Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Proposed Rule) Regulatory Impact Analysis
The proposed rule, if finalized, would establish for any applicant deciding to use this path the requirements for a nonprescription drug product with an additional condition for nonprescription use (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 this rule would expand consumer access to certain drug products in a nonprescription setting.
We estimate that reduction in access costs to consumers who could transfer from a prescription to a nonprescription drug product with an ACNU could be about $26.7 dollars with a range of $0 to $53.4 dollars per consumer per purchase. In addition, the value of the potential reduction in the number of repetitive meetings with applicants that would occur during the approval process could be about $55,469 dollars per applicant with a range of $45,260 to $66,174 dollars. Private and government sponsored drug coverage plans would experience cost savings if their cost of coverage declines, we do not estimate such cost savings due to lack of data. We assume that applicants submit applications only when they believe that the profits from the approval will exceed the costs of the application.
Monetized costs include a one-time cost of reading and understanding the rule for those potentially interested in pursuing this path for their drug products. Using a 7-percent discount rate, the primary estimate, annualized over a ten-year horizon, equals $821 dollars with a range of $379 to $1,264. These annualized costs are the same using a 3-percent discount rate.
Regulatory Impact Analysis
Federal Register: 87 FR 38313, June 22, 2022
Docket: FDA-2021-N-0862