Indian healthcare sees US FDA norms on patient labeling as key to clear and concise drug information

Bengaluru, July 26, 2022: 

Indian healthcare sees US FDA norms on patient labeling for human prescription drug and biological products as key to clear and concise drug information for the sick and their caregivers.

The global regulatory authority noted that these norms recommend pharma companies to develop the content and format of a Patient Instructions for Use (IFU) document for human prescription drug and biological products, as well as drug-led or biologic-led combination products submitted under a new drug application (NDA) or a biologics license application (BLA).

Healthcare providers noted that it was important to provide patients clear and concise information that is easily understood for the safe and effective use of such products. The IFU is written for patients or their caregivers who use drug products that have complicated or detailed patient-use instructions.

The recommendations according to the regulatory authority 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 which is that they are not constituent parts of drug device, biologic-device, or biologic-drug-device combination products submitted under BLA or NDA, then the labeling for combination products is intended for use by healthcare providers.

The IFU is a form of prescription drug labeling. For drugs for which self-administration may be complicated such as requiring the patient to perform multiple steps to prepare, administer, store, and dispose the drug, the IFU is intended to give directions that are understandable for patients. This is in an effort to promote the safe and effective use of that drug, said regulator.

In the case of a drug-led or biologic-led combination product that includes a device constituent part, the IFU provides directions on the use of the device. This covers the device preparation, injection of the drug or biologic, and product storage of the device or combination product as a whole. Also, an IFU may be appropriate for a product with one set of dosing instructions for adult patients and another set for pediatric patients. In this situation, two separate IFU documents may be appropriate.

The IFU is developed by the applicant, reviewed and approved by FDA, and provided to patients when the product is dispensed. Applicants must submit true representations of both the content and format of the IFU, including page layout, graphic design, and color, for FDA’s review and approval.
The IFU guides the patient on how to safely and effectively use a prescription drug product and commonly includes instructions on preparation, administration, handling, storage, and disposal. The primary purpose of an IFU is to provide detailed, step-by-step written instructions, including visuals if appropriate, in a patient-friendly manner, as visuals can complement written instructions, stated the guidance.

The global regulator cautioned that the IFU must not be false or misleading and must be updated when new information causes, it to become inaccurate, false, or misleading. This insists on pertinent information on how to use the drug product. Pharmabiz