OTC Birth Control and the Regulatory Impact

by | Jul 20, 2023 | Clinical Trials, FDA, Pharma, Pharmaceuticals, Post-Market, Safety

            Last week the FDA approved the first over-the-counter birth control drug. Opill, manufactured by Perrigo, is the first daily oral contraceptive that will be available without a prescription.[1] The main constituent of Opill, Norgestrel, was originally approved for prescription use in 1973. The switch from prescription only to over the counter can sometimes be a complicated process, needing to take into account a variety of risks that the drug poses to public health. With the switch from prescription only to OTC, many other firms are beginning to review the possibility and implications of switching their own products from prescription to OTC.

            Rx to OTC switches are not unique, but are also not extremely common. Since 2020 there have only been 10 drugs that have been converted to over the counter, including last week’s Opill. Other drugs that have made the switch include Narcan, the drug used to treat opioid overdose, and Nasonex nasal spray for allergies.[2]

            So, what exactly is the process to make the switch from Prescription to Nonprescription? In general, the change can be initiated through the NDA process. There are two types of switches: full and partial. Full switches are when a drug product covered under an NDA is switched entirely to OTC, a partial switch is when some indications are switched to OTC while retaining others with a prescription status.[3]

            To make the switch, safety and efficacy data should be submitted to the FDA demonstrating that the product is safe in a nonprescription setting. This can include data from new clinical trials (run after NDA approval) to demonstrate safety/efficacy compared against data from the original clinical trials. In addition, data supporting that customers can understand how to safely use the drug without the supervision of a healthcare professional and post-marketing safety surveillance data needs to be included in the application.

            If you need support with determining if your drug could be eligible for an OTC switch, the experts at EMMA International can help! Give us a call at 248-987-4497 or email info@emmainternational.com to learn more.

[1] FDA (July 2023) FDA Approves First Nonprescription Daily Oral Contraceptive, retrieved on 7/19/2023 from: https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive

[2] FDA (July 2023) Prescription to Over-the-Counter (OTC) Switch List retrieved on 7/19/2023 from: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/prescription-over-counter-otc-switch-list

[3] FDA (June 2022) Prescription-to-Nonprescription (Rx-to-OTC) Switches, retrieved on 7/20/2023 from: https://www.fda.gov/drugs/drug-application-process-nonprescription-drugs/prescription-nonprescription-rx-otc-switches

Madison Green

Madison Green

Director of Technical Operations - Mrs. Green serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Mrs. Green also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Mrs. Green holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

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