#2: Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements

February 15, 2017

In 2013, the FDA released a guidance entitled “Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements.”  This guidance was finalized after taking industry comments into consideration, and was issued to assist Sponsors in complying with content and format requirements for labeling drug and biological products under the Physician Labeling Rule (PLR).  In a previous blog post, we touched on the history of the labeling rule and the FDA’s thinking behind this final rule.

The main goal of the PLR was to provide physicians with information that was easier to access, read, and that promoted product labeling as a guide in making prescribing decisions.  To accomplish this, the PLR created three main sections of labeling:

  1. Highlights of Prescribing Information (Highlights)
  2. A Table of Contents
  3. Full Prescribing Information (FPI).

Highlights

The Highlights section is meant to quickly convey the most critical information a physician.  This section is created by summarizing the FPI, and represents more than a simple rephrasing of that information.  The FDA noted that it is rarely acceptable for content to be repeated verbatim from the FPI.  The FDA also focused on language style, which should be direct and succinct.  The guidance also provides specific content recommendations for each component of the Highlights section with associated formatting requirements.  Recommendations and requirements that Sponsors should specifically note include:

  • The Major Recent Changes section needs to include substantial changes made to the Boxing Warning, Indications and Usage, Dosage and Administration, Contraindications, and Warnings and Precautions sections for 12 months after the change is made.
  • The entire Highlights section cannot exceed a half page of information.
  • Cross references are encouraged, and in some places required, to limit repetition of information and to facilitate citations within the Highlights section.
  • The Highlights section must include a Patient Counseling Information section. This section is used to reference FDA approved patient labeling, such as a Medication Guide, and contains the information that should be conveyed to patients when the product is being prescribed, dispensed, or administered.

Table of Contents

The Table of Contents follows the Highlights section and the lists sections and subsections included within the FPI.

Full Prescribing Information (FPI)

The FPI section contains the detailed prescribing information necessary for safe and effective use of the drug.  This information is similar to the labeling information provided in the previous label format, however the FPI has a different format and organization.  An example of these format changes includes the combination of the Warnings and Precautions sections into a single section.  Additionally, sections in the FPI that were previously optional, such as the Clinical Studies section, are now required.  The PLR guidance provides specific information and examples of these reorganized and newly required sections.

Information found in approved labels is crucial for all stakeholders in the medical decision making process.  Having labels conform to the PLR standard helps physicians make better informed decisions on patient health, and improves the knowledgeable use of pharmaceutical products.  This guidance is crucial for any Sponsor making changes to approved labeling or when converting labeling to PLR format.  ProPharma Group is well versed in all FDA labeling regulations for drug and biological products, including the PLR.  If your company has any labeling or other FDA concerns, please contact us.




Agency Alerts General Regulatory

February 15, 2017

FDA Releases Anxiously Awaited Biosimilar Labeling Guidance, Part 2: Label Content

More on FDA’s draft guidance in our preceding FDA News article, entitled “FDA Releases Anxiously Awaited Biosimilar Labeling Guidance, Part 1: An Overview of FDA’s Recommendations.”   Late last month...

Read More
General Regulatory

February 15, 2017

FDA Comments on Proposed Prescription Drug Labeling

Standardized prescription drug labeling was implemented by FDA in 1979. In the following years as labeling became more complex, FDA re-evaluated its usefulness and published a final rule in 2006...

Read More
Agency Alerts General Regulatory

February 15, 2017

FDA Reopens Comment Period on Proposed Labeling Regulations for “Conventional Foods” & Dietary Supplements

On March 3, 2014, FDA announced a proposed rule that would amend the regulations regarding the labeling of conventional foods and dietary supplements. In this announcement, the Agency sought feedback...

Read More