FDA Discusses Upcoming Proposed Rule on One-Page Patient Medication Information

Officials from the US Food and Drug Administration (FDA) gathered on Thursday at DIA's advertising and promotion conference in Washington, DC, to discuss recent research, guidance for industry and enforcement action on pharmaceutical and medical device advertising and promotion.

The new administration’s impact on FDA was not discussed, though some officials discussed how FDA is moving forward with initiatives begun under President Barack Obama’s administration.

Elizabeth Walther, regulatory counsel in FDA’s Office of Medical Policy Initiatives, discussed the issuance of a proposed rule, lingering for the last several years, that would establish a new Patient Medication Information framework whereby companies would submit an abbreviated one-page document meant to highlight for patients the most important information about a prescription drug.

The information on the one-pager, which would be reviewed by FDA and stored in a central FDA repository, is intended to be used at home by patients, and is not meant to replace or impact professional labeling, instructions for use or patient counseling, Walther explained.

According to an Office of Management and Budget posting, which says the proposal is due for release this month, “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.”

The need for this abbreviated information for patients comes as FDA notes that patients currently receive one or more types of written patient information that are frequently duplicative, incomplete, conflicting or difficult to read and understand and is not sufficient to meet the needs of patients.

What remains to be seen is whether such a proposed rule would be issued under FDA leadership appointed under the new Donald Trump administration and whether this proposed rule would fall under the new “one in, two out” executive order.