FDA Plans Update to Prescription Medication Guides

May 30, 2023

The FDA is looking to revamp the information patients receive for prescription drugs and some outpatient blood products.

In a proposed rule announced today, the agency said it wanted to create a new Patient Medical Information guide that would help patients use their prescription drug products safely and address the rise of health care misinformation and disinformation.

The agency says the proposed drug labeling regulations strive to provide “clear, concise, accessible, and useful” information that helps patients better understand their prescription treatments.

“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,” FDA Commissioner Robert Califf, MD, said in a statement.

Here’s what you need to know:

• About:  The one-page guide would highlight essential information in a standard format, including the drug name, a summary of indications for use, important safety information, and side effects.
• The issue:  FDA leaders say the current system for written information for prescription drugs and other biological products can be confusing, conflicting, incomplete, or repetitive. 
• By the numbers:  The FDA estimates medication nonadherence contributes to nearly 25 percent of hospital admissions, 50 percent of treatment failures, and approximately 125,000 deaths in the U.S. annually.
• Submit your feedback:  The agency is accepting public comment during the next 180 days on the proposed rule.
• Quotable:  “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,” Califf said.

“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,” Califf said in the statement.

Additional information about the proposed rule is available online.