USA – FDA proposes long-awaited patient medication information rule

The US Food and Drug Administration (FDA) has proposed new drug labeling requirements to make it easier for patients to understand their medication while improving prescription adherence. The agency also argues that the rule will save manufacturers and regulators both time and resources.

FDA proposed a new rule on 30 May that would require manufacturers to publish a one-page Patient Medication Information (PMI) for their prescription drugs, certain biologics, and blood and blood components given in outpatient settings. The proposed rule is being issued more than a decade after the agency first began looking into developing such a requirement.

“Patient Medication Information would provide patients with clear, concise, accessible, and useful written information for prescription drugs and certain biological products and would be delivered in a consistent and easy-to-understand format to help patients use their prescription drug and certain biological products safely and effectively,” said FDA Commissioner Robert Califf. “Patient Medication Information’s consistent formatting may help facilitate translations to other languages and make it easier for artificial intelligence or other technologies to convert the information, where feasible, to formats that assist the visually impaired.”…