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  5. Guidance Recap Podcast | Patient Medication Information (PMI) Proposed Rule
  1. Guidances | Drugs

Guidance Recap Podcast | Patient Medication Information (PMI) Proposed Rule

Thank you for joining us for another episode of the Guidance Recap Podcast. The Guidance Recap Podcast provides highlights for FDA guidance documents straight from the authors. Today, we’re expanding our podcast beyond guidance documents to discuss an FDA proposed rule. My name is Kylie Haskins, and I am the host for today’s podcast. In this episode, I am excited to be talking with Chris Diamant. He is a Regulatory Counsel in the Office of Medical Policy for the Center for Drug Evaluation and Research or CDER. He will be sharing some thoughts with us on the Medication Guide: Patient Medication Information Proposed Rule that FDA published in May 2023. Welcome, Chris. Thank you for speaking with us today.

Could you provide a brief overview of the Medication Guide: Patient Medication Information Proposed Rule?

Yes. The proposed rule introduces Patient Medication Information or PMI. This would be a new type of Medication Guide that would require FDA approval. Specifically, the proposed rule, if finalized, would require applicants to prepare PMI for prescription drug products used, dispensed, or administered in an outpatient setting, including blood components transfused in an outpatient setting.

Outpatient settings for prescription drugs include retail pharmacies, hospital ambulatory care pharmacies, and other places where prescription drugs are dispensed or administered by a health care provider to the patient, such as infusion or dialysis centers.

I would like to note that when we talk about drug products in this proposed rule, we are focused only on prescription drugs that are dispensed in outpatient settings. These drugs include generics of brand-name prescription drugs. They also include biological therapeutics and their biosimilars.

The intent of the proposed PMI for prescription drugs is to improve public health by providing patients with clear, concise, accessible, and useful written prescription drug product information delivered in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.

Why is FDA issuing this proposed rule?

FDA values the significance of written information to communicate and promote the safe and effective use of prescription drugs. Today, patients may receive one or more types of written medication information regarding prescription drug products. In certain instances, the written medication information has been duplicative, incomplete, conflicting, or difficult to read and understand. The proposed PMI would provide patients with clear, concise, accessible, and useful written information about their prescription drug products. PMI would be a one-page written document presented in an easy-to-understand format.

Who would be required to create PMI?

If finalized, this proposed rule would require applicants of all new and approved New Drug Applications and Biologics License Applications to create PMI for prescription drug products that are to be used, dispensed, or administered on an outpatient basis. Applicants of New Drug Applications and Biologics License Applications would be required to submit PMI to FDA for approval.

If finalized, the proposed rule would also require applicants of new and approved Abbreviated New Drug Applications to submit PMI. Abbreviated New Drug Applications are for generic drugs. The PMI for the generic drug would be the same as the PMI for the generic’s brand-name counterpart, which is also called a reference listed drug. We anticipate that there may be cases where an abbreviated new drug application is submitted for a reference listed drug that no longer has FDA approval. In these cases, where the abbreviated new drug product would not have a PMI to reference, FDA will create a PMI template that can then be referenced by the applicant.

If finalized, the proposed rule would also require blood establishments to make PMI available to transfusion services for distribution to patients.

How will PMI be distributed to patients?

The proposed rule would require the distribution of PMI to patients who receive prescription drug products in an outpatient setting and for patients transfused with blood and blood components in an outpatient setting. The most common outpatient settings for prescription drugs are retail pharmacies and hospital ambulatory care pharmacies, where the patient takes the prescription drug product home and uses it. Outpatient settings also include those settings in which the prescription drug product is dispensed to a health care provider who administers it to the patient. This includes, but is not limited to, clinics, health care providers' offices, dialysis centers, and infusion centers, including those administering blood and blood component transfusions.

The one-page PMI document would be made available as a printed document but could also be made available electronically if the patient requests the PMI in an electronic format.

FDA would store all approved PMI in a central repository, which would be accessible to industry and the public.

What type of information is in the proposed PMI?

The proposed rule would require PMI to be a one-page document with standardized content and format.

The PMI would include the following information:

  • Drug Name
  • Important Safety Information
  • Common Side Effects, and
  • Directions for Use

The proposed rule snapshot that accompanies this podcast includes an example of a PMI for a fictitious prescription drug.

What are the benefits of the proposed PMI?

The proposed PMI would provide many benefits:

  • Help improve public health by providing patients with clear, concise, accessible, and useful patient information.
  • Highlight the most important information the patient needs to know about the product and provide basic directions on how to use the product.
  • Consist of a single page document, with standardized content and formatting, that is intended to make it easier for patients to access important information on the product.
  • Provide patients with PMI in printed form that would allow them access to the information. However, the proposed rule would allow for a patient to request an electronic copy, if preferred.

When would the proposed rule take effect?

FDA proposes that the final rule based on this proposed rule would become effective 6 months after the date of publication in the Federal Register. For instance, if the final rule is published in the Federal Register on August 1 of this year, then it would become effective on February 1, 2025.

FDA is proposing a 5-year implementation schedule for PMI for prescription drug products (except blood and blood components). The proposed rule would require a staggered implementation schedule for applicants to submit PMI to FDA for New Drug Applications, Biologics License Applications, and efficacy supplements.

For specifics about the staggered implementation for prescription drugs, I encourage listeners to review either the accompanying proposed rule snapshot or the proposed rule.

During the implementation of the final rule, all FDA-approved Patient Package Inserts or Medication Guides would continue to be available as a potential element of a Risk Evaluation and Mitigation Strategy. However, each Patient Package Insert or Medication Guide would be withdrawn once its prescription drug product has an FDA-approved PMI.

During the proposed 5-year implementation schedule of the final rule, the current regulations governing Medication Guides and Patient Package Inserts would remain in place but would no longer be applicable to a prescription drug product once that prescription drug product has FDA-approved PMI.

FDA did not propose an implementation schedule for blood collection establishments to develop and submit PMI to FDA for approval and for transfusions to provide the PMI to patients because of the need to explore the feasibility of industry jointly developing PMI documents.

Will a printed copy of PMI be available for patients?

Yes. By default, patients would receive PMI in a printed format. However, if the patient prefers to receive their PMI electronically, then the proposed rule would allow PMI to be made available in that format.

Will PMIs replace all current FDA-approved Medication Guides and Patient Package Inserts?

Yes. The rule proposes that Patient Medication Information will be a new type of FDA-approved Medication Guide (specifically a form of patient labeling that conforms to the specifications set forth in subparts A and B of the proposed rule). Once FDA-approved PMI are in place for all prescription drug products that currently have Medication Guides, then FDA would withdraw the current regulations requiring those Medication Guides that existed before the implementation of PMI for certain prescription drug products.

During the implementation period of the final rule, the current regulations governing Medication Guides would remain in place, but the regulations regarding Medication Guides implemented prior to PMI would no longer be applicable to a prescription drug product once it has FDA-approved PMI. The same thing would be true for Patient Package Inserts, also known as PPIs. That is, FDA would also withdraw the current regulations requiring PPIs for oral contraceptives and estrogen-containing products after all such prescription drug products that had PPIs have FDA-approved PMI.

Are there exceptions to the proposed rule?

The proposed rule would allow for waivers from one or more of the proposed requirements for PMI if FDA determines that any requirement is inapplicable, unnecessary, impracticable, or contrary to patients’ best interests for a particular prescription drug product. Waivers may be requested—such as for the proposed requirements for format and content of PMI or for submitting and distributing PMI. Waivers could be initiated by FDA or requested by a person or entity that is covered by the final rule. FDA will evaluate such requests on a case-by-case basis.

FDA proposes to exclude manufacturers of preventive vaccines that do not have Medication Guides from the requirement to create and distribute PMI. The Centers for Disease Control and Prevention manages a comprehensive preventive vaccine program that includes providing information on preventive vaccines to patients. This current system for developing and providing vaccine information statements to patients meets the goals of PMI for these products.

What is the status of the proposed rule?

The public comment period for the proposed rule ended on November 27, 2023. FDA received over 57,000 comments. FDA is reviewing these comments.

For our final question, what are a couple of key items about the proposed rule that you especially want listeners to remember?

I think the most important thing to remember is that the proposed rule PMI is to benefit patients. The intent of PMI is to inform patients about their prescription drug products, including blood or blood components for transfusion. This proposed rule is intended to improve public health by providing patients with clear, concise, accessible, and useful written prescription drug product information delivered in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.

Patients would receive PMI in outpatient settings. Each PMI would have the same categories of information, would be written in a way that would be easily read and understood by the general population, including individuals with low literacy and comprehension levels, and would be one page in length. The document would be available in a printed copy and can be made available electronically if a patient requests this format.

The proposed rule has a 5-year, staggered implementation plan for prescription drugs dispensed in outpatient settings.

Christopher Diamant, thank you for taking the time to share your thoughts on the proposed rule on Patient Medication Information. We all have learned so much from insights on this document. We would also like to thank the proposed rule working group for writing and publishing this document.

To the listeners, we hope you found this podcast useful. We encourage you to look at the accompanying proposed rule snapshot and to read the proposed rule.

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