FDA’s Office of Pharmaceutical Quality is now officially up and running, although one of the tenets of the reorganization, its new integrated review of applications, has been in place for a few months.

After two years of preparation and waiting, the agency announced Jan. 12 that OPQ had officially launched. The “super office” serves as the focus for all quality efforts within the Center for Drug Evaluation and Research.

In the process of setting up OPQ, several changes to the process for reviewing the submissions were already implemented. FDA’s new method, which allows staff to focus on the portions of the application that could generate the most risk, already is in place.

It will take about six months before the new system is fully implemented. OPQ Deputy Director Lawrence Yu said applications submitted after October 2014 already are on the new team-based system.

“We have been doing this for a couple months … and many of the employees would tell me, … why [were] we not [doing] it yesterday?” Yu said during a press conference announcing the OPQ launch.

Instead of working through all the sections of an application systematically, in the new OPQ reviewers will look first at those sections where there is the most risk to patients, based on what is known about the product.

The idea of the team-based review concept also is to ensure one quality assessment is relayed to the sponsor. A group of in-house, discipline-specific reviewers will look at the documents submitted, and work together with field investigators inspecting manufacturing facilities ([A#14140604004]).

Traditional Reviews Will Maintain Staff

Those applications that were pending prior to October 2014 will continue to be reviewed using the traditional review process, Yu said.

CDER Director Janet Woodcock also said reviewers that already have been assigned to an application will not change.

“What we hear from most companies is you don’t want to change horses in the middle of the race,” she said. “We’re going to have stability there of the team and they’re going to finish that application.”

Woodcock initiated the reorganization that created the Office of Pharmaceutical Quality. It moved the chemistry reviewers and other staff from the Office of Generic Drugs into a separate office to work alongside Good Manufacturing Practice and other related personnel.

The office is expected to have dosage form specialists, in part because they can better determine whether a proposed formulation will experience problems. The move also was expected to allow OGD to increase its focus on clinical issues and policy development Also see "Pharmaceutical Quality And Generic Drugs: Janet Woodcock Explains Her Vision" - Pink Sheet, 25 March, 2013..

Senior Management Hiring Remains Difficult

While hiring is ongoing to fill needed rank-and-file positions is ongoing, a permanent OPQ director has not been selected.

Woodcock has taken the reigns of the office in the interim. She said the permanent director position will be advertised soon.

Finding a permanent director for OPQ’s Office of Surveillance also is a priority, she said. It is tasked with finding quality information on all the manufacturing facilities FDA oversees.

Theresa Mullin was named the acting director. She had been heading parts of FDA’s patient-focused drug development effort Also see "CDER Office of Product Quality Ready To Go: New Structure Sends Strong Signal To Industry" - Pink Sheet, 30 October, 2014..

Woodcock said senior managers have been difficult to recruit, but a number of other staffers already have been hired.

Many of those were hired thanks to the Generic Drug User Fee program. As part of the agreement with industry that allowed the agency to charge user fees for ANDAs and other generic drug applications, FDA agreed to improve its review times and make other changes. It was enacted as part of the 2012 FDA Safety and Innovation Act.

The agency estimated it would need more than 900 additional staff across CDER to handle the added responsibilities and plans to hire them by the end of fiscal year 2015 ([A#00140630007]).

However, OGD has said those projections were not adequate to handle the workload the office has received ([A#00140303008]).

FDA has been looking to fill several senior leadership positions throughout CDER for several months, but the process has been difficult for a number of reasons ([A#00140324010]).

FDA Pharmaceutical Quality Office Launches With Team-based Reviews

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