FDA Proposed Rule Seeks to Make Nonprescription Drugs More Broadly Available

Federal drug regulators have proposed a new rule that is designed to broaden access to nonprescription medications for Americans, which would convert some medications that were previously prescription-only available without a prescription in certain circumstances.

Last week, the U.S. Food and Drug Administration (FDA) announced a new proposal to increase availability of non-prescription drugs in the Federal Register, outlining potential requirements that could be implemented to ensure appropriate self-selection or appropriate use of medications by consumers, without the supervision of a doctor.

Millions of people use nonprescription drug products to self-manage heath conditions every day. The proposed rule would broaden the range of nonprescription drugs available to consumers and allow them to “self-treat certain common conditions.”

The agency said the proposed rule is intended to “increase options for the development of safe and effective nonprescription drugs.” The agency has not mentioned any specific drugs which are currently targeted to be converted from prescription to nonprescription.

“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,” FDA Commissioner Robert M. Califf, said in the press release.

If finalized, the rule would expand options for consumers by establishing requirements for a drug company to submit a new application to bring a drug product to market for nonprescription use.

If the FDA finds the labeling is not sufficient to ensure consumers can choose a drug on their own and use the drug independently, the manufacturer may submit an application proposing an additional condition for nonprescription use that a consumer must successfully fulfill to obtain the nonprescription drug product.

In some cases, the drug maker could require a consumer to respond with specific answers to a set of questions on a self-selection test available by app or automated telephone system to purchase certain nonprescription drug products.

The main goal is for the FDA to allow for some nonprescription drug products to be available to consumers if they determine the product can be safe and effectively used by consumers without the supervision of a doctor.

The proposed rule will be open for public comment for 120 days after the date of publication in the Federal Register, or until October 26, 2022.

Comments can be submitted electronically through the electronic filing system https://www.regulations.gov or in writing to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.