Interesting Change Coming to the FDA

U.S. regulators are telegraphing plans to reorganize, bucking its resistance-to-change zeitgeist

By Emil W. Ciurczak, Contributing Editor

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If there is one thing the pharmaceutical industry has always been known for it’s this: resistance to change. This inertia is common. It begins in pharmacy school, gains traction through industry, and then peaks at the FDA and its international counterparts. From one point of view, such aversion to change supports consistency of product production. From the other, as many suppose, it’s due to expansive profit margins that insulate the industry from certain commercial and competitive realities. In the case of the FDA, resistance to change is symptomatic of an under-funded and under-staffed agency. Like many of my colleagues, I’ve grown to accept the status quo, so imagine my surprise when I heard about a massive FDA reorganization.

My first thought was that any reorganization must be cosmetic, but my presupposition fell apart after reading a recently released FDA memo (italics mine):

“In order for FDA to best adapt to the ongoing rapid changes in the regulatory environment, driven by scientific innovation, globalization, the increasing complexity of regulated products, new legal authorities and additional user fee programs, the Commissioner has formed a Program Alignment Group (PAG). … the PAG is charged with identifying and developing plans to modify FDA’s functions, processes and possibly its structure in order to address these matters and best achieve mission-critical Agency objectives … This initiative will provide an opportunity for CDER to continue modernization of operations in order to address the challenges noted above and to implement our new legislative responsibilities, including those imposed by the FDA Safety and Innovation Act and the Generic Drug User Fee Amendments of 2012 (GDUFA). … Most of you are aware of the proposed elevation of the Office of Generic Drugs to a super office, and the concomitant efforts to establish a new Office of Pharmaceutical Quality (OPQ). The work to establish OPQ will need to be closely coordinated with the Office of Regulatory Affairs (ORA).”

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In a recent webcast, (acting) Deputy Director (OPS) Lawrence Yu stated that the concepts embodied in the QbR (Question based Review) approach, now used in ANDAs will be extended to NDAs in 2014. There are several reasons for this expansion:

1. There is a large backlog of applications, some of which is due to each company using its own format for a NDA. Using a “template,” even only with high-level questions, will speed the process by enabling reviewers to find and evaluate the sections they need to find.
2. Many companies acquire their APIs from 3rd party manufacturers and no longer make their own. Both the ideas in ICH Q11 and QbR extend the responsibility for API characterization to the company that makes the final product. Blind acceptance of CoA is no longer an option. This puts “branded” drugs in the same vulnerable position as generics with regard to potential problems with API purity.

What Dr. Yu was saying is that the additional requirements will become official in 2014. He was explaining how the super-department will streamline the review and inspection approaches for “branded” and generic companies. This will, if nothing else, allow NDAs and ANDAs to be evaluated more judiciously and allow the “good” products to market sooner than later.

The new OPQ, working with ORA, will work as a combination of an industrial Quality Assurance department and an “overseer” for the new departments under OPS. There have been complaints that generics are treated differently than proprietary drug companies (strangely, each claims the other is favored in inspections).

Maybe I am just being naïve, but I find this reorganization exciting, especially since Drs. Yu and Woodcock are insisting that QbD is alive and well and being emphasized under the new organization. They may come up with a new (and hopefully improved) acronym, but I will always refer to the process as QbD. Watch this space for more developments.

Published in the October 2013 edition of Pharmaceutical Manufacturing magazine

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