FDA introduces proposal to advance consumer access to nonprescription drugs

On Monday, FDA issued a proposed rule aimed at expanding the range of marketed nonprescription drugs available to consumers. The Nonprescription Drug Product with an Additional Condition for Nonprescription Use rule seeks to empower consumers to self-treat certain common conditions and improve public health.

“Nonprescription drug products play a vital role in America’s health care system, as millions of people use them to self-manage conditions every day,” said FDA Commissioner Robert M. Califf, MD. “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.”

If finalized, the proposed rule would establish the requirements for a drug company that submits a new application to bring a nonprescription drug product to market with an additional condition for nonprescription use. Under the proposal, when FDA determines that labeling alone is not enough to ensure the consumer can appropriately self-select and use a drug in a nonprescription setting, an applicant may submit an application proposing an additional condition for nonprescription use that a consumer must successfully fulfill in order to obtain the nonprescription drug.

FDA is encouraging public comment on the proposed rule. The comment period will end 120 days after the date of publication in the Federal Register.