FDA issues innovative proposal to increase nonprescription drug access

The US Food and Drug Administration (FDA) has issued an innovative proposal intended to increase consumer access to nonprescription drugs.

Nonprescription drug treatments are used by consumers without the supervision of a healthcare professional (HCP). When using these treatments, it is up to the consumers to decide if the drug is the correct one for their condition and to ensure they use the drug appropriately.

Currently, nonprescription drug treatments are limited to ones that provide sufficient information that allows consumers to appropriately self-select and use the drug.

If finalised, the proposed rule would require drug companies to include an additional condition for nonprescription use when submitting a new application to bring a nonprescription drug treatment to market.

Commenting on the proposed rule, FDA commissioner Robert Califf, said: “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.

“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.”

Under the proposed rule, when the FDA finds that ‘Drug Facts Labelling’ is not sufficient as the primary source for a nonprescription drug treatment to ensure appropriate self-selection and use by consumers, an applicant may propose an additional condition for nonprescription use that a consumer must successfully fulfil to obtain the product.

An applicant of a nonprescription drug treatment must also implement one or more FDA-approved conditions that ensure appropriate self-selection or appropriate actual use, or both, by consumers of the nonprescription drug treatment.

This could mean proposing an additional condition that requires a consumer to respond with specific answers to a set of questions on a self-selection test via a phone app or 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 allow appropriate self-selection and/or appropriate actual use of the product, and consumers can use the product safely and effectively without the supervision of an HCP, it may approve the product for nonprescription use with the additional condition.