The US Food and Drug Administration (“FDA”) issued two new draft guidances relating to the labeling requirements for human prescription drug and biological products.
The first guidance, entitled “Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products – Content and Format Guidance for Industry,” applies to prescription drugs that are regulated under the Controlled Substances Act (“CSA”), and for prescription drugs that are not regulated under the CSA but for which there is “important information to convey to health care providers related to abuse and dependence.” The guidance is intended to assist drug applicants in drafting the “Drug Abuse and Dependence” section of labeling, and is divided into four topics, as follows.
General principles: The section should include information on the drug’s “potential for abuse, misuse, addiction, physical dependence and tolerance,” as well as information about any abuse-deterrent properties. The section should also “clearly and concisely” and accurately summarize the product’s abuse-potential and signs and symptoms of withdrawal, and to facilitate prescribing decisions that provide for the safe and effective use of the product.
Information that should be included: The “Drug Abuse and Dependence” labeling section should include subsections describing which CSA schedule applies to the product; information related to abuse, misuse and addiction, derived from clinical trials, relevant nonclinical data, and human abuse potential studies, for example; and, information related to dependence, withdrawal and tolerance.
How to write, organize and format the information: The “Drug Abuse and Dependence” section should follow general formatting recommendations, and should delineate information with headings and subheadings when appropriate.
How relevant information should be distributed elsewhere in labeling: To the extent possible, redundancy should be avoided. However, information that is pertinent to other sections’ “scopes and purposes” should be included in those other respective sections of the labeling. For instance, information related to the abuse, misuse and addiction of opioid products should appear succinctly in the “Boxed Warning” and “Warnings and Precautions” sections, in addition to the detailed information in the “Drug Abuse and Dependence” section.
The guidance also notes that holders of drug marketing applications have an ongoing duty to ensure their labeling is accurate, and must change the content of the labeling when the existing information becomes “inaccurate, false or misleading.”
The second guidance, entitled “Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products – Content and Format,” provides recommendations for the content and format of Instructions for Use (“IFU”) documents for these enumerated products. This guidance is intended to “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.”
As to the IFU content, the guidance recommends including information describing how to use the drug product, as well as information relating to dosage and administration, how the drug is supplied, storage and handling, and patient counseling information. The IFU should be written in “nontechnical language” using an active voice and command language. In addition, sentences or phrases should begin with action verbs whenever possible. Abbreviations should be avoided as they are easily misinterpreted.
As to the IFU format, the guidance notes the importance of proper formatting on the understanding and use of the drug information. The guidance recommends specific fonts and font sizes, and the use of capitalization and other means of emphasis (e.g., using bold, italicized or underlined text) to organize information. The guidance also encourages the use of step-by-step instructions with visuals to assist in understanding.
Comments on both draft guidances are due by September 2, 2019.02