The Integration of FDA Facility and Inspection Programme for Human Drugs: A Concept of Operations agreement, coordinated by the Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA), details the responsibilities for pre-approval, post-approval, surveillance and cause-for inspections in US and abroad.
“ConOps [concept of operations] will enable CDER and ORA to more effectively manage the growing complexity of the pharmaceutical landscape,” said the regulatory body.
According to CDER’s Janet Woodcock and associate commissioner for regulatory affairs Melinda Plaisier, ConOps will ensure consistency, efficiency, and transparency in facility evaluations, inspections, and regulatory decision-making for marketing applications, and enhance the quality and increasing access to facility and regulatory decisional information across the FDA.
The agreement will also meet user fee commitments and improve times for regulatory, advisory, and enforcement actions to promote drug quality and effectiveness, said the CDER and ORA.
Drug user fees
As of October 2018, the Generic Drug User Fee Amendments II (GDUFA II) – under the FDA Reauthorisation Act (FDARA) signed into law on August 18 - dictates the Agency must communicate final inspection classifications to site owners within three months of an inspection.
“It is essential that we mobilise to prepare for the commitments of the reauthorisation of the human drug user fees,” said Woodcock and Plaisier.
As a result, Woodcock and Plaisier said the departments plan to enforce the document guidelines before the end of the year.
“Implementation of the programme will help us meet the GDUFA II commitments,” they said.
Generic Drug User Fee Amendments
The Generic Drug User Fee Amendments, under the FDA Reauthorisation Act (FDARA), enables the FDA to assess industry user fees, in order to speed up the review of generic drug applications.
GDUFA II addresses inspections of facilities, notification of issues that could impact approval, and communication of final inspection classifications.
The Reauthorisation Act has been widely applauded by industry and trade groups.
President of non-for-profit trade association Pharma & Biopharma Outsourcing Association (PBOA) Gil Roth commended the White House for signing it into law.
“GDUFA II will empower the FDA and industry to work toward swifter approval of cost-lowering generic drugs,” he said.
Meanwhile, Healthcare Supply Chain Association (HSCA) CEO Todd Ebert said the reauthorisation “will increase competition in the generic drug market and help to preserve patient and provider access to critical treatments.”