After 'Arduous' Setbacks, FDA's Generic Drug Strategy Takes Shape in New Leadership

Posted 21 July 2014 | By Alexander Gaffney, RAC 

After 'Arduous' Setbacks, FDA's Generic Drug Strategy Takes Shape in New Leadership

The US Food and Drug Administration's (FDA) long-awaited reorganization of its Office of Generic Drugs (OGD) is finally getting underway, the agency said in a statement today.

Background

Since late 2012, FDA has been planning to elevate OGD to a so-called "Super Office"—an office which reports directly to the director of the Center for Drug Evaluation and Research, a position now held by longtime Director Janet Woodcock.

OGD was previously a sub-office of the Office of Pharmaceutical Science (OPS). Under the reorganization, however, OGD would not only emerge as a more distinct entity, but it would also assume duties now held by other CDER offices.

The changes, Woodcock explained in a September 2012 email to FDA staff, come at a time when the agency is increasingly focused on generic drugs, which account for a large and growing percentage of prescriptions filled in the US. Generic drugs have also been the focus of many of FDA's foreign inspections, which have turned up endemic quality issues in some regions, such as India.

But since Woodcock announced the changes, FDA has suffered several major departures that threatened to derail—or at least delay—the effort.  In March 2013, Greg Geba, OGD's then-new director, announced he would resign, citing some of the changes set to occur under the reorganization.

Geba's position was filled on an interim basis by Kathleen "Cook" Uhl, a 15-year veteran of FDA.

Then, in September 2013, FDA announced that its long-time leader of the Office of Pharmaceutical Science, Keith Webber, would be leaving the agency to take a job in the pharmaceutical industry. As FDA officials noted, Webber had been central to many of the agency's top generic drug initiatives.

… New Offices

Since then, FDA has been relatively quiet about its "super office" plan for OGD with the exception of a December 2013 notice indicating that the plan had been approved, and that four offices would be created within OGD:

  • Office of Research and Standards (includes the Division of Therapeutic Performance and the Division of Quantitative Methods and Modeling)
  • Office of Bioequivalence (includes three divisions of bioequivalence and a Division of Clinical Review, which includes the OGD Safety and Surveillance Team)
  • Office of Generic Drug Policy (includes the Division of Legal and Regulatory Support and the Division of Policy Development)
  • Office of Regulatory Operations (includes a Division of Project Management, a Division of Labeling Review, a Division of Filing Review, and a Division of Quality Management Systems)

… New Leaders

Now, in a 21 July 2014 update to that notice, FDA has announced that it has filled all four of those offices with new leaders.

  • Rob Lionberger, now acting deputy director for science, will lead the Office of Research and Standards (ORS), which includes the Division of Therapeutic Performance and the Division of Quantitative Methods and Modeling.
  • John Peters, now a supervisory medical officer, will lead the Office of Bioequivalence (OB), which includes the three Divisions of Bioequivalence and the Division of Clinical Review.
  • Jason Woo, now the implementation manager for the Generic Drug User Fee Act (GDUFA), will lead the Office of Regulatory Operations (ORO), which includes the Division of Filing Review, the Division of Labeling Review, the Division of Project Management, and the Division of Quality Management Systems.
  • Keith Flanagan, regulatory counsel at OGD, will remain as transition lead for the Office of Generic Drug Policy (OGDP), which includes the Division of Policy Development and the Division of Legal and Regulatory Support.

In a statement emailed to FDA staff, Woodcock conceded that the OGD reorganization had been a "long and arduous task" thus far, but that the benefits of the reorganization would benefit both FDA and the public in the coming years.

"The new structure will allow the Agency to conduct reviews of generic applications in a much more timely and effective manner while meeting GDUFA goals that become more rigorous and challenging each year." Woodcock wrote.

 

FDA Statement


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