3M HEALTH CARE INFECTION PREVENTION DIV – FDA CRL

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter to 3M Health Care for its New Drug Application (NDA 208288) for SoluPrep™ Film-Forming Sterile Surgical Solution. The application, initially submitted in July 2015, could not be approved due to several deficiencies spanning clinical, pharmacology, nonclinical, product quality, and microbiology areas. Clinically, the company failed to demonstrate consistent efficacy for the product in the inguinal region during pivotal simulation studies, requiring a repeat study with appropriate controls. Furthermore, significant financial disclosure information was missing for subinvestigators in key trials, raising concerns about data integrity. The FDA requested detailed explanations of efforts to obtain this information and analyses to assess its impact. Regarding product safety and quality, the application lacked adequate human pharmacokinetic data for the active ingredients, requiring either comprehensive literature support or a new study. Two impurities in the drug product exceeded established limits set by ICH Q3B(R2) guidance, necessitating qualification studies. Microbiology concerns focused on an inadequate container closure integrity test method for the product’s ampules and pouch, which failed to reliably detect potential microbial ingress. The FDA mandated a validated method demonstrating container integrity. 3M Health Care must address these issues to gain approval.