Cody Miller Patient Medication Information Act
This bill amends the Federal Food, Drug, and Cosmetic Act to direct the Food and Drug Administration (FDA) to regulate the authorship, content, format, and dissemination of patient medication information for prescription drugs. (Patient medication information includes the instructional brochures provided to patients when a prescription is filled.)
FDA regulations must require drug patient medication information to be scientifically accurate, to be based on the approved professional labeling, and to include plain language that is not promotional in tone or content and that provides specified information including drug uses and side effects.
The regulations must include standards for: (1) timely reviews and updates of patient medication information, (2) updates to help communicate information that is shared by similar drugs, and (3) assessing the effectiveness of patient medication information in promoting patient understanding and safe and effective use of medications. The FDA must develop a public electronic repository for all patient medication information.
When a prescription drug is sold or dispensed, patient medication information must be provided.
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