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The following is attributed to FDA Commissioner Robert M. Califf, M.D., MACC

SILVER SPRING, Md., May 30, 2023 /PRNewswire/ -- Providing people with accurate and timely information to help them take their prescription medications safely and effectively is an important priority for the U.S. Food and Drug Administration. Evidence suggests that more easy-to-read information can help patients reduce preventable adverse drug reactions and improve health outcomes.

Currently, patients may receive one or more types of written information for prescription drugs and certain biological products, depending on the medication they are prescribed. Studies have found that the current system for written information for prescription drugs and certain biological products can be confusing, conflicting, incomplete, or repetitive.

When such critical information is difficult to understand, patients can become frustrated, stop taking their medications, or not take their medications as directed, which can be harmful to their health. 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, today, 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 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. 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 their prescription drugs and certain biological products when provided in an outpatient setting and 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 information and be more cost-efficient for drug and certain biological product manufacturers.

We also view this proposal as one way to fight our nation's crisis with health care misinformation and disinformation, which is a top priority for the agency. Having ready access to direct and easy to understand information in a consistent format for prescription drugs and certain biological products may reduce instances of both accidental and purposeful misinterpretations.

Today's proposed rule is a practical step towards improving the nation's health. 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 negative 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.

Media Contact: Carly Kempler, 240-672-8872

Consumer Inquiries: Email, 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration