FDA Considers First-Ever OTC Birth Control Pill Application Since Rowe’s Fall

“When you sell a product without a prescription, you must prove that the benefits outweigh the risks. This is a rigorous and lengthy process, but we believe it is the right thing to do,” Frederik Welgreen, director of strategic operations and innovation at HRA Pharma, said in an interview with POLITICO. “Now it is more important than ever. So I really hope the FDA will carefully consider this and make a decision based on scientific evidence. If so, I am sure that pills will appear in the pharmacy very soon.”

However, the usual FDA response time for such applications is at least 10 months, which means that the drug could hit the shelves before mid-2023.

The best access to contraceptives was high demand activists in anticipation of the overturning of the decision of the Supreme Court Rowe vs. Wade and within weeks of the ruling, demonstrations took place outside the White House and across the country asking the Biden administration to “give the pill free.”

National Study of Adult Women found that nearly 30 percent of those looking for a contraceptive prescription face barriers to getting one, with the most common barriers being lack of health insurance, difficulty traveling to a clinic or pharmacy, and not having a regular doctor. Other study found that Texas patients who received over-the-counter birth control pills in Mexico were more likely to continue taking them over time than those who had to get a prescription in Texas.

Minors with their parents’ health insurance often fear that getting a prescription will show up on their family’s benefit claim. This is one of the reasons why HRA Pharma is asking the FDA to allow the sale of pills without age restrictions.

“We believe that people under 18 would benefit from greater access to contraceptives, and we included a number of adolescents in our studies,” Velgreen said.

Researchers and reproductive rights advocates say that if the pill gets FDA approval, they will continue to fight to get it covered without copays even when purchased without a prescription — a battle that will involve federal and state officials alike.

“We need updated guidance from HHS to make sure OTC birth control is covered by the Affordable Care Act,” said Kelly Blanchard, president of Ibis Reproductive Health. “Congress could also provide that through legislation.”

Blanchard added that while increased availability of the pill could help prevent unwanted pregnancies, she doesn’t see FDA approval as a solution to the recent elimination of abortion in more than a dozen states.

“People are entitled to and deserve all reproductive health services, including the full range of contraceptive methods and abortions,” she said.

Another company, Cadence Health, also plans to ask the FDA to approve his own application for OTC birth control, but there is still more research to be done and it could be years before it is filed.