FDA lays out new manufacturing inspection blueprint

The FDA is reorganizing the way it handles manufacturing inspections, saying the new system should speed drug approvals and eliminate surprises that drugmakers sometimes face when plant questions delay them.

In a blog post last week, FDA Commissioner Scott Gottlieb said the first part of this new program is underway with the decision to reorganize field offices around programs instead of geographic regions, a plan he says focuses the expertise where it is most needed.

Next, the agency is creating a new operational plan in which the FDA’s Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA) will integrate drug review programs with the facility evaluations and inspections for human drugs.

As part of that, the FDA is creating what it calls Integrated Quality Assessment teams, so that field and review staff can better determine where the high manufacturing risks will be.

“Our inspectional force will benefit from insights that might be offered by the review teams who have carefully evaluated products being manufactured,” Gottlieb said. “Meanwhile, our review staff will benefit from the deeper understanding they will glean through more direct and regular contact with the professionals who are inspecting facilities and seeing the kinds of things that can go wrong during the manufacturing process.”

The new approach will be used along the inspection spectrum, covering pre- and postapproval inspections, surveillance inspections and for-cause inspections at both U.S. and international manufacturing facilities.

“We hope that by communicating more quickly with product developers when manufacturing problems are identified, this agreement will help make inspectional issues less likely to cause approval delays or prolong the time it takes to get important products to patients who can benefit from them,” the commissioner said.

Janet Woodcock, director of the CDER, has for several years been moving her operations toward a stronger focus on quality in hopes of cutting down on the kinds of manufacturing issues that lead to recalls and production and supply interruptions, which are costly for drugmakers and a problem for patients and providers.

The FDA Office of Pharmaceutical Quality was formed, and the once-disparate oversight for generic versus branded drugs, and preapproval versus postapproval, were combined with teams of experts following drugs through their life cycle. The agency is also working more closely with agencies like the European Medicines Agency, Health Canada and others to share info to keep better tabs on companies in far-flung places.

Part of that plan was to ask drugmakers for certain manufacturing metrics that the FDA could use to assign grades to plants, and then focus on those with issues to try to head off problems before they grow to point that they require some kind of regulatory  intervention.