New FDA Rule for Labeling Requirements for Prescription Drugs

FDA is working on new rules to require a simplified one-page Medication Guide for prescription drugs to supplement the longer package inserts that usually accompany a drug to make it easier for the patients to understand their medication. Earlier this week FDA announced its major policy goals for this year and it contains several things that have been in the works for a few years such as addressing nicotine addiction, controlling compounding pharmacies, food safety testing labs, and modernizing its review processes. But two new proposed policies could have a deeper impact on the use of prescription drugs and biologics by patients. The first proposed policy intends to simplify and abbreviate the drug information currently included in the package inserts to one page guides. When a patient receives their prescription from the pharmacy, they usually get two documents; the instructions to use, and the package insert for the drug. The package insert could be several pages long, and contain a lot of detailed information that is poorly understood by an average consumer. Research has shown that package inserts are rarely studied by the patient and hence the patient is unable to fully understand the benefits and risks of their medication. Under the new policy, manufacturers will be required to create a one-page simplified Medication Guide written in clear, concise, and simplified plain language for ease of understanding by the patient. The policy aims to providing clear, concise, easily readable drug information, delivered in a consistent and easily understood format, “to help patients use prescription drug products safely and effectively and potentially reduce adverse drug reactions due to incorrect use”. Another related proposed policy aims to make it easier to transition prescription drugs to non-prescription status, allowing self-medication by patients. Ability to self-treat common conditions and chronic conditions could allow patients to use mobile apps to manage their conditions and save time and cost of getting prescriptions. With this policy, FDA seems to hedge its bets on mobile app-driven self health management by patients. The two policies are bundled as “Consumer Empowerment” initiatives. The details of the one-page Medication Guide and the modified or new rule to easily transitioning prescription drugs to non-prescription status should be released later this year. The policy announcement did not clarify if the one-page Medication Guide will be needed for all drugs, new drugs, or selected new drugs.  Since these are planned to rules and not just Guidance Documents, their impact would likely be immediate and long-term. Simplified medication guide should be welcomed by patients, and self-medication is inevitable with the increased use of mobile health apps.