FDA rule would facilitate prescription-to-OTC switches but nix a third class of drugs

“The proposed rule would establish an Additional Condition for Nonprescription Use [ACNU] category for prescription products the FDA says consumers currently can’t appropriately self-select and use without a prescription. This is somewhat analogous to the Risk Evaluation and Mitigation Strategies, which allow certain prescription drugs with potential safety issues to be approved for patients with additional requirements for use, such as verifying a negative pregnancy test for a drug that can cause birth defects or requiring a monthly lab test before the drug can be dispensed.

With an ACNU, a drug company must meet several FDA-approved conditions to ensure that consumers appropriately self-select a medication, appropriately use it, or both without the supervision of a health care practitioner. The FDA has kept the definition broad of what fulfilling an ACNU may entail, but patient education is certainly key. Two specific examples the FDA has suggested are requiring patients to complete a questionnaire or view a video, both with assessments to confirm their understanding of the medication. [..]

A company seeking to add over-the-counter status to a drug may submit a New Drug Application or an Abbreviated New Drug Application that references the drug’s original application. In the new application, the company must provide key elements of the ACNU and how it will be operationalized or administered. The FDA will require data from robust self-selection and label comprehension studies to demonstrate that labeling alone is not sufficient for people to self-select the medication, such as difficulty calculating the risk of a side effect. The application must also specify exactly how the ACNU will result in consumers being able to self-select the product. [..]

Over-the-counter products have traditionally been for acute, self-limiting conditions. With this proposed rule, however, the FDA has indicated flexibility in allowing for OTC use of certain prescription medications for chronic diseases or conditions, such as high cholesterol, diabetes, and high blood pressure. [..]

While the FDA anticipates cost savings to patients who switch from prescription to OTC drugs, this is not certain, as payers have traditionally excluded over-the-counter products from insurance coverage; patients pay for them out of pocket. It isn’t yet clear if payers will reimburse patients for the out-of-pocket expenses for these new OTC drugs, or if they will shift the cost to patients. [..]

How over-the-counter drugs approved under an Additional Condition for Nonprescription Use will be dispensed must be addressed, especially since over-the-counter drugs are sold in a variety of venues, ranging from pharmacies to dollar stores and gas stations. Many questions must be answered: Should these drugs be sold in any location, or should they be limited to sale in pharmacies where a pharmacist is present? Should they be over-the-counter or behind-the-counter? Can pharmacies secure a third class of drugs based on the FDA’s proposed rule?

The FDA’s proposed rule has important ramifications as it will decrease the number of prescriptions written and dispensed. The public comment period on the proposed rule is set to expire on October 26, 2022.”

To be sure, fewer medical visits to get prescriptions and requests for prescription medications will mean fewer medical claims for payers.

Full article, M Rumore, STAT, 2022.7.12