Reports: FDA generic drug chief resigns

NEW YORK — The director of the Food and Drug Administration's Office of Generic Drugs is stepping down, according to published reports.



Pharmalot, a blog run by journalist Ed Silverman, reported that Greg Geba is leaving the office over differences resulting from a recent reorganization, effective Friday.

In his resignation letter, Geba wrote that the OGD has issued almost 600 complete response letters and approved nearly 200 generic drug applications since the Oct. 1 implementation of the Generic Drug User Fee Amendments.

The Generic Pharmaceutical Association, an industry trade group, expressed concerns that Geba's departure could lead to "further disruption" at the OGD in the wake of the office having no leader from 2010 to 2012.

"GPhA was disappointed to learn of Dr. Gregory Geba’s departure from the FDA’s Office of Generic Drugs," GPhA president and CEO Ralph Neas said. "Today, 80% of prescriptions dispensed in America are generics. GPhA and its member companies rely on the strength and continuity of the OGD on critical matters such as regulations governing the entry to market of new, cost-saving generic versions of critical medicines, and the implementation of the GDUFA process."