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June 28 -- The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). The proposed rule, if finalized, would establish requirements for a nonprescription drug product that has an ACNU that an applicant must implement to ensure appropriate self-selection or appropriate actual use, or both, by consumers without the supervision of a healthcare practitioner. The proposed rule is intended to increase options for applicants to develop and market safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers. Either electronic or written comments on the proposed rule must be submitted by October 26, 2022.

The proposed rule, if finalized, would establish requirements for a nonprescription drug product with an ACNU. The evidentiary standards that an application must meet under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and current FDA regulations for demonstrating safety and effectiveness would continue to apply to nonprescription drug products approved with an ACNU. This proposed rule would establish additional application requirements, labeling requirements, and postmarketing reporting requirements for a nonprescription drug product with an ACNU.

The proposed rule would establish the requirements for a new drug application (NDA) or abbreviated new drug application (ANDA) for a nonprescription drug product with an ACNU. An applicant would be required to submit a separate application for the approval of a nonprescription drug product with an ACNU, rather than a supplement to an application approved as a prescription drug product. In addition to applicable existing application requirements, NDA applicants would also be required to describe the ACNU and submit information to support the ACNU.

The proposed rule would clarify that an ACNU would constitute 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.

The proposed rule would specify that FDA would refuse to approve an NDA or ANDA for a nonprescription drug product with an ACNU if the application fails to meet the applicable requirements of proposed § 314.56 (21 CFR 314.56).

The proposed rule would establish postmarketing reporting requirements for a nonprescription drug product with an ACNU. NDA and ANDA applicants would be required to submit a report with information concerning any incident of failure in the implementation of an ACNU, such as a consumer gaining access to the drug product without fulfilling the ACNU.

The proposed rule, if finalized, would establish, for any applicant, the requirements for a nonprescription drug product with an ACNU. Compared to the traditional labeling paradigm of nonprescription drug products, this approved ACNU in addition to the labeling would ensure the appropriate self-selection, appropriate use, or both, of a drug product. We expect that this proposed rule, if finalized, would expand consumer access to certain drug products in a nonprescription setting.

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. We estimate a reduction in access costs to consumers who could transfer from a prescription to a nonprescription drug product with an ACNU. Our primary estimate for this item is $26.70 with a range of $0 to $53.40 per consumer per purchase. There may also be cost savings associated with a potential reduction in the number of repetitive meetings between FDA and industry. Our primary estimate is $55,469 per applicant with a range of $45,260 to $66,174. Government and private insurance payers may also experience cost savings because the availability of nonprescription drug products with an ACNU may decrease future medical costs and the number of submitted insurance claims. In addition, we assume that applicants would submit applications when they believe that the profits from a potential approval would exceed the costs of the application. We lack information to monetize these potential profits and costs. We do not monetize our estimates of benefits over a 10-year horizon because of the high uncertainty about the number of applicants, applications, potential approvals, the number of purchases that might occur, and consumer preferences to switch products. For details, see the Preliminary Regulatory Impact Analysis (PRIA), the Uncertainty and Sensitivity section, as well as the Appendix of the same document.

Monetized costs include a one-time cost of reading and understanding the rule for those applicants potentially interested in submitting applications for their nonprescription drug products with an ACNU. Our primary estimate of these costs equals $821 with a range of $379 and $1,264 using a 7-percent discount rate annualized over a ten-year horizon.

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. 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 (Ref. 1). Nonprescription drug products are usually available for consumers to purchase at pharmacies, supermarkets, or other retail locations, and from online retailers.

FDA 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.

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 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 (Ref. 2).
 
Proposed rule: https://www.federalregister.gov/d/2022-13309
FDA announcement: https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/fda-announces-proposed-rule-nonprescription-drug-product-additional-condition-nonprescription-use
FDA news release: https://www.fda.gov/news-events/press-announcements/fda-introduces-innovative-proposal-advance-consumer-access-nonprescription-drugs

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