March 3, 2023 – The FDA is actively collecting ideas on the right way to safely allow the over-the-counter sale of certain prescription products, comparable to contraceptives and erectile dysfunction medications.
The possible rule changes might be accomplished by October, Roll Call reported.
Drug manufacturers would want to take additional measures to make sure their products are secure for users. For example, users might must take part in a brief phone call or complete a survey online or in a store. The additional measures would help prevent people from using products in the event that they are at high risk of unintended effects or because they're taking medications that would interact dangerously with the brand new over-the-counter products.
“I don’t know if anyone really knows what it’s going to look like because I think it’s going to be product specific,” Dr. Marcia Howard, vice chairman of regulatory and scientific affairs on the Consumer Healthcare Products Association, told Roll Call.
Currently, the FDA is gathering ideas from manufacturers and safety officials. According to Roll Call, other options for safeguards could include using electronic health records to find out whether someone meets OTC eligibility requirements or requiring users to observe training videos before purchasing a product.
In July, the pharmaceutical manufacturer HRA Pharma announced It had submitted an application to the FDA to make its contraceptive Opill available over-the-counter. The company said in October that it awaits a decision by the FDA this spring.