, Connecticut, Hawaii, Illinois, Iowa, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, Vermont, and Washington" came together to ask the agency to approve OTC birth control.

According to a press release from the California Department of Justice about the letter, "approval of the pill would allow individuals — especially those from vulnerable populations — greater control over their health, lives, and futures, and help them avoid the health and economic perils that come with unwanted pregnancies."

The multistate effort comes as the FDA reviews an application for the approval of Opill, a progestin-only birth control pill, for OTC use.

French pharmaceutical company HRA Pharma submitted the application in July, shortly after the Supreme Court overturned Roe v. Wade -- though the company said the timing of their application was unrelated.

The AGs' letter, however, states that FDA approval of an OTC birth control pill is important in the wake of that Supreme Court decision. The release about the letter states "many states have banned or restricted abortion care, narrowing the choices for those seeking reproductive care and making access to birth control even more critical nationwide, including for Californians who may be traveling, living, working, or studying in anti-abortion states."

If the leaked Supreme Court draft opinion overturning Roe v. Wade takes effect, it could also lead to tighter state restrictions on birth control, says Seema Mohapatra, law professor at Southern Methodist University.

Hormone-based pills have long been the most common form of birth control in the U.S., used by millions of women since the 1960s. They have always required a prescription, generally so health professionals can screen for conditions that raise the risk of rare, but dangerous, blood clots.

The French drugmaker’s application compiles years of research intended to convince the Food and Drug Administration that women can safely screen themselves for those risks and use the pill effectively.

“For a product that has been available for the last 50 years, that has been used safely by millions of women, we thought it was time to make it more available,” said Frederique Welgryn, HRA’s chief strategy officer.

The press release from the California DOJ argues three main reasons why Opill should be approved for OTC use:

  1. "It has been found to be safe and effective for most users," with a much lower risk of blood clots from progestin-only pills like Opill than traditional combination estrogen and progestin birth control pills. The progestin-only pills remain "over 90% effective in preventing unwanted pregnancies — more effective than methods such as spermicide, condoms, or the sponge," the release said.
  2. "It would remove barriers to obtaining birth control faced by many," the release said. Many people who try to get a birth control prescription have a hard time getting a doctor's appointment, or end up having to travel for their visit. There are also restrictions on how many pills a birth control user can get each month, which means many users end up skipping a pill that has to be taken every day just because they could not get their next pack when needed.
  3. "It would provide critical help to people from vulnerable populations," reducing inequality and making healthcare more accessible for everyone. According to the release, "barriers to accessing birth control disproportionately impact people of color, low-income families, and individuals living in rural areas, who are more often underinsured or uninsured, and thus find it harder to get the reproductive care they need."

The letter itself lists a number of other benefits to birth control, including but not limited to: increased health for mothers and children, lower maternal mortality, higher engagement in the workforce, economic independence for women, higher productivity in the workforce, fewer children living in poverty, better educated children, and fewer pregnancies in people under the age of 22.

"Further," the letter adds, "those with unintended pregnancies are more likely to experience serious complications from the end of pregnancy including eclampsia, more likely to stay tethered to abusive partners, more likely to suffer anxiety and loss of self-esteem in the short term, less likely to have aspirational life plans for the coming year, and more likely to experience poor physical health for the years after the pregnancy."

Birth control pills are already available over the counter in over 100 countries worldwide, according to the American Academy of Family Physicians.

An FDA approval could come next year and would only apply to HRA’s pill, which would be sold under its original brand name, Opill. The company acquired the decades-old drug from Pfizer in 2014, but it's not currently marketed in the U.S.

The FDA is required to hold a public meeting to evaluate HRA’s application before making a decision. Safety considerations are likely to take center stage.

Executives at HRA, which is owned by Perrigo Co., expect a decision in the first half of 2023.

Read the full letter here.

The Associated Press contributed to this report.

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