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Remarks to the Food and Drug Law Institute’s 56th Annual Conference

Remarks of Melinda Plaisier
Acting Associate Commissioner for Regulatory Affairs
April 23, 2013


Good afternoon.  It is a pleasure to talk with you about FDA’s Office of Regulatory Affairs (or ORA), and the challenges and opportunities we are addressing this year and into the future.

This is a time of extraordinary change and opportunity. Last year, in Commissioner Hamburg’s keynote address, she spoke of several things driving change and driving our work –

  • new legislation,
  • compelling public health imperatives,
  • advances in science and technology, and
  • globalization.

She went on to say that it was a critical time for FDA to navigate a changing landscape and position ourselves to address the challenges, while seizing the opportunities – to respond to globalization and scientific advancement, and fundamentally to ensure we can fulfill our mission to serve the public and promote and protect public health.

I believe those statements are as salient today as they were a year ago.  Let me tell you about ORA, and how we are responding.

For anyone who might be new to FDLI, or not yet familiar with FDA’s organization, ORA is traditionally referred to as “FDA’s inspectorate” or just “the field”.  We are approximately 4300 strong, spread across the U.S. in 20 districts, grouped into five regions, with over 225 offices/resident posts or home domiciles, and now also have 12 foreign offices, managed by the Office of International Programs, 5 of which include investigators. 

ORA is comprised of:

  • investigators, including criminal investigators;
  • compliance officers who work with the investigators and Center offices of compliance to translate inspections into actions, where warranted;
  • imports staff who protect our borders, screening all FDA-regulated products offered for import into the U.S. working with Customs and other federal agencies with border safety and security responsibilities;
  • we have a national network of 13 laboratories, who provides the regulatory science foundation for the work we do;
  • we leverage and collaborate with federal, state and local partners through our state cooperative programs, state liaisons,  and staff in the office of partnerships who oversee contracts, grants and other cooperative arrangements with states to conduct work on our behalf, among other things; 
  • we also leverage increasingly with foreign regulatory counterparts;
  • we have a new communications staff focused on improving transparency internally and externally;
  • we are building up policy and risk management expertise, and enhancing our risk analytics;
  • we have a network of recall coordinators, consumer complaint coordinators, emergency response coordinators, establishment inventory  coordinators, and quality  systems managers;
  • and a robust infrastructure of admin, mission support, and training – all whom work across ORA.

ORA is enterprise-wide, working across the agency with all of FDA’s program centers.

You may know, about two years ago, Dr. Hamburg established Directorates within FDA, each led by a Deputy Commissioner. 

  • Foods/Feed is comprised of the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine;
  • Medical Products and Tobacco is comprised of  the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research,the Center for Devices and Radiological Health and the Center for Tobacco Products; and
  • ORA is part of the Global Regulatory Operations and Policy Directorate (or GO), coupled with the Office of International Programs. 

This reorganization was intended to create synergy between the programs and through the Deputy Commissioners across the agency.

About the same time the Commissioner reorganized into the directorates, she also issued a special report that lays out a vision for the future on global cooperation – the Pathway to Global Product Safety and Quality. I hope you have heard of this report, & more importantly you’ve read it – on the web.

It lays out a new global operating model that relies on

  • enhanced intelligence,
  • information sharing,
  • data-driven risk analytics, and the
  • smart allocation of resources through partnerships.

FDA has been engaged globally for decades, but recently the agency has taken a more holistic and strategic approach.  If you heard the Commissioner this morning, we are actively engaged in implementing new legislative mandates under the Food Safety Modernization Act, the FDA Safety & Innovation Act; and the Generic Drug User Fee Act, and we are still implementing the new Tobacco Control Act.

Truly we are at a place where we have more new legislative authority at one time, than ever before, as Congress recognized that we are facing challenges ensuring a global supply chain of products as never before.

We are also working to implement two FDA five-year strategic plans – the agency’s overall Strategic Plan and the Strategic Plan for Science.

When the GO Directorate was stood up, the first priorities were:

  • globalization challenges & import safety;
  • integrating domestic and international programs to best promote & protect public health; and,
  • Implementing the Pathway strategy.

So what does all of this mean for ORA?

ORA has been changing and the ORA of today will not be the ORA of five years from today.  Change is expected, normal, and critical for any organization to stay current.  One of the biggest changes for ORA is shifting from a historically domestically focused agency to a global approach.  

ORA’s primary historic role working globally was in conducting foreign inspections, which we began in 1955 on an “as needed” basis. Foreign inspections were adopted as routine in the early 1970’s, followed by the establishment of the first Foreign Inspection Manual and Travel Guide issued in 1983.

Many of the investments ORA made in those early years were related to Memoranda of Understanding that were primarily compliance agreements, following specific problems in an individual country. 

Certainly, our foreign inspection program has grown. In FY 12 we conducted 2758 foreign inspections in 73 countries, which represented a 23% increasefrom the previous year, and we expect the numbers of foreign inspections to continue to increase, but, so too, are the ways in which FDA engages with foreign partners. 

Last December, FDA signed an arrangement with New Zealand’s Ministry for Primary Industries, recognizing each other’s food safety systems as comparable to each other. This arrangement is a new level of regulatory cooperation that may be used to enable FDA to make risk-based decisions regarding foreign inspections, admitting products in to the U.S., and follow-up actions when food safety incidents occur.

We are currently conducting pilot systems recognition with Canada.

Coupling ORA with OIP in the GO Directorate is providing increased opportunities for ORA to begin to leverage with foreign partners in new ways that can have a significant impact on how we deploy our limited resources and expand the safety net.

If you attended the plenary sessions earlier today, you heard Deb Autor, and others, talk about FDA’s Global Strategy and the GO Directorate Strategic framework, which provides ORA the overall direction to set our course for the future, with emphasis on four primary elements:

  • Advancing Public Health
  • Leveraging and Collaborating
  • Analyzing and Utilizing Global Data to Manage Risk; and
  • Achieving organizational and operational excellence.

Let me touch on each area and some of the initiatives we have underway.

First, we are committed to Advancing Public Health.

Our mission of promoting and protecting public health has not changed, but as we work to continue to implement the new statutory authorities and mandates given to us by Congress, we are working with the program centers to develop new approaches and modernize existing approaches.   

With FSMA, we have an expanded set of administrative tools, and over the last couple of years have begun exploring new inspectional models, piloting and assessing the use of abbreviated inspections for some food and drug inspections.  Different models for foods and drugs, but similar intent to develop new approaches linked to risk.

We are also beginning to develop the capability and capacity to conduct systems recognition audits, I previously mentioned, audits of third parties, and we continue to oversee work with our state regulatory partners.

We are continuing to enhance ORA’s national network of 13 laboratories, working with the centers to establish strategic priorities, and ensuring our labs and scientists are at the forefront with the continual evolution of science.

Our 13 laboratories, chemistry and microbiology mobile labs and our newest addition, the screening station at Port Everglades we are standing up this calendar year, represent an enormous asset to ORA and the agency. 

We are looking at ways to enhance our laboratory infrastructure, science, and collaborations, and ensure that our scientists stay ahead of the scientific curve. 

Second, we are committed to leveraging and collaborating with a diverse group of partners.

We have a long history of partnering with others, and both continuing to invest in those existing partnerships and developing new partnerships as well as cross-agency coalitions will be critical for success in our new globalized environment.

We are focused on the mechanics.

For example, we are furthering our federal/state integration as mandated by FSMA, but also which predates FSMA.  We have been heavily invested in the Partnership for Food Protection, a 50-state initiative dating back to 2008.

Through this investment we are working closely with state partners to increase information sharing, improve joint work planning, enhance collaborations on compliance, and training, among other things. 

The overarching goal of all of our partnerships is to ultimately reach a state of mutual reliance, where trusted regulatory partners are at the table determining the best approach, sharing tools, authorities, knowledge, skills, and leveraging resources to expand the collective safety net.

Along the way, we can point to some solid achievements.  We launched a mobile lab pilot with Salinas Valley Collaborative, UC-Davis, the Western Institute of Food Safety and Security, USDA, CFSAN and industry to investigate and identify the incidence, environmental factors, and root causes of produce contamination with food borne pathogens in CA fields.

We are working to establish a pilot to review inspection reports from foreign partners, and working to develop a program for assessing foreign regulatory systems.  It is essential that we understand the inspectional capabilities of key foreign inspection regimes as we continue to confront the increasing numbers of imported products. In FY 12 we had over 27 million line entries, we anticipate over 34 million this FY, and project over 44 million in FY14. 

We simply must continue to assess our operations to ensure we are best positioned to meet the future.

Globally, we planned and conducted 17 joint inspections and observed two inspections with foreign partners. This may seem like small numbers, but it is unprecedented in the expansion of inspectional collaborations globally. 

Most critically, this lays the foundation for us to being to partner with our foreign regulatory counterparts to leverage both their data and strategically manage our resources where we have confidence and can choose not to reinspect where they have previously inspected.  We are not there yet, but we are working towards that goal.

We have implemented broad information sharing with the Canadian Food Inspection Agency and Health Canada and we routinely conduct border-to-border meetings to discuss import procedures, share information on import issues, and improve enforcement on both sides of the border.

On the domestic front, we successfully executed a pilot last year with certain states to leverage enforcement tools and activities and share information in real-time. The six-month program was a success in that the participants were nearly unanimous that the pilot led to immediate action to protect public health through:

  • improved communication
  • established relationships;
  • facilitated leveraging of resources; and
  • supported improved critical thinking and risk based solutions to compliance and public health issues.

We are also working with federal partners and are working closely with U.S. Customs and Border Protection on the development of ACE, their Automated Commercial Environment, which creates a single window for all agencies.  FDA has embedded both technical and operational staff in the ACE working groups in support of their initiative.

Today, FDA-regulated products originate from more than 150 countries, 130,000 importers and 300,000 foreign facilities. With this continued increase in imports, our domestic portfolio, the scope of FDA-regulated products, and the truly global nature of our work, we must be committed to leveraging and collaborating with all partners. 

Mutual reliance can’t be aspirational – it is essential. 

Third, it is imperative that we analyze and utilize global data to manage risks.

For all of us – you and FDA – whether we focus on food, drugs, biologics, medical devices, or any other commodity or product, we know that evaluating risk is an integral part of our work. 

For us in ORA, it is about where and what to inspect, investigate or enforce to protect consumers and public health.
In a perfect world, data continually drives the evaluation of risk across every aspect of our work.  That is what we are working to do – increase the use of risk and data analysis.

We know that under GDUFA, we will be increasing the number of foreign inspections we conduct and expanding inspectional data sources.  In addition to increasing the use of risk analytics to better target our work, we are also addressing operations. 

We are working to expand our dedicated foreign inspection cadres, OIP is working to increase the number of investigators posted abroad in certain locations, we are staffing up our Office of Policy and Risk Management to recruit new disciplines as we approach the use of risk analytics differently.

We have initiated a pilot implementing an automated data system in a few of our laboratories to facilitate and enhance electronic data capture, storage and analysis, which in the future, should allow for more timely sharing of data between FDA and domestic and foreign regulatory partners.

Recently we rolled out the Private Laboratory Analytical Tracking System (CMS-PLATS), to all of ORA’s Compliance Branches and Laboratories. We expect to use this cutting edge system to facilitate our review of private laboratory analytical reports.

The nationwide implementation of CMS-PLATS is expected to bring consistency and uniformity throughout the field and to increase the agency’s ability to manage the review, evaluation, and processing of private laboratory submissions.

ORA has deployed the Predictive Risk Based Evaluation for Dynamic Import Compliance Targeting (PREDICT). PREDICT is a sophisticated computer screening system that uses intelligence from many sources – such as intrinsic product risks, past inspection results and information about such threats as extreme weather that could spoil a shipment – to flag the riskiest imports before they arrive.

PREDICT enables FDA to focus its border resources on those imports most likely to pose a danger and stop many contaminated products at the border, whiles easing entry of low risk products. 

We recently implemented the Import Trade Auxiliary Communications System (ITACS), that provides the import trade community with the ability to log in and check the status of FDA-regulated entries and lines at any time without needing to call an office. They can also submit entry documentation electronically which will be linked to specific entries/lines; and, ITACS provides information on the availability of shipments scheduled for examination or sampling.

We are currently working on further enhancements to this new system.

And, we have developed new technology to increase efficiencies and information access, such as the Counterfeit Detection Device – the CD3  – a rapid screening tool developed by our Forensic Chemistry Center. 

In fact, the CD3 was just last month the recipient of an HHS Innovates award.  HHSinnovates is aimed at building a culture of innovation across the Department – a product, process, system, service or business model.  We are extremely proud of FCC scientists for their invention and innovation.

The CD3 is a device and methodology to screen for counterfeit pharmaceutical dosage forms and packaging in a non-destructive manner. This is an inexpensive, rugged and portable, hand-held electronic device that allows real-time rapid screening results in the field.  It is currently being used at a number of points of entry. 

It is an example of the innovative spirit of FDA, and the creativity and skill of ORA’s scientists. And, is an example of how we are using new technology in the field.

Another example is the use of a hand-held tablet for inspection, the “egg farm inspection prototype” – or the “egg pad”.   We launched a pilot last year to put rugged tablets in the hands of our investigators. While this first launch was with a tablet that was a bit bulky, it was just that – a first launch – and we continue to explore better tablets or tools fit for use in the field.

The goal is to move away from the old “green notebooks” – pen and paper - and put modern tools in the hands of our employees.

These are just a few examples of how we are working to leverage innovative tools to increase efficiency and protect public health.

Lastly, we are working to achieve organizational, operational, and workforce excellence.

From an internal perspective, we are committed to achieve excellence in every aspect of ORA operations – in our partnerships through strategic resource management, optimizing our laboratory resources, and enhancing and improving our IT infrastructure.

On October 1, of last year, we stood up a reorganization in ORA HQ, similar to the one established by the Commissioner at the agency-level.  The ORA reorganization was intended to do four things:

  • Elevate our partnerships – the former Division of Federal/State Relations is elevated to an Office and renamed Office of Partnerships highlighting the importance of the collaborations we have with our federal, state and local partners.
  • Elevate our science – the former Division of Regulatory Science is now an Office and renamed Office of Regulatory Science  -  demonstrating the importance of our science and laboratory infrastructure, as we seek to recruit an executive level scientist to drive strategic planning for our laboratories and the regulatory science work we do with the centers. 
  • Create offices to mirror the agency-level directorates – Office of Food/Feed and Office of Medical Products and Tobacco – we believe once fully staffed, the structure will support an increased focus on specialization.
  • Increase the number of Senior Executives and strengthen the overall senior leadership across the field.

Our work force remains our most valued asset.  We are committed to continuing to invest in our employees through enhanced training and development programs and we are working to develop certification programs, management training, and leadership development. 

We are also assessing how we hire, the disciplines and grades, and ensuring we not only work to continue to train and develop those on board, but recruit and hire the right people for the jobs of the future.

Dr. Hamburg has stated that “Today, we recognize that to successfully protect the U.S. public health, we must think, act, and engage globally.  Our interests must be broader than simply those within our own borders.”

ORA has embraced that challenge, and we are evolving to ensure we stay evergreen, and are the nimble, responsive, and current inspectorate FDA needs and the public deserves and expects.

We are in a time of significant change, which we see as a time of significant opportunity.  As we rise to the occasion, we will continue to strive every day, to build and enhance the global public health safety net for all consumers.

Thank you very much for the opportunity to highlight ORA.  It is a cadre of extraordinary men and women, dedicated to serving public health. I am privileged to lead them and proud to represent them here today. 

Thank you.