Dara A. Corrigan
Associate Commissioner for Regulatory Affairs
Speech at FDLI/April 5, 2011
Good morning, I am honored to speak here today on behalf of the FDA and in particular the office that I lead, the Office of Regulatory Affairs, otherwise known as ORA. It has been a privilege to work with Dr. Hamburg, a person I deeply respect and who has devoted her career to ensuring the safety of the public and Ralph Tyler, a chief counsel who understands what a good counselor and advocate in the government should be. Without their support over the last six months, my job would have been even harder than the daunting challenge that it is every day.
My job is a job with a vast scope. Every morning, I get briefed on the key developments and it ranges from a frog in frozen vegetables to the importation of the drug used in lethal injections to deaths related to spiked dietary supplements to the strategy for imports related to the Japanese earthquake and tsunami. When I interviewed for this job, over the course of about a year and a half, I often asked myself why exactly I wanted the job and what the challenges would be. My background is somewhat eclectic, Department of Justice, US Attorney’s Office, Centers for Medicare and Medicaid Services, Acting Inspector General, partner at a law firm, health policy analyst at HHS.
For me, the opportunity to work at FDA – in ORA – was one that would meld my enforcement and policy background with the goal of protecting the public health.
One of the questions that I asked Dr. Hamburg and Dr. Sharfstein, the former principal deputy commissioner, was how you deal with the fact that your decisions could have a significant impact on the public health of individual people, a real challenge of the job. They did not shy away from the question, but were very direct in acknowledging the challenge and stressing the need to dig deep into the facts and make decisions based upon the risk to the public.
For all of us who work in this area – whether it be food, drugs, biologics or any of the products regulated by the FDA – it is always about evaluating risk. For people in ORA, it is about where and what to inspect, investigate and enforce. In a perfect world, you would have data continually driving the evaluation of risk across all of the regulated products. It is a lofty goal, but it is and will drive my decisions.
Those of you who know me know that I am direct, plain spoken, and data driven. Of the approximately 4,300 people in my office, there are not a lot of lawyers. People sometimes feel like I am cross examining them, but it is part of the discipline that makes for good enforcement. That is - relentless pursuit of the facts combined with an assessment of the impact or risk to public health. During my tenure at ORA, which I hope will be a long one, you will discover that I will take responsibility for the decisions and actions of this Office.
During my first 6 months, one thing is crystal clear. I lead an organization with some of the most expert and dedicated public servants in the federal government. It is not unusual for folks to be debating issues very early in the day and very late into the evening. I have had the experience of people out in the districts emailing after midnight on a weekend to let me know their views on a pending enforcement matter or to vent about a difficult case.
I went on a seafood inspection last month – an inspection that began at 4:00 in the morning. I know I cannot do my job without meeting people in the field and experiencing their challenges. Other than being tired and very, very cold, I watched Edward Potter and CB Brown patiently inspect a fish processor with respect, diligence and professionalism.
Our office literally has boots on the ground – all around the world – and I am committed to facing the challenges of an increasingly complex and global market. Where we have had successes we will build on them. Where we have gone off track we will make corrections.
When I arrived last October, ORA was already in the midst of exceptional change – change brought about primarily because of substantial increases in our budget. After years of stagnation and then recognition by Congress and the administration that we did not have the resources to do our job, things have changed. In the last three years we have not only increased our ranks significantly, we have also worked to grow our programs and invest in the organization..
We’ve purchased and installed new analytical equipment, including portable equipment for use in the field … We’ve hired approximately 800 Investigators and Analysts and worked to address the many infrastructure challenges that accompany organizational growth....We’ve invested in training and development.
- We’ve recently launching a mentoring program that holds the potential for enriching development, transferring knowledge, and contributing to succession planning.
- We’re partnering with the Office of Personal Management to establish leadership development programs to ensure effective succession planning;
- We’re working with the other FDA program centers to develop and implement certification programs to make sure our investigators are trained to the most current science and manufacturing.
We’ve dedicated additional resources to foreign inspections and successfully launched pilots within the last two years that are now part of the way we do business with three dedicated foreign inspection cadres (drug, devices, and foods).
And we are investing in new and better IT systems such as PREDICT. As many of you may know, PREDICT is designed to help improve and expedite the screening of imports by preventing adulterated, misbranded, or otherwise violative goods from ever coming into the country and expediting the entry of those that are non-violative.
Despite the current Federal budget uncertainty, I pledge to continue to make investments to ensure the health of ORA so we are positioned to meet our growing public health responsibilities, especially since the passage of the food safety legislation.
I think it is significant that Commissioner Hamburg’s first speech as Commissioner, two years ago, focused on enforcement. She told her audience at that time that "Effective enforcement is key to FDA’s public health mission." And, that “A strong FDA enforces the law.
As the new head of ORA, I intend to do everything that I can to insure that the FDA is strong and gets stronger. I do not see enforcement as an end in itself, but rather a means to an end. I have learned and changed a lot by being on many sides of enforcement—in court, as agency counsel, in the Inspector General’s office, representing industry and in a more academic policy position. Strong enforcement to me is one of many tools available to the FDA to protect the public health.
Dr. Hamburg has challenged us to be faster, tougher and smarter in the way we enforce the FDA’s regulations and laws. Following that lead, I have organized ORA’s enforcement activities around four principles: strategic coherency, vigilance, responsiveness, and transparency.
The focus of FDA’s overall strategy is prevention. We want to prevent public health emergencies before they happen. At our best, we stop crimes and violations before they are committed.
To that end:
- We are reaching out to industry and working collaboratively to close gaps in quality management and security that could become problematic.
- We are forming partnerships with foreign governments to proactively address issues raised by the global nature of the pharmaceutical and food supply chain.
- We will continue to build a risk based approach to our decisions on utilizing our enforcement resources.
- And we are improving our scientific infrastructure so we can move faster when there is an emergency and be more effective when law enforcement needs forensic assistance.
How do we achieve strategic coherency
First, what does that even mean? Washington is so acronym happy (FDA is no exception) and lofty that sometimes, people have no idea what you actually mean. Strategic coherency is when we use data to track problems, we adjust strategy, we target our resources and we enforce consistently across industry. I want to give you two examples of concrete issues that I will take on in the next year. One relates to improving our recall system and the other taking a historical look at firms that have had problems with their compliance history.
With respect to recalls, we have been criticized over the years for various problems with our recall process. After collecting and examining historical data, we are committed to doing things better. We will be looking at ways to manage the recall process as a national resource so that we can allocate the work generated by recalls more efficiently. This will help make sure that both the FDA and industry can better manage the process. We hope to collaborate with industry to have a faster close-out process. We are analyzing whether we can or should use outside third parties to assist in the close-out audit process.
With respect to using historical data as a way to assess risk, I have seen examples in my tenure of problematic compliance histories for certain firms. Doing a continual assessment of data over the years is one important key to evaluating risk and we are doing work across the country to ensure that we are enforcing consistently and in a principled way across the country. It is important to look more carefully at firms that are out of compliance several times over a five year period. Better risk targeting helps those who are in compliance and uses FDA’s scarce resources to target repeat problems. It also provides useful data to spot trends and to educate ourselves and the public about recurring problems.
Enforcers have to be vigilant
Our ability to increase the number of investigators and the number of inspections they perform is resource limited. Especially given the current budget situation, we have no choice but to make our processes more efficient and smarter.
- We are creating a cadre of specially trained professional inspectorates so that we can increase the frequency and rigor of the oversight of the products we regulate.
- We are leading an agency-wide effort to develop a uniform enforcement policy for all of the centers and offices to follow.
- We are pushing for tougher penalties on drug counterfeiters.
I have high expectations and hold myself and others accountable for accomplishing the mission – for safeguarding public health through rapid response, critical thinking, swift, aggressive action, and high quality work with a strong science foundation. I care deeply about the views, thoughts, and recommendations of our operational staff and have made a point to visit, talk, and listen. I will continue to do that, beginning with taking questions after I finish my remarks today.
We have an internal quality management system that is still in its infancy, but I know that we will be able to improve both the processes we use and the quality of the work that we do. Good management and quality is dependent upon both internal and external feedback.
FDA is a new agency for me and I have never worked with as many different scientists and people who focus on public health. They are different from lawyers. At first I felt like I had fallen into an alternative world where endless policy debate continued around the clock. And I found myself thinking “for goodness sake, make a decision.” I think folks at the FDA are often so respectful that if there is not agreement, it can’t be a good idea.
That’s not so in lawyer/enforcement world. I am a vigorously debate and decide type of person.
So my goal is to be more timely and responsive within the FDA environment.
We are about to begin a new way to process enforcement cases that will shorten the review time, eliminate the sequential process within FDA, and not sacrifice the quality or objectivity of the review. In the past, FDA had a lengthy process for the consideration of the merits of seizures and injunctions that moved from the field to headquarters in my office, to the scientific center to the counsel’s office. It was almost like the court process. You have the Assistant United States attorneys bringing cases in district court (my office), then you had appellate review (moving to the Centers within FDA) and then you had Supreme Court review (moving to the office of chief counsel at FDA). Scholarly and spirited memos were written, more debate occurred and it was very difficult to move quickly to an enforcement action or decision not to proceed.
This is going to change. There will no longer be sequential review or multiple memos. There should be a significant decrease in lag between inspection and enforcement.
Another example of a way that we are trying to be more timely and responsive is our warning letter improvement process. It is another way to improve the way we enforce the law by making principled enforcement decisions in a more timely and consistent way.
We issued more warning letters in fiscal year 2010 than in the previous six fiscal years. Specifically, there was a 42% increase in the number of warning letters issued last year than in 2009 and 68% of those 2010 warning letters were issued within a 4 month timeframe. That compares to 51% in 2009. And, in 2010, the number of seizures and injunctions increased by about half over the number in 2009.
I’m using these numbers to show you how much more work is being done by the ORA investigators and analysts – but both you and I know that increasing numbers in enforcement is not a goal; we must measure results over time. Good companies deserve respect and those with a history of noncompliance deserve more scrutiny and increasing penalties.
Transparency ORA’s work to protect the public health has been under-recognized because the Office has not been as transparent as it could be. It is always harder for investigators. To be fair to those companies we regulate, inspect and investigate, we should not and cannot disclose certain information. But, we can be more transparent.
We will do better.
Just yesterday, we unveiled an improved search engine on our product recall page that will provide information on all recalls, including food recalls, in an easy to read format and will provide status information on any mandatory recalls that we require under the new food safety legislation.
To help consumers, the new tool will provide information in a table format. It will organize information from news releases on recalls since 2009 by date, product brand name, product description, reason for the recall and the recalling firm. As required by the food safety legislation, we will provide status information on whether the recall is completed or on-going. This information will be provided for mandatory recalls and when the FDA has developed a case to justify a mandatory recall. We worked with consumer groups to make sure this actually works and is user friendly – and we will continue to make improvements to the tool.
We are publicizing our enforcement actions and where appropriate discussing some of our state of the art investigative methods. We are using various web technologies and social media to keep the public informed of our actions on their behalf.
Beyond the four principles that I have outlined for our enforcement efforts, I wanted to end by discussing some of the specific work we are doing in our office. We are actively and constantly engaged in the implementation of the food safety legislation. Mike Taylor, the Deputy Commissioner for Foods, has already spoken to FDLI about the passage of the food safety law and will be speaking at this conference. This law significantly changes the way that ORA will approach food safety by providing us with new enforcement tools like administrative detention, mandatory recall authority and the ability to request records from food firms.
Beyond the new enforcement tools, it will require us to classify firms by placing them in risk categories. ORA is focused on this legislation and we are leading the teams devoted to making the policy choices related to inspections, enforcement tools, imports and federal state relations.
A new level of engagement is required under this law with industry, states, consumers and foreign governments. We helped to lead several public fora on the food safety legislation last week and we will continue to hold meetings, speak publicly and solicit input.
I also wanted to mention that FDA’s Office of Criminal Investigations has been actively involved in a group known as the Pharmaceutical Cargo Security Coalition (PCSC). Comprised of representatives from local, state and federal law enforcement as well as the pharmaceutical industry, this group focuses on the sharing of intelligence, identifying emerging trends related to pharmaceutical cargo thefts, and helping to identify and implement measures to better secure the transportation, shipment and storage of pharmaceutical products. Often, stolen drugs enter the secure drug supply chain as a result of illicit transactions by unscrupulous individuals and pharmaceutical wholesalers operating in an unregulated sub-market where illicitly obtained drug products are bought and sold.
This strategy has two objectives: first, it alerts industry about the theft and about FDA's mission to protect the public from the possible harm from receiving stolen drug products that may not have been stored or handled properly. This public notification serves to make the products “hot” and difficult for the thieves to sell, making it more difficult to move the products back into the legitimate supply chain. Second, it advises drug distributors and pharmacies to contact FDA/OCI if they receive any unsolicited or suspicious offers to buy drug products or if they think that they may have already unwittingly purchased the stolen products.
As a result of recent cargo thefts involving FDA-regulated products, the Office of Criminal Investigations has created a cargo theft web page where cargo theft-related press releases and FDA issued notices will be posted.
Finally, as I said when I began, we have evaluated and taken actions to address the issues raised by the Japan Earthquake, Tsunami and conditions at the nuclear plants. We issued an import alert and import bulletin. We:
- Established criteria to flag import entries of concern
- Conducted field exams of entries
- Led communications with states
- Established communication with Pacific Island Territories to identify their current operations and their needs
- Published a lab methodology on the internet to support state or private labs that may conduct analyses
- Put Food Emergency Response Network (FERN) Radiological labs on notice to assure adequate sample analysis capacity with ORA's Radiological lab
- Conducted a number of media interviews so that people in this country and in the territories understand the risks associated with the events in Japan.
As you can see, I have come to FDA/ORA at a pivotal time - a time of significant organizational change – and a time that allows me to do something that will have a significant impact on public health all across the nation – and even the globe. That’s why I find the opportunities to lead ORA into the future exciting and promising.
I look forward to meeting many of you in the months to come, and sharing with you and the public our progress.
I thank you very much for asking me to speak today and I’m happy to take questions now.