The US Food and Drug Administration (FDA) has proposed a new, easy-to-read medication guide for patients known as the Patient Medication Information (PMI)1. The new medical guide will be required for all prescription drugs and certain biological products, including both brand name and generic.
The FDA's proposal is based on extensive research indicating that many patients struggle to understand the written information that accompanies their prescription drugs. This lack of understanding can result in medication nonadherence, significantly impacting the product's safety and effectiveness. As cited in the proposed rule, "it is estimated that nonadherence contributes to as many as 25% of hospital admissions, 50% of treatment failures, and approximately 125,000 deaths in the US per year"23.
The PMI is designed to be a one-page, easy-to-read document that offers patient crucial information about their medication. It includes details like the drug/biologic product name, concise summary of the indications and uses, important safety information, common side effects, and directions for use. Additionally, the PMI will feature a designated section where patients can record their own questions and concerns.
The PMI's key features include:
The PMI's comprehensive approach holds significant potential for enhancing patient safety and healthcare outcomes by addressing various aspects of medication management and patient understanding. For example, the PMI could help to:
The FDA is currently inviting public comment on the proposed PMI until November 27, 2023. After the public comment period, the FDA will review the comments and make a decision about whether to finalize the proposal. If the proposal is finalized, the PMI will be required to be included with all prescription drugs and certain biological products dispensed to patients in outpatient settings. The timing of implementation for the PMI is anywhere from one to five years after the final rule is published. The public comment period allows patients, healthcare professionals, and stakeholders to contribute valuable insights, leading to a more comprehensive and effective final PMI. The proposed implementation schedule for the PMI is summarized below:
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NDAs, BLAs, and Efficacy Supplements |
Time by which PMI must be submitted to the FDA |
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Applications submitted on or after the effective date of the final rule |
Time of submission (part of application) |
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Applications pending at the time of the effective date of the final rule |
No later than one year after the date of approval of the pending application |
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Applications approved on or before the effective date and that have a Medication Guide required under part 208 or a PPI required under §310.501 or §310.515 |
No later than one year after the effective date of the final rule |
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Applications approved from January 1, 2013, up to and including the effective date of the final rule that do not have a Medication Guide required under part 208 or a PPI required under §310.501 or §310.515 |
No later than two years after the effective date of the final rule |
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Applications approved from January 1, 2008, up to and including December 31, 2012, that do not have a Medication Guide required under part 208 or a PPI required under §310.501 or §310.515 |
No later than three years after the effective date of the final rule |
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Applications approved from January 1, 2003, up to and including December 31, 2007, that do not have a Medication Guide required under part 208 or a PPI required under §310.501 or §310.515 |
No later than four years after the effective date of the final rule |
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Applications approved on or before December 31, 2002, that do not have a Medication Guide required under part 208 or a PPI required under §310.501 or §310.515 |
No later than five years after the effective date of the final rule |
The FDA's proposed easy-to-read PMI marks a significant milestone in patient-centered healthcare. By reimagining the way medication information is presented, this initiative addresses the longstanding challenges associated with complex medical language and supports individuals in making informed decisions about their treatment.
If a marketing application is in your near future, Sponsors are encouraged to understand the new PMI standard. At ProPharma, we continue to keep up on the current regulatory developments from the FDA and look forward to working with clients to ensure their development and marketing are in good regulatory compliance.
Contact us to learn how the new PMI implementation affects your company's marketing application and to explore ProPharma's regulatory expertise.