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

Celebrating 30 years of easier access to cost-saving generic drugs

By: Margaret A. Hamburg, M.D.

Thirty years ago today, President Ronald Reagan signed into law the Drug Price Competition and Patent Term Restoration Act of 1984, better known today as the Hatch-Waxman Amendments. This law, championed by Senator Orrin Hatch and Representative Henry A. Waxman, made it easier for generic drugs to enter the market, and has greatly expanded access to important—often life-saving—drugs. Over the 10-year period 2003 through 2012, generic drug use is estimated to have generated more than $1.2 trillion in savings to the health care system and to have benefitted the health and well-being of innumerable lives.

Margaret Hamburg, M.D.Thanks to the insight of its creators, one of the strengths of this law is the fact that it provided financial incentives for pharmaceutical companies that develop and manufacture new and innovative trade name products. Under the law, sponsors of qualifying trade name drugs are provided an opportunity to extend a patent to make up for patent life lost during the process of testing and approval of the product.

The law also, however, provided a clear pathway to market for generic drugs. Before Hatch-Waxman, little more than a third of branded prescription drug products even had a generic available, and those that were available were not as widely used. Today, most drugs that go off patent face competition from cost-saving generic drugs. As a result, about 85 percent of all prescriptions filled are for generic versions.

Importantly, while Hatch-Waxman has provided powerful cost savings for American consumers, its value in providing greater access to medication cannot be overlooked. For over 30 years, millions of consumers who otherwise would not have been able to afford needed medication now have access to lower-cost, quality, generic drugs that are just as safe and effective as their brand-name counterparts.

Despite the enormous success of Hatch-Waxman, FDA faces challenges as we continue efforts to ensure access to affordable and quality generic drugs.

FDA is working to reduce the current backlog of generic drug applications for new generic drug products. Fortunately, the Generic Drug User Fee Amendments of 2012, GDUFA for short, provides additional funding for FDA’s generic drug program. We’re allocating significant time and money towards reducing the backlog.

As our world economy experiences greater globalization, it has becoming increasingly important for FDA to allocate its resources based on potential risk around the globe. More than 80 percent of the ingredients used to make our drugs now come from overseas suppliers. FDA is committed to working to ensure that, no matter where the ingredients are from or where the drugs are made, the American public can be assured their products are safe. GDUFA funding also helps FDA address global inspections, and we are diligently working to monitor production across the globe.

FDA salutes the vision of Senator Hatch and Representative Waxman. Their landmark legislation has improved the health of generations of Americans. And we’re proud of the role FDA has had in implementing Hatch-Waxman and helping to assure its success. We look forward to continuing to enhance Americans’ access to safe, effective, and affordable generic prescription drugs.

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

The FDA Drug Shortage Assistance Award… Recognizing manufacturers who help prevent or alleviate drug shortages

By: Douglas C. Throckmorton, M.D.

As part of our continuing commitment to prevent drug shortages and minimize their impact on public health, FDA has launched the FDA Drug Shortage Assistance Award.

Douglas C. Throckmorton, M.D.This award recognizes efforts of drug manufacturers who have cooperated with FDA and implemented strategies to help provide medically necessary drugs in short supply for patients, while maintaining federally mandated quality standards.

Recently, FDA announced the first recipients of the award: Guerbet Group and Clinigen Group plc, two companies who worked diligently with FDA to help ensure adequate supplies of important medicines for patients in need.

Guerbet Group worked with FDA to help alleviate the shortage of ethiodized oil injection, an important imaging agent for a variety of patients with certain forms of liver cancer. The company’s work included acquiring the new drug application (NDA) for Ethiodol, a form of ethiodized oil; submitting the relevant applications to restart its manufacture under the trade name Lipiodol; and gaining additional approval for a medically necessary indication that was of critical concern during the shortage. Clinigen helped ensure supplies of a medication needed for patients with AIDS who also have a serious eye condition called CMV (cytomegalovirus) retinitis. The company’s work included acquiring the NDA for Foscavir (foscarnet sodium) injection, and submitting the relevant applications to return the product to market.

The FDA Drug Shortage Assistance Award is given to drug manufacturers who, among other factors, have demonstrated a strong commitment to preventing or alleviating a shortage of a medically necessary drug, by:

  • Taking one or more actions to alleviate or prevent a drug shortage, such as increasing production or submitting an application for approval of a drug in shortage;
  • Making a significant impact on public health; and
  • Using a facility that was substantially compliant with current good manufacturing practice (CGMP) for at least one inspection prior to the intervention and during the time the candidate used it to manufacture the shortage drug.

FDA plans to continue to recognize manufacturers with this award based on their ability to meet the criteria.

FDA is committed to preventing and reducing the impact of drug shortages. The FDA Drug Shortage Assistance Award is one of the tools outlined in our Strategic Plan for Preventing and Mitigating Drug Shortages to help address ongoing drug shortages in our nation’s health care system.

On behalf of patients in need of critical medication, FDA thanks Guerbet Group and Clinigen Group plc for their commitment to help ensure access to quality medications, and we offer our sincere congratulations to these award recipients. Shining a spotlight on the efforts of drugs manufacturers who have made outstanding efforts in this area will hopefully inspire other manufacturers to follow suit.

Douglas Throckmorton, M.D., is Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research

Three encouraging steps towards new antibiotics

By: Janet Woodcock, M.D.

You may have been hearing about a variety of Federal Government actions to address the growing need for new antibiotics. For instance, in an FDA Voice blog last week Commissioner Hamburg discussed the President’s national strategy for Combating Antibiotic Resistant Bacteria (CARB) and our collaboration with a wide variety of organizations to address this issue. You may have also noticed another recent blog talking about FDA’s work on the Generating Antibiotics Incentives Now Act (GAIN Act), the Antibacterial Drug Development Task Force, a public meeting, a Federal Register Notice, and multiple guidance documents, all aimed at building up the nation’s arsenal of effective antimicrobial drugs.

Janet WoodcockThere are many government activities in this area, so I’d like to boil things down a bit. A critical fact is that our efforts are starting to show signs of success. Over the last few months, FDA has approved three new antibiotics to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by bacteria like Staphylococcus aureus, including methicillin-resistant strains, also known as MRSA infections.

  • On May 23, FDA approved Dalvance (dalbavancin), an injectable drug, administered intravenously in two doses one week apart.
  • On June 20, FDA approved Sivextro (tedizolid phosphate), available for intravenous and oral use, administered once daily for six days.
  • On August 6, FDA approved Orbactiv (oritavancin), an injectable drug administered as a single dose to comprise a full course of therapy.

In these approvals, the drug’s manufacturer was able to take advantage of recently enacted incentives to help bring new antimicrobials to market. Each of these drugs was approved after being designated as a Qualified Infectious Disease Product (QIDP) under the GAIN Act. As part of this QIDP designation, FDA’s review of the drug application was expedited. The designation also qualified the drugs for five years of marketing exclusivity to be added to certain exclusivity already provided by the Food, Drug, and Cosmetic Act. To date, FDA has granted the QIDP designation to 39 antibiotics under development.

Development of these three new antibiotics was also helped a great deal by the scientific collaboration among stakeholders dedicated to advancing new antimicrobial therapies. The Biomarkers Consortium of the Foundation for the National Institutes of Health, academic and industry experts, and other contributors made valuable recommendations to the FDA regarding designing scientifically sound studies to show the effectiveness of these drugs in clinical trials.

We still have a long way to go in getting a leg up on building a new and more effective arsenal of antimicrobial products. And once approved, it will be critical for health care professionals to appropriately prescribe these new antibiotics. But with ongoing collaborative, concerted efforts by the many public and private stakeholders, we can continue to advance and help build a national antibacterial research and development enterprise capable of bringing new drugs to the patients who need them. These three approvals are an encouraging start!

Janet Woodcock, M.D., is the Director of FDA’s Center for Drug Evaluation and Research

Learn more by reading Dr. Woodcock’s testimony: 21st Century Cures: Examining Ways to Combat Antibiotic Resistance and Foster New Drug Development.:

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