2) I've seen FDA internal memo for re-org which places "external Federal Authorities" in control over internal FDA authorities (which has NEVER happened before)
The FDA continues to change and likely not in the way Big Pharma likes: First, the forbes article from Sept 8, 2013 is below which discusses the FDA reorg. and below that from RAPS Regulatory Affairs Professional Society - an Oct 16, 2014 article that further discusses one of the most recent FDA reorg changes and I believe this will have an impact on the final fate of a possible larger than life buyout of Peregrine Pharmaceuticals, because if PS Targeting is allowed to be placed in combination with many generics... this places even more pressure for some Big Pharma to control PS Targeting. Those in control of confirming the quality and FDA approval of a generic drug (such as Docetaxel..etc) will make those new generic company owners also want to secure a relationship with Peregrine Pharmaceuticals and possibly.... just simply buy them out and make an offer they can't refuse. I believe Actavis is big into Generics and they just spent more than any other pharma out there over the past 2 years.. even more than Roche spent for Genentech and one could argue that more of that money Roche spent on Genentech was being paid back into their family of funds vs the Actavis buyout of Allergan for $66 Billion... and months earlier they spent $8.5 Billion and $25 Billion. Seems like when they see something they like.... Billions means nothing to get what they want.
Hopefully CALICO is paying attention... can't sit idle in this Big Pharma space or you will not have a Google like mindset if you do not just go out and buy up your future pipeline. Ok... I admit it, hopefully the start of a bidding war is just months away.
Woodcock also outlined major changes occurring at CDER as a result of the OPQ reorganization:
Some functions and personnel from OPS will be transferred to OPQ.
The Office of Compliance will cede its preapproval and surveillance inspection activities to OPQ.
The Office of Scientific Investigations will cede its inspection-related activities for bioequivalence/bioavailability and non-clinical studies to the Office of Translational Sciences (OTS).
The Office of Compliance will focus on compliance and enforcement operations and policy to minimize consumer exposure to unsafe, ineffective, and poor quality drugs.
The Office of Translational Sciences' Division of New Drug Bioequivalence Evaluation and the Division of Generic Bioequivalence Evaluation will now be under CDER's new "Office of Study Integrity and Surveillance."
The Office of Biostatistics will have a new division, the Division of Biometrics VIII to focus on supporting the delivery of comprehensive statistical services to the Office of Generic Drugs.
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Did FDA Just Announce A Major Reorganization?
Sept 8, 2013
FDA Commissioner Peggy Hamburg announced Friday, in an interal email (pasted below) that she was forming a “Program Alignment Group” 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.”
By the sounds of it, the new task force (which comprises the agency’s most senior leaders) is going to look for ways to bring better alignment between the FDA’s different offices and medical product centers. This is a critical endeavor since more of the products that FDA is tasked with regulating don’t fit into the traditional categories in which FDA has historically divided its work.
Many new medical products transcend boundaries between drugs, devices, and biologics. Many cosmetics contain particles that mirror the nano-technology found in devices. Many foods have drug-like features. In such a world, the boundaries between FDA’s different centers may no longer make as much sense.
Regulation is increasingly being based on the function of a product (its platform as well as its therapeutic goals), rather than its traditional definition of food, drug, device, biological, and cosmetic. More new medical products comprise complex systems that incorporate many elements — including devices, drugs, and biologics.
But will FDA have the fortitude to break up its existing functional divisions, and adopt a real program orientation? It’s unlikely to happen in the near term.
There will be a lot of internal resistance. A major re-organization will create a lot of dislocation. Big bureaucracies don’t respond well to this sort of dramatic change.
The best proxy was the merger of FDA’s drug and biologics center. That re-organization was unexpectedly announced in 2002, only to be largely rolled back in 2004 after internal resistance to the change mounted.
More likely, the current initiate will result in FDA creating a few model programs that cut across its existing centers – and some mandates for better alignment. The focus is likely to fall on FDA’s post-market regime and its inspection resources, which right now reside across the different centers. I’d expect those to be better integrated after any reorganization.
But the review functions will likely remain intact under the existing divisions. Yet FDA and its Commissioner deserve credit for getting this sort of re-alignment underway and tackling these questions.
In the long run, substantial organizational change is probably needed, even if it doesn’t get implemented in one stroke. The agency is going to have to follow the science and re-organize its different executive units to reflect the increasingly cross-functional complexity of the products that FDA is tasked with evaluating.
From: CDER Center Director
Sent: Friday, September 06, 2013 11:24 AM
To: FDA-CDER-wide
Subject: FDA Establishes the Program Alignment Group
CDER Staff:
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). Comprised of senior Agency leaders, 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 group of senior leaders will achieve this goal by working together to promote the strategic, operational, and resource management alignment needed for FDA to continue to fulfill its mission.
As a member of the PAG, I am pleased to share with you the email and memo (below) that I received from the Commissioner this morning. 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 Food and Drug Administration Safety and Innovation Act and the Generic Drug User Fee Amendments of 2012 (GDUFA).
Many of CDER’s current modernization efforts center around the regulation of pharmaceutical quality. 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). We recognize that in order to accomplish GDUFA and other commitments, CDER and ORA need to have an integrated program for regulating pharmaceutical quality, with well-defined leads, coherent policy and strategy development, well-designed and coordinated policy implementation, and a de-layered management structure. Moving toward this new model will take time and a level of organizational change across CDER and ORA, including streamlining management and decision making and clarifying roles and responsibilities, metrics and accountability, and decision rights. Similar considerations apply to other inspectional programs.
I am confident that any changes implemented as a result of this evaluation will not only improve efficiency in our program areas and in our collaborations across the Agency, but also provide us with a solid foundation that allows us to continuously adapt to the ever-changing challenges and new demands placed on CDER. This is important as we continue to meet our critical public health and regulatory mission to ensure safe, effective, and high-quality drugs are available to the American public.
I look forward to participating in the PAG discussions. The first report from the PAG is due to the Commissioner in the next several months. FDA will then assess the recommendations and decide how to proceed. I am committed to keeping you informed about the outcome of the PAG’s evaluation; you may expect additional communications from me once the Agency determines its next steps in this process.
If you have questions about this email or the memo, please send them to the Ask Janet email account via Outlook.
Janet Woodcock
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From: Hamburg, Margaret
Sent: Friday, September 06, 2013 10:09 AM
To: Dunham, Bernadette M; Landa, Michael; Midthun, Karen; Plaisier, Melinda K; Shuren, Jeff; Solomon, Steven M; Taylor, John M.; Taylor, Michael R; Woodcock, Janet; Zeller, Mitchell
Cc: Barclay, Lisa; Harris, Walter
Subject: Program Alignment Group
Over the past few years, FDA has experienced unparalleled challenges and demands posed by the increasing breadth, depth, and complexity of the products it regulates. That, combined with significant strides in scientific innovation and increased biomedical discovery, the globalization of the food system and medical supply chains, as well as the expansion in FDA’s regulatory authorities via many new forms of legislation, require the Agency to continue to find ways to ensure that we are meeting our critical public health and regulatory mission.
Therefore, to be in the best position to effectuate the steps necessary to successfully address these challenges, I am pleased to formally appoint you to the Program Alignment Group (PAG). The PAG will be comprised of senior Agency leaders charged with identifying and developing plans to modify FDA’s functions and processes in order to address the challenges noted above and to best achieve mission-critical Agency objectives. This group of senior leaders will attain this goal by working together to promote the strategic, operational, and resource management alignment needed for FDA to continue to fulfill its public health mission.
More information about the PAG can be found in the attached memorandum. The group will look at what changes may be necessary from an operational standpoint to transform the Agency from a domestic Agency operating in a globalized world to a truly global Agency fully prepared for a regulatory environment in which product safety and quality know no borders.
I want to thank you, as senior FDA leaders, for engaging in this important work together to move FDA into the future as a modern and globalized public health-regulatory Agency. I look forward to watching your progress in the months ahead as we embark on this path together.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
MEMORANDUM
Date: September 6, 2013
From: Margaret A. Hamburg, M.D. Commissioner of Food and Drugs
To: Members of the Program Alignment Group
Bernadette Dunham, Director of Center for Veterinary Medicine Michael Landa, Director of Center for Food Safety and Applied Nutrition Karen Midthun, Director of Center for Biologics Evaluation and Research Melinda Plaisier, Associate Commissioner for Regulatory Affairs Jeffrey Shuren, Director of Center for Devices and Radiological Health Steven Solomon, Acting Deputy Associate Commissioner for Regulatory Affairs John Taylor, Acting Deputy Commissioner for Global Regulatory Operations and Policy Michael Taylor, Deputy Commissioner for Foods and Veterinary Medicine Janet Woodcock, Director of Center for Drug Evaluation and Research Mitchell Zeller, Director of Center for Tobacco Products
cc: Lisa Barclay, Chief of Staff, Walter Harris, Deputy Commissioner for Operations
Subject: Directorate/ORA/Centers Coordination and Program Alignment
Background
In recent years, FDA has experienced unparalleled challenges posed by globalization, scientific innovation, and the increasing breadth and complexity of the products it regulates. In addition, FDA’s regulatory authority and mandates have expanded through groundbreaking legislation such as the Family Smoking Prevention and Tobacco Control Act, the Food Safety Modernization Act, the Affordable Care Act, the Food and Drug Administration Safety and Innovation Act, the Generic Drug User Fees Amendments of 2012, the Animal Drug User Fee Act, and the Animal Generic Drug User Fee Act. These challenges, authorities, and mandates have significant implications for FDA’s operations, and the strategic relationship between the Directorates, ORA, and the Centers.
The Assignment
To best adapt to these developments and to effectuate the steps required to successfully address these changes, I am charging the Program Alignment Group (the Acting Deputy Commissioner for Global Regulatory Operations and Policy, the Deputy Commissioner for Foods and Veterinary Medicine, the Associate Commissioner for Regulatory Affairs and Acting Deputy, and the Center Directors) to identify and develop plans to modify Agency functions and processes in order to best achieve mission-critical Agency objectives. The work that FDA must accomplish requires the combined efforts and commitment of the offices and programs across the Agency. Therefore, it is imperative that there be greater clarity and transparency about relative roles and responsibilities of the Directorates, ORA, and the Centers, as well as greater operational and program alignment among these organizations that avoids duplication of function and effort, if FDA is going to succeed in the future.
More specifically, we need to transition to distinct commodity-based and vertically-integrated regulatory programs with well-defined leads, coherent policy and strategy development, well-designed and coordinated implementation, and a de-layered management structure. This move towards a specialized program-based model will take time and a level of organizational change across both the Centers and ORA. Implementing this vision of vertical integration and streamlining of management and decision making will require discussion in the near term regarding roles and responsibilities, metrics and accountability, and decision rights.
I charge you to start working on a core set of operational changes that are necessary to achieve optimal alignment between the Directorates, Centers, and ORA. These initial areas include, but are not limited to:
Specialization, to the extent that it has not been achieved, across FDA’s inspection and compliance functions, that enables the Agency to mirror, adapt to, and track the continuing program-based specialization within FDA’s regulated industries and the demands of new legislation; Training that is developed collaboratively by ORA and the Centers and leads to the development of competency requirements, training curricula, certification/ qualification/accreditation processes, performance assessments, and a continuing education program that enables FDA to enhance and maintain its world-class workforce; New work planning that improves FDA’s selection of firms, inspection frequency, and compliance efforts that is based on risk factors, public health outcomes, past inspectional history, and operational experience, and that is reported through performance-based metrics clearly demonstrating public health and compliance outcomes; Compliance policy and enforcement strategies that are clear, current, outcome-based, and effectively communicated in order to maximize FDA’s ability to protect public health and to exercise effective and efficient industry oversight; Laboratory optimization that increases specialization; fosters program alignment and collaboration between the Directorates, ORA, and the Centers; and enhances efficiency within the current laboratory configuration; and Center and ORA practices, processes, and resources that are effectively aligned in order to support ORA’s implementation of FDA’s commodity-based and prevention-focused regulatory programs.
To successfully implement these initial changes will take time, commitment, continued investment and evaluation, unity, and my support. Therefore, I am requesting that you work collectively to further define and implement these changes. Please report back to me within the next three months on your plans, including timing, for addressing these issues.
As with any organization that is implementing fundamental change, we need to continuously evaluate and improve our processes, management, and structure. I appreciate your willingness to work together to address the changes necessary to move FDA into the future as a modern and globalized public health-regulatory Agency, and I look forward to periodic updates as these processes, plans, and concepts are developed.
FDA Announces Major Agency Reorganization, With Focus on Drug Quality
Posted 16 October 2014 By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) is finally preparing to launch the Office of Pharmaceutical Quality (OPQ), a new effort to focus on the quality of drug products. Background
The creation of OPQ was proposed in September 2012 by Janet Woodcock, the director of the Center for Drug Evaluation and Research (CDRH).
"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 at the time. "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."
OPQ was envisioned as a way to oversee drug quality throughout the product lifecycle, instead of the fragmented pre-market/post-market approach now taken by FDA. Accordingly, Woodcock announced that the Office of Pharmaceutical Science (OPS), Office of Generic Drugs (OGD) and Office of Manufacturing and Product Quality (OMPQ) and Office of Compliance (OC) would both be ceding some of their quality functions to OPQ. Temporary Setbacks
But since then, CDER's plan for OPQ has hit several setbacks. In March 2013, then-director of the Office of Generic Drugs Greg Geba announced he would be resigning from the agency, citing the "realignment of OGD's Chemistry, Manufacturing and Controls (CMC) functions into the new OPQ." Geba had only joined FDA around nine months prior to his resignation.
Then, in September 2013, Keith Webber, the acting director of FDA's Office of Pharmaceutical Science, announced that he would step down as well to join the pharmaceutical company Perrigo. Webber was heavily involved in the planning process for OPQ, but said the offer he received from Perrigo was too good to pass up. OPQ Gets Launch Date, Leadership
But despite those minor setbacks, CDER has never backed down from its plans to get OPQ up and running—unsurprising given the full-throated support it has received from Woodcock.
And now OPQ has gotten final approval to launch from FDA, along with an expected launch date—1 January 2015—and a slate of leaders for the new "super office."
In an email to CDER employees on 16 October 2014, Woodcock said she would serve as the first acting director of OPQ, with support from Deputy Director Lawrence Yu, who replaced Webber as acting director of OPS in September 2013.
Also joining OPQ will be a large slate of other leaders:
Office of Program and Regulatory Operations (OPRO): Giuseppe Randazzo (Acting) Office of Policy for Pharmaceutical Quality (OPPQ): Ashley Boam (Acting) Office of Biotechnology Products (OBP): Director: Steve Kozlowski Office of New Drug Products (ONDP): Sarah Pope Miksinski (Acting) Office of Lifecycle Drug Products (OLDP): Susan Rosencrance (Acting) Office of Testing and Research (OTR): Lucinda (Cindy) Buhse (Acting) Office of Process and Facilities (OPF): Christine Moore (Acting) Office of Surveillance (OS): Theresa Mullin (Acting)
"The acting and vacant leadership positions will be formally competed through FDA’s human resources process so that they may be filled on a permanent basis," Woodcock explained in an email. OPQ Duties
In her statement to CDER staff, Woodcock said she was "pleased" at the reorganization of CDER, and OPQ in particular. The new structure "is expected to provide better alignment among all drug quality functions at CDER, including review, inspection and research," she said.
"The organizational structure, along with new processes and policies, will support our mission to ensure that safe, effective, high quality drugs are available for the American public," Woodcock added.
There will also be benefits for the pharmaceutical industry, Woodcock explained. "This office will provide internal customers with a single drug quality assessment that captures the overall OPQ recommendation on approvability, and OPQ will provide feedback on quality deficiencies earlier in the review cycle."
OPQ will also create a "uniform drug quality program" for all drug manufacturing sites—domestic and foreign—and all product types—new drugs, generic drugs, and over-the-counter (OTC) drugs, she said. Big Changes at FDA
Woodcock also outlined major changes occurring at CDER as a result of the OPQ reorganization:
Some functions and personnel from OPS will be transferred to OPQ.
The Office of Compliance will cede its preapproval and surveillance inspection activities to OPQ.
The Office of Scientific Investigations will cede its inspection-related activities for bioequivalence/bioavailability and non-clinical studies to the Office of Translational Sciences (OTS).
The Office of Compliance will focus on compliance and enforcement operations and policy to minimize consumer exposure to unsafe, ineffective, and poor quality drugs.
The Office of Translational Sciences' Division of New Drug Bioequivalence Evaluation and the Division of Generic Bioequivalence Evaluation will now be under CDER's new "Office of Study Integrity and Surveillance."
The Office of Biostatistics will have a new division, the Division of Biometrics VIII to focus on supporting the delivery of comprehensive statistical services to the Office of Generic Drugs.
"Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that is the cornerstone of a broad clinical pipeline." -- Big Pharmas nightmare... unless they are fortunate enough to have The Bavi Edge!
