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The proposed rule would amend FDA medication guide regulations to require a new form of patient labeling, Patient Medication Information, for submission to and review by the FDA for human prescription drug products used, dispensed, or administered on an outpatient basis. The proposed rule would include requirements for Patient Medication Information development, consumer testing, and distribution. The proposed rule would require clear and concise written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.

Statement of Need:

Patients may currently receive one or more types of written patient information regarding prescription drug products.  That information is frequently duplicative, incomplete, conflicting, or difficult to read and understand and is not sufficient to meet the needs of patients.  Patient Medication Information is a new type of one-page Medication Guide that FDA is proposing to require for certain prescription drug products.  Patient Medication Information is intended to improve public health by providing clear, concise, accessible, and useful written prescription drug product information, delivered in a consistent and easily understood format, to help patients use prescription drug products safely and effectively and potentially reduce preventable adverse drug reactions and improve health outcomes.

Summary of the Legal Basis:

FDA’s proposed revisions to the regulations regarding format and content requirements for prescription drug 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).

Risks: The current system does not consistently provide patients with useful written information to help them use their prescription drug products safely and effectively. The proposed rule would require consumer-tested and FDA-approved Patient Medication Information for certain prescription drug products used, dispensed, or administered on an outpatient basis.

Alternatives:

FDA evaluated various formats for patient medication information.

Anticipated Costs and Benefits:

The monetary benefit of the proposed rule stems from an increase in medication adherence due to patients having more complete information about their prescription drug products.  The proposed rule would impose costs that stem from developing, testing, and approving Patient Medication Information.

Risks:

The current system does not consistently provide patients with useful written information to help them use their prescription drug products safely and effectively. The proposed rule would require consumer-tested and FDA-approved Patient Medication Information for certain prescription drug products used, dispensed, or administered on an outpatient basis