FDA Issues Two New Labeling Guidances to Aid Sponsors

The FDA announced the availability of two draft labeling guidance documents today.  One, titled Instructions for Use—Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products—Content and Format (for standardizing the instructions for use section of labeling), and the other, titled Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products—Content and Format (to help sponsors develop a standard drug abuse and dependences section of the labeling).  The Federal Register notices can be found here and here.

The notices also suggest that the FDA will be issuing additional labeling guidance throughout the year in an effort to help sponsors make drug product and biologic labeling more understandable and consistent.

The Instructions for Use (IFU) guidance states, “The IFU is developed by applicants for patients who use drug products that have complicated or detailed patient-use instructions.  The recommendations in this guidance are intended to help develop consistent content and format across IFUs and to help ensure that patients receive clear, concise information that is easily understood for the safe and effective use of such prescription products.”  The FDA goes on to say, “The primary purpose of an IFU is to provide detailed, action-oriented, step-by-step written and 68 visual instructions in a patient-friendly manner.”

The Agency stresses that the IFU should be consistent with the Package Insert (PI).  In addition, the “FDA also recommends that the IFU include additional details not typically discussed in the PI where those details are important for the safe and effective use of the drug product by patients (for example, how to administer the drug product using a co-packaged syringe).”

The IFU should be written in non-technical language, using active voice commands, and avoid using abbreviations as these may be confusing to the patient or caregiver.

The remainder of the guidance describes, on a step by step basis, the content and suggested format of the IFU document.  Remember, the IFU document must be approved by the Agency prior to use as part of the product labeling.  The full guidance can be found here.

The Drug Abuse and Dependence Section of Labeling guidance “is intended to assist applicants in writing the DRUG ABUSE AND DEPENDENCE section of labeling, as described in the regulations for the content and format of labeling for human prescription drug and biological products.”  It is intended to be used for products that:

  • Prescription drugs controlled under the Controlled Substances Act (CSA)
  • Prescription drugs not controlled under the CSA for which there is important information to convey to health care providers related to abuse and dependence

The draft guidance provides information on the:

  • The general principles to consider when drafting the Drug Abuse and Dependence section of the labeling
  • What information to include in the Drug Abuse and Dependence section, including common terminology and definitions related to abuse and dependence
  • How to write, organize, and format the information within the Drug Abuse and Dependence section
  • How information related to topics presented in the Drug Abuse and Dependence section should be distributed elsewhere in labeling

The draft guidance goes into detail on content and how each of the label sections of the PI for abuse and dependence information should be laid out and distributed among labeling sections.  There is also a section of what not to include in the Drug Abuse and Dependence section of the label.  The full draft guidance can be found here.