FDA's Drug Center Creating New Office Of Pharmaceutical Quality, Hamburg Says

Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.

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).


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.

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.

Request Health Care on Bloomberg Law