The departure of Gregory Geba as chief of the US Food and Drug Administration's Office of Generic Drugs has caused alarm for drugmakers in the sector who are worried about a perceived lack of leadership.
Dr Geba, formerly deputy chief medical officer at Sanofi, has resigned after being in the post for just eight months. In an email to staff, Janet Woodcock, director of the FDA Center for Drug Evaluation and Research said Dr Geba felt that the "pending alignment" of the OGD's Chemistry, Manufacturing and Controls function into the new Office of Pharmaceutical Quality would create "challenges for implementing his original and full vision for OGD’s remit".
Dr Woodcock noted that Dr Geba "came to CDER during a busy time and has led OGD’s work to improve efficiencies in the generic drug review process". Specifically, he was instrumental in "significantly reducing the backlog of pending Abbreviated New Drug Applications, preparing for the hiring of new staff, and successfully guiding OGD in implementing the Generic Drug User Fee Act (GDUFA), as well as overseeing OGD-related organisational changes".
In response, the Generic Pharmaceutical Association in the USA said it was disappointed to learn of Dr Geba’s departure. Chief executive Ralph Neas said 80% of prescriptions dispensed in the country are generics and the GPhA relies 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".
He went on to say the sector "requires a reliable, consistent and properly-staffed regulatory partner", noting that "from 2010 to 2012, the OGD had no leadership. Now, with Dr Geba gone, "we are significantly concerned about further disruption at the FDA [as] 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".