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Women’s Health: Regulators to consider over-the-counter sale of birth control pills

Some Birth Control Pills

*A French drugmaker argues its extensive research showed that women could then determine the risks and benefits of using the pills themselves

Isola Moses | ConsumerConnect

A French pharmaceutical company is petitioning the United States (US) Food and Drug Administration (FDA) to sell its birth control pills over-the-counter (OTC). Report indicates since the medicines were introduced in the early 1960s, birth control pills have required a doctor’s prescription.

HRA Pharma produces and markets hormone-based contraceptives – the most common form of birth control pills, Associated Press report said.

The application comes days after the US Supreme Court overturned Roe vs. Wade, the landmark 1973 ruling that legalised abortion.

The company said the latest ruling from the high court was completely unrelated to its application.

Frederique Welgryn, HRA’s Chief Strategy Officer, said: “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.”

The company also said it had conducted an extensive research to back up its claim, that women now have enough experience using the pills that they can determine the risks and benefits themselves.

An FDA decision is not expected right away, but the agency has shown recent signs of relaxing the way some prescription drugs are handled.

The agency recently amended the emergency use authorisation (EUA) for the COVID-19 treatment pill Paxlovid to allow pharmacists to prescribe it to patients.

Pressure in Congress

Pressure was building in the US Congress to provide over-the-counter access to birth control pills long before the Supreme Court’s ruling that overturned Roe vs. Wade, report stated.

HRA Pharma’s application, if granted, would only apply to the company’s pill – Opill.

If granted, other drugmakers would likely file their own applications.

In March 2022, the House Pro-choice Caucus sent a letter to FDA Commissioner Dr. Robert Califf, asking his agency to “follow the science” as it considers making birth control pills available to Americans over the counter and without the need for a prescription.

The lawmakers wrote: “This is a critical issue for reproductive health, rights, and justice.

“We ask for your ongoing commitment to advancing public health and following the science and data in all decisions, including the timely review of the oral contraception applications.”

Physicians have long supported the requirement for a prescription for birth control pills because the drugs can carry a risk. Specifically, doctors screen women for the potential for blood clots before prescribing the pills, according to report.

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