In June of 2017, FDA released a document entitled “Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations.” This white paper/concept of operations (ConOps) reviews the coordinated operational efforts between the Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA).
The anticipated outcomes of the operating model will enable FDA to meet new challenges presented by the complex pharmaceutical industry intricacies. The ConOps will assist the FDA with ensuring consistency, efficiency and transparency during facility evaluations and inspections, as well as during the regulatory decision-making process. Additionally, clear roles and responsibilities across functional units will be established with enhanced collaboration between CDER and ORA offices.
The most anticipated results are meeting the Generic Drug User Fee Amendments II (GDUFA II) commitment to communicate Surveillance Inspection classifications to facility owners within 90 days following the close of an inspection and meeting GDUFA or Prescription Drug User Fee Act (PDUFA) application timeframes for Pre-Approval Inspections. With increased access to facility and regulatory decisional information as laid out in this ConOps, improvement is expected in meeting User Fee commitments while improving the timelines of enforcement actions.
Information within the ConOps applies to Pre- and Post-Approval, Surveillance, and For-Cause Inspections.
Of particular interest is the Surveillance inspections with and Official Action Indicated (OAI) classification. If the facility inspection indicates an initial OAI classification, ORA forwards electronic documents to the Office of Manufacturing Quality (OMQ) within 45 days of close of the inspection. OMQ makes a final classification and, subject to input from the Office of the Chief Counsel, issues a decisional letter in the following 45 days (90 days following the inspection closing). If an inspection is classified as final OAI, OMQ, solely or in collaboration with ORA, takes an appropriate action within 3 months of the decisional letter.
As part of the commitments made by FDA in the context of GDUFA II, the agency agreed to communicate final surveillance inspection classifications to facility owners within 90 days of an inspection. NAI/VAI (No Action Indicated/Voluntary Action Indicated) by way of the Field Management Directive (FMD) 145, and OAI by way of a decisional letter.
FDA began to operationalize this agreement at the end of 2017 with a goal of 90 percent in this timeframe in 2018.
The entire document entitled Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations can he viewed here. Let’s hope the concept meets reality along the way.