For immediate release:
Statement from:

Robert M. Califf, MD, MACC
Food and Drug Commissioner – Food and Drug Administration

Providing people with accurate and timely information to help them take their prescribed medications safely and effectively is a top priority for the United States Food and Drug Administration. Evidence suggests that easier-to-read information can help patients reduce adverse reactions to preventable drugs and improve health outcomes.

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

When such critical information is difficult to understand, patients may become frustrated, stop taking their medications, or not take them as directed, which can be detrimental 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 existing types of written information for prescription drugs and some biologics can have a negative impact on public health, and we are eager to address it.

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

Patient drug information would provide patients with clear, concise, accessible, and useful written information for prescription drugs and certain biologic products, and would be provided in a consistent and easy-to-understand format to help patients use their medications prescription and certain organic products safely and effectively. Consistent formatting of patient medication information can help facilitate translations into other languages ​​and make it easier for artificial intelligence or other technologies to convert the information, where possible, into formats that assist the blind.

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

  • Name of the drug/biological product
  • Brief summary of indications and uses
  • Important safety information
  • Common side effects
  • Instructions for Use

Patient drug information would be provided to patients with their prescription drugs and certain biologics when provided in an outpatient setting, and would also be available online for public access. In addition to the primary goal of making it easier for patients to use medicines safely and effectively, drug information for patients would also replace two types of FDA-approved prescription patient information and some biologics information that are currently required, which would reduce duplicate information and be more cost-effective for manufacturers of medicines and certain biological products.

We also view this proposal as a way to combat our nation’s crisis with health care misinformation and disinformation, which is a top priority for the agency. Having immediate access to straightforward, easy-to-understand information in a consistent format for prescription drugs and some biologics can reduce both accidental and intentional misinterpretations.

The rule proposed today is a practical step toward improving the health of the nation. Our public health mission is to ensure that medicines and certain biological products are used safely and effectively, to help people feel empowered and confident in their ability to manage their care, and to prevent adverse health outcomes.

We encourage public comments for the Medication Guide: Proposed rule for patient drug information during the public comment period. As always, the FDA will review and consider feedback as we develop the final rule.

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The FDA, an agency within the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products for human and medical devices. The agency is also responsible for the safety and security of food supplies, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products in our nations.