 FDA issues draft guidance on drug interaction studies with acid-reducing agents Today, the Food and Drug Administration issued a draft guidance for industry, "Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications." The guidance assists sponsors of investigational new drug applications and new drug applications during drug development in evaluating the need for and design of drug-drug interaction (DDI) studies involving acid-reducing agents (ARAs). ARAs such as antacids, histamine H2-receptor antagonists (H2 blockers), and proton pump inhibitors (PPIs) are widely used, and many of these drugs are available over the counter. ARAs can affect the solubility and dissolution characteristics of orally administered drugs by elevating gastric pH. As a result, concomitant administration of a drug with an ARA could alter the bioavailability of the drug, potentially resulting in a loss of effectiveness for weak-base drugs or increased adverse events for weak-acid drugs. Consequently, there is an increased risk for clinically significant DDIs with concomitant administration of drugs with ARAs. The draft guidance discusses when drug developers should conduct DDI studies with ARAs and provides recommendations on the design and conduct of DDI studies. The guidance also discusses interpreting and communicating the results and recommendations from these studies. For additional information on designing drug-drug interactions studies or labeling, visit the Drug Development and Drug Interactions webpage. FDA is publishing this draft guidance to collect additional public comments. You may submit comments on the draft guidance to the docket (Docket No. FDA-2020-D-1794) available at https://www.regulations.gov. This draft guidance, when finalized, will represent the FDA's current thinking on this topic. | 
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