New FDA Proposal Would Make Adding OTC Approval to Prescription Drugs Easier


The FDA is accepting comments on the proposed rule through Oct. 26, 2022.

A new FDA proposed role would broaden the range of over-the-counter medications for consumers, the agency said in a news release.

The agency’s Nonprescription Drug Product with an Additional Condition for Nonprescription Use proposal would expand options for consumers by establishing the requirements for a drug company that submits a new application to bring a nonprescription drug product to market.

When the FDA finds that labeling alone is not sufficient to ensure that the consumer can appropriately self-select and use a drug product in a nonprescription setting, a pharmaceutical manufacturer may submit an application proposing an additional condition for nonprescription use that a consumer must successfully fulfill to obtain the nonprescription drug product.

“Nonprescription drug products play a vital role in America’s healthcare system, as millions of people use them to self-manage health conditions every day,” FDA Commissioner Robert M. Califf, M.D., said in a press release. “As part of the FDA’s ongoing efforts to improve public health, this proposal can broaden the types of drugs that can be approved as nonprescription—increasing availability of drugs that would otherwise only be available by prescription.”

The cost savings of having the prescription drugs available OTC is significant.

The FDA estimates the primary cost savings to consumers would be $26,70 per product, with a range of $0 to $53.40 per consumer per purchase, the agency said in the proposed rule. “There may also be cost savings associated with a potential reduction in the number of repetitive meetings between FDA and industry. Our primary estimate is $55,469 per applicant with a range of $45,260 to $66,174.”

Government and private insurance payers may also realize cost savings because the availability of nonprescription drug products with an Additional Condition for Non-Prescription Use (ACNU) may decrease future medical costs and the number of submitted insurance claims, according to the FDA.

The manufacturer applying for the non-prescription use must “ensure appropriate self-selection or appropriate actual use, or both, by consumers of the nonprescription drug product,” the FDA said.

For example, an applicant could propose an additional condition for nonprescription use that requires a consumer to respond with specific answers to a set of questions on a self-selection test available by either a phone app or an automated telephone response system in order to purchase the nonprescription drug product.

“Under the proposed rule, if the FDA finds that the additional condition for nonprescription use will permit appropriate self-selection and/or appropriate actual use of the product, and consumers can use the product safely and effectively without the supervision of a healthcare practitioner, it may approve the product for nonprescription use with the additional condition for nonprescription use,” the agency said.

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