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The proposed rule is intended to increase access to a wider variety of nonprescription drug products.  Under the proposed rule, an applicant could submit an application to FDA for approval of a nonprescription drug product with a requirement that ensures consumers’ appropriate self-selection, appropriate actual use, or both in order to obtain the drug without a prescription.

Statement of Need:

Nonprescription products have traditionally been limited to drugs that can be labeled with information for consumers to safely and appropriately self-select and use the drug product without supervision of a health care provider.  There are certain prescription medications that may have comparable risk-benefit profiles to over-the-counter medications in selected populations.  However, appropriate consumer selection and use may be difficult to achieve in the nonprescription setting based solely on information that may be included in labeling.  FDA is proposing regulations that would allow for approval of a nonprescription drug product that would have additional requirements that could be met by consumers to obtain the drug without a prescription.  The proposed rule outlines a framework for the use of innovative approaches to assist consumers with nonprescription drug product self-selection or use.  This pathway should lead to approval of a wider range of nonprescription drug products.

Summary of the Legal Basis:

FDA’s proposed revisions to the regulations regarding labeling and applications for nonprescription drug products labeling are authorized by the FD&C Act (21 U.S.C. 321 et seq.) and by the Public Health Service Act (42 U.S.C. 262 and 264).

Alternatives:

FDA evaluated various requirements for new drug applications to assess flexibility of nonprescription drug product design through drug labeling for appropriate self-selection and appropriate use.

Anticipated Costs and Benefits:

The benefits of the proposed rule would include increased consumer access to drug products which could translate to a reduction in under treatment of certain diseases and conditions. Benefits to industry would arise from the flexibility in drug product approval. The proposed rule would impose costs arising from the development of an innovative approach to assist consumers with nonprescription drug product self-selection or use. 

Risks:

None.