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  6. Nonprescription Drug Product with an Additional Condition for Nonprescription Use; Final Regulatory Impact Analysis
  1. Economic Impact Analyses of FDA Regulations

Nonprescription Drug Product with an Additional Condition for Nonprescription Use; Final Regulatory Impact Analysis

The Food and Drug Administration (FDA) is issuing a final rule to establish the requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). Compared to traditional nonprescription drug products, which consumers must be able to self-select and use based on their labeling, this approved ACNU, in addition to the labeling, will ensure the appropriate self-selection, the appropriate use, or both of a nonprescription drug product without the supervision of a practitioner licensed by law to administer such drug.  We expect this rule will increase options for applicants to develop and market safe and effective nonprescription drug products and will increase consumer access to appropriate, safe and effective drug products. The FDA conducts objective economic analyses of all important proposed and final regulations, which includes the Regulatory Impact Analysis (RIA) as well as other analyses mandated by various statutes and executive orders.

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 $33.62 per consumer per purchase with a range of $0 to $67.23.  We also quantify the value of the potential reduction in the number of meetings with applicants that will occur during the approval process.  This estimate includes benefits to us and industry.  Our primary estimate is $68,773.11 per applicant with a range of $56,332.65 to $81,763.56. We do not aggregate our estimates of benefits because of the high uncertainty about the number of applicants, applications, potential approvals, and purchases that might occur; and consumer preferences to switch drug products.  However, we present estimates in the uncertainty section of this analysis.  

Although an applicant will incur the costs to develop and submit an application for a nonprescription drug product with an ACNU, for this analysis, we assume that applicants submit applications only when they believe that the profits from the approval will exceed the costs of the application.  We lack information to monetize these potential profits and costs.

Monetized costs include a one-time cost of reading and understanding the rule per interested party in pursuing this path for their drug products. We do not aggregate these estimates for more than one interested party because of the high uncertainty about the number of interested parties over this time horizon. The primary estimate equals $1,156.74 with a range of $533.88 to $1,779.60.  

Government-sponsored and commercial insurance payers may experience cost savings because the availability of nonprescription drug products with an ACNU may decrease insurance claims and, potentially, future medical costs.  For example, access to drug products under this new pathway will allow consumers to treat some medical conditions using nonprescription drug products with an ACNU without the supervision of a practitioner licensed by law to administer such drugs.  We do not estimate such cost savings due to lack of data. 

Regulatory Impact Analysis

Nonprescription Drug Product with an Additional Condition for Nonprescription Use (PDF - 517.31KB)

Federal Register: 89 FR 105288 
Publication Date: December 26, 2024
Docket: FDA-2021-N-0862

 

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