Generic drugmakers concerned over FDA turmoil

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."

The director's position was open from 2010 to 2012, before Dr. Geba was hired. Then, two months after Geba was recruited from private industry last year, CDER Director Janet Woodcock elevated the OGD to "super office" status, giving it oversight over some other offices in the agency. It was a suggestion the office was going to get the respect those in the generic drug business believe it deserves. At the same time, however, Woodcock created the Office of Pharmaceutical Quality and gave it responsibility to oversee quality throughout the life cycle of a drug. As part of that, the chemists in the OGD--perhaps half of its staff of 300--will move to the new office.

In a note to his staff obtained by FiercePharma, Geba said he "fully" supports the new emphasis on quality but was concerned that taking resources away from OGD would make it difficult to accomplish its goals. "The pending realignment of OGD's CMC functions and movement of the chemistry divisions into the proposed new Office of Pharmaceutical Quality inevitably resets the scope of responsibilities and remit of our office."

His resignation happens today and it has spurred talk about just how committed Woodcock and the FDA really are to generic drugs. Bob Pollock, who was acting deputy director of the OGD before leaving in 1994 to work for Lachman Consultants hinted at disgruntlement in a blog post this week. "While we have not heard of any specific reason for his resignation, one could speculate that Dr. Geba was not happy with the announced organizational changes affecting the OGD. While, on one hand, being elevated to Super Office Status, on the other, the OGD chemists appear to be heading out of OGD into the Office of Drug Product Quality. This, which could potentially reduce immediate OGD staff by almost 50%, could be a reason for the move ... At this critical time for OGD with GDUFA implementation in full swing, we will now have to see how the Agency responds."

- here is Ralph Neas' statement
- read Pollock's blog post