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Is it a bird? Is it a plane? No, it’s a super office! US FDA rejigs generics wing

By Gareth MacDonald+

10-Dec-2013

The US FDA has beefed up its Office of Generic Drugs (OGD), affording the division ‘super-office’ status in a move that reflects the growing importance of non-branded medicines in the world's biggest market.

The new status will give the OGD oversight of four sub offices focused on research and standards, bioequivalence, policy and regulatory operations with the latter office having responsibility for labelling review, filing and quality management systems.

CDER head Janet Woodcock first mooted the reorganization in September 2012, explaining thatn the move was prompted by the introduction of Generic Drug User Fee Amendments (GDUFA) laws earlier that year.

With the historic passage of the GDUFA and a heightened public focus on generic drugs, I am proposing to elevate the Office of Generic Drugs (OGD) to a “super Office” — an office that houses subordinate offices within its organizational structure.

As a super Office, OGD would report directly to me, as do other super Offices such as the Office of New Drugs and the Office of Surveillance and Epidemiology, and a number of other CDER offices.”

ANDA submissions

Under the leadership of director Kathleen Uhl, the new super office will receive and manage the abbreviated new drug application (ANDA) review process, provide safety, surveillance, clinical, and bioequivalence reviews for generics and develop policy and regulatory science for generic drugs.

According to US Food and Drug Administration (FDA) data at present round 8 out of 10 prescriptions filled in the country are for non-branded drugs. Similarly, a report by IMS Health suggested that 84% off all medicines dispensed in 2012 were generic.

Speaking at the Generic Pharmaceutical Association’s (GPhA) technical conference in October Uhl predicted that the number of ANDA submissions will increase and argued that the OGD's new super office status was an apporpriate response to this trend.

"There is no point in looking at how things were done," she said, adding that GDUFA requires a new approach to the ANDA review process for OGD. Her full presentation is avaialble here .

The table above is based on the most up to date data the FDA has made available.

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