On June 27, 2022, FDA issued a Proposed Rule which would facilitate Rx to OTC switches. While OTC products are typically for acute self-limiting conditions, OTC use of certain prescription medications for chronic diseases or conditions would be allowed under the rule. The rule would establish an “Additional Condition for Nonprescription Use” (ACNU) for certain prescription products for which FDA has found that labeling alone is not sufficient to ensure that the consumer can appropriately self-select and use a drug product in a nonprescription setting. This is somewhat analogous to the Risk Evaluation and Mitigation Strategies (REMS) for prescription drugs. Some drug products may be available as both an OTC product with an ACNU and via prescription. Requirements include NDA or Abbreviated New Drug Application (ANDA) application submission, additional labeling and post-marketing reporting, especially for failures to execute the ACNUs. Examples of ACNUs in order for consumers to purchase the OTCs are questionnaires, assessment tests, available by kiosks, a phone “app” or automated telephone response systems.
Both brand and generic manufacturers will be able to expand their OTC product development. Cost saving for patients is uncertain as there may be no payer reimbursement but instead a cost shift to patients. The proposal benefits insurers/payers who will see less claims for medical visits. The impact on the bottom line for community pharmacies may vary with increased consumer demand but reduced Rx volume. Restriction of sale of the OTCs with ACNUs to pharmacies is not addressed in the FDA proposal, nor is there any mention of a “Third Class of Drugs.” Many questions and details with implications for pharmacy need to be addressed, and stakeholders, including national/state pharmacy organizations, need to be engaged throughout this proposed rulemaking process.
The Public Comment period expires on October 26, 2022. Frier Levitt can prepare comments as well as facilitate regulatory submissions for OTCs with ACNUs. Whether you are an OTC manufacturer or a large generic drug manufacturer, our Government Affairs/FDA/IP attorneys have the knowledge and background to assist you with your regulatory needs. Contact Frier Levitt and speak to one of our attorneys.
