FDA Invites Students to Sharpen their Research Skills

By: Nysia George, Ph.D., and Tom Powers

NCTR Intern Claire Boyle, a graduate student from Florida State University

NCTR Intern Claire Boyle, is a graduate student from Florida State University. Get this and other NCTR photos on Flickr.

Biology. Chemistry. Bioinformatics. Toxicology.

Practical, hands-on laboratory work is important for all college students who want to become scientists—but, for many of them, such experiences are out of reach.

That’s one of the reasons why every summer, our National Center for Toxicological Research (NCTR)—FDA’s internationally acclaimed toxicological research center in Jefferson, Arkansas—hosts a special internship program for science students interested in toxicology research.

The 2014 program was exceptionally successful for both the students and the Center.

Applications poured in from more than 200 students pursuing a variety of majors in universities from coast-to-coast. The competition was intense, and the 21 selected students came from schools in 13 states. But they were all alike in two fundamental ways: they were top students, and were eager to hone their scientific skills in real FDA laboratories.

NCTR Intern Luis Valencia, a senior from Texas A&M University

NCTR Intern Luis Valencia, is a senior from Texas A&M University. Get this and other NCTR photos on Flickr.

During their 10 weeks at NCTR, the students worked on projects varying from the development of bioinformatics and statistical methods for RNA sequencing data, to evaluating effects of silver nanoparticles in plastic food containers. They conducted in-vitro experiments; examined effects of nicotine treatment; gained lab experience in cell culture; and were trained in computational modeling or statistical programming.

Each student’s experience was unique and addressed the student’s interests.

The interns gave the program top grades. For example Claire Boyle, a graduate student from Florida State University, said about the lab work: “I like it a lot more than classes. There they tell you that you can do research once you get into the real world. I’ve never had an opportunity to do that before coming here [to NCTR], and that’s the aspect of the program I like best. It’s given me insight into what I want to do for the rest of my life!”

Luis Valencia, a senior from Texas A&M University, echoed similar praise. “This isn’t some pointless classroom assignment; this is the FDA. Something you discover [in this lab] could save a life.” He continued, “I’m having a great experience at NCTR. [My NCTR mentor] let me design my own experiment and helps me a lot. I’m already on my second trial and we’re getting good results.”

The internship program, which was partly funded by the FDA’s Office of Minority Health, is one of the many ways NCTR reaches far and wide to strengthen the scientific foundations of our agency. We engage with scientists within FDA and across other government agencies, industry, and academia to develop scientific information that is vital for sound regulatory policy. We cooperate with colleagues abroad to advance international standardization of regulatory science. And we’re mindful that all quest for knowledge starts with education.

If you are a science student interested in toxicology research, or if you know someone who is, it’s not too early to consider the NCTR’s 2015 internship program. To qualify for admission, a candidate must meet the GPA requirements and provide evidence of success in science courses. He or she will also need letters of recommendation and a personal statement describing his or her research interests.

If you believe you have what it takes, you could be among the select few chosen to join us in the summer of 2015. Applications are accepted throughout the month of February. We look forward to your application!

For more information about the program go to: Summer Student Research Program (NCTR)

For more information about the FDA Office of Minority Health go to: Minority Health

Nysia George, Ph.D., is the National Center for Toxicological Research’s Intern Program Coordinator.

Tom Powers is the National Center for Toxicological Research’s Communication Officer.

Regulatory Science Collaborations Support Emergency Preparedness

By: Jean Hu-Primmer, M.S.

Scientists love a challenge. And coordinating government agencies, healthcare providers, and numerous additional partners to protect public health in emergency situations is definitely a challenge.

Jean Hu-Primmer

Jean Hu-Primmer, Director of Regulatory Science Programs in FDA’s Office of Counterterrorism and Emerging Threats.

FDA’s Medical Countermeasures Initiative (MCMi) is working with federal agencies (through the Public Health Emergency Medical Countermeasures Enterprise), product developers, healthcare professionals, and researchers, among other partners, to help translate cutting-edge science and technology into safe, effective medical countermeasures. Through these collaborations, MCMi supports research to help develop solutions to complex regulatory science challenges.

Data are critical to help FDA evaluate the safety and effectiveness of medical countermeasures—products that can save lives—during public health emergencies. But collecting data in the midst of an emergency is exceptionally challenging. Working with the Biomedical Advanced Research and Development Authority (BARDA), FDA is teaming with critical care physicians nationwide to help address these challenges.

Under a contract awarded last month, FDA and BARDA will work with the U.S. Critical Illness and Injury Trials Group (USCIITG) to gather important information about medical countermeasures used during public health emergencies. Physicians will help address challenges with collecting and sharing data rapidly in emergencies, including streamlining electronic case reporting for clinical trials and rapidly disseminating key findings to FDA and other stakeholders to support clinical decision-making.

During this four-year project, USCIITG will also develop and pre-position a simple influenza treatment protocol in 10 hospitals throughout the U.S. during the 2015-2016 influenza season. The project will help doctors more easily use an investigational treatment protocol for patients with severe influenza, and test the data collection and reporting system during peak times. The goal is to help streamline the process during future influenza seasons and emergencies.

When it is not ethical or feasible to test the effectiveness of products in humans—such as countermeasures for potential bioterror agents—products may be approved under the Animal Rule. When products are approved under the Animal Rule, FDA requires additional studies, called phase 4 clinical trials, to confirm safety and effectiveness. In addition to the MCMi work, BARDA is funding USCIITG to investigate conducting phase 4 clinical studies during public health emergencies. USCIITG partners will train on these protocols, have them reviewed through their Institutional Review Boards (a requirement for all human studies), and create plans for enactment. USCIITG will then conduct an annual exercise to test these plans, a unique approach to broader science preparedness.

MCMi has also recently awarded regulatory science contracts to support other aspects of emergency preparedness, including two projects to investigate decontamination and reuse of respirators in public health emergencies (awarded to Battelle and Applied Research Associates, Inc.), and an award to support appropriate public use of medical countermeasures through effective emergency communication.

Our work involves big challenges. Through regulatory science, and through new and expanding collaborations, we continue to address these challenges to better prepare our nation to use medical countermeasures in emergencies.

Want to help? We’re currently accepting submissions for additional research to support medical countermeasure preparedness. If you have an idea for a new medical countermeasure regulatory science collaboration, we’d love to hear from you.

You can also visit BARDA’s MCM Procurements and Grants page for more information.

Jean Hu-Primmer, M.S., is Director of Regulatory Science Programs in FDA’s Office of Counterterrorism and Emerging Threats.

FDA’s Program Alignment Addresses New Regulatory Challenges

By: Margaret A. Hamburg, M.D.

Over the last year, a group of senior FDA leaders, under my direction, were tasked to develop plans to modify FDA’s functions and processes in order to address new regulatory challenges. Among these challenges are: the increasing breadth and complexity of FDA’s mandate; the impact of globalization on the food and medical product supply chains; and the ongoing trend of rapid scientific innovation and increased biomedical discovery.

Margaret Hamburg, M.D.The Directorates, Centers and the Office of Regulatory Affairs (ORA) have collaborated closely to define the changes needed to align ourselves more strategically and operationally and meet the greater demands placed on the agency. As a result, each regulatory program has established detailed action plans. Specifically, each plan describes the steps in transitioning to commodity-based and vertically-integrated regulatory programs in the following areas: human and veterinary drugs; biological products; medical devices and radiological health; bioresearch monitoring (BIMO); food and feed; and tobacco.

These action plans focus on what will be accomplished in FY 2015 and outline the need to develop detailed future plans for the next five years in some cases. The plans represent what each Center and ORA have agreed are the critical actions to jointly fulfill FDA’s mission in the key areas of specialization, training, work planning, compliance policy and enforcement strategy, imports, laboratory optimization, and information technology.

Because each Center has a unique regulatory program to manage, there are understandably variations among the plans. However, there are also common features across most of the plans: the need to define specialization across our inspection and compliance functions; to identify competencies in these areas of specialization and develop appropriate training curricula; to develop risk-based work planning that is aligned with program priorities and improves accountability; and to develop clear and current compliance policies and enforcement strategies.

Below are some highlights from the plans that illustrate these features:

  • Establish Senior Executive Program Directors in ORA. In the past, for example, the Center for Drug Evaluation and Research (CDER) would work with several ORA units responsible for the pharmaceutical program. Now, the Centers will have a single Senior Executive in ORA responsible for each commodity program, allowing ORA and the Centers to resolve matters more efficiently.
  • Jointly develop new inspection approaches. The Center for Devices and Radiological Health (CDRH) and ORA plan, for example, will begin to focus some inspections on characteristics and features of medical devices most critical to patient safety and device effectiveness. ORA investigators will perform these inspections utilizing jointly developed training.
  • Invest in expanded training across ORA and the Centers. The Center for Biologics Evaluation and Research (CBER) and ORA will jointly develop a biologics training curriculum, redesign investigator certification, and cross-train Center and ORA investigators, compliance officers and managers.
  • Expand compliance tools. Field investigators will be teamed with subject matter experts from the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine to make decisions in real time, working with firms to achieve prompt correction of food safety deficiencies and to help implement the preventive approaches outlined by the FDA Food Safety Modernization Act (FSMA). If industry does not quickly and adequately correct critical areas of noncompliance that could ultimately result in food borne outbreaks, we will use our enforcement tools, including those provided under FSMA, as appropriate.
  • Optimize FDA laboratories. ORA and the various Centers will establish a multi-year strategic plan for ORA scientific laboratory work, including hiring and training analysts, purchasing and using equipment, and allocating resources and facilities. At the same time, ORA is committed to conducting an ongoing review of its labs to ensure that they are properly managed and operating as efficiently as possible.
  • Create specialized investigators, compliance officers, and first-line managers. A bioresearch monitoring (BIMO) working group is developing a plan for a dedicated corps of ORA investigators to conduct BIMO inspections, and a dedicated cadre of tobacco investigators is being established.

Working together to implement these action plans will take time, commitment, and continued investment and we’ll need to monitor and evaluate our efforts. These plans will help us implement the new FSMA rules announced in September, as well as the Agency’s new medical product quality initiatives under the FDA Safety and Innovation Act and Drug Quality and Security Act.

FDA’s Program Alignment is a well-thought out approach that responds to the needs of a changing world. I look forward to the ways in which these action plans will ultimately enhance the FDA’s public health and regulatory mission.

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

FDA Invents: How Technology Transfer Gets FDA Inventions from Lab to Marketplace

By: Alice Welch, Ph.D.

If you think the term “government invention” is an oxymoron—well, think again. You may be surprised to learn that many of the breakthrough technologies that shape our lives today are the brainchildren of government researchers—including those at FDA.

Alice WelchTake the Internet and that GPS in your car or on your cell phone. Both technologies were developed by the U.S. Department of Defense —as were the turbine engines that power the wind farms generating some 6% of our nation’s electrical energy. Those long-lasting radial tires on your vehicle? They’re reinforced with a material five times tougher than steel that was developed by a NASA partnership. And you can thank the government for your flu shot and the development of many other life-saving vaccines such as those for hepatitis A and B and HPV.

Government funding is also critical in supporting and accelerating research in academia and industry that leads to game-changing innovations. Technologies like bar code scanners, Internet search-engines, and the touch screens on your tablet and smartphone might not have been possible without the research funding from the National Science Foundation.

Like other government agencies, FDA drives innovation in its own mission-critical work by supporting collaborative research with external partners and by transferring our life-saving inventions to the commercial market. Making all of this happen is a dedicated team of experts from across the agency that forms FDA’s Technology Transfer Program.  Managed from within the Office of the Chief Scientist, the Technology Transfer Program means many things at FDA.

To our researchers, it means they can access unique resources, participate in scientific collaborations, or obtain the technical expertise they need to make their research possible. These resources support and complement the work underway in FDA’s research laboratories. Whether it’s conducting research into how a blood product becomes a commercially produced therapy, or how to improve vaccine manufacturing, or tracking how patients use a product, the research of FDA’s scientists is fundamental to informing FDA’s evaluation of the safety and effectiveness of our regulated products.

To FDA inventors, Technology Transfer means they can get their inventions translated into commercial products that protect and promote public health. A little known fact is that in the course of their research, FDA scientists regularly gain new scientific insights and invent novel technologies or processes. The Technology Transfer team helps move these technologies to the private sector under license agreements so that new products in areas like vaccines, food-pathogen detection systems, counterfeit drug detection, and manufacturing can be created and made available on the market. To give you a sense of what we mean when we say that “FDA drives innovation,” in the last few years alone, our researchers have produced and reported about 20 patentable inventions annually.

And for FDA’s many collaborators, Technology Transfer means they’re able to engage with our researchers to solve scientific problems and create solutions to support FDA’s regulatory mission. To establish these collaborations and get the right resources for FDA researchers, our Technology Transfer team uses special tools or legal agreements, such as Material Transfer Agreements, Confidential Disclosure Agreements, Research Collaboration Agreements, and Cooperative Research and Development Agreements.

Each of these tools is designed to meet the needs of the research project at hand. They enable FDA researchers to obtain materials not available at the agency and to establish successful scientific exchanges with experts in the scientific community—at universities, small businesses, nonprofits or for-profits, or other government agencies.

Technology Transfer’s efforts may not be the stuff of headlines, but they’ve produced huge dividends for public health. They’ve helped guide FDA researchers through negotiating agreements, to establish collaborations, and to ensure that the tools they use to report, transfer and protect the patents of technologies align with legal and policy requirements. Look for my next few blog posts, where I’ll highlight some exciting, high-impact public health contributions based on FDA inventions.

Learn more:

FDA Researchers Build Partnerships to Advance Innovations

Alice Welch, Ph.D, is Director of FDA’s Technology Transfer Program

New Data Dashboard Tool Shares FDA’s Inspection, Compliance and Recall Data

By: Douglas Stearn

Douglas StearnAs part of our commitment to transparency FDA is pleased to announce that we have released a new online tool to provide insight into our compliance, inspection, and recall activities.

This new dynamic tool represents a departure from the downloadable spreadsheet-based datasets that we have posted in the past. Instead, the FDA data dashboard presents information in an easy-to-read graphical format. It also provides access to the underlying data allowing anyone interested to see related data and trends.

Our new dashboard provides data for FY 2009 to FY 2013, and allows access to data on:

  • inspections;
  • warning letters;
  • seizures and injunctions;
  • and statistics, specifically for recalls.

We plan to update the data semi-annually.

The dashboard is staged in a cloud environment, and it allows you to:

  • download information for additional analysis;
  • manipulate what you see by selecting filters;
  • rearrange the format of datasets and the way columns are sorted;
  • drill down into data; and
  • export charts and source information for further review.

We developed this new dashboard after President Obama issued a Presidential Memorandum on Regulatory Compliance in January 2011.

The President directed federal agencies to make publicly available compliance information easily accessible, downloadable and searchable online, to the extent feasible and permitted by law. FDA formed internal working groups that same year to develop recommendations for enhancing the transparency of our operations and decision-making processes. These working groups identified an online tool as a way to present compliance and enforcement data in a user-friendly manner. The dashboard represents the latest example of our commitment to compiling and posting a wealth of FDA data  for public review and feedback.

FDA works within a global environment and is carrying out more inspections around the world. We collaborate with regulatory authorities across the globe to protect public health. Our data dashboard provides information about inspections in this global environment, and makes this information more readily accessible to the public. Now you can use the dashboard to see this kind of inspection-related information to better understand our regulatory decisions.

A “feedback mechanism” is available so you can send comments, questions or concerns directly to us at FDADataDashboard@fda.hhs.gov.

This rollout effort is part of FDA’s continuing commitment to share inspection, compliance, and recall data. We will continue to update the FDA data dashboard and provide public access to this timely and important information.

Douglas Stearn is Director of the Office of Enforcement and Import Operations within FDA’s Office of Regulatory Affairs

FDA’s New Roadmap for Progress: Strategic Priorities 2014-2018

By: Margaret A. Hamburg, M.D

The U.S. Food and Drug Administration regulates products that represent about 20 cents of every dollar American consumers spend on products. This includes the safety and effectiveness of drugs, medical devices, and vaccines, the safety of blood supply to food supply, cosmetics, dietary supplements, products that emit radiation, and more recently, tobacco. This fact can be easy to gloss over, but if one pauses for a moment to reflect on this fact, it is clear that the FDA’s regulatory role is large and truly meaningful to all of our everyday lives.

Margaret Hamburg, M.D.When the FDA was first established, our regulated industries were predominantly local, the volume of imported products was low, and even the movement of goods across country was minimal. But times have changed, and so have the strategies we employ to address those changes. Over the last five years alone, the FDA’s regulatory portfolio has increased to now include regulating tobacco products, developing a new global system for protecting food safety, and addressing challenges created by the global expansion of research, commerce and trade.

In fact, more often than not today, a drug or medical product that ends up on the shelves of an American drugstore or in our hospitals will come, at least in part, from some foreign source. Nearly 40 percent of finished medicines that Americans now take are made elsewhere, as are about 50 percent of all medical devices. Approximately 80 percent of the manufacturers of active pharmaceutical ingredients used in the United States are located outside our borders.

These and other new challenges and transformative developments in global science, technology and trade are rapidly altering the environment in which we work to fulfill our broad public health mission. In order to continue to carry out that mission, we need a set of clearly defined priorities and goals, as well as the strategies for reaching them. Therefore, I am pleased to announce the release of a revised set of FDA Strategic Priorities which will guide the agency in how we continue to promote and protect the health of the American public.

The new Strategic Priorities document sets the path for our Agency over the next four years. It establishes a framework for integrating our five strategic priorities – regulatory science, globalization, safety and quality, smart regulation, and stewardship.

Although each priority is significant in and of itself, the priorities are also interconnected and must not be addressed in isolation. In addition, this new roadmap sets forth FDA’s core mission goals and objectives, such as improving and safeguarding access to the products FDA regulates – and promoting better informed decisions about their use.

The Strategic Plan has been in development for more than a year and was created by a hard-working team of talented and knowledgeable FDA employees representing programs from across the agency. While this team drove the Plan’s creation, it is backed by the commitment of all of us at the FDA. My hope is that these priorities, which will be repeatedly cited in our speeches, policies and writings, will serve as our foundational guidepost, providing the strategic direction to help the agency continue to provide the level of service and protection the American people deserve.

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

Reflecting on New Food Protections in the Wake of PCA Convictions

By: Howard Sklamberg and Michael R. Taylor

Last Friday, Sept. 19, 2014, a federal jury in Georgia returned guilty verdicts against two former officials of and one broker for the Peanut Corporation of America (PCA) in connection with practices that led to a 46-state outbreak of Salmonella poisoning in 2009. While there were more than 700 reported cases, including nine deaths, epidemiological projections by the Centers for Disease Control and Prevention put the total number of illnesses at more than 22,000.

Howard Sklamberg

Howard Sklamberg

The convictions arise from the unlawful sale of Salmonella-tainted peanuts and peanut products. According to the evidence, the trio participated in a scheme to fabricate documents stating that the foods were free of disease-causing bacteria when, in fact, there had either been no testing or the testing had revealed the presence of such bacteria.

We can’t tell you this will never happen again. But we can say that five years after the original actions that led to the PCA convictions, we have stronger protections in place – with more coming soon – that will help prevent foodborne illnesses while empowering us to act swiftly against those who flaunt food-safety regulations.

The FDA Food Safety Modernization Act (FSMA), signed into law in 2011, was passed by Congress with the intent of building a safety net that would provide protections at all points along the global food-supply chain – from farm to table.

FSMA empowers FDA to facilitate the growth of a food-safety culture, working with federal and state agencies, and with farmers, food manufacturers and importers, to bring about widespread compliance with the new regulations mandated by the food safety law.

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

Michael R. Taylor

We are still in the midst of rulemaking designed to help keep food safety problems from happening in the first place. We can never prevent all problems and will still have to be vigilant and take action when problems do occur. But having a prevention-based system in place will go a long way to keeping food safe for American consumers. We have proposed seven rules since January 2013 to implement such a system, and last week we issued supplemental proposals to make practical and targeted changes to four of those rules related to the safety of produce, human and animal food products, and imported foods. We are working on implementation strategies well in advance of the 2015 dates on which the rules will be final so we will be ready to put these new requirements in place. We are also working on a plan for outreach and education, so that everyone involved in providing our food – including growers, food processers and importers — will know what the rules require and will have adequate time to plan.

What you may not see in the language of the proposed rules is that FDA is reinventing itself to become as much a coach as a cop. In partnership with state and federal agencies, we will help provide technical assistance and education, and we will provide guidance to help farmers and industry build a framework that protects their products from contamination and, if potential hazards are identified, enables them to act immediately to control them.

That’s not to say that we won’t use tough enforcement tools when necessary, as evidenced by the PCA prosecution. When consumers are at risk, FSMA has given FDA greater authority to take action, in addition to bringing a civil action or seeking criminal prosecution. We can issue mandatory recalls when a company fails to voluntarily recall unsafe food; we can detain products that are potentially in violation of the law to keep them from being moved; and in certain situations we can suspend the registration of a facility to prohibit it from distributing food.

The law gives us these powers. But the vast majority of farmers, manufacturers and importers are committed to providing safe food. FSMA also gives us the power to work with them in partnership to keep foods safer than ever for you and your family.

Howard Sklamberg is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

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

Read the U.S. Department of Justice press release:

http://www.justice.gov/opa/pr/peanut-corporation-america-former-officials-and-broker-convicted-criminal-charges-related

FDA’s First Food Safety Challenge Targets Salmonella Detection

By: David G. White, Ph.D.

An estimated one in six Americans is sickened by foodborne illness annually, resulting in about 3,000 deaths each year. To keep our food safe, FDA wants to develop faster and more sensitive technologies to detect contaminants such as harmful bacteria. That’s why the agency is launching its first Food Safety Challenge, an effort to strengthen our food supply by fostering innovation in technologies that will more quickly detect pathogens in produce.

David WhiteThe first challenge will focus on Salmonella, one of our most pervasive food-safety problems today. According to the Centers for Disease Control and Prevention (CDC), Salmonella causes about 1.2 million illnesses in the United States every year, with about 23,000 hospitalizations and 450 deaths. Salmonella infections have been associated with eating foods, such as meat, eggs and fresh produce, contaminated with animal or human feces. The main causes of Salmonella illness are poultry and eggs. FDA’s goal is to prevent Salmonella contamination from happening, but we need to detect it quickly and efficiently when it is present in order to remove foods from the marketplace.

Through this innovation challenge, FDA wants to engage with others outside the agency who are not traditionally working in food safety—be they scientists, academicians, entrepreneurs, innovators, engineers or physicists—to find an ingenious approach to this problem so we can detect the disease-causing bacteria before they reach the consumer.

We’re focusing on produce first because it has a major impact on public health.  According to the CDC, contaminated produce causes 46% of foodborne illness and 23% of foodborne illness-related deaths. But detecting low levels of Salmonella in produce can be like finding a needle in a haystack: difficult, expensive and time-consuming. Even a simple tomato might have up to a billion surface bacteria that do not cause harm to humans. Quickly detecting just the few types of bacteria that do cause harm, like Salmonella, is a daunting task.

Accurate detection is our highest priority. But rapid detection is also important. Testing for microbial contamination of produce currently can take up to several days. Meanwhile, the produce may sit in a warehouse, where its shelf life decreases with each passing day. Consumers can’t eat it, and producers can’t sell it. Those limitations affect the economy – from consumers to producers to farmers.

Maybe other scientists and innovators outside FDA have revolutionary techniques that they never thought of applying to food safety. We hope so. There are many new technologies that might be invaluable to our field laboratories, where we’re testing at least hundreds of pounds of produce a week.

We have already conducted a significant amount of research on food safety here at FDA. We have a lot of answers, but not all of them. Our hope is that this challenge will provide solutions that would increase the speed of FDA’s detection efforts without sacrificing specificity and sensitivity or comparability to reference methods. The challenge is open to U.S. citizens and permanent residents 18 and older and to entities incorporated in and maintaining a primary place of business in the United States, with certain exclusions for federal entities, employees and grantees. Participants will submit cutting-edge techniques to speed detection of Salmonella in produce. Their work will be evaluated by experts in food safety and foodborne pathogen detection from FDA, CDC and the U.S. Department of Agriculture. The winners (and there could be more than one) will share a total prize pool of $500,000.

These ideas will not only benefit U.S. consumers, but their effects will ultimately be felt worldwide. Everybody wants safe food, not just in the United States, but all over the world.

We hope that the 2014 FDA Food Safety Challenge creates an avenue for ideas and dialogue. We want to learn from others and adapt best practices so consumers can continue to trust the foods they eat.

To learn more about, and sign up for, the Food Safety Challenge, visit www.foodsafetychallenge.com.

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

FDA’s Take on the Executive Order and National Strategy to Combat Antibiotic-Resistant Bacteria

By: Margaret A. Hamburg, M.D.

Few issues in public health today are as critical and time urgent as combating the growing threat of antibiotic resistance. We are delighted to stand with the White House in the development and response to the President’s Executive Order and the National Combating Antibiotic-Resistant Bacteria (CARB) Strategy. Fighting antibiotic resistance is both a public health and national security priority. FDA has played a key role in the development of this important effort, and we already have made strides on many fronts to make sure that we have effective antibiotics for the future.

Margaret Hamburg, M.D.Antibiotics are precious medicines that have saved millions of lives by treating infections caused by bacteria. But their misuse, and overuse, has serious health consequences and has contributed to antibiotic resistance—in which these drugs become less effective, or ineffective, against harmful bacteria.

The consequences of antibiotic resistance must not be underestimated. With each passing day, concern mounts that more patients will have few or no therapeutic options because of resistance to available therapies. In fact, the Centers for Disease Control and Prevention (CDC) estimates that each year at least 2 million illnesses and 23,000 deaths in the United States are caused by antibiotic-resistant bacteria.

It is a high priority for FDA to work with our partners to find solutions for this serious public health problem.

To address the need for effective antibiotics, FDA is working hard to ensure development of new strategies. These include vaccines to help prevent infection with bacteria in the first place; devices to aid in the accurate diagnosis of the cause of infection and of resistant infections; and new drugs to treat patients with serious infections for whom we have few, or no, treatment options because of resistance to currently available antibiotics.

We have been engaging with outside groups to advance the science of clinical trials. For instance, we have worked with the Clinical Trials Transformation Initiative on increasing the efficiency of clinical trials; with the Engelberg Center for Health Care Reform at the Brookings Institution to address overarching issues in antibiotic development, such as the major technical and financial barriers; and with the Biomarkers Consortium of the Foundation for the National Institutes of Health (NIH) on endpoints for studying antibiotics in clinical trials. In fact, we recently joined NIH to hold a workshop to examine the technical challenges related to antibacterial product development and to discuss innovative regulatory and clinical trial approaches for bringing new products to market. (The final agenda and presentations are available online.)

FDA also has been actively implementing the Generating Antibiotics Incentives Now (GAIN) Act, a provision within the Food and Drug Administration Safety and Innovation Act (FDASIA) to promote the development of antibacterial and antifungal drugs. To date, FDA has granted 57 Qualified Infectious Disease Product (QIDP) designations under GAIN to 39 different unique molecules. Antibiotics that have a QIDP designation receive, upon request, priority review, typically shaving four months off review times, and fast track designation, which results in early consultation, including on clinical trial design, between FDA and antibiotic sponsors. QIDPs also can receive an additional five years of marketing exclusivity in addition to existing exclusivity periods at the time of approval. We’re pleased that already three QIDP designated antibacterial drugs have been approved in the past few months: Dalbavancin in May 2014, Tedizolid Phosphate in June 2014 and Oritavancin in August 2014.

Furthermore, FDA promotes the appropriate and responsible use of antibiotics in clinical medicine. Antibiotic labels contain information for health care professionals and patients on appropriate use. And we work to improve the integrity of the global supply chain for pharmaceutical products to minimize the chance of a patient receiving a substandard drug, which in some instances could promote antimicrobial resistance.

In addition, FDA has developed—and is working to implement—two strategies to ensure the judicious use of medically important antimicrobial drugs in food-producing animals. This is a vital step to better protect antibiotic effectiveness for both human and animal populations. Accordingly, we asked the manufacturers of these antibiotics used in food-producing animals to remove all growth promotion indications. Once their labels have been changed, the products can no longer be used legally for growth promotion purposes, or without veterinary oversight. We have now secured the commitment of all 26 affected animal health companies, and 31 products have been withdrawn from the market. Two other companies have implemented label changes and we will be working with the other companies to make sure that they do so as well. The second track will ensure that all remaining therapeutic uses of the affected medically important antibiotics in food-producing animals will take place under the supervision of a veterinarian. The agency continues to work under a three-year transition period, and we remain encouraged by the process.

A successful strategy to combat antibiotic-resistant bacteria will require effort and input from all involved groups, including from health care professionals and patients themselves. For our part, FDA continues to work with government partners, product developers and the scientific community as well as other critical stakeholders to address the unique and complex regulatory, scientific and policy challenges associated with this public health issue. The Executive Order and CARB strategy announced today will clearly boost our and the nation’s efforts to meet these challenges more effectively.

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

20 Years of Improving Women’s Health: 1994 – 2014

By: Margaret A. Hamburg, M.D.

Margaret Hamburg, M.D.As we celebrate the 20th anniversary of the FDA’s Office of Women’s Health, I would like to highlight some of the work we’ve done to help improve women’s health, both looking across FDA and within the office. Whether it is approving new treatments for chronic conditions like heart disease, conducting research or helping to protect pregnant women from foodborne illnesses, the work we do at FDA makes a difference throughout a woman’s life.

Consider our product approvals. In 1996, for example, our agency approved a product for use in Pap smears that revolutionized the detection of cervical cancer; ten years later we approved the first vaccine for the prevention of this cancer. We have also approved advances in breast imaging, including 3D breast tomosynthesis and automated screening ultrasound.

We have encouraged innovation in lupus treatment and approved the first new lupus drug in 50 years. And we approved the latest generation of cardiac synchronization therapy devices which our own FDA scientists have shown particularly benefit women with heart failure.

FDA has also supported research to help us better understand how medical products affect women. Since 1994, the Office of Women’s Health research program has provided $30 million to support over 300 research projects, workshops, and trainings on a wide range of topics including cancer, HIV and osteoporosis. More than 25 percent of these research dollars have been directed at cardiovascular disease, the number one killer of women, with studies examining such issues as QT interval prolongation (a disorder of the heart’s electrical activity), how breast cancer drugs can affect the heart, and sex differences in various cardiac interventional therapies. FDA’s medical product centers have also sponsored women’s health research and initiatives such as the Health of Women Program that promote a better understanding of sex differences.

The results have been impressive: OWH’s research alone has been published in over 290 articles in peer-reviewed journals and has made impact on the regulatory decision-making process, including guidance documents, label changes, and standards development. Indeed, FDA’s guidance to industry is an important way that the agency has been helping to address important issues in women’s health.

Over the years, FDA guidance has encouraged greater inclusion of women in clinical trials and the evaluation of sex differences. Our own analysis last year found that women make up about half of the representation in these studies, but the numbers are lower for medical devices. So we have more to do and recently issued guidance to medical device developers to address this concern.

We have also made great strides in our communication and outreach to women during the past two decades. OWH’s Take Time to Care Program has built partnerships with other government agencies, retailers, and national organizations that provide millions of women with FDA safety information. Over the years, we have launched other educational initiatives like the Food Safety for Moms-to-Be and expanded the women’s health resources available via our “For Women” website and social media to make sure that women have tools to help them make informed decisions about the use of FDA-regulated products.

I am pleased at how much we have done to promote and protect women’s health since 1994. At the center of much of this change has been the consistent, driving force of the Office of Women’s Health and its determined leader, Marsha Henderson. I encourage you to check out OWH’s 20th Anniversary brochure to learn more about the progress that has been made. And I hope that you will collaborate with us on the work that still needs to be done.

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