The road to making birth control pills over-the-counter in the U.S.

Driving the news: FDA advisers will meet on Nov. 18 to review the application for Opill, which has been available with a prescription in the U.S. since 1973.

• Two advisory committees will consider switching the drug from prescription to over-the-counter and weigh how the drug itself is used, said Susan Lee, a partner at the law firm Goodwin who specializes in the FDA's regulation of drugs and biologics.
• HRA partnered with the research organization Ibis Reproductive Health, which also leads the Free The Pill Coalition, a group that advocates for greater birth control access.

Catch up fast: More than 50 Democratic House lawmakers this spring pressed FDA commissioner Robert Califf to "follow the science" and swiftly consider applications for OTC birth control pills "without delay and based solely on the data."

• "The upcoming FDA hearing puts us one step closer to ensuring that everyone who wishes to access contraception is able to do so," Rep. Judy Chu (D-Calif.), who is part of the House Pro-Choice Caucus' leadership, said in a statement to Axios.

The big picture: But questions about affordability loom large because under federal law, health plans are only required to cover contraceptives obtained with a prescription.

• A 2017 study in Women's Health Issue found that on average adults are willing to pay $15 a month and teens $10 a month for birth control. However, the cost an individual pack of oral contraceptives is between $20 and $50, according to the National Women's Health Network.
• It's still unclear what HRA Pharma will charge. The company is "committed to ensuring this product is affordable for anyone who needs it," said Frederique Welgryn, HRA Pharma's chief strategic operations and innovation officer.

What they're saying: An FDA approval for OTC birth control "doesn't fix the issue" of accessibility, "but it certainly helps," said Daniel Grossman, director of the Advancing New Standards in Reproductive Health program at the University of California, San Francisco.

• Grossman noted past attempts to approve OTC birth control, but said this time, reproductive health advocates and medical providers have joined to "make sure that it's done in a way that improves access for populations that are currently facing barriers," meaning without age restrictions and at an affordable cost with insurance coverage.
• If the FDA ultimate clears Opill for retail sales, some in Congress could press for legislation that would guarantee insurance coverage of OTC contraceptives.

Advocates are calling on the Biden administration to issue updated guidance clarifying that health plans must cover OTC contraceptives even without a prescription, particularly ahead of the FDA's decision.

• "There's a tremendous opportunity for them to do that around the time of what we expect to be a historic advancement of reproductive health," said Dana Singiser, co-founder of the Contraceptive Access Initiative.

Zoom out: There are 13 states that require insurers to cover over-the-counter birth control methods.

• Last month, California became the latest to mandate health plans pay for "over-the-counter FDA-approved contraceptive drugs" without cost-sharing.

What else is happening: HRA Pharma will present research to demonstrate that Opill meets the FDA's OTC criteria, including having an easy-to-understand drug facts label and a means for people to determine that the pill is appropriate for them without health provider oversight.

• Some medical experts say that OTC access to contraceptives should not replace medical consultations.
• HRA Pharma's Welgryn said that making birth control available without a prescription "doesn’t remove the option for people to seek other types of care. ... [T]hey can still choose another method, the one that they will see as the most convenient for them — And they can still discuss this  with their healthcare provider."
• The application comes at a fraught moment in reproductive health, after the Supreme Court overturned the constitutional right to abortion. Some fear red states' attempts to legislate bans could extend to emergency contraception and IUDs.

Worth noting: A 2018 research paper published in Women's Health Issue found that most women interested in OTC birth control would not stop visiting their health providers to obtain gynecological screenings and other preventive services.

Between the lines: The application process for HRA Pharma's drug has been particularly fast.

• Typically, the FDA will take six to eight months after an application is submitted to schedule an advisory meeting if needed. HRA Pharma sent an application in July and a meeting was scheduled in September.
• The speed is "unusual," Lee said, adding that normally the FDA schedules advisory meetings closer to when the agency is ready to make a final decision.

What's next: A few days before the advisory meeting takes place in November, the FDA will issue briefing documents containing the questions they are looking for the committees to answer.

• The questions that the FDA poses will serve more as an indication of where the agency is leaning towards — potentially approving or rejecting Opill as an OTC oral contraceptive.

Don't forget: The FDA will need to make a final decision on whether to approve the drug, which is likely to come at some point in 2023.

• The agency is not required to follow the advisory committees' recommendation.