The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug Interactions (DIs) section for human prescription drug and biological product labeling as well as how drug interaction information should appear in other areas of the product’s labeling.
FDA said the goal of the guidance is offer recommendations to applicants on how to write drug interaction content for labeling on these products and “to enhance communication of clinically significant drug interactions and facilitate the safe and effective use of prescription drugs by healthcare practitioners.”
“Prescription drug labeling must contain a summary of the essential information necessary for safe and effective use of the drug and is a primary tool for FDA to communicate drug interaction information to healthcare practitioners,” the agency wrote in a accompanying Federal Register notice. “Effective communication of drug interaction information informs the optimal use of the drug and the healthcare practitioner’s clinical decision-making.”
According to the draft guidance, the applicant must document clinically significant observed or predicted drug interactions in the Drug Interactions section, including interactions with over-the-counter drugs, prescription drugs, drug classes, and foods as well as interference with laboratory tests. It also must contain “specific practical instructions” for the prevention and management of drug interactions that are clinically significant, descriptions of any known mechanisms of the drug interaction, and the potential clinical effects of the drug interaction.