Easy-to-Read Medication Guide Proposed

The U.S. Food and Drug (FDA) Commissioner Robert M. Califf, M.D., today issued the following statement 'Providing people with accurate and timely information to help them take their prescription medications safely and effectively is an essential priority for the FDA.

And evidence suggests that more easy-to-read information can help patients reduce preventable adverse drug reactions and improve health outcomes.

As of May 30, 2023, studies have found that the current system for written information for prescription drugs and certain biological products can be confusing, conflicting, incomplete, or repetitive.

Research suggests that medication nonadherence can contribute to nearly 25% of hospital admissions, 50% of treatment failures, and approximately 125,000 deaths in our country each year.

While medication nonadherence is complex, inconsistency with the existing types of written information for prescription drugs and certain biological products can negatively impact public health, and we are eager to fix it.  

To address this problem, we are proposing to require a new type of Medication Guide called Patient Medication Information for prescription drugs and certain biological products (both brand name and generic) used, dispensed, or administered on an outpatient basis, as well as for blood and blood components transfused in an outpatient setting.

Patient Medication Information would provide patients with transparent, concise, accessible, and useful written information for prescription drugs and certain biological products. It would be delivered in a consistent and easy-to-understand format to help patients use their prescription drugs and certain biological products safely and effectively.

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. 

These FDA-approved, one-page documents would highlight the essential information patients need to know in a standardized format, including:

• Drug/Biological product name
• Concise summary of the indications and uses
• Important safety information
• Common side effects
• Directions for use

Patient Medication Information would be given to patients with prescription drugs and certain biological products in an outpatient setting. It would also be available online for the public to access.

In addition to the primary goal of more easily helping patients use medications safely and effectively, Patient Medication Information would also replace two types of FDA-approved written prescription drug patient information and certain biological product information that are currently required, which would reduce duplicative details and be more cost-efficient for drug and certain biological product manufacturers.

Our public health mission is to ensure drugs and certain biological products are used safely and effectively, help people feel empowered and confident in their ability to manage their care, and prevent adverse health outcomes.

We encourage public comments for the Medication Guide: Patient Medication Information proposed rule during the public comment period.

As always, the FDA will review and consider feedback as we develop the final rule. Consumer Inquiries can be sent to email, 888-INFO-FDA.

The unedited FDA statement is posted at this link.