06.28.22
The US Food and Drug Administration issued a proposed rule titled, "Nonprescription Drug Product with an Additional Condition for Nonprescription Use," which the agency says is intended to broaden the range of marketed nonprescription drugs available to consumers, empowering them to self-treat certain common conditions and improving public health.
Nonprescription drug products are important for the treatment of many conditions and diseases, although at present most nonprescription drug products are intended to provide temporary relief of minor symptoms or self-diagnosable, self-limited conditions and diseases, rather than chronic diseases, said FDA. Unlike prescription drug products, nonprescription drug products may be accessed and used safely and effectively by consumers without the supervision of a healthcare practitioner when certain conditions are met.
Currently, nonprescription drug products are limited to drugs that can be labeled with sufficient information to enable consumers to appropriately self-select and use the drug product without the supervision of a healthcare practitioner. Self-selection is the decision consumers make to use or not to use a drug product based on reading the information on the drug product labeling and applying knowledge of their personal medical history. Nonprescription drug products are usually available for consumers to purchase at pharmacies, supermarkets, or other retail locations, and from online retailers.
According to FDA, the proposed rule has the potential to broaden the types of drug products that FDA could approve as nonprescription.
Under the proposed rule, when labeling alone is not sufficient to ensure that the consumer can appropriately self-select or appropriately actually use, or both, a drug product correctly in a nonprescription setting, an applicant may submit an application proposing an ACNU (additional condition for nonprescription use) that a consumer must successfully fulfill to obtain the nonprescription drug product with an ACNU. For example, an applicant may submit an application for a nonprescription drug product with an ACNU that enables a consumer to treat a chronic condition that currently does not have a nonprescription treatment. The availability of nonprescription drug products with an ACNU may provide public health benefits by facilitating consumers' self-care and autonomy over their medical treatment.
An additional condition for nonprescription use is one or more FDA-approved conditions that an applicant of a nonprescription drug product must implement to ensure appropriate self-selection or appropriate actual use, or both, by consumers of the nonprescription drug product. 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. As with all proposals, the safety of patients remains a top priority.
"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," said FDA Commissioner Robert M. Califf, M.D., in the FDA statrement about the proposed rule. "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 electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 26, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date, according to FDA.
More information on submitting comments can be found here.
For more information on the proposed rule, visit the Nonprescription Drug Product with an Additional Condition for Nonprescription Use Proposed Rule webpage.
Nonprescription drug products are important for the treatment of many conditions and diseases, although at present most nonprescription drug products are intended to provide temporary relief of minor symptoms or self-diagnosable, self-limited conditions and diseases, rather than chronic diseases, said FDA. Unlike prescription drug products, nonprescription drug products may be accessed and used safely and effectively by consumers without the supervision of a healthcare practitioner when certain conditions are met.
Currently, nonprescription drug products are limited to drugs that can be labeled with sufficient information to enable consumers to appropriately self-select and use the drug product without the supervision of a healthcare practitioner. Self-selection is the decision consumers make to use or not to use a drug product based on reading the information on the drug product labeling and applying knowledge of their personal medical history. Nonprescription drug products are usually available for consumers to purchase at pharmacies, supermarkets, or other retail locations, and from online retailers.
Treating Chronic Conditions
FDA said it “recognizes the potential benefit of providing consumers with access to additional types of nonprescription drug products, such as some drug products that are currently available only by prescription and that treat chronic diseases or conditions. However, there are certain drug products that an applicant may seek to market on a nonprescription basis where labeling alone cannot adequately communicate the information needed for consumers to appropriately self-select, use, or both self-select and use the drug product safely and effectively without the supervision of a healthcare practitioner.”According to FDA, the proposed rule has the potential to broaden the types of drug products that FDA could approve as nonprescription.
Under the proposed rule, when labeling alone is not sufficient to ensure that the consumer can appropriately self-select or appropriately actually use, or both, a drug product correctly in a nonprescription setting, an applicant may submit an application proposing an ACNU (additional condition for nonprescription use) that a consumer must successfully fulfill to obtain the nonprescription drug product with an ACNU. For example, an applicant may submit an application for a nonprescription drug product with an ACNU that enables a consumer to treat a chronic condition that currently does not have a nonprescription treatment. The availability of nonprescription drug products with an ACNU may provide public health benefits by facilitating consumers' self-care and autonomy over their medical treatment.
An additional condition for nonprescription use is one or more FDA-approved conditions that an applicant of a nonprescription drug product must implement to ensure appropriate self-selection or appropriate actual use, or both, by consumers of the nonprescription drug product. 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. As with all proposals, the safety of patients remains a top priority.
"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," said FDA Commissioner Robert M. Califf, M.D., in the FDA statrement about the proposed rule. "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."
Public Comments
The FDA is encouraging public comment for this proposed rule.The electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 26, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date, according to FDA.
More information on submitting comments can be found here.
For more information on the proposed rule, visit the Nonprescription Drug Product with an Additional Condition for Nonprescription Use Proposed Rule webpage.