It’s always a good feeling when an outside organization recognizes an FDA employee for excellent performance in pursuit of our agency’s public health mission.  Recently, this was done by the Parenteral Drug Association (PDA) when it honored the work of two of my colleagues:  Kenneth Nolan and Kurt Brorson.  Ken received the PDA’s Distinguished Service Award, and Kurt the PDA’s Gordon Personeus Award. I ’m very pleased to congratulate both of them.

PDA is a global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. As such, its mission is similar to the public health goals pursued by Ken and Kurt in the course of their daily work for our agency.

Ken was given the Distinguished Service Award for special acts, contributions or service that contributed to the success and strength of PDA. As an FDA liaison to a large number of domestic and international trade associations and educational organizations, Ken advances FDA’s mission while helping these stakeholders prepare high value programs for their major meetings and conferences.

Ken responds to these groups’ requests for FDA speakers by using his many contacts throughout the agency to identify the most appropriate FDA experts on the desired topics. These presentations help increase the audiences’ understanding of FDA’s regulations, policies and initiatives designed to protect consumers and patients. Ken also often answers stakeholders’ questions about new regulations or requirements, explains their potential impact, and suggests how to best comply with them.

This is a two-way street. Ken’s work doesn’t help only scientific, industry, educational and trade groups better understand FDA’s requirements and priorities. The information he receives from these organizations provides our agency with important insights that help us do our job. We learn what’s on our stakeholders’ and potential partners’ minds, and how we can work together more effectively to advance the public health. 

For many organizations, Ken is the go-to guy they depend on to provide and explain information they need about FDA.

Kurt Brorson, Ph.D., received the award that commemorates Gordon Personeus, the past PDA president, one that also honors contributions of special importance to the association.

Kurt is one of FDA’s many highly accomplished scientists. A research biologist, he has done exemplary work and won numerous FDA awards in both the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research. He’s also the author of more than 70 scientific journal articles and book chapters.

Kurt Brorson and Ken Nolan

For the past few years, Kurt has served as associate editor for the well-respected PDA Journal of Pharmaceutical Science and Technology. In addition, from 2005-2012, he was an active contributor to the PDA Biotechnology Advisory Board. His most notable achievement with PDA was a six-year, lab-based effort to establish the first nomenclature standards for virus filters, a key safety factor in the production of biotech medicines. Nomenclature in this case is a way to categorize virus filters according to their performance to ensure their consistent use across the industry.

It’s easy to get caught up in FDA’s efforts to ensure the safety, quality and effectiveness of a myriad of regulated products, and overlook our agency’s critical work of explaining what we are doing and how we can work together to better serve consumers and patients. The PDA awards are a prominent testimony to the essential role of this outreach, communication and cooperation, and its great contribution our mission. Ken and Kurt have made us proud, and they have my sincere congratulations.  

Lawrence Bachorik, Ph.D., is Assistant Commissioner for the Office of Communications in the Office of External Affairs

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

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

As we continue to implement the exciting new tools provided by the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), we are inviting interested members of the public to use the Internet to track our progress.

Leslie Kux

FDASIA gave FDA new authorities to help FDA establish improved systems for combating drug shortages, protect the drug supply chain in an increasingly global market, and get generic medicines on pharmacy shelves and available to consumers more quickly. It is also encouraging companies to invest in discovering and developing new antibiotics, accelerate patient access to new medical treatments and breakthrough therapies, and promote the development of more treatments for children.

To track FDASIA’s progress, we leveraged an existing FDA web page that publishes pertinent information about a wide variety of FDA initiatives, and we added what we think are even better web tools for searching for specific details about a particular action.

The site currently shows that more than 30 of the tasks aimed at improving public health are completed. The site also lists numerous other steps involved in implementing the law and in each case provides a targeted completion date for the task and links to more information. Each task listed also includes a contact for more information or how to get answers to questions—either the e-mail address of an individual FDA employee or of an office specifically designated to handle that task.

Weaving the new authorities from the 140-page law into existing programs is a Herculean task, and doing it right takes time. We are committed to get the job done as quickly as possible while still making the best decisions that will serve the nation now and in the future.

Malcolm Bertoni

We established this web page to make that process transparent, and to encourage the input of those involved. Our immediate focus is on those provisions of the law that will have the greatest public health impact for which resources are in place, allowing us to act quickly.

We appreciate that some may be interested in viewing the nitty-gritty detailed listing of the many, complex actions involved in implementing FDASIA, and some may not. But we know the actions themselves will prove important to consumers and patients, who will ultimately benefit from the provisions of this new law.

Consumers and industry can find in-depth information, including fact sheets, news releases and technical information, at the FDASIA web page. FDASIA represents the potential for major improvements, and we are using everything at our disposal, to pursue the important goals it presents.

Leslie Kux is FDA’s Assistant Commissioner for Policy

Malcolm J. Bertoni is FDA’s Assistant Commissioner for Planning

Ted Elkin

While food safety—preventing unintentional contamination from sources likely to be found in the food chain—is a priority for FDA, so is food defense—protecting our food from intentional contamination by saboteurs, terrorists or other criminals.

Such an incident, should it occur, could have widespread public health and economic consequences. Therefore we work hard every day to minimize such risk.

In the last decade, FDA has provided various tools, resources, guidance, and information to the food industry to help them prevent intentional contamination. We work closely with state and local governments, as well as with the food industry, to better understand the vulnerabilities in the food system and identify the appropriate strategies to protect the food supply.

Julia Guenther

Recently, we released a new tool that will help the owners and operators of food facilities develop customized food defense plans to minimize the risk of intentional contamination.  It’s a software program called the Food Defense Plan Builder and it’s designed to be easy to use. This desktop tool can be downloaded free of charge at www.fda.gov/food/fooddefense/.

This exciting new tool guides users through a series of substantive questions about the user’s food facility and the food manufactured, processed, packed, or held there to help the user develop a facility specific food defense plan. The tool will guide owners and operators by prompting them to ask the right questions in food defense planning: What are we already doing to protect our facility? What aren’t we doing that we should or could be doing? What are the vulnerable points within our system and how do we provide added protections? And it even helps with developing a plan to manage, track and prioritize the action steps identified using the tool.

While the use of the Food Defense Plan Builder is voluntary, we strongly encourage food facilities to create food defense plans. In our complex, global marketplace, it’s no exaggeration to say that an incident at one company could affect the whole world.

So, what’s your plan?

Ted Elkin, is Director, Office of Analytics and Outreach, at FDA’s Center for Food Safety and Applied Nutrition

Julia Guenther, is a Policy Analyst, Food Defense and Emergency Coordination Staff, at FDA’s Center for Food Safety and Applied Nutrition

It has been 11 years since Congress passed the Best Pharmaceuticals for Children Act mandating the creation of the Office of Pediatric Therapeutics (OPT) at FDA.  But it has been light years in terms of the progress we have made to ensure that children have access to innovative, safe and effective medical products.

Increasingly, parents can rest assured that the medications they give their children have been tested—in children—in scientifically necessary and ethical clinical trials. OPT’s Pediatric Advisory Committee has reviewed over 200 products for their safety when used by children. Today, nearly 500 drug and biologic products have been improved by including, in their labeling, information describing safety, effectiveness and, where appropriate, dosing relating to use of the product in children. 

We’ve come a long way. And as director of OPT since 2003, pediatrician Dianne Murphy, M.D., has led the charge.

It is because of her indefatigable work on behalf of children that the American Academy of Pediatrics (AAP) has bestowed on Dr. Murphy its Excellence in Public Service Award (EPSA) “representing the highest honor awarded…to a public servant for distinguished service to the nation’s children, adolescents and young adults.” In the letter informing Dr. Murphy of this honor, AAP says her work at FDA “has profoundly improved the lives of children in the U.S. and around the world through increased access to needed therapeutics.”

I couldn’t agree more.

For many years before Dr. Murphy began her tenure at FDA, the playing field badly needed leveling when it came to safety in children’s drugs. Very few drugs—even those meant solely for children’s use— were actually tested on children. For one thing, some drug companies, eager to get their new products out while they still held exclusivity (that is, the period of time during which generic drugs cannot be developed), were reluctant to take the time or go to the expense. Many people, too, felt it was unethical to use children as so-called “guinea pigs.”

Without the information gained from testing children in clinical trials, health care professionals and parents alike could only guess when trying to gauge the correct dosages for children.

This was an enormous problem. Children are vulnerable. Their organs are developing, and they are experiencing physical changes that affect how a drug is metabolized. As Dr. Murphy has often said, guessing at the dose just doesn’t work. Children must be studied if we are to give them safe and effective treatments.     

The sea change began ten years before her arrival at FDA, when AIDS was entering the public consciousness. Dr. Murphy has told me that at the time, she was treating children in her practice who were dying of AIDS because there were no drugs available specifically to address their unique needs.

Based on that hard lesson, a major priority when she came to FDA was to ensure that drugs for children first be tested in children in clinical trials. Dr. Murphy has worked with FDA scientists and reviewers to ensure that pediatric studies are rigorously designed and conducted in accord with current scientific understanding of the characteristics that make children unique. And she has championed FDA’s involvement in the international arena, where FDA has emerged as a leader in regulatory thinking.

In achieving this honor, Dr. Murphy is in very good company. She shares it with such distinguished former honorees as First Lady Michelle Obama, the late Sen. Edward M. Kennedy, Rep. Henry Waxman, former FDA Commissioner David A. Kessler, and National Institutes of Health Director Francis S. Collins.

At FDA, we offer our congratulations, and our thanks.    

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

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

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

“What’s in a name?” Shakespeare famously asked. “A rose,” his Juliet reasoned, “by any other name would smell as sweet.” And often, we know, that’s true.  But other times, a change in name can signify some larger, more substantive shift.

The latter was the case in mid-April when we sat down in Washington to meet with one of China’s key regulatory agencies, the China Food and Drug Administration (CFDA). Just weeks before arriving in Washington, during the 12^th People’s Congress in Beijing, CFDA had gained new authorities from the Chinese government, and had been given a new name. CFDA became the new moniker for what was formerly known as the State Food and Drug Administration (SFDA). At the same time, it gained enhanced authorities. Most notably, CFDA was given overall authority over China’s domestic system for food safety, absorbing roles previously overseen three other Chinese government agencies. CFDA was also elevated to become a ministry, reporting directly to China’s State Council—the equivalent in U.S. terms of becoming a cabinet-level agency.

But even before this name change and “promotion” within the Chinese government, CFDA had evolved significantly in the years since we began high-level talks with them in 2007. Over the years, these bilateral meetings— which are required annually under the terms of the agreement the U.S. Department of Health and Human Services signed with then-SFDA in 2007—have served as a barometer of our evolving relationship with Chinese regulatory authorities.

Names and titles in the picture (from left to right): Xinyu WENG, Division Director, Dept. of Drug Safety & Inspection, CFDA; Enxue CUI, Council, Bureau of Investigation & Enforcement, CFDA; Zhenjia BIAN, Commissioner's Special Representative, CFDA; Margaret A. Hamburg, Commissioner, USFDA; Jianhua DING, Supervisor-General, Dept. of International Cooperation, CFDA; Lanming WANG, Director-General, Dept. of Medical Device Supervision, CFDA; Xiangyu WANG, Deputy Division Director, Dept. of International Cooperation, CFDA

In 2007 and 2008— years that by all accounts were difficult ones for China with respect to the safety of its exports— exchanges were often challenging, fraught with tension and growing pains. These early efforts represented the first-ever set of talks between senior officials at FDA and then-SFDA, and took place in the context of highly-publicized product-safety issues that dominated those years. Challenges have certainly not gone away in the intervening years, but our April 2013 talks made clear that our relationship with CFDA has matured significantly since those early efforts. Where 2007 represented, in many ways, an introduction, and 2008 marked the first-ever establishment of a bilateral work plan, today, most officials involved in these talks come to the table well-known by their colleagues on the other side of the table. And the slate of topics for our April meeting made clear the deep collaboration between FDA and CFDA across more than a dozen topic areas.

While much of the strengthening of our relationship with CFDA has come through day-to-day collaboration between FDA’s China Office and CFDA officials in Beijing, there are significant ties in multiple areas across our agencies:

• A working group on economically-motivated adulteration (the fraudulent substitution of a substance in a product to increase value or reduce production costs for the purposes of economic gain) meets on a regular basis by video, linking Washington-based experts with CFDA’s key decision-makers.
• Experts from FDA’s Center for Devices and Radiological Health now meet regularly with their counterparts from CFDA under the auspices of the International Medical Devices Regulatory Forum.
• FDA and CFDA collaborate closely under the auspices of the World Health Organization’s Working Group for Member States on Substandard, Spurious, Falsely-Labeled, Falsified and Counterfeit Medicines. FDA and CFDA inspectors observe one another’s inspections, and in May 2013, FDA and CFDA will co-host workshops to enhance our collaboration in the fight against internet-based, illegal distribution of adulterated drugs.

The list goes on. Change— of organizational names, of personnel— will continue. Based on our recent talks with CFDA, however, it is clear that one constant will remain: the mature relationship our agencies have built enabling us to better address challenges to consumer and patient safety in years to come.

Mary Lou Valdez is FDA’s Associate Commissioner for International Programs

Peanut butter. Cantaloupe. Dog food. Tuna. Cheese.

Any of these products might show up on your weekly grocery list.

Each was found to be the source of a foodborne illness outbreak over the past two years.

In the first 17 months since it was launched in August 2011, FDA’s Coordinated Outbreak Response and Evaluation Network (CORE) evaluated 211 incidents of illnesses that were possibly related to FDA-regulated products. After careful analysis, 63 of those incidents were determined to indeed be related to FDA-regulated products and an active CORE response began with one goal: Stop the outbreak.

The highlights of CORE’s work are outlined in our new report entitled “FDA’s CORE: A Food Safety Network 2011-2012.”  As CORE’s director, I could say that I’m proud of what my team has accomplished. But that would be an understatement.

Every day, members of the CORE network at FDA, the Centers for Disease Control and Prevention and state and local agencies, are working to identify, stop and prevent outbreaks. Each outbreak is unique, and so are the results of each investigation. In many cases, though, the network is able to identify, trace and stop an outbreak in its tracks. Contaminated products are pulled out of distribution and removed from grocery store shelves—and hundreds of people may have been spared illness.

CORE introduced a whole new concept into FDA’s response to foodborne illness outbreaks. That is, not just to assemble a team of experts when an outbreak strikes, but to have a full-time, ongoing “core” staff of three teams—Signals and Surveillance, Response, and Post-Response—dedicated respectively to finding the outbreak, stopping the outbreak, and preventing the next outbreak.     

There’s a seamless passing of the baton, and it’s exciting, too. CORE is constantly changing and evolving. Every unique outbreak teaches us new lessons we can apply to the next.

In very short order, CORE proved that FDA could work in close and vital partnership with a huge cast of supporting characters across the country, an extended network of experts from regulatory, public health, agricultural agencies and laboratory staff at the federal, state and local levels. CORE also proved that these partnerships would pay off.

We learn lessons about the science of illness and how it spreads, about the role manufacturers or farmers or packagers or a host of others play. We learn new ways to collect and then crunch the data, and new ways to apply it. We build new relationships and extend our network of experts across the country.

Most importantly, we see first-hand the health hazards that could develop and—if we do our jobs right—we learn how to minimize the chance that they will develop.

So we’re not simply responding to the outbreak. In the intricate chain from farm, to manufacturer, to shipper, to grocer, to your kitchen table, we’re finding ways to help prevent foodborne illness from ever harming you and your family.

Kathleen Gensheimer, M.D., MPH, is Chief Medical Officer and FDA’s Director of Outbreak Investigation and Response

Bob Temple, M.D.

Alzheimer’s disease is one of America’s most pressing and rapidly growing public health problems.

Therefore I announce with great pride and respect that one of FDA’s leaders in the field of Alzheimer’s disease research and drug development has been nationally recognized for his contributions to combating this progressive and debilitating disease. I cannot think of a more deserving individual than Dr. Russell Katz, “Rusty” to us, to be so honored.

At its recent National Alzheimer’s Dinner, the Alzheimer’s Association awarded Rusty the Ronald and Nancy Reagan Research Award, which honors researchers who are leading the way in promising and innovative approaches to Alzheimer’s treatment, prevention and care. He joins a distinguished list of past honorees from the Mayo Clinic, University of Virginia, Johns Hopkins University School of Medicine, Harvard Medical School, and many other outstanding organizations.

Dr. Katz first joined FDA in 1983. Today, he is director of FDA’s Division of Neurology Products, the division that reviews and approves drugs for neurological conditions, including those for patients with Alzheimer’s disease.

One in eight older Americans suffers from Alzheimer’s disease (AD), the sixth-leading cause of death in the United States. As Rusty has noted, “The aging of the baby boomers is fueling what could turn a public health problem into a public health crisis.” If no treatments are developed to prevent, cure or slow the progression of AD, the number of Americans suffering from this pernicious disease will grow from 5.4 million to as many as 16 million by 2050, according to estimates by the Alzheimer’s Association.

Dr. Katz has been a critical figure in the advancement of research and drug development for Alzheimer’s disease, building strong partnerships in the Alzheimer’s community and strengthening the science needed to evaluate the safety and effectiveness of potential new drugs.

He has been particularly instrumental in helping drug developers focus on ways to study drugs in the early stages of AD, and when there is hope that disease progression can be stopped or delayed before too much damage is done. With his colleagues he drafted an FDA “guidance” on conducting studies in early stages of AD. It addresses difficult questions, such as these: how do we select patients for clinical trials for early-stage AD drugs despite the fact that early stages of the disease are hard to diagnose? And how can we determine the effectiveness of a drug for early-onset AD when symptoms are difficult to define?

FDA is devoted to seeing new treatments for AD enter the development pipeline. No one has been more instrumental in helping to implement that vision than Dr. Katz. We thank him for his dedication and hard work, and along with the Alzheimer’s Association, applaud him for all that he does to advance public health.

Bob Temple, M.D., is Deputy Director for Clinical Science in FDA’s Center for Drug Evaluation and Research.

Deborah M. Autor

Somewhere right now, malaria patients facing a life-threatening illness are being treated with counterfeit or substandard anti-malarial drugs, including falsified products, that threaten their recovery and can contribute to drug resistance. We are proud to announce the Food and Drug Administration’s launch of a partnership that will use a clever, innovative tool invented by FDA scientists to quickly and cheaply test suspect counterfeit or substandard anti-malarial drugs, including falsified products. The partnership will test the effectiveness of this hand-held, battery-operated tool, called Counterfeit Detection Device, Version 3, or, simply, CD-3. It will be deployed first in Ghana and then, after data is collected, in a second testing region.

This effort, which we hope will expand worldwide, is aimed at catching products that both deprive people of critical, life-saving help and add to disease burden because substandard doses can lead to drug resistant strains of the malarial parasite.

Melinda K. Plaisier

Malaria kills more than a 660,000 people each year, mostly children. It is most prevalent in Africa and Southeast Asia. In Southeast Asia and sub-Saharan Africa, more than a third of anti-malaria drugs are counterfeit or substandard, and a recent review indicates that number might be as high as two-thirds.

CD-3 is the brainchild of FDA scientists Nicola Ranieri and Mark Witkowski of FDA’s Forensic Chemistry Center (FCC), who recognized that since substances have unique responses to light, they might be able to develop a portable tool that could identify counterfeits on the spot, even in remote locations. As the initial tool has undergone a number of revisions, capabilities have been added, applications have been developed, and CD-3 has become a more powerful tool. From prototypes, scientists at FCC built a number of CD-3s, which are currently being used in the U.S. at ports and international mail centers, and during criminal investigations at the FCC.

To gear up for a global deployment strategy, FDA has separately signed a letter of intent with Corning, Inc., to optimize the tool, using information gathered from the studies in Ghana and the second testing region. FDA is hopeful that the improved tool will eventually be manufactured for use around the world.

The CD-3 tool contains a library of information about authentic drugs and the packaging they come in. It allows the user to compare authentic images of a product with the suspect product, instantaneously showing clear differences between suspect and authentic products that would not have been clear to the naked eye.

The Unites States Pharmacopeia, with funding through the U.S. Agency for International Development and the President’s Malaria Initiative, currently conducts drug surveillance programs at the test sites where CD-3 will be tested. FDA is providing ten CD-3s in the first test, and technical support will be provided by the Centers for Disease Control and Prevention and the National Institutes of Health. The non-profit Skoll Global Threats Fund is providing additional funding for the initial testing in Ghana.

We are thrilled about these developments and proud of this important, multi-sector collaboration and our highly dedicated staff who are making it possible. It is a credit to them, to our partners, and to all of FDA, that they are able to bring this innovative solution to such a significant global public health problem.

To learn more watch the CD-3 video below and read the Consumer Update: FDA Invention Fights Counterfeit Malaria Drugs

Deborah M. Autor, Esq., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

Melinda K. Plaisier is FDA’s Acting Associate Commissioner for Regulatory Affairs