FDA Weighs First Over-the-Counter Birth Control Pill Application Since Roy’s Fall

“When you bring a product over the counter, you have to prove that the benefits outweigh the risks. It’s a tough and long process, but we feel it’s something that needs to be done,” Frederik Wellgreen, HRA Pharma’s chief strategic operations and innovation officer, told POLITICO in an interview. “Now is more important than ever. So I really hope that the FDA takes a thorough look at this and that the decision is based on science. If that’s the case, I’m sure there will be over-the-counter pills available very soon.”

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

Better access to birth control was a most requested Activists before the Supreme Court’s decision to be overturned Roe v. Wade And in the weeks since the decision, demonstrations have taken place outside the White House and around the country, calling on the Biden administration to “release the pill.”

National Survey of Adult Women found that nearly 30 percent of those seeking a birth control prescription face barriers to obtaining it, the most common of which are 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 over the counter in Mexico were more likely to continue taking them over time than those who had to obtain a prescription in Texas.

Minors with their parents’ health insurance often fear that the prescription will show up on their family’s benefit statement — one of the reasons HRA Pharma is asking the FDA to allow the pill to be sold without age restrictions.

“We believe people under 18 would benefit from better access to contraception, and we have included some teenagers in our studies,” Wellgreen said.

Reproductive rights researchers and advocates say that if the pill wins the FDA’s blessing, they will continue to fight to make it available without insurance, even if purchased over the counter — a battle that will involve both federal and state officials.

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

Blanchard added that while more access to 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 have the right to and deserve reproductive health, including a full range of contraceptive methods and abortion,” she said.

Another company, Cadence Health, Also plans is asking the FDA to approve its own application for over-the-counter birth control, but more research is still to be completed and it could still be years before it is submitted.

FDA Weighs First Over-the-Counter Birth Control Pill Application Since Roy’s Fall

Source link FDA Weighs First Over-the-Counter Birth Control Pill Application Since Roy’s Fall

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