As companies begin planning for the upcoming year, attorneys who sit on promotional review committees should consider the significant guidance published by the U.S. Food and Drug Administration (“FDA”) and update process aids and related trainings. For example, this summer, FDA finalized its guidance for developing both the content and format of patient Instructions for Use (“IFU”) inserts for prescription drugs and biological products, and drug-led or biologic-led combination products submitted under a new drug application (“NDA”) or biologics license application (“BLA”) (the “Guidance”).[1] IFUs are written for patients or caregivers who use drug products that have complicated or detailed patient use instructions (to promote the safe and effective use of the drug).[2] The IFU is developed by the applicant (i.e., the manufacturer), reviewed and approved by FDA, and provided to patients when the product is dispensed.
The final Guidance clarifies a number of important points, including advice on meeting with FDA to discuss the IFU during the investigational new drug (“IND”) phase and expanding the content of the Guidance from drug-device combination to drug-led combination products.[3]
Key Takeaways of the Guidance
This Guidance is one of several documents being issued by the Agency to fulfill its performance goals under the fifth authorization of the Prescription Drug User Fee Act (“PDUFA”) VI. The recommendations are intended to inform the development of patient IFUs so that they are clear, concise, and easily understood to further ensure the safe and effective use of covered products.
The Guidance breaks down content recommendations into two categories—general content recommendations and specific content recommendations.
Under its general content recommendations, FDA recognizes that although IFUs must be consistent with the approved Prescribing Information (“PI”), the IFUs can and typically do include additional information that is necessary for the user. IFUs should also be using language to facilitate understanding and readability by patients with low literacy skill, including headings and subheadings that clearly identify the focus of each topic in the IFU.
The Guidance also offers ten specific content recommendations addressing all aspects of IFUs, including:
The Guidance also provides recommendations related to IFU format intended to make the IFU easier for patients to read. These formatting recommendations include:
Differences Between the Final Guidance and the Draft Guidance
This final Guidance makes minor changes to the draft version released for comment in July 2019. Most of the changes are editorial and intended to provide additional clarity. These changes include:
[1] Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products – Content and Format, Guidance for Industry, Food and Drug Admin. (July 2022).
[2] The recommendations in the Guidance do not apply to labeling for stand-alone devices or for device constituent parts of cross-labeled combination products if the device constituent is marketed under a device authorization (i.e., devices that are not constituent parts of drug-device, biologic-device, or biologic-drug-device combination products submitted under BLA or NDA), labeling for combination products for which the device constituent part provides the primary mode of action, or labeling intended for use by health care providers. The recommendations in this Guidance also do not apply to stand-alone devices regulated under a BLA, such as devices associated with blood collection and processing procedures.
[3] Applicants must submit true representations of both the content and format of the IFU for FDA’s review and approval and, according to the Guidance, applicants are encouraged to “meet with FDA as early as the investigational new drug application (IND)/pre-IND phase, if appropriate, to discuss the development of any IFU.”
[4] Page 3. “For drugs for which self-administration may be complicated (such as requiring the patient to perform multiple steps to prepare, administer, store, and/or dispose the drug), the IFU is intended to give directions that are clear and understandable for patients, and therefore, promote the safe and effective use of that drug.”
[5] Page 3. “The Agency encourages applicants to meet with FDA as early as the investigational new drug application (IND)/pre-IND phase, if appropriate, to discuss the development of any IFU.”
DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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