Woodcock Proposes Creation of Generics Super Office, New Office of Drug Quality

Posted 10 September 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is preparing for the likely elevation of the Office of Generic Drugs (OGD) to a new 'Super Office' in which a number of other CDER offices would be contained.

"I am proposing to elevate the Office of Generic Drugs (OGD) to a 'Super Office,'" wrote Janet Woodcock, director of CDER, in an email to FDA staff on 7 September. "As a 'Super Office,' OGD would report directly to me, as do other Super Offices such as the Office of New Drugs (OND) and the Office of Surveillance and Epidemiology (OSE), and a number of other CDER offices."

The information indicates a large shift in the center's prioritization of generic products, wrote Woodcock. OGD is presently a sub-office of the Office of Pharmaceutical Science, led by Director Helen Winkle. Under the reorganization, however, OGD would shift to being under the umbrella of the CDER executive office, and likely assume some of the duties of other departments as well.

The OGD Super Office, if created, will be led by current OGD Director Greg Geba, MD, who only joined CDER in July 2012. Previously, Geba served as the deputy chief medical officer for Sanofi US.

The changes are coming in response to what Woodcock referred to as a, "Heightened public focus on generic drugs," which now account for more than 80% of prescriptions filled in the US. An April 2012 presentation by FDA's Russell Wesdyk, OPS science coordinator, noted that submissions for generic drugs have surged in recent years, increasing more than 300% since 2001. The agency's resources available for generics have hitherto remained flat, and though the agency stands to obtain new funding under new generics user fees, the new changes seem to be aimed at providing more concentrated resources and authority for the review of generic medicines.

New Focus on Quality

Woodcock also proposed the formation of a new office called the Office of Pharmaceutical Quality (OPQ), which would oversee drug quality throughout the product lifecycle. The office would assume some functions currently vested in OPS and the Office of Manufacturing and Product Quality (OPMQ).

"Quality is the underpinning of everything we do, and it is imperative that we have a drug quality program as robust as those programs we presently have for drug efficacy and drug safety," said Woodcock. "We must be strategic and have systems in place to identify and respond to quality issues before they become problems. This is especially critical due to the global nature of drug manufacturing and the sourcing of raw materials outside of the US."

Woodcock said the center was still being stages of being explored, and did not provide any information on who might eventually lead OPQ.

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