March 3, 2023 – The FDA is actively gathering ideas for how to safely allow some prescription-only products, like birth control and erectile dysfunction medications, to be sold over the counter.

The potential rule changes could be finalized by October, Roll Call reported

Drugmakers would need to take extra steps to ensure safety of their products by users. For example, users may have to participate in a brief phone call or take a survey online or in a store. The extra steps would help prevent people from using products if they are at high risk for side effects or because they take medications that could interact dangerously with the new OTC products.

“I don’t know that anyone really knows what it will look like, because I think it’s going to be product specific,” Marcia Howard, PhD, vice president of regulatory and scientific affairs at the Consumer Healthcare Products Association, told Roll Call.

Currently, the FDA is gathering ideas from manufacturers as well as from safety advocates. According to Roll Call, other options for safeguards could include using electronic health records to identify whether someone meets OTC eligibility requirements or making users watch educational videos prior to acquiring a product.

In July, the drugmaker HRA Pharma announced it had submitted an application to the FDA to make its birth control product, called Opill, available over the counter. The company said in October it expects a decision from the FDA this spring.

Show Sources

Roll Call: “FDA could widen path for OTC birth control, statins.”

HRA Pharma: “Perrigo’s HRA Pharma Submits Application to FDA for First-Ever OTC Birth Control Pill,” “Perrigo Receives Notification of Postponement for Joint FDA Advisory Committee to Review Opill® Daily Oral Contraceptive for Over-The-Counter (OTC) Use.”

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