FDA's Drug Center Creating New Office Of Pharmaceutical Quality, Hamburg Says Wednesday, February 27, 2013 from Pharmaceutical Law & Industry Report ®

By Bronwyn Mixter 
The Food and Drug Administration's Center for Drug Evaluation and Research is working on creating a new office of pharmaceutical quality, FDA Commissioner Margaret A. Hamburg said Feb. 22.
Speaking at the Generic Pharmaceutical Association's (GPhA) annual conference, Hamburg said the new office would not impose any new quality requirements but rather enforce existing quality standards.
“We must be strategic and have systems in place for continual quality surveillance,” Hamburg said. “Quality is one of our highest priorities” in 2013, she added.
In 2012, CDER Director Janet Woodcock said CDER was exploring the idea of creating a new Office of Pharmaceutical Quality (OPQ) to oversee quality throughout the lifecycle of a drug (10 PLIR 1196, 9/14/12).

Generic User Fees

Hamburg also said the Generic Drug User Fee Amendments of 2012 (GDUFA) is moving forward, and “it is going to make an enormous difference.”
The generic drug user fees give FDA the funding it needs to reduce the backlog of generic drug applications, Hamburg said.
Hamburg said FDA has collected $125 million in GDUFA fees for 2013 so far. However, she noted, the budget situation and sequestration have “significant implications” for using generic user fees and budget dollars. Budget cuts under the Budget Control Act of 2011--known as sequestration--are scheduled to be implemented at the beginning of March, while legislation funding the federal government expires at the end of March. In September 2012, a report from the White House Office of Management and Budget classified all budgetary resources available to FDA, including user fees, as subject to sequestration (10 PLIR 1332, 10/12/12).

Biosimilars

FDA is moving forward with creating a biosimilars pathway, Hamburg said. A pathway to approve biosimilars was created in a 2010 law, but FDA is still implementing it.
In 2012, FDA issued three draft guidances for industry on biosimilars, and the agency “is moving forward to finalize” these guidances, Hamburg said (10 PLIR 173, 2/10/12).
“So far FDA has yet to receive an application for a biosimilar product,” Hamburg said. “We are ready” and “eager to engage in that next stage of the process.”
Hamburg said FDA has met with several manufacturers about developing biosimilar products.
Additionally, Hamburg said FDA is seeking public comments on its strategic plan to prevent drug shortages. FDA published a notice requesting comments in the Feb. 12 Federal Register (78 Fed. Reg. 9,928) (11 PLIR 206, 2/15/13). The Food and Drug Administration Safety and Innovation Act (FDASIA) requires the development and implementation of a strategic plan for enhancing FDA's response to preventing and mitigating drug shortages, according to the notice.

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The Federal Register notice requesting comments on FDA's drug shortage plan is at http://www.gpo.gov/fdsys/pkg/FR-2013-02-12/pdf/2013-03198.pdf.

Source found here

A Letter From Janet Woodcock Regarding Changes at FDA

 Fri, 09/07/2012.

Here's the official letter announcing changes at FDA in the CDER division from CDER Director, Dr. Janet Woodcock
CDER Staff:
I want to inform you about some important proposed organizational changes for CDER.
I am having a series of meetings with staff in the Office of Generic Drugs, the Office of Pharmaceutical Science, and the Office of Compliance to discuss these proposed changes in more detail. With the historic passage of the Generic Drug User Fee Amendments of 2012 (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.
Generic drugs, which now make up nearly 80 percent of prescriptions filled in the United States, have come to represent affordable access to treatment for many patients. Under the proposed restructuring, OGD Director Greg Geba, M.D., would continue to lead the expanding generic program with the goal of enhancing our ability to give consumers timely access to high-quality, safe, and effective generic drugs. Effective immediately, Dr. Geba will be detailed to me in the Office of the Center Director. Mary Beth Clarke, acting director of the Office of Executive Programs, will continue to be the CDER lead on GDUFA implementation, working closely with OGD and other CDER components to implement this important program.
Also, I will be proposing other structural changes to sharpen our focus and bolster our resources around pharmaceutical quality. 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. Further, 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 United States.
Toward these goals and underscoring our commitment to drug quality, we will be exploring the creation of a new Office of Pharmaceutical Quality (OPQ), which would be charged with overseeing quality throughout the life cycle of a drug. OPQ could take on some of the functions currently within the Office of Pharmaceutical Science (OPS), as well as other quality-related functions.I will also propose realigning some functions from the Office of Manufacturing and Product Quality (OMPQ) in the Office of Compliance into the new OPQ. Other OMPQ functions related to enforcement and compliance would continue to reside in the Office of Compliance. All of these changes would be part of our ongoing efforts to ensure that CDER’s organizational structure supports our mission to ensure safe, effective, and high-quality drugs for the public. As a regulatory agency, we want the public to be confident that we are successfully dealing with the global economy that is constantly adding more players, more technologies, and more complexity. I believe these organizational changes would give us the foundation we need to meet these new and ever-changing challenges.
Janet Woodcock