“If you’re selling a product over the counter, you have to prove that the benefits outweigh the risks. It’s a rigorous and lengthy process, but we believe it’s the right thing to do,” Frederic Welgreen, HRA Pharma’s chief strategic operations and innovation officer, told POLITICO. “It’s important now more than ever. So I really hope that the FDA will take a hard look at this and that the decision will be based on science. If that’s the case, I’m sure pills will be available without a prescription very soon.”

The FDA’s normal timeline for responding to such applications, however, is at least 10 months, meaning it could take until mid-2023 before the drug is on shelves.

Improved access to birth control the highest demand activists on the eve of the annulment of the Supreme Court decision Roe v. Wade and in the weeks since the ruling, with demonstrations organized outside the White House and across the country asking the Biden administration to “release the pills.”

National Survey of Adult Women found that nearly 30 percent of those seeking a birth control prescription faced barriers to obtaining it, with the most common barriers being lack of health insurance, difficulty traveling to a clinic or pharmacy, and not having a regular doctor. Another study found that Texas patients who obtained birth control pills without a prescription in Mexico were more likely to continue taking them over time than those who needed to obtain a prescription in Texas.

Minors who have their parents’ health insurance often worry that the prescription they receive will show up on their family’s benefits report — one of the reasons HRA Pharma is asking the FDA to allow the pill to be sold without age restrictions.

“We believe that people under the age of 18 would benefit from better access to contraception, and we included a number of teenagers in our research,” Welgreen said.

Researchers and reproductive rights advocates say that if the pills get the FDA’s blessing, they’ll continue to fight to make sure they’re covered by insurance without copays, even if they’re over-the-counter — a fight that will involve both federal and state officials .

“We want updated guidance from HHS to ensure that over-the-counter birth control is covered by the Affordable Care Act,” said Kelly Blanchard, president of Ibis Reproductive Health. “Congress can also provide this through legislation.”

Blanchard added that while making the pill more accessible 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 have the right and deserve all reproductive health care, including the full range of contraceptive methods and abortion,” she said.

Another company, Cadence Health, also plans to ask the FDA to approve its own over-the-counter birth control application, but more research still needs to be completed and it could be years away from filing.

https://www.politico.com/news/2022/07/11/fda-weighs-first-ever-application-for-over-the-counter-birth-control-pills-in-the-wake-of-roes-fall-00044819

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