Generic drugmakers concerned over FDA turmoil

Director of OGD resigns after 8 months as his office loses staff

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Generic drugmakers are feeling a little taken advantage of. They produce 80% of the drugs used in the U.S. Their products are saving federal health programs billions of dollars, and they are now helping cover some of the FDA budget through user fees. But it took the FDA two years to fill the top position at the Office of Generic Drugs (OGD), and then after 8 months the new director, Dr. Gregory Geba, is calling it quits. His resignation today comes as about half the OGD staff is being reassigned to a new office overseeing quality.

Ralph Neas--Courtesy of GPhA

"Now, with Dr. Geba's departure, we are significantly concerned about further disruption at the FDA," Ralph Neas, CEO of the Generic Pharmaceutical Association (GPhA), said in a statement Thursday. "These vacancies and changes hold the potential to distract from the critical mission of the OGD, and slow the flow of information, guidance, and approvals needed to achieve an optimal generic drugs market for patients, payers and the health care system ... We trust that FDA is doing everything possible to ensure that the Office of Generic Drugs is fully staffed so that it can continue its regulatory mandate and GDUFA implementation."


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