Keeping You Informed: An Update on FDA’s Judicious Use Strategy for Antimicrobial Drugs in Food-Producing Animals

By: David G. White, Ph.D.

Today, “antibiotic resistance” is a widely recognized concern. With the rise of bacteria that are resistant to many, and in some cases, all standard treatments, scientists and medical professionals are not alone in focusing on this problem. The general public is increasingly aware of the ongoing research and how antibiotic resistance can affect their immediate communities.

David WhiteAntibiotic or antimicrobial resistance is an extremely complex and challenging phenomenon that is driven by many factors. For example, bacteria can spontaneously mutate to become resistant to antimicrobials, even ones they’ve never previously been exposed to. Overuse in both humans and animals is another complicating factor. Although progress has been made in curbing inappropriate drug uses in human and veterinary medicine, more work is clearly needed.

In December 2013, FDA started the clock on major changes regarding the use of antimicrobials in food producing animals by asking the animal pharmaceutical industry to relabel certain antimicrobials used in feed in two ways: by removing those indications approved for “growth production/feed efficiency,” and by requiring veterinary oversight and involvement in order to obtain these products when they are needed to assure animal health.

We’re now six months into a three-year transition period for these actions to take place, and we’re happy to report that we’ve secured the voluntary engagement of all 26 affected animal health companies. Out of the 283 drug products, 31 have been withdrawn from the market completely, and partial label changes have been completed for two other products.

Today we released our first biannual progress report on this strategy. FDA has committed to keeping the public updated on the implementation of these changes, and we intend to release progress reports every six months. These reports will highlight changes made by drug companies to their products over the previous six months, and provide a summary of changes that are in progress.

FDA will continue to update its chart of affected applications in real time as companies make label changes.

Developing strategies for reducing antimicrobial resistance is critical for protecting both human and animal health. We are still in the early stages of implementing this part of our overall effort to slow the development of antimicrobial resistance. We’ve been working with drug companies to move this strategy forward, and we are in continual discussions with both the animal health and animal production industries to help identify the most efficient ways to make these changes to their products.

While these changes are significant steps forward, the strategy is still in its early stages. The changes are just one part of FDA’s overall strategy for monitoring and reducing antimicrobial resistance. We see these progress reports as a way to evaluate the impact of our measures on how medically important antimicrobials are used in food producing animals, but we also know there’s more work to do. Additional actions may be warranted in the future, and FDA will be continually assessing their impact to determine appropriate next steps.

As we move forward, FDA is working with federal partners, veterinary groups, and consumer advocates to develop additional ways to measure success in slowing the development of antibiotic resistance and preserving the effectiveness of existing antimicrobial drugs. As with any strategy, there will be additional challenges, but FDA remains committed to addressing them and sharing what we learn along the way.

David G. White, Ph.D., is the chief science officer and research director in FDA’s Office of Foods and Veterinary Medicine

OpenFDA: Innovative Initiative Opens Door to Wealth of FDA’s Publicly Available Data

By: Taha A. Kass-Hout, M.D., M.S.

Today, I am pleased to announce the launch of openFDA, a new initiative from our Office of Informatics and Technology Innovation (OITI). OpenFDA is specifically designed to make it easier for web developers, researchers, and the public to access and use the many large, important, health data sets collected by the agency.

Taha Kass-HoutThese publicly available data sets, once successfully integrated and analyzed, can provide knowledge and insights that cannot be gained from any other single source.

Consider the 3 million plus reports of drug adverse reactions or medication errors submitted to FAERS, the FDA Adverse Event Reporting System (previously AERS), since 2004.

Researchers, scientists, software developers, and other technically-focused individuals in both the private and public sectors have always been invited to mine that publicly available data set – and others – to educate consumers, which in turn can further our regulatory or scientific missions, and ultimately, save lives.

But obtaining this information hasn’t always been easy.

In the past, these vast datasets could be difficult for industry to access and to use.  Pharmaceutical companies, for example, send hundreds of Freedom of Information Act (FOIA) requests to FDA every year because that has been one of the ways they could get this data. Other methods called for downloading large amounts of files encoded in a variety of formats or not fully documented, or using a website to point-and-click and browse through a database – all slow and labor-intensive processes.

openFDA logoOpenFDA will make our publicly available data accessible in a structured, computer-readable format. It provides a “search-based” Application Programming Interface – the set of requirements that govern how one software application can talk to another – that makes it possible to find both structured and unstructured content online.

Software developers can now build their own applications (such as a mobile phone app or an interactive website) that can quickly search, query or pull massive amounts of public information instantaneously and directly from FDA datasets in real time on an “as-needed” basis. Additionally, with this approach, applications can be built on one common platform that is free and open to use. Publicly available data provided through openFDA are in the public domain with a CC0 Public Domain Dedication.

Drug adverse events is the first dataset – with reports submitted from 2004 through 2013 available now.

Using this data, a mobile developer could create a search app for a smart phone, for example, which a consumer could then use to determine whether anyone else has experienced the same adverse event they did after taking a certain drug.

As we focus on making existing public data more easily accessible, and providing appropriate documentation and examples to developers, it’s important to note that we will not release any data that could be used to identify individuals or reveal other private information.

OpenFDA uses cutting-edge technologies deployed on FDA’s new Public Cloud Computing infrastructure enabled by OITI, and will serve as a pilot for how FDA can interact internally and with external stakeholders, spur innovation, and develop or use novel applications securely and efficiently. As we move forward with the early stages of openFDA, we will be listening closely to the public, researchers, industry and all other users for their feedback on how to make openFDA even more useful in promoting and protecting the public health.

Taha A. Kass-Hout, M.D., M.S., is FDA’s Chief Health Informatics Officer and Director of FDA’s Office of Informatics and Technology Innovation.

Building Expertise and Crossing Boundaries to Improve Oversight

By: Howard Sklamberg, J.D.

To keep the food supply safe, have safe, effective, and high quality medical products, and decrease the harms of tobacco product use, we have to work with the rest of the world.

Howard SklambergAs FDA’s Deputy Commissioner for Global Regulatory Operations and Policy (GO), I oversee FDA’s efforts to further advance its thinking and strategies from a primarily domestic to a globally focused regulator.

GO coordinates the efforts of FDA’s Office of Regulatory Affairs (ORA) and the Office of International Programs (OIP), and works with all of FDA’s product centers on scientific, manufacturing or other regulatory challenges. The highly skilled and dedicated workforce in ORA and OIP is responsible for conducting domestic and foreign inspections, deepening collaborations with local, state and foreign regulatory partners, helping these regulatory partners to strengthen their regulatory systems, and fostering the use of science-based standards and regulatory coherence around the globe to promote the public health of our citizens.

We have to be able to share information with our regulatory partners. We need their help to implement new regulations that have worldwide impact on the oversight of food under the Food Safety Modernization Act and medical products under the Food and Drug Administration Safety and Innovation Act. Working together with these partners, we can ensure an effective public health safety net for our citizens and communities.

An important new priority for FDA is to make fundamental changes in the way we operate in today’s world by aligning our efforts across the agency to keep pace with the acceleration of scientific innovation and the global expansion of the markets. So much of FDA’s work cuts across multiple product areas. How do we make that work as a large and complex agency?

Commissioner Hamburg and senior leaders across the Agency are committed to strengthening our ability to do just that and are collaborating to achieve greater operational and program alignment across the Centers and ORA.

A key part of this process is to enhance specialization across FDA. For ORA, enhanced specialization means that investigators, compliance officers, import reviewers, laboratory personnel, managers and others will have increased technical expertise in a specific commodity area and will work closely with subject matter experts in FDA’s centers. Over time, ORA’s geographic-based model will evolve to a commodity-specific, program-based model that will provide ORA staff the opportunity to gain increased expertise in specific product areas, such as pharmaceuticals, food, animal feed, medical devices, biologics, and tobacco. They will work as part of a team with the staff from other centers, collaborating, for example, with the Center for Drug Evaluation and Research on pharmaceutical oversight or with the Center for Food Safety and Applied Nutrition on food safety issues.

It is especially important that experts in the centers and ORA be engaged in helping to develop compliance policies and priorities. Working with the centers on these broader concerns puts ORA investigators and compliance officers in a better position to implement the preventive approaches contained in new statutes and work together more seamlessly with the centers.

These and other changes that are part of the agency’s focus on program alignment will deepen our knowledge and make us more effective and efficient, with more clarity and coherence in our communications and actions.

This process is still in its early stages. There is a lot of planning still to be done, and we will work to ensure a transparent and inclusive process. Nevertheless, change is coming and I am excited and proud to be part of a transformation that can only strengthen our efforts to safeguard the foods and medical products that are so important in the lives of people all over the world.

Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

Getting it Right on Spent Grains

By: Michael R. Taylor

Since the March 31 close of the comment period on FDA’s proposed animal feed rule, we’ve received a lot of questions and comments about so-called spent grains. Spent grains are by-products of alcoholic beverage brewing and distilling that are very commonly used as animal feed.

Michael TaylorTo add to the picture, spent brewer and distiller grains are just a subset of the much broader practice of human food manufacturers sending their peels, trimmings, and other edible by-products to local farmers or feed manufacturers for animal feed uses rather than to landfills. One industry estimate is that 70 percent of human food by-product becomes food for animals.

We’ve heard from trade groups and members of Congress, as well as individual breweries raising concerns that FDA might disrupt or even eliminate this practice by making brewers, distillers, and food manufacturers comply not only with human food safety requirements but also additional, redundant animal feed standards that would impose costs without adding value for food or feed safety.

That, of course, would not make common sense, and we’re not going to do it.

In fact, we agree with those in industry and the sustainability community that the recycling of human food by-products to animal feed contributes substantially to the efficiency and sustainability of our food system and is thus a good thing. We have no intention to discourage or disrupt it.

We also believe the potential for any animal safety hazard to result from this practice is minimal, provided the food manufacturer takes common sense steps to minimize the possibility of glass, motor oil or other similar hazards being inadvertently introduced, such as if scraps for animal feed were held in the same dumpster used for floor sweepings and industrial waste.

We understand how the language we used in our proposed rule could lead to the misperception that we are proposing to require human food manufacturers to establish separate animal feed safety plans and controls to cover their by-products, but it was never our intent to do so. In fact, we invited comment on practical ways to address by-products in keeping with their minimal potential risk.

We will take the necessary steps to clarify our intent in the rules themselves so there can be no confusion. As we previously announced, this summer we plan to issue revised proposals for comment on several key FSMA issues and we will include changes consistent with the points I’ve outlined in this blog.

Our door at FDA has been wide open to stakeholders at every step of the FSMA process. We have learned a lot through active, two-way dialogue with those who have concerns about what we propose or ideas about how we can achieve our food safety goals in the most practical way. We hope and fully expect that dialogue to continue.

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

Interested in a Science Career at FDA? Our Web Portal Opens the Door

By: Jesse Goodman, M.D., M.P.H.

As a physician and a scientist, I value being part of a rich, vibrant scientific community. Since coming to FDA, I’ve been gratified to help lead and support a large group of talented, dedicated scientists who are passionate about what they do. Because science is at the core of everything we do at FDA, the majority of FDA’s staff are scientists, including engineers and medical professionals. A robust scientific workforce strongly engaged in the new sciences is critical to the success of FDA’s mission to protect and promote the public health.

Jesse GoodmanUnfortunately, I am often reminded that many people are unfamiliar with the cutting-edge research going on at FDA, and how important top-notch science and research are to our mission. Scientists, including those who may be exploring career options, are often unaware of the myriad scientific disciplines and expertise FDA must have to advance and apply the science required to assess the increasingly complex products we regulate. The outside world knows too little about the many innovative activities FDA scientists engage in, often with a wide range of collaborators, to keep our foods and medicines safe and help speed new therapies from bench to bedside.

So I’m delighted that we have now launched a comprehensive, one-stop web portal – FDA Science Careers and Scientific Professional Development - to showcase FDA’s exciting, multidisciplinary scientific work force and culture and how important science is to our public health mission. We want scientists – from students, to recent grads, mid-career, and seasoned professionals – to be aware of the diversity of FDA’s career opportunities so that we may continue to attract top scientists, including engineers and medical professionals who want to use their expertise to make a real difference in the world.

Entering our career portal, you will have access to the latest information on our fellowship programs and our internship, graduate, and faculty programs, which help us attract outstanding scientific academic talent. These opportunities include:

Once on board, FDA scientists benefit from a dynamic, state-of-the-art, scientific professional development culture, with daily opportunities to attend a variety of scientific courses, seminars, and workshops. You can find out more about FDA’s efforts to support scientific professional development through the career portal’s Training and Development section. FDA-sponsored scientific engagement ranges from cross-agency and external collaborations – including FDA’s Centers of Excellence in Regulatory Science and Innovation - to lectures by global scientific thought leaders.

For scientists and other professionals who want to make a real difference in the world, I can think of no better place to work than FDA. The opportunities to build a rewarding career and work on exciting and important issues while protecting and promoting our nation’s health are exceptional.

Jesse L. Goodman, M.D., M.P.H., is FDA’s chief scientist.

Driving Innovation Is a Key Part of Our Mission

By: Margaret A. Hamburg, M.D.

Ensuring the safety of the food supply and the safety and effectiveness of drugs, devices and biologics has always been at the core of FDA’s responsibility to protect the public health – and always will be.

Margaret Hamburg, M.D.But what is often lost or neglected in discussions about FDA’s vigilance on behalf of consumer and patient safety is how this kind of oversight and regulation, when done right, can be a key driver of innovation throughout society. Whether it involves the development of some remarkable new drug or oversight of a particular product, the addition of rigorous regulatory science from FDA helps to safeguard the safety and effectiveness of innovative new products; ensures that these scientific achievements quickly reach their full potential; and builds a pathway for ongoing innovation. That’s why we continue to adapt and change regulatory policies in response to – and in anticipation of – scientific opportunities so that they can best be harnessed to improve health and medical care.

There are many recent examples of this thoughtful approach to innovative products. For instance, we have put in place a new breakthrough pathway to market for promising drugs that may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. Using this new approach, we have already approved two treatments for rare types of cancer and one for hepatitis C. And there may be considerably more in the weeks and months ahead because many companies have expressed interest. So far we have received 119 requests for designation and granted 35.

In a very different realm, another example is mobile medical apps. We took a measured and sensible approach that promotes innovation when we finalized guidance related to these devices earlier this year. Although many mobile apps pertain to health, CDRH intends to focus its oversight on a very small subset of those mobile apps that are medical devices. We have called that subset “mobile medical apps” and we are approaching their regulatory oversight within a risk-based framework. We believe this approach will promote innovation while protecting patient safety by focusing on those mobile apps that pose greater risk to patients.

As explained in the final mobile medical application guidance, our regulation of software as a medical device – and a mobile app is software – is based on risk and functionality, and that functionality should be treated the same regardless of the platform on which it is used. For example, an electrocardiography device – an ECG machine – that measures heart rhythms to help doctors diagnose patients is still an ECG machine regardless of whether it is the size of a bread box or the size of a smartphone. The risks it poses to patients and the importance of assuring for practitioners and patients that it is safe and effective are essentially the same.

And, just a few weeks ago, we authorized for marketing four innovative gene-sequencing devices. Two of these products comprise a system that allows laboratories to develop clinical tests that can look at a person’s genetic makeup and detect abnormalities that could be responsible for illness. FDA realized the innumerable uses of these systems from the outset, and rather than focusing on specific diseases or areas of the genome, we took a tool-based regulatory approach. We assessed whether the devices overall measure what they are intended to measure accurately, reliably and precisely so that there can be greater confidence in the test results. These types of genome sequencers represent a significant step forward in the ability to generate genomic information that may ultimately improve patient care.

Each of the new medical products we approve and usher to the market involves a balancing of risks and benefits, which is based on study and evaluation of hard data and the best available science. It is a huge responsibility that FDA is charged with, nowhere more so than when dealing with unfolding technologies that offer enormous potential – but that also may present real risks for people and their health.

We know there will be new and continuing challenges that arise with additional technological developments and advancements in science and medicine. This is why FDA’s regulatory role in these emerging areas continues to develop as well, sometimes even as the technologies themselves are taking shape

But our goal remains constant – to protect the public health through smart regulation that helps to enhance innovation and ensure that new medical technologies have real value to the people who will use them, and that they are used effectively and safely to address their needs.

Margaret A. Hamburg is Commissioner of the Food and Drug Administration

FDA Confers with International Counterparts to Advance Regulatory Science

By: Margaret A. Hamburg, M.D.

I have recently returned from the 8th International Summit of Heads of Medicines Regulatory Agencies, which was hosted on December 3-6, 2013, by the Netherlands’ Medicines Evaluation Board in Amsterdam. These annual meetings are an important forum for the exchange of information, views and regulatory strategies among the chief executives of major and like-minded medicines regulatory agencies. I was particularly pleased to be able to contribute to these discussions as a speaker on a panel on regulatory science together with Dr. Tatsuya Konda, M.D., Ph.D., the chief executive of Japan’s Pharmaceuticals and Medical Devices Agency.

Margaret Hamburg, M.D.The theme of this year’s summit was “Changes in the Regulatory Landscape,” and my foreign colleagues and I had plenty to talk about. Overcoming the challenges and reaping the benefits of regulatory science is even more critical today, when the FDA and other regulatory agencies face new and growing tasks in the global marketplace. All of us have to contend with the huge changes in the size and nature of international trade caused by emerging markets, developing economies, and increased cross-border flows of goods, information and capital.

As regulators, my international counterparts and I have many issues in common. They include the increasing complexity of new drug products and drug development; growing geographic distribution of markets; greater demands for public accountability and transparency in our work; budgetary and political challenges to regulatory oversight; and, the overriding need to keep up with the rapid changes in science and technology. Given these shared concerns, building cross-border partnerships and finding common solutions is paramount.

I reiterated to the conference our goal to encourage and strengthen cooperation and collaboration among those nations that are actively working to advance regulatory science. Regulatory science endeavors to use current and emerging knowledge to create new tools, standards and approaches for reliable assessment of the safety, effectiveness, quality and performance of medical products. At its best, this process is based on findings, evaluations, discussions and collaboration by scientists throughout the world.  And it is meetings like the recent summit in Amsterdam that help enhance this cooperation and the development of strategies that promote and strengthen the understanding, acceptance and application of regulatory science.

As the FDA embraces its international role in today’s complex regulatory environment, we fully accept the need to think and act globally more than ever before. I look forward to working with other nations’ regulators, the academic community, non-governmental organizations and industry as we join forces to advance regulatory science, the road to even better protection and advancement of the public health.

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

Help Us Find Out Why Jerky Treats Are Making Pets Sick

By: Linda Tollefson, D.V.M. 

As a veterinarian and lover of animals, I find that working at FDA is a dream job in many ways. In the Foods and Veterinary Medicine program, there are veterinarians in many different jobs that all have to do with keeping both people and animals safe. 

Within the program, FDA’s Center for Veterinary Medicine (CVM) is a working testimonial to animals and their companion people. Desks and office doors are covered with photos of pets — dogs and cats of course, horses for sure, and even our favorite reptiles, birds, cows, pigs, sheep and a few great goats. Water cooler conversations are full of stories about the antics of our friends and family members (with and without fur, fins or feathers) and the challenges of caring for an aging animal. 

That’s why it means so much to us when we are able to target what is making an animal sick, and why it hurts, both personally and professionally, when the cause of illness eludes us despite global efforts to track it down. 

How to Report a Complaint about Jerky Pet Treats

As of September 24, 2013, over 3,600 dogs and 10 cats have reportedly become ill from eating jerky pet treats, nearly all of which were imported from China. While most pets have fully recovered, approximately 580 of these pets have died. The mystery that CVM is trying to solve is this: What is causing the reported illnesses and deaths in dogs (and some cats) that have eaten jerky pet treats made in China? 

The Center has been investigating these illnesses and deaths since 2007, working with experts in academia, industry, foreign governments and state labs. CVM’s Office of Research has been working with the Veterinary Laboratory Investigation and Response Network (Vet-LIRN), a consortium of animal health labs nationwide, to examine both animal diagnostic and tissue samples from pets that have become ill and the jerky pet treats themselves. 

Researchers in CVM labs, working together with other labs across the country, have tested jerky pet treats for microbiological contaminants, heavy metals and elements, pesticides, rodenticides, molds, antibiotics and other compounds. We’ve also analyzed hundreds of medical records and lab results, including examining and testing fluids and tissues of sickened pets. FDA inspection teams have visited manufacturing plants and suppliers in China and met with representatives from the Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), the Chinese regulatory agency responsible for pet food, to discuss U.S. requirements for pet food safety. Jerky pet treats from pet owner’s homes have been tested and compared with store samples. We’ve even made our own jerky to try to duplicate the commercial process. 

So why don’t we know what exactly is causing these illnesses? We’re not sure, but we know that we need more information about the pets that are getting sick. In order to get that information, we need the help of pet owners and veterinarians. To that end, we have issued a “Dear Veterinarian” letter asking veterinary practitioners who treat animals they suspect may have been sickened by eating jerky treats to report these cases to CVM through the FDA Safety Reporting Portal right away so that we can suggest certain tests (and cover the cost of these tests in many cases) when appropriate. We are working with our partners in Vet-LIRN labs across the country to test urine, blood and tissue samples from ill pets that may have been sickened by jerky treats. This collaboration helps leverage our resources and pool scientific expertise for the greatest effect. 

Despite extensive media coverage of the illnesses associated with these products and our own outreach efforts including through the CVM web site, we know there are still pet owners who are unaware of this issue. In response, FDA has developed a Fact Sheet for pet owners that can be made available at veterinary hospitals, pet supply stores, other stores selling pet food, and anywhere pet owners visit. The Fact Sheet explains what symptoms to look for, how to contact your local FDA office, and the status of our jerky pet treat investigation so far. We hope that these tools will help prevent more pets from becoming sick and will provide us with the clues we need to crack the case. 

What we do know is that our pets bring joy to our lives. It’s our mission, both as public servants and animal lovers, to find – and eliminate – the cause of these illnesses. 

Linda Tollefson is Associate Commissioner for FDA’s Office of Foods and Veterinary Medicine

Thinking Globally to Strengthen Science and Public Health Locally

By: Margaret A. Hamburg, M.D.

There are many good reasons to go to Arkansas in September. To visit Little Rock, nestled in the rolling hills between the Ouachita Mountains and the Arkansas River, and recently chosen as America’s number one most livable city. To attend the Annual Eureka Springs Antique Automobile Festival or the Ozark Quilt Festival. Or to take in the William Jefferson Clinton Presidential Library in Little Rock or visit his childhood home in Hope. And yet, none of these were the prime rationale for why more than 100 scientists, researchers, government regulators, and students from around the world came to this state. Instead, these committed individuals traveled from places as far away as Brazil, South Korea, and Australia to attend the Third Annual Global Summit on Regulatory Science hosted this week by FDA’s National Center for Toxicological Research (NCTR). 

Margaret Hamburg, M.D.They were here to help plan and build an organization to ensure that at a time of growing global demands and pressures, we can more efficiently turn the extraordinary potential and promise of science and technology into real-world products and programs that matter and make a difference to the public health.

The concept at the heart of this gathering is an occasionally neglected but fundamental component of the scientific enterprise and of FDA’s work and mission, regulatory science. Regulatory science is critical to speeding innovation, improving regulatory decision-making, and strengthening our ability to better assess the safety, quality and efficacy of a wide range of products, including food, drugs and devices. It is the work of regulatory science that truly enables us to have the knowledge and tools needed to translate scientific discovery and innovation into the products that hold such great promise.

That’s why one focus of the meeting was how to build a training model for regulatory scientists. Because even when individual nations have high standards for scientific training, fully leveraging the opportunities in science today requires an added focus on the specific critical thinking skills necessary to design, implement, and interpret studies within the regulatory context.

A number of programs at FDA for instance, are helping to ensure that scientists – both at the agency and around the globe – have this foundation. For example, NCTR has been collaborating with various Arkansas universities for a number of years to offer research training opportunities through a fellowship program that offers research training to postdoctoral students, as well as a training program for summer interns at the undergraduate level. So far, these programs have helped train students from more than 47 countries, as well as within Arkansas and across the nation.

One program I am especially excited by is the Arkansas Center of Excellence in Regulatory Science (ACERS), a public-private partnership that grew out of a Memorandum of Understanding I signed with the State of Arkansas in 2011. The five research universities that are part of the MOU are working collaboratively to join their vast computing capabilities, bioinformatics training, and other resources, with the equally impressive capabilities of NCTR and FDA to develop a powerful public resource. And just this week, at the Governor’s mansion, I signed the Partnership Intermediary Agreement, which will further strengthen the work of the Center, by facilitating the transfer of NCTR technology to the private sector.

Another important forward-looking aspect of ACERS is the creation of the Program in Regulatory Sciences at the University of Arkansas for Medical Sciences. This curriculum will help provide both current graduate students – and their broader scientific communities — with the critical skills needed to apply their scientific expertise to the decision-making needed for regulatory science within their specialties. These students represent the shape of things to come and provide an important step toward achieving the global promise of scientific innovation.

All of this speaks to the second important principle at the center of this week’s gathering in Arkansas – strengthening opportunities for collaborations being built among scientists from different governments, academia, industry, and elsewhere. Quite simply, collaboration is a cornerstone of regulatory science.

FDA increasingly is required to act in an environment in which food and product safety and development know no global boundaries. To respond effectively we must strengthen collaboration among international partners. This will allow us to offer a unified focus on regulation in the name of science to help ensure the availability and safety of the supply of food, drugs, and other products around the world.

The discussions this week in Arkansas furthered the development of innovative technologies, approaches, and, perhaps most significantly, partnerships that enhance the use and translation of basic science into regulatory applications, as well as new collaborative systems for communication, education and training. These efforts offer extraordinary promise for the future of regulatory science in the global context and for the delivery of the kinds of innovative, safer and more effective products that patients and consumers expect and deserve.

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

Salute to Science: FDA’s Student Poster Symposium

By: Margaret A. Hamburg, M.D.

Margaret Hamburg, M.D.For many people, the hot summer months in the nation’s capital mean a time to depart for the beach or other less humid destinations. But one of the events I look forward to each year takes place during the hottest days of summer, right here on FDA’s White Oak Campus just outside of Washington, DC. It’s when I get to participate in the annual Salute to Science Student Poster Symposium.  Each of the posters on display offers a detailed and stimulating summary of the approximately 100 projects undertaken by FDA student interns during their internships.

Now celebrating its 8th year, the internship program provides high school students, college undergraduates and even postgraduates with a great training ground for the next stage of their scientific education. Each intern takes on a hands-on research topic to pursue under the watchful eye of a scientific mentor from either FDA’s Center for Devices and Radiological Health (CDRH), the Center for Veterinary Medicine (CVM) or from the U.S. Air Force Wind Tunnel, which is located next door to our White Oak Campus.

As I looked over the posters and talked to the students about their projects, I was struck by their scientific sophistication as well as the remarkable range of topics addressed, ranging from a “virtual human head simulator,” which provides electrical stimulation that could be used to design novel neuro-prosthetic devices, optimize treatments, and assess the safety of medical devices such as MRIs, to the evaluation of a laser beam profile on optical properties of intraocular lens implants. The array of work demonstrated not only the promise of these students, but the breadth of scientific work undertaken here at FDA.

I was especially pleased to see so many young women participating in our internship program, given that women make up only 24 percent of the nation’s overall science and engineering workforce. The fact is, FDA is a welcoming place for female scientists and engineers; in addition to me, many of our top scientific positions are held by women.

This internship, and the Commissioner’s Fellowship Program for health care professionals, scientists, and engineers who may not have considered FDA in planning their career path, are helping to lay the groundwork for and train the next generation of FDA scientists.

They are part of our efforts to integrate strong science and research training requirements and programs, cultivate the expert institutional knowledge and innovation necessary to address gaps and challenges posed by novel products and areas, and continue to ensure safety and efficacy in the service of medicine and public health.

I am confident that the bright, creative, enthusiastic, and hard-working students who participated in FDA’s intern program will be part of the next generation of scientific leaders and innovators, and seeing their efforts gives me great hope for the future of this agency, and of the nation.

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