Article by Sarah Daniels
“Instructions for Use — Patient Labelling for Human Prescription Drug and Biological Products — Content and Format : Guidance for Industry” was released by the US FDA in July 20221 (here on in referred to as the IFU).
This brief article summarises the key points and where appropriate compares this document to the closest EU equivalent: The “Guideline on The Readability of The Labelling and Package Leaflet of Medicinal Products for Human Use Revision 1, 12 January 2009”2 (here on in referred to as the PIL).
Both the IFU and the PIL have a common objective, to ensure that patients receive clear and concise information that is easily understood for the safe and effective use of medicinal products. Additionally, they both aim for consistency in the content and format of either document.
A key difference is that the FDA document is guidance only, while its EU counterpart is an interpretation of the legally binding Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.
The IFU applies to human prescription drug and biological products, as well as drug-led or biologic-led combination products submitted under a new drug application or a biologics licence application. Similarly, the PIL applies to all EU marketing authorisation procedures and to all EU medicinal products, but it also includes those available without prescription.
The IFU/PIL are forms of prescription drug labelling. They are developed by the applicant, reviewed and approved by Competent authority (FDA and EMA respectively), and provided to patients when the product is dispensed.
The primary purpose of an IFU/PIL is to provide detailed, step-by-step written instructions, including visuals if appropriate, in a patient-friendly manner.
There should be:
1. Consistency with the FDA/EMA - Approved Prescribing Information,
2. Language and Readability should be appropriate for patients with low literacy skills i.e., at or below the national average reading level. Both give pointers on how to simplify language.
The table below gives some examples of FDA and EMA guidance on language:
The PIL additionally advises on the type of paper to use. e.g., the weight should be such that the paper is sufficiently thick to reduce transparency, which makes reading difficult and avoid the use of glossy paper.
Specific Content Recommendations
Whilst falling short of giving a full-blown template, the FDA provides subheadings and recommendations in a consistent order.
EU guidance provides links to the actual template and notes having used the templates provided. Marketing authorisation applicants/holders will still need to format the resulting text into the relevant full colour mock-ups or specimens of the package leaflet.
The table below provides a summary of the main headings, the guidance provide more detail:
Both IFU and the PIL provide guidance on formatting. The table below shows a few examples:
Both IFU and PIL are intended for a similar purpose, and both provide guidance on how the documents should be written. The older EU PIL guidance goes a little further than the IFU e.g., has recommendations for braille, paper weight etc. But essentially, they cover the same ground, both aiming to ensure patients get clear easy to understand information on their medicinal product.
1. Instructions for Use — Patient Labelling for Human Prescription Drug and Biological Products — Content and Format
2. Guideline on The Readability of The Labelling and Package Leaflet of Medicinal Products for Human Use