FDA proposes rule broadening nonprescription drug access for consumers

Regulatory NewsRegulatory News
| 28 June 2022 | By Jeff Craven 

The US Food and Drug Administration (FDA) has issued a new proposed rule that would allow drug companies to add conditions for consumers to access nonprescription drug products.
A limitation of current nonprescription drug labeling is that it doesn’t always adequately communicate the information consumers need to self-select a product on their own. FDA said the goal of the proposed rule is to increase access to new nonprescription drugs where drug labeling alone is insufficient to allow self-selection of nonprescription drug products by consumers.
“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, MD, stated 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.”
Under the proposed rule, a new drug application (NDA) or abbreviated new drug application (ANDA) for a nonprescription drug with an additional condition for nonprescription use (ACNU) would be subject to new requirements such as a separate application for approval, labeling requirements, and postmarketing reporting requirements. In the case of an NDA, applicants would also need to submit a description and supporting information for the ACNU.
One example of an ACNU that would allow the consumer to self-select a nonprescription drug product is a test completed on a smartphone app or through an automated phone response system, the agency said. However, that is not the only use case of applicable conditions for these products. “The proposed definition for an ACNU is intentionally broad to give applicants flexibility regarding the types of additional conditions applicants may propose and how those additional conditions can be implemented,” FDA wrote.
FDA said nonprescription drug products with ACNU would be required to show “a meaningful difference between a prescription drug product and a nonprescription drug product that makes the nonprescription drug product safe and effective for use without the supervision of a healthcare practitioner licensed by law to administer the drug.”
“For instance, two drug products could have the same active ingredient, dosage form, strength, route of administration, and indication, with one made available as a nonprescription drug product with an ACNU and the other product made available only by prescription,” FDA wrote. The prescription and ACNU drugs would be considered different products by FDA, and both could be marketed separately, they noted.
Nonprescription drug products with ACNU would also have post-marketing reporting requirements that ensure the consumer isn’t able to obtain the product without completing the ACNU.
The agency said the finalization of this proposed rule would give consumers access to nonprescription drugs that would be otherwise unavailable without the additional condition. “Greater access to drug products would allow consumers to treat certain medical conditions using nonprescription drug products with an ACNU without the supervision of a healthcare practitioner,” they wrote.
FDA also estimated a cost savings component to the rule, noting that consumers could see a reduction in costs for medications by moving from a prescription to nonprescription drug product with ACNU. There is also a potential cost savings if the new proposed rule results in fewer repetitive FDA-industry meetings. Additionally, FDA noted payers could see potential cost savings if they transition from prescription to nonprescription drug product with ACNU because due to fewer submitted insurance claims.
The agency is seeking public comments about the proposed rule, the content of statements advising consumers to complete the ACNUs present on drug labeling, and the benefits and burdens of filing reports related to failures in implementing ACNUs in settings due to a single point of failure for multiple consumers, such as a kiosk malfunctions at a pharmacy. FDA is accepting written and electronic comments until October 26, 2022.
Nonprescription Drug Product With an Additional Condition for Nonprescription Use


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