Tag Archives: FSMA

Science Is the Foundation of Food Safety at FDA

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By: Michael R. Taylor, J.D.

Science is the foundation of everything we do at FDA to keep your food safe.

Michael R. Taylor, J.D.The Food Safety Modernization Act that President Obama signed into law in 2011 emphasizes prevention of foodborne illnesses. Margaret Hamburg, FDA’s commissioner, has made it our priority to base the agency’s regulatory decisions on sound, cutting-edge science.

We’re on the case.

The Office of Food and Veterinary Medicine (OFVM), which I am privileged to lead, is acting on a number of fronts to strengthen its scientific foundation. I am pleased to welcome David White as OFVM’s chief science officer and research director. Dr. White previously served as the director of the Office of Research at FDA’s Center for Veterinary Medicine. Palmer Orlandi Jr., another veteran scientist at FDA, is now our office’s senior science advisor.

We are marshalling our forces to work in the strongest, most effective way to keep the food that you eat, the food that you share with your family, free of dangerous levels of chemicals and bacteria like Salmonella, Listeria and E.coli.

We are prioritizing the work of our scientists in laboratories across the country based on which potential contaminants, such as disease-causing bacteria or chemicals, post the greatest risk to you.

Dr. White is the chairman of FDA’s Science and Research Steering Committee, which is made up of representatives from agency’s offices and center involved in food safety. These experts talk about research projects, before they even start, to ensure that everything we do furthers the goal of addressing the greatest threats to food safety.

FDA scientists are taking many different paths to that goal. Some respond to emergencies, working to rapidly identify the source of an outbreak. Others work longer term, exploring the genetic makeup of disease-causing bacteria and recovering information that will facilitate rapid identification in the future. Because science is always evolving and advancing, there are scientists who work to make sure that FDA has the most advanced tools with which to evaluate new technologies.

Scientists are developing new ways to detect bacteria like Salmonella in foods that include leafy greens, spices and pet foods. These tools will be invaluable surveillance tools that will help FDA prevent illness outbreaks. We are also exploring if certain bacteria would inhibit the spread of their disease-causing brethren if applied to tomatoes and other crops. This is just a sampling of the research that goes on every day at FDA.

FSMA gave FDA a mandate to implement a system that emphasizes prevention and prioritizes food safety challenges based on the risk they present to public health.

Our job is to make that mandate a reality. Part of the challenge is constantly evaluating our science and research agenda to make sure that it mirrors our public health priorities. These priorities change shape as bacteria evolve, new hazards emerge and new food-producing technologies are developed.

When you hear about science at FDA, there’s nothing theoretical about it. We are continually identifying the greatest threats to food safety and meeting them head on.

Michael R. Taylor is Deputy Commissioner for Foods and Veterinary Medicine

Let’s Keep Talking—and Listening—About Food Safety

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By: Michael R. Taylor, J.D.

Everyone has a stake in the rules that FDA is proposing to strengthen the food safety net in this country.

Michael R. Taylor, J.D.We have reached out far and wide to engage in conversations about the first two proposed rules mandated by the FDA Food Safety Modernization Act. The produce safety rule would set standards for production and harvesting of fruits and vegetables. The preventive controls rule for human food would set safety requirements for food facilities.

Since these rules were proposed in January 2013 and published in the Federal Register for public comment, my colleagues and I have been engaged in an ongoing dialogue with a range of consumers, farmers, manufacturers and others who are affected by the proposals.  When we say that we want the public to comment, we mean it. We need that feedback to ensure that what we plan to do is what we should do. In fact, we have extended the comment periods for both proposed rules for another 120 days.

I recently met with tree fruit farmers from Washington State who wanted to talk about how they would be affected by proposed standards for irrigation water. I’ve attended other small-group meetings with a cross-section of people and organizations concerned about what these rules will mean to them. And our FSMA implementation team has been providing overviews of the proposed rules and answering stakeholder questions every day since the rules were first published.

On a larger scale, there have been three public meetings, in Washington, D.C., Chicago and Portland,OR. At each meeting, the crowd was large, diverse, and intensely interested, asking detailed questions about the basis for certain provisions and how they would work in specific cases. We learned a lot that will help us address these questions and be sure that the final rules are both effective for food safety and workable across the great diversity of the food industry. 

We also learned that a broad cross-section of our industry and consumer stakeholders are eager to push forward and work with us to successfully complete this crucial rule-writing step in FSMA implementation.   

None more so than 15-year-old Rylee Gustafson, who nearly died from eating contaminated spinach six years ago. She spoke in Portland:

“When people ask me why I am passionate about food safety, the answer is simple:  I don’t want anyone to have to go through what I did—or worse, die because of something they ate. I have been able to take my experience and make a positive impact by sharing my story. But my job as a food safety advocate is far from over. Being here today—to support the FDA in the release of the proposed produce safety rule and to encourage the agency to finalize it quickly with the hope that fewer people, young and old, are forced to suffer because of foodborne illness—is just the next chapter in my story.”

Rylee reminds us why we do this work and why we are so committed to helping write that next chapter.

There are three more FSMA-mandated proposals on the horizon that form the basic framework for a modern, prevention-based food safety system. Two are designed to keep imported foods safe from contamination and the third is to protect animal food. Then, as now, we will want your opinion of what we’re planning. We want to engage you as partners in making these reforms a reality.

Michael R. Taylor, J.D., is Deputy Commissioner for Foods and Veterinary Medicine

FDA’s International Food Safety Capacity-Building Plan: Improving Food Safety Protections Around the World

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By Julie Moss, Ph.D., R.D., and Katherine Bond, Sc.D.

Our increasingly globalized world means that more and more of the food we eat is imported. Congress recognized this fact of modern life by passing the FDA Food Safety Modernization Act (FSMA), landmark legislation signed into law in 2011 that shifts the emphasis from responding to food safety incidents to preventing them.

Julie Moss

In that spirit, Congress saw the importance of improving the capacity for food safety protections. It directed FDA to develop a comprehensive plan to expand the technical, scientific and regulatory food safety capacity of foreign governments and their respective food industries in countries that export foods to the United States.

FDA has met that challenge, recently releasing its International Food Safety Capacity-Building Plan, which provides a strategic framework intended to guide FDA’s capacity-building efforts over the next five years. FSMA marks the first time that Congress has charged FDA with comprehensively addressing the building of international food safety capacity, a development that has been very exciting for us.

While this mandate is new, we have successfully supported food safety capacity-building efforts and conducted training programs for many years. The agency has participated in global, multilateral food safety programs, including work with the World Health Organization, train-the-trainer programs (in areas such as good agriculture practices), various seminars and web postings, and collaborations with other U.S.government agencies, among other efforts. However, FSMA allows us to take this work to a whole new level.

For example, we are working with foreign governments to see if we can exchange more scientific and technical information, such as outbreak and inspection data. This will open up communication channels and promote collaboration with those governments. We are also working to support both the acceptance of laboratory methods across the international community as appropriate and the exchange of information on current and new laboratory methods. This helps ensure that the data obtained from different domestic and international laboratories is of good quality and can be easily compared.   

We have developed a plan that incorporates many of FSMA’s main principles, including comprehensive prevention, risk-based resource allocation, and partnering. The plan’s key goals are:

  • Goal 1: Ensure efficiency across the Foods and Veterinary Medicine Program
  • Goal 2: Increase effectiveness through evidence-based decision making
  • Goal 3: Support the exchange of information between FDA and other foreign government agencies or other entities
  • Goal 4: Enhance technical assistance and capacity-building in food safety

    Katherine Bond

Overall, the plan charts a direction for how we will prioritize our capacity-building efforts based on risk, how we will link capacity-building efforts to their impact on public health, and how we will work in partnership with counterpart authorities, industry and other organizations to achieve lasting food safety results. Through this plan, countries that export to the United States will have an opportunity to learn about our food safety capacity-building priorities and see the breadth of the efforts that we are pursuing.   

In developing this plan, we consulted with foreign governments, industry, non-governmental organizations, certain U.S.officials, academia and other stakeholders. A public meeting was held on June 19, 2012, and comments received were considered in development of the plan [Docket No. FDA-2012-N-0437].

Given the breadth of this work, it is essential that we collaborate with partners to get the work done. We realize we can’t do it alone. Partnerships are important in everything we do, and even more so with capacity building. We also recognize the importance of establishing strong relationships and mutual support among all stakeholders from farm to table. As we begin to implement this new plan, we look forward to sharing ideas and new information with our international counterparts and other interested stakeholders, leveraging resources that will help us improve global food safety.

Julie Moss, Ph.D., R.D., is Deputy Director, International Affairs Staff in FDA’s Center for Food Safety and Applied Nutrition

Katherine Bond, Sc.D., is Director, Office of Strategy, Partnerships and Analytics, in FDA’s Office of International Programs

 

Public Meeting on Food Safety Highlights First Two Proposed Rules

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By: Michael R. Taylor

Last week, we kicked off a series of public meetings—with about 400 people participating—to stimulate dialogue and gain input on FDA’s first two proposed rules to implement the FDA Food Safety Modernization Act. In her opening remarks, Dr. Hamburg noted how her appointment as FDA Commissioner by President Obama, coming on the heels of the illnesses and deaths attributed to contaminated peanut products, helped make food safety a high priority for her and the Administration.

Michael R. Taylor, J.D.It was fitting that we held our first meeting in a USDA auditorium in Washington, D.C., because we have worked closely with USDA and with other government partners at the state and local level, as well as with industry and consumer groups, to get the rules right.  That means holding a lot of meetings to explain the proposed rules, visiting farms and facilities, and opening dockets for comments from interested parties, to receive as much input from the public as possible before we finalize the rules.

The diversity of those who signed up to make public comments at the meeting shows how important food safety is to all of us, from victims of foodborne illness to farmers and food manufacturers. First up was 15-year-old Dana Dziadul, who was three years old when she became ill from Salmonella in cantaloupe. The compelling stories from Dana and other victims of foodborne illness, and their families, remind us all that first and foremost, we have a public health obligation to address the harsh reality that each year, 3,000 people die and more than 100,000 are hospitalized because of foodborne illness. Our first obligation is to do everything we can to reduce these numbers.

We also know that improving food safety helps avoid the disruptions in the marketplace that result from illness outbreaks and recalls of food and maintain consumer confidence in healthful foods, such as the produce that the proposed rules cover. This convergence of interests has made our current food safety initiatives a real community effort, with industry, consumers and government coming together around the common goal of modernizing our food safety system to better prevent problems. We all have a responsibility, and we all have a role, in making and keeping food safe.

The work ahead may sound simple—having the right standards in place that are based on the best information we have on how to prevent hazards, and making sure these standards are met. But we have much yet to accomplish. We have to make sure the standards are flexible enough to address the diversity of operations across the country—from small farms to large facilities, from Maine to California. We also need to be sure FDA is ready to operate under this new, prevention-oriented framework, which will require employee training and ensuring our resources are focused on the greatest risks. And we are committed to providing technical assistance so that industry, especially small operations, can meet the new requirements when they are finalized.

These two proposed rules we have announced are very important, but we have three additional rules coming to further form our food safety framework. To address the safety of imports, we will soon be proposing a rule that requires that importers based in the United States verify that their overseas supplies are following prevention-based standards that provide the same level of public health protection as those that are in place here. Also addressing imports is a proposed rule on the accreditation of the third party auditors that industry uses to help them determine if food safety standards are being met. The third proposed rule coming addresses preventive controls for animal food, including pet food.  Preventive controls are steps that firms must put in place to control hazards such as microbial contamination that could occur in a food facility.

We will be holding two more public meetings—one in Chicago and one in Portland, Oregon. You can find more information on our web site at fda.gov/fsma. Six meetings in various states across the country also are scheduled. Your comments are important to us, and I encourage you to submit comments at regulations.gov before the May 16th deadline. 

The road ahead is a long one, and it will take years, and sustained commitment, to have our framework fully in place. But, for America’s families and our vibrant food system, the hard work is absolutely worth it!

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

 

Basing Food Safety Standards on Science and Prevention

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By: Margaret Hamburg, M.D.

Two of my highest priorities as FDA commissioner have been strengthening the scientific foundation of FDA’s regulatory decisions and ensuring the safety of an increasingly complex and global food supply.

Margaret Hamburg, M.D.That’s why I take such pride in FDA’s proposal of two rules that set science-based standards for the prevention of foodborne illnesses. One will govern facilities that produce food, and the other concerns the safety of produce.

The Preventive Controls for Human Food rule proposes that food companies—whether they manufacture, process, pack or store food— put in place controls to minimize and reduce the risk of contamination. The Produce Safety rule proposes that farms that grow, harvest, pack or hold fruits and vegetables follow standards aimed at preventing their contamination. 

These rules represent the very heart of the prevention-based reforms envisioned by the landmark FDA Food Safety Modernization Act (FSMA) and focus on preventing food safety problems before they happen.

These two rules are also part of a larger, ongoing reform effort, with other rules that set similarly high standards for imported and animal foods to be released in the near future.

In our interconnected world, FDA’s vigilance must extend globally. About 15 percent of our food is imported, and in some categories that percentage is much higher. For example, half of our fruits and a fifth of our vegetables come from abroad. We need a strategy that will address all of these complexities and challenges.

In drafting the proposed rules, FDA conducted extensive outreach and talked with key stakeholders, including farmers, consumer groups, state and local officials, and the research community. They build on existing voluntary industry guidelines and best practices for food safety, which many producers currently follow.

We want to continue to engage the public. So, I encourage Americans to review and comment on these rules, which are available for public comment for 120 days.

I believe this also showcases FDA’s adherence to solid science in its policy- and decision-making. The new draft rules recognize that the science of food safety is constantly evolving and that our oversight must take into account issues such as emerging disease-causing bacteria and new understandings of how hazards can be introduced into food processing.

FDA is committed to working with industry to provide the support they need, especially the smallest businesses. That’s why we are working with stakeholders through the Produce Safety Alliance, the Sprouts Safety Alliance, and the Preventive Controls Alliance to continue outreach efforts and to make educational and technical information readily available to industry.

Meeting the public health demands of a global marketplace. Bringing solid science to bear on our decision making. And safeguarding the well-being of American families with a prevention-focused food safety system. That’s FDA at work in the 21st century.

Margaret Hamburg, M.D., is Commissioner of the Food and Drug Administration

FDA Writing New Chapters in Food Safety History

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By: Michael R. Taylor, J.D.

Yesterday, Sunland Inc. entered into a court ordered agreement imposing requirements that must be complied with if the company is to operate. This consent decree follows FDA’s suspension of Sunland’s food facility registration in November as a result of evidence linking Sunland to an outbreak of Salmonella Bredeney that sickened 42 people in 20 states, as well as the company’s history of violations. The company was barred from distributing food in intrastate or interstate commerce while its registration was suspended. 

Mike Taylor, J.D.Yesterday’s consent decree may be seen by some as a final step in the process, but at FDA we see it as a beginning. Certainly, it is a new beginning for the company, which must correct the problems identified during recent FDA inspections before being allowed to market its nut butter products. More broadly, though, it is the beginning of a new chapter in FDA history.

With the suspension of Sunland’s food facility registration, for the first time FDA was, in effect, able to independently prevent a company from distributing food that could have caused harm to consumers. This was our first use of this new authority granted by the FDA Food Safety Modernization Act (FSMA), and it will be an important tool for FDA to use in the future to ensure the accountability of companies for the safety of the food they produce. 

Under the decree, Sunland must hire an independent sanitation expert to develop a program to ensure products are produced in a sanitary way and according to good manufacturing practices. The company must also conduct environmental testing to ensure that disease-causing bacteria aren’t present in its facility or in its final food products. FDA will evaluate the programs Sunland sets up, and will not allow the company to operate its peanut butter plant until we determine that its products can be safely produced. 

Paving the way for this new beginning of accountability for food safety was the work of the many employees from FDA and CDC, and state and local governments, who responded to and investigated this outbreak. The work done on this investigation was outstanding. Within days of being notified of the outbreak, our Coordinated Outbreak Response and Evaluation (CORE) network was making headway on the investigation. A link was made between the illnesses and the product and its manufacturer, and our investigators in the field ramped up their on-going investigation of Sunland’s facility to find the source of the outbreak.  

I also think that FDA’s first use of the suspension authority provided by FSMA demonstrates the promise that FSMA itself holds in all its aspects. The suspension of Sunland’s registration demonstrates FDA’s new enforcement tools, but we are also working on other new preventative tools as well. 

As I said earlier, we are writing new chapters in the history not just of FDA, but of food safety. Our response to the recent Salmonella Bredeney outbreak related to peanut butter was a fine example of our newest innovations, like CORE, and using our authority to suspend a registration. But there is still more to come.

Michael R. Taylor, J.D., is Deputy Commissioner for Foods and Veterinary Medicine

 

Enhancing the Global Food Supply by Building International Capacity

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By: Julie Moss

In a global marketplace, food must be safe regardless of where it comes from. That means consumers should feel confident in the safety of the food they eat, whether it comes from India or Indiana. In fact, the distinction between imported and domestically produced food is blurring, as many U.S. food products are made with imported ingredients. Responding to this increasingly globalized food supply system, FDA held a public meeting on June 19 to discuss FDA’s plan to expand the food safety capacity of foreign governments and their respective food industries in countries that export food to the United States. This approach is known as capacity building.

microphoneCongress recognized the need for capacity building in the Food Safety Modernization Act (FSMA), of 2011 when they tasked FDA with developing a comprehensive plan to expand the technical, scientific and regulatory food safety capacity of foreign governments and their respective food industries in countries that export foods to the U.S. FSMA marks the first time that Congress has charged FDA with comprehensively addressing international food safety capacity building, a development that has been very exciting for FDA. I have the pleasure of co-leading the work group to develop the plan with Katherine Bond, who is with FDA’s Office of International Programs.

Although the specific charge provided by Congress is new, this type of work is not. FDA has been engaged in international capacity building for many years, traveling overseas to conduct food safety training programs on Good Agricultural Practices, Good Aquaculture Practices and to provide hands-on laboratory training, for example. But the international capacity-building plan mandated by FSMA allows us to take this work to a new level.

Of course, food safety capacity building isn’t just about strengthening foreign food safety systems—we build capacity domestically as well. For example, FDA provides grants to organizations that represent State and local laboratories to strengthen laboratory collaboration and equivalency. FDA has also participated in several public-private collaborations to provide food safety training here in the U.S.

The June 19th meeting gave the public an opportunity to view and comment on draft recommendations that we’re considering for inclusion in the capacity-building plan. A number of organizations provided input on the recommendations, including the Grocery Manufacturers Association, the U.S. Department of Agriculture’s Foreign Agricultural Service, the World Bank, the United Nations, the governments of Canada and the Philippines, the U.S. Agency for International Development, the Center for Science in the Public Interest, and Campbell Soup. Given the breadth of this input, it is essential that FDA collaborate with partners to get the work done. FDA can’t do it alone.

FSMA requires that we include, as appropriate, certain elements in developing the plan—such as provisions for bilateral and multilateral arrangements and agreements, secure electronic data sharing, and training on U.S. requirements for safe food. But we aren’t stopping there. We are also considering incorporating additional themes into the plan to ensure that FDA performs its work effectively and intelligently. This means using available data to determine where the need is the greatest by country and by commodity, and it means being able to measure the impact of our efforts.

FDA’s international capacity-building plan is still under development, and your input is most welcome. You can review a summary of our draft recommendations, and comments are due to FDA’s Division of Dockets Management by July 20, 2012.

Julie Moss is Deputy Director, International Affairs Staff, of FDA’s Center for Food Safety and Applied Nutrition

Succeeding on Produce Safety

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By: Michael R. Taylor, J.D.

We get our fresh produce from all over the place – from the broad lettuce fields of Salinas, the smaller truck farms of North Carolina and Delaware, and the road side produce operations that dot Long Island. And just about everywhere in between.

But, as much as we all enjoy locally-grown produce bought at a nearby farmer’s market, our quest for abundant supplies of fresh fruits and vegetables year round has turned our eyes and our markets outward. We now import 50% of our fresh fruit and 20% of our fresh vegetables, with Mexico being our largest source of both. In fact, two-thirds of imported fresh vegetables and almost 30% of imported fresh fruit comes from Mexico.

Michael R. Taylor, J.D.I recently spent a day in Tubac, Arizona, participating in the America Trades Produce conference. Tubac is near Nogales, which is the site of the highest volume port of entry for produce coming into the United States from Mexico – sometimes over 1,000 truckloads per day.

The conference brought together people on both sides of the border with a stake in this trade – growers and shippers of produce, importers, federal and state officials from the United States, and our regulatory counterparts from Mexico. I went to the meeting to talk about FDA’s progress in implementing the Food Safety Modernization Act (FSMA), which will transform how we oversee the safety of fresh produce, whether grown in Mexico or the United States.

I came away with some strong impressions. First, food safety is a front-of-mind topic for the produce industry. Those trading across the border of course have trade concerns, such as avoiding logistical delays in entering goods at the port of entry. But the people I spoke with consider food safety central to their business. That’s why they wanted to hear from me about FSMA implementation and why the conference program included exercises using realistic scenarios to share knowledge about how to manage recalls and other food safety incidents.

Second, they know that managing problems after they occur is not nearly enough.  Significant outbreaks of illness affecting major produce commodities have harmed consumers and consumer confidence and cost millions in lost sales. That’s why many in the industry have invested in growing and handling practices they know can prevent contamination and illness. And it’s why they voice strong support for implementing FSMA, which will create a level playing field of modern, prevention-oriented standards to ensure wider adoption of sound food safety practices.

Finally, they want to get on with building the new import safety system mandated by FSMA. In addition to new produce safety standards, FSMA requires importers to have a verification program that provides assurances that the food they import is as safe as domestic produce, strengthens the private audit system, mandates more foreign inspection by FDA, and directs FDA to partner more closely with foreign governments to ensure food safety. These reforms respond directly to concerns reflected in a 2011 food-industry sponsored survey showing that only 50% of Americans have confidence in the safety of the food supply and 61% consider imported food less safe due to the lack of adequate government oversight.

Building the new import system can be a win-win for consumers and industry. By building in prevention and verification from the point of production, the system can make produce safer, bolster public confidence, and streamline the border entry process, which is crucial for the shelf life and quality of perishable fruits and vegetables.

People often say to me “You folks at FDA must really have your hands full implementing FSMA.”  That’s true, and even an understatement. The day in Tubac reminded me, however, why we’ll succeed. Modernizing the food safety system is a community effort.  We have broad common interests that motivate our individual and collaborative efforts.  By working together, we make success the only possible outcome.

Michael Taylor is Deputy Commissioner for Foods at FDA

Beyond Rulemaking: Building the Scientific Infrastructure for Food Safety under FSMA

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By: Michael R. Taylor, J.D.

One year has passed since the FDA Food Safety Modernization Act was enacted, and we are making remarkable progress in developing regulations to implement many of the law’s provisions. It’s certainly a big job, requiring a lot of hard work by many at FDA. 

As we proceed with rulemaking, we also need to be sure we have the infrastructure in place and the resources available to operate in the FSMA environment called for by Congress. FSMA requires industry to focus on preventing problems and on addressing risks in the food supply. But in order to implement the new requirements, FDA will need up-to-date information on what the hazards are, how to detect them, and what steps can be taken all along the farm–to-table chain to minimize them to the extent possible.   

Michael R. Taylor, J.D.

Our existing scientific foundation is strong, but we must be ready for the new challenges posed by FSMA. Our scientific leadership, capacity and partnerships all must be up to the task. One important step we are taking now is to recruit a Chief Science Officer and Research Director to provide strategic direction and lead our research and methods development activities. This individual will work with our scientists and policy experts to be sure that the resources we have available—including expertise and funding—are dedicated to our most critical public health needs. He or she will also need to anticipate our needs for the future.

This means prioritizing research based on our most critical needs and data gaps. This needs to be done strategically across all of our food programs and in concert with other research offices within FDA. It means determining what new methods, such as rapid analytical tests, are needed to identify contaminants in foods and to ensure that industry is meeting our food safety requirements. And, it means collaborating with other research entities in the public and private sectors.

By working closely with our research partners in other government agencies, academia and industry, we can leverage each other’s work and avoid duplication.

FDA chemist uses gas chromatography to measure levels of melamine in food samples. Our Chief Science Officer and Research Director will also make sure we identify and invest in scientific disciplines and specialties that are critical to carry out our mission. Science and technology change rapidly, and we must have the right expertise, training, equipment and facilities to keep up.

A lot is at stake. FSMA provides the framework for the new prevention- and science-based food safety system, but we must have the science to support the framework and make the right decisions to protect the public health. Americans expect us to have the right science at our fingertips to protect themselves and their families. FSMA must be accompanied by change within FDA so we are ready to operate the new food safety system – and we are ready to meet that challenge head on.

Michael Taylor is Deputy Commissioner for Foods at FDA

FDA: Reflection on 2011 and Looking Forward to 2012

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By: Margaret A. Hamburg, M.D.

The beginning of a New Year is a wonderful time to reflect on the past year and to think about what lies ahead. While 2011 had its share of challenges for us at FDA, it was also a time of significant accomplishment. We are excited about the many opportunities that 2012 will bring to the Agency.

2011 began with the most sweeping reform of our food laws in more than 70 years. FSMA promises an even safer food supply than we enjoy today and a wonderful opportunity to help promote public health.  We also continued the hard work of implementing the Family Smoking Prevention and Tobacco Control Act.

Margaret Hamburg On the medical product front, there were a multitude of outstanding activities and advances.  Importantly, we renewed our focus on the importance of innovation, in our own work and in the products we are tasked to review.  This was also a remarkable year for innovative drug approvals.  During Fiscal Year 2011, the FDA approved 35 novel drugs, targeting diseases such as late-stage lung cancer, metastatic breast cancer, and hepatitis C.

We also worked to continually strengthen the science that guides our policies, including many important collaborations with key partners and stakeholders.  Even with all of our ongoing work, when crises came in 2011, we acted swiftly to protect the American people.  We also continued to strengthen our capacity to address one of the greatest challenges in this new century – our increasingly globalized world.  “Pathway to Global Product Safety and Quality”

In 2012, FDA will meet new and complex challenges and continue our work in implementing FSMA and the Tobacco Act, promoting advancements and innovation in medical products, and broadening our strategic globalization and regulatory science initiatives. We will be working closely with Congress and stakeholders to support the reauthorization of user fees for pharmaceutical products (PDUFA), and medical devices (MDUFA), as well as to authorize new user fees for generic drugs (GDUFA) and biosimilars.

I am confident, thanks to the dedication of the employees of the FDA, that we will continue to make invaluable contributions to the lives of you, the American people.

I wish you and your family a healthy and happy 2012.

Margaret Hamburg, M.D., is Commissioner of the U. S. Food and Drug Administration.