0910-AH68 201710 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Medication Guides; Patient Medication Information

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.

]]> Economically Significant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined No Regulatory 21 CFR 208 21 CFR 606.123 (new) 21 CFR 310.501 and 310.515 (removal) 21 CFR 201.57 (a)(18) (revision) 21 CFR 201.809(f)(2) (revision) 21 CFR 314.70(b)(2)(v)(B) (revision) 21 CFR 610.60(a)(7) (removal) ... 21 U.S.C 321 et seq. 42 U.S.C. 262 42 U.S.C. 264 21 U.S.C. 371 Yes

Patients may currently receive one or more types of written patient information regarding prescription drug products. Research has shown that frequently the information received  is duplicative, incomplete, conflicting, or difficult to read and understand and such information 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 adverse drug reactions due to incorrect use and improve health outcomes.

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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).

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FDA evaluated providing additional guidance to entities that supply patients information about prescription drugs and various formats for patient medication information.

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

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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 FDA- approved Patient Medication Information for certain prescription drug products used, dispensed, or administered on an outpatient basis.

]]> NPRM 05/00/2018 Yes Businesses None No No Yes No Chris Wheeler Supervisory Project Manager 0910 Food and Drug Administration FDA 301 796-0151 cderomp@fda.hhs.gov 10903 New Hampshire Avenue, Building 51, Room 3330, Silver Spring MD 20993