Prescription Medication Information (PMI) will, if FDA has its way, replacing medication guides and other information provided to patients. The goal of the new PMI is to “highlight essential information that the patient needs to know about the prescription drug product and basic directions on how to use the product. The pre-publication of the proposed rule appeared in the Federal Register (FR) today (here). PMI would be a one-page document that follows standardized format and content requirements. PMI would consist of the following headings:
- [Insert Drug Name] is
- Important Safety Information
- Common Side Effects
- Directions for Use
The FDA intends to provide a template PMI to new drug application, biologic license holders and blood and transfused products manufacturers to use in an outpatient setting. Once an approved NDA, BLA has a PMI approved, abbreviated new drug application (ANDA) holders would need to supplement their approved application and begin submitting amendments to pending ANDAs.
The PMI is designed to be a one-page document that simplifies the most important information to aid the patient in understanding the best way to identify the best use of the medication along with information about warnings etc., that will hopefully improve the safe and effective use of the product. Previously Medication guides, consumer information sheets and other written information have been disseminated often containing different information in different ways. In research conducted by and for the FDA, the Agency has determined that a single source of information, provided in a uniform format and in easily understood language would be the most useful for patients. The PMI will consolidate that information into a single document to assist the consumer in using the medication properly and being able to identify appropriate warnings that may potentially signal a problem with the use of the medication. The PMI will, over time, replace the other forms of approved patient information in existing applications.
For NDAs and BLAs that are no longer marketed but served as a reference listed drugs for an ANDA, the Agency will develop a PMI to provide to ANDA application holders to copy. Applicants of approved ANDAS would be required to submit a supplement to their applications for the RLD’s PMI and for those pending ANDA applications, an amendment to their application for a PMI that would be identical in content the RLD’s PMI with the only exceptions being for changes that are permitted because the drug is produced by a different applicant. Supplements will be required to be submitted over a 5-year period starting 1 year after the final rule is published and the FR notice provides the time estimates and workload burden for each type of submitter (e.g., NDA, BLA or ANDA).
While there are provisions for waivers for complying with timelines in the guidance (very limited) FDA provide a couple of examples in the document that may allow for an extension of time to comply or for a waiver from the one page requirement (if FDA determined that more than one page would be required to adequately provide to the patient information regarding the safe use of the drug.
Check out the 115-page proposed rule at the link above. The comment period is 180 days so start thinking about what you want to tell the Agency, and also it will be a good idea to plan and budget for this project as the finale rule may be here before you know it!
