FDA Engages Internationally to Promote Access to Safe, Effective Animal Medicines

By: Bettye Walters, D.V.M.

Regulators around the world are reaching across national borders as they work together to ensure the safety of veterinary medical products.

Bettye WaltersI am a veterinarian on the International Programs Team at the FDA’s Center for Veterinary Medicine (CVM). In this role, I attended the 4th Global Animal Health Conference in Tanzania on June 24 and 25 and participated in the global dialogue about the use and availability of high quality, safe and effective veterinary medical products in developing countries, especially in Africa. FDA embraces the One Health approach, which recognizes the connection between the health of people, animals and the environment.

I was accompanied by my colleague Steven Vaughn, D.V.M., who heads CVM’s Office of New Animal Drug Evaluation. Dr. Vaughn has years of experience exploring the most effective ways to regulate animal medications to ensure that they are high quality and safe.

The conference was attended by leading figures from the world’s governments, academia, industries, and international organizations and its focus was on the concept of “regulatory convergence,” a process that allows countries to bring their regulatory processes into closer alignment. We tackled important ideas related to promoting market control, including the surveillance of veterinary products on the market and improving access to effective animal drugs. We also discussed fostering systems for mutual recognition of regulatory oversight and standards, forming regional organizations, and implementing African regional harmonization initiatives to create a convergence of international guidelines.

If all countries can agree on the testing and safety of animal drugs, each country could have faster access to new medical products and be able to better leverage often-limited resources. While globalization provides many challenges, FDA believes it also offers opportunities for innovation if regulators, industry, and academia are working together for the benefit of all countries.

It’s a small world and solutions to public health problems, for both people and animals, are increasingly found on the world stage. FDA is committed to working with its global partners to promote cooperation in veterinary medicine.

Bettye Walters, D.V.M., is a veterinary medical officer on the International Programs Team at FDA’s Center for Veterinary Medicine.

FDA Continues its Collaboration with Canada in Phase 2 of the U.S.-Canada Regulatory Cooperation Council

By: Lou Valdez, M.S.M.

For more than 30 years, FDA has enjoyed a robust partnership with our Canadian regulatory colleagues. In FDA, we are excited to build upon this relationship in Phase 2 of the U.S.–Canada Regulatory Cooperation Council (RCC).

Lou ValdezThe RCC was established in 2011 by U.S. President Barack Obama and Canadian Prime Minister Stephen Harper to develop smarter and more efficient and effective approaches to regulatory cooperation between the two countries. The RCC aims to bring the U.S. and Canadian regulators and stakeholders closer in terms of sharing information, combining expertise, eliminating duplicative work and creating an enabling environment to foster and facilitate ideas.

In Phase 1 of the RCC, our governments identified important regulatory issues to work together to improve. For example, as a result of the cooperation between FDA and Health Canada, we reduced the regulatory burden for industry through the development of the Common Electronic Submission Gateway (CESG). Led by our FDA Medical Product Centers, the CESG allows industry to simultaneously submit electronic applications to both FDA and Health Canada for pharmaceutical and biological products.

In Phase 2, over the next three years, FDA has committed to work with the Canadian Food Inspection Agency (CFIA) and Health Canada in the areas of:

  • Food Safety
  • Medical Devices
  • Over-the-Counter Drug Products
  • Pharmaceutical and Biological Products, and
  • Veterinary Drugs.

Together with CFIA and Health Canada, we developed five individual work plans describing specific activities within the above areas and two Regulatory Partnership Statements outlining the institutional frameworks for this cooperation.

Throughout the implementation of these work plans, American and Canadian stakeholders will have opportunities to engage with the regulatory agencies to provide updates on significant industry and consumer trends and associated implications for regulatory systems.

FDA is committed to continuing our valued partnership with Canada and using the RCC as an important tool upon which to build. Learn more about FDA’s work under the RCC at http://www.trade.gov/rcc/.

Lou Valdez, M.S.M., is FDA’s Associate Commissioner for International Programs

Veterinary Feed Directive Will Protect Both People and Animals

By: Michael R. Taylor

For the past several years, the FDA has been taking steps to fundamentally change how antimicrobials are legally used in food-producing animals. The agency is moving to eliminate the use of these drugs for production purposes – such as speeding weight gain – and bring their remaining therapeutic uses in feed and water under the supervision of licensed veterinarians. These changes are critical to ensuring these drugs are used judiciously and only when necessary for legitimate animal health purposes.

Michael TaylorToday, we added another element to our overall strategy, one that recognizes the important role that veterinarians fulfill as guardians of animal health and preservers of judicious use of medically important antimicrobials. The Veterinary Feed Directive (VFD) final rule lays out what veterinarians must do when they need to authorize the use of these products in feed to protect the animals they serve.

This rule is a key piece of FDA’s initiative to combat the overuse of antimicrobial medications — including antibiotics — in both people and animals, which has created a global health crisis. Disease-causing bacteria commonly develop resistance to the medications created to kill them, but misuse of these important treatments ups the ante. FDA is particularly concerned about the use of “medically important” antibiotics in animal agriculture because they are also used to treat human disease and could become useless if bacteria become resistant to their effects.

Of course, change takes time. Since December 2013, we have been implementing a plan with animal drug companies to phase out the use of medically important antibiotics for enhanced food production. We have been working since then with drug companies, animal producers and veterinarians to change how these antibiotics are used in animals that enter the food supply, such as cattle, hogs and poultry.

Partnership and collaboration is delivering results. All 25 affected animal drug companies agreed to work with FDA to remove production uses for growth promotion and feed efficiency from the approved uses of their drug products, and move the therapeutic uses of these products from over-the-counter availability to a marketing status requiring veterinary oversight. By December 2016, we expect to see significant changes in the way medically important antibiotics are used in animal agriculture as compared to how they have been used for decades.

What will this mean in practice? Once these changes are fully implemented, it will be illegal to use these medically important antibiotics for production purposes, period. Instead of having unrestricted over-the-counter access, animal producers will need to obtain authorization from a licensed veterinarian to use these medications for therapeutic uses — for prevention, control or treatment of a specifically identified disease.

The VFD rule respects the diversity of circumstances that veterinarians encounter on the farm, but also ensures that their oversight is in line with nationally consistent principles. They will be required to have sufficient knowledge of the animals being treated by examining them or visiting the facility at which their care is managed.

Specifically, veterinarians play an important role in animal and human health and their oversight, as an integral part of the VFD process, will help ensure that medically important antimicrobial drugs will be used in feed according to label directions and only when appropriate to meet specific animal health needs. That means using a product for a specifically-identified disease, at the right dose, and for the period of time stipulated on the product label.

We aren’t done yet. The next step is getting the data we need on how medically important antibiotics are now being used on farms, information that will be essential to measuring the impact of our judicious use strategy. Right now we collect antibiotic sales and distribution data but do not have explicit regulatory authority to require data to be submitted on how antibiotics are actually being used in farm animals. We are evaluating how to obtain additional detailed information on such things as the species, indication, dose, and duration of use in order to better understand links between usage patterns and trends in antibiotic resistance. This will help provide a more comprehensive and science-based picture of antibiotic use and resistance in animal agriculture. FDA is actively engaged with the U.S. Department of Agriculture, the Centers for Disease Control and Prevention, and a wide array of stakeholders to fill this need. We plan to hold a public meeting this summer to discuss how to collect and present this data.

Finally, FDA has been actively engaging veterinary organizations, animal producer organizations, and other stakeholders to express concern about some currently-approved preventive, therapeutic uses of medically important antibiotics that have no limit on how long they can be given to the animal. This is not what we consider a judicious use. We believe that veterinarians should work with their clients to explore alternative approaches for managing certain animal health conditions, and we will be working with animal producers and drug companies to make any needed changes in approved conditions of use.

Antimicrobial resistance is everyone’s problem. It requires determination and cooperation to make the changes needed to protect the utility of these life-saving drugs. We are grateful for the way our partners and stakeholders across the food system are responding to this challenge.

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

FDA to Industry: Let’s Increase the Availability of Safe, Effective Animal Drugs

By: Martine Hartogensis, D.V.M.

Just as drugs for people benefit from FDA review to ensure their safety, effectiveness and quality, so do drugs for animals.

Martine HartogensisUnfortunately, this fact is ignored by some companies that sell unapproved animal drugs. By bypassing the FDA’s drug approval process, these firms potentially put the health of animals—and people—at risk. That’s why the FDA is working to get these products off the market.

There are different pathways to FDA approval and legal marketing of an animal drug product, but each pathway requires a drug company to expend both time and financial resources to generate the appropriate scientific evidence to support the approval. Companies that bypass the FDA drug approval process may be endangering the animals given unapproved drugs and people who either handle the unapproved drugs or eat food from animals treated with them. In addition, those who market unapproved drugs have an unfair competitive edge, and might prompt others to also break the law in order to compete in the marketplace. This slippery slope leads to a diminished supply of animal drugs that have been reviewed by the FDA for safety and effectiveness.

FDA’s rigorous review process also makes certain that the manufacturing process preserves the drug’s strength, quality and purity, and ensures that it has been consistently produced from batch to batch. FDA also requires that the product labeling is truthful and complete.

In some circumstances, the unapproved drug may be the only one of its kind available. In these cases, FDA often works with the company to develop the evidence that the product is safe and effective. Making innovative, FDA-approved animal medications legally marketable is an important part of FDA’s mission to protect the public health.

But while being helpful, FDA is also stepping up efforts to combat illegal animal drug sales, both on the ground and online.

We’ve recently issued warning letters to several marketers, distributors and manufacturers of unapproved animal drugs and expect to issue more in the coming year. Our enforcement actions could include seizures of violative products and/or injunctions against manufacturers and distributors of unapproved animal drugs. We also continue to regularly update the agency’s web page on unapproved animal drugs with information for veterinarians and industry.

We’ll continue to do all we can to make the animal drug approval process as straightforward and efficient as possible. But we need industry to do its part, so that we can continue to make more safe and effective drugs available to veterinarians, animal producers and pet owners.

Martine Hartogensis, D.V.M., is Deputy Director, Office of Surveillance and Compliance at FDA’s Center for Veterinary Medicine

A Year of Significant Progress in Public Health

By: Margaret A. Hamburg, M.D.

Margaret Hamburg, M.D.A new year offers both an opportunity to look forward and an opportunity to reflect on the achievements of the previous year. And, in 2014, FDA’s accomplishments were substantial, touching on many of the agency’s broad responsibilities to protect and promote the public health.

Whether our achievements involved medical product safety and innovation, food safety and nutrition, tobacco control, or other areas of our important work, all were accomplished thanks in large part to our ability to respond to evolving needs and opportunities including the embrace of new approvals, technologies and cutting-edge science.

Consider these highlights:

Drug Approvals: This past calendar year, FDA approved 51 novel drugs and biologics (41 by CDER and 10 by CBER), the most in almost 20 years. Among CDER’s 2014 approvals are treatments for cancer, hepatitis C and type-2 diabetes, as well as the most new drugs for “orphan” diseases since Congress enacted the Orphan Drug Act over 30 years ago. Seventeen of these new approvals are “first in class” therapies, which represent new approaches in the treatment of disease. In addition, CBER approved many important biological products in 2014, including a number of groundbreaking vaccines for meningitis B, the flu, and certain types of Human Papillomavirus, the latter of which is expected to prevent approximately 90 percent of the cervical, vulvar, vaginal and anal cancers caused by HPV.

These developments are a testament not just to our expanding understanding of human biology, the biology of disease and the molecular mechanisms that drive the disease process, but also to FDA’s innovative approaches to help expedite development and review of medical products that target unmet medical needs, while adhering to the established standards for safety and efficacy. These include enhanced guidance to shape the research and development agenda, early input on clinical study needs and design, expedited review programs, targeted regulatory advice and other tools and incentives that spur investment and innovation in new medical products to address unmet medical needs.

Opioids: This past year FDA took several actions to address the abuse of opioid drugs. First, we approved abuse deterrent labeling for three opioid products that are designed to deter prescription drug abuse. These drugs used different technologies to combat the abuse problem in different ways, such as by making the product resistant to crushing or dissolving or using “aversive technology” to discourage users from taking more than the approved dosage of the drug. To help encourage the development of more drugs in abuse-deterrent forms, we are also working to provide additional advice to manufacturers. Although abuse-deterrent opioid drugs are not a silver bullet to prevent opioid abuse, we believe that our work in this area will give physicians effective new treatment options with less risk of abuse.

FDA also worked to improve the treatment of patients who overdose on opioids. We approved a new dosage form of naloxone, with an autoinjector to enable a caregiver to administer the drug in the emergency treatment of opioid overdose (as it rapidly reverses the effects of an overdose). While we continue to support development in this area, this approval offers a new valuable tool to help prevent the tragedy of opioid drug overdose.

Antibiotic Resistance: We made important strides in confronting the growing resistance of some bacteria to antimicrobial drugs. Our efforts, which are a critical part of the recently unveiled National Strategy on Combating Antibiotic Resistant Bacteria, offer a multi-pronged approach that recognizes that to effectively address this challenge means simultaneously addressing the many different causes for increasing antibiotic resistance. One important response has been efforts to expand the pipeline of new medical products, including therapeutics to treat and cure infection, diagnostics to aid in the identification of the cause of infection and of resistant infections, and vaccines to help prevent infection with bacteria in the first place.

These efforts are already having an impact. In 2014, FDA approved four novel systemic antibiotics. In contrast, only five new antibiotics had been approved in the previous ten year period.

In addition to working on the human medical product side, we also developed and, over the next two years will be implementing, an important complementary strategy to eliminate the use of medically important antibiotics for growth promotion in food-producing animals. This strategy, once fully implemented, also will bring the remaining uses of such drugs to treat, control or prevent disease in these animals under the oversight of veterinarians. All 26 animal health companies who produce those drugs have committed to participate, and 31 products already have been withdrawn from the market.

Pharmacy Compounding: We continued to respond effectively to the 2012 outbreak of fungal meningitis that was linked to contaminated compounded drugs. This included conducting more than 90 inspections of compounding facilities across the nation in the past year. As a result, numerous firms that engaged in poor sterile practices stopped making sterile drugs, and many firms recalled drugs that have been made under substandard conditions. Where appropriate, we have worked with the Department of Justice to pursue enforcement action against some of these facilities.

We also have continued to implement the compounding provisions of the Drug Quality and Security Act (DQSA), and to develop and implement policies to address compounding by state-licensed pharmacies and the new category of registered outsourcing facilities.

Food Safety: Over the past year, the Agency has made great strides in implementing the landmark FDA Food Safety Modernization Act (FSMA). Through our proposed rules for preventive controls requirements for both human and animal food, standards for produce safety, foreign supplier verification programs, third party auditor accreditation, focused mitigation strategies to prevent intentional adulteration of food aimed at causing large-scale public health harm, and requirements for sanitary transportation practices to ensure the safe transport of food, we are working to ensure the safety of American consumers related to the foods they eat.

Nutrition: Good health depends not just on food safety, but also on what we choose to eat. FDA plays an important role in promoting good nutrition and healthy food choices by helping consumers understand the importance and benefits of good nutrition – and of being able to make informed choices about what we eat.

New rules in 2014 to finalize requiring calorie information on restaurant menus and vending machines give our citizens information they need to make healthy food choices and hopefully help reduce the epidemic of obesity in the United States. We also proposed changes to the familiar “Nutrition Facts” label on packaged foods which, when finalized, will give our citizens updated nutrition information, reflecting the most current nutrition science, to help them make healthy choices when purchasing packaged foods.

Tobacco Control: There are few areas that have as profound an impact on public health as tobacco products, which is why, five years ago, Congress gave FDA the responsibility to oversee the manufacture, marketing, distribution, and sale of tobacco products.

Over the past year, we worked with state authorities to conduct more than 124,000 inspections of retailers to enforce the ban on the sale of tobacco products to children. We unveiled the first of its kind national public education campaign—The Real Cost—to reduce youth smoking. And we took the first steps towards extending the agency’s tobacco product authority over additional products such as electronic cigarettes (e-cigarettes), cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco, and dissolvables not already subject to such authority through our proposed “Deeming Rule.” In addition, as part of ongoing work on product review decisions, eleven tobacco products that were allowed to enter the market during a provisional period established by the Tobacco Control Act were found “not substantially equivalent” to a predicate tobacco product. As a result of this finding, these products can no longer be sold or distributed in interstate commerce or imported into the United States.

Ebola: The tragic Ebola epidemic in West Africa demonstrates that we do not have the luxury of closing our eyes – or our borders – to the public health problems that exist in the rest of the world. I’m proud that FDA has played an important role in the response to this disease, working closely with colleagues in our government as well as the scientific community, industry and a range of other organizations and nations. We have helped facilitate the development, testing, manufacture, and availability of investigational products for use in diagnosing, treating and preventing Ebola, and worked with sponsors and health care providers to facilitate access to these products as clinical circumstances warrant. In August 2014, FDA designated the drug Z-Mapp as an orphan drug for Ebola, with the hope that this would incentivize further development and study.

And I’m very pleased to report that FDA is represented on the ground in West Africa by dedicated officers of the Commissioned Corps of the Public Health Service who continue to staff and operate the Monrovia Medical Unit in Liberia that was built to treat the health workers who became ill responding to the outbreak. Like everything FDA does, both at home and abroad, our actions on Ebola represent our agency’s continuing commitment to health and safety, and the use of science to advance these important goals.

I am extremely proud of our accomplishments in 2014, and I am confident that FDA will have a successful 2015, as we continue our work to protect and promote the public health.

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

FDA’s FY 2016 Budget Request

By: Margaret A. Hamburg, M.D.

Margaret Hamburg, M.D.FDA oversees products that represent more than 20 cents of every dollar that American consumers spend. Today, FDA presented its FY 2016 budget to Congress.This sensible budget request will help ensure that FDA can continue to fulfill its vast responsibilities to protect the public health, safety, and quality of life of the American public.

I want to share the cover letter that I wrote to Congress outlining some of our specific proposals.

 

Letter from the Commissioner

I am pleased to present the FY 2016 Food and Drug Administration (FDA) Budget.

FDA fulfills its important mission to promote and protect health in an increasingly complex and globalized world in many ways.  The scope of our work includes assuring that foods are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drugs, vaccines and other biological products, and medical devices intended for human use are safe and effective; and regulating tobacco products.  We also play a lead role in protecting the public from electronic product radiation and assuring that cosmetics and dietary supplements are safe and properly labeled.  Finally, we have devoted – and will continue to devote – substantial resources to advancing the public health by helping to speed product innovations.

FDA’s responsibilities continue to expand as we work to fulfill the mandates of groundbreaking legislation passed in recent years, including the Family Smoking Prevention and Tobacco Control Act of 2009, the Patient Protection and Affordable Care Act of 2010, the Food Safety Modernization Act (FSMA) of 2011, the FDA Safety and Innovation Act (FDASIA) of 2012, and the Drug Quality and Security Act of 2013.  Further, with so many FDA-regulated products manufactured in whole or in part outside of our borders, FDA is keenly focused on the complexities of regulating in a global marketplace.

In FY 2014, we took important steps to finalize a key set of proposed food safety rules; worked to improve the safety of compounded pharmaceutical products by conducting more than 90 inspections and implementing compounding legislation through proposed regulations, guidances, and other actions; published the “deeming rule” to extend FDA’s tobacco authority; and collaborated with federal, international, and industry partners to expedite the development and availability of medical products.  In addition, FDA has worked intensively to respond to the Ebola epidemic in West Africa by facilitating the development and availability of investigational diagnostics, therapeutics, and vaccines with the potential to help combat the epidemic.

FDA continues to seek new ways to obtain the most public health value for the federal dollar as we implement expanded authorities.  The products that FDA regulates are essential to public health, safety, and quality of life and represent over 20 cents of every consumer dollar spent on products in the United States.  Yet, in terms of our FDA budget, each American taxpayer contributes approximately $8 per year for the vast array of protections and services provided by FDA.

In FY 2016, we are requesting essential and timely resources to address critical food and medical product safety issues.  Mindful of the fiscal environment, we have identified targeted reductions where possible and identified long-term needs for additional user fees to balance budget authority growth.  FDA is requesting a total of $4.9 billion to support our various mandates to protect the American people.  This includes a $148 million budget authority increase to focus on the following:

  • delivering a farm-to-table system of prevention, including improved oversight of imported foods, through effectively implementing the final rules required by FSMA;
  • combating the growing threat of antibiotic resistance – in which drugs become less effective, or ineffective, against harmful bacteria;
  • promoting the development and appropriate use of reliable molecular and genetic diagnostics – precision medicine tools – to “personalize” the diagnosis, treatment, and prevention of disease;
  • implementing key FDASIA requirements to improve medical product review and inspections;
  • addressing the safety of compounded drugs;
  • continuing implementation of new requirements for review of sunscreen ingredients under the Sunscreen Innovation Act; and
  • supporting modern facilities to provide the laboratories and office space needed to meet FDA’s expanded legislative mandates.

As a science-based regulatory agency with a public health mission, FDA plays a unique and essential role in promoting and protecting public health and safety.  We are committed to meeting the needs and expectations of the American people.

Margaret A. Hamburg, M.D.

Commissioner of Food and Drugs

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) (credit carol at dresshead.com). 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’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

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