Super Oversight for Generics

The Office of Generic Drugs (OGD) is now officially a “super” office in FDA’s Center for Drug Evaluation and Research (CDER), with more divisions and staffers added to better manage application reviews, product safety and regulatory oversight. OGD will review bioequivalence and clinical studies and product labeling, with added support from new offices for policy and regulatory science. OGD acting director Kathleen Uhl continues to head the operation, including a transition team to manage staff shifts. However, some 200 chemists and microbiologists will remain in CDER’s Office of Pharmaceutical Science pending establishment of a new Office of Pharmaceutical Quality in CDER that will house CMC and microbiology review functions for both new drugs and generics.

“Super” OGD is under pressure to improve review operations, as generic-drug manufacturers have become increasingly vocal about FDA’s slow pace in approving new abbreviated new drug applications (ANDAs) and reducing the application backlog. Newly instituted generic-drug user fees went up for 2014, which was expected under the Generic Drug User Fee Act, but now small firms are seeking exemptions to facility fees they consider burdensome. Fees on production plants run more than $200,000 a year and have to be paid while an ANDA awaits approval, which still can take years. Companies without other products on the market claim that this is a hardship, and legislation has been proposed to set up a fee waiver request process. The bill is unlikely to pass, but puts more pressure on FDA to improve the generic-drug review program.