FDA’s International Food Safety Capacity-Building Plan: Improving Food Safety Protections Around the World

By Julie Moss, Ph.D., R.D., and Katherine Bond, Sc.D.

Our increasingly globalized world means that more and more of the food we eat is imported. Congress recognized this fact of modern life by passing the FDA Food Safety Modernization Act (FSMA), landmark legislation signed into law in 2011 that shifts the emphasis from responding to food safety incidents to preventing them.

Julie Moss

In that spirit, Congress saw the importance of improving the capacity for food safety protections. It directed FDA to develop a comprehensive plan to expand the technical, scientific and regulatory food safety capacity of foreign governments and their respective food industries in countries that export foods to the United States.

FDA has met that challenge, recently releasing its International Food Safety Capacity-Building Plan, which provides a strategic framework intended to guide FDA’s capacity-building efforts over the next five years. FSMA marks the first time that Congress has charged FDA with comprehensively addressing the building of international food safety capacity, a development that has been very exciting for us.

While this mandate is new, we have successfully supported food safety capacity-building efforts and conducted training programs for many years. The agency has participated in global, multilateral food safety programs, including work with the World Health Organization, train-the-trainer programs (in areas such as good agriculture practices), various seminars and web postings, and collaborations with other U.S.government agencies, among other efforts. However, FSMA allows us to take this work to a whole new level.

For example, we are working with foreign governments to see if we can exchange more scientific and technical information, such as outbreak and inspection data. This will open up communication channels and promote collaboration with those governments. We are also working to support both the acceptance of laboratory methods across the international community as appropriate and the exchange of information on current and new laboratory methods. This helps ensure that the data obtained from different domestic and international laboratories is of good quality and can be easily compared.   

We have developed a plan that incorporates many of FSMA’s main principles, including comprehensive prevention, risk-based resource allocation, and partnering. The plan’s key goals are:

  • Goal 1: Ensure efficiency across the Foods and Veterinary Medicine Program
  • Goal 2: Increase effectiveness through evidence-based decision making
  • Goal 3: Support the exchange of information between FDA and other foreign government agencies or other entities
  • Goal 4: Enhance technical assistance and capacity-building in food safety

    Katherine Bond

Overall, the plan charts a direction for how we will prioritize our capacity-building efforts based on risk, how we will link capacity-building efforts to their impact on public health, and how we will work in partnership with counterpart authorities, industry and other organizations to achieve lasting food safety results. Through this plan, countries that export to the United States will have an opportunity to learn about our food safety capacity-building priorities and see the breadth of the efforts that we are pursuing.   

In developing this plan, we consulted with foreign governments, industry, non-governmental organizations, certain U.S.officials, academia and other stakeholders. A public meeting was held on June 19, 2012, and comments received were considered in development of the plan [Docket No. FDA-2012-N-0437].

Given the breadth of this work, it is essential that we collaborate with partners to get the work done. We realize we can’t do it alone. Partnerships are important in everything we do, and even more so with capacity building. We also recognize the importance of establishing strong relationships and mutual support among all stakeholders from farm to table. As we begin to implement this new plan, we look forward to sharing ideas and new information with our international counterparts and other interested stakeholders, leveraging resources that will help us improve global food safety.

Julie Moss, Ph.D., R.D., is Deputy Director, International Affairs Staff in FDA’s Center for Food Safety and Applied Nutrition

Katherine Bond, Sc.D., is Director, Office of Strategy, Partnerships and Analytics, in FDA’s Office of International Programs


FDA Must Have New Authorities to Regulate Pharmacy Compounding

By: Margaret A. Hamburg, M.D.

The deadly outbreak of fungal meningitis associated with a compounded medication was a horrible tragedy, and I’ve asked myself many times if and how it could have been prevented. I speak for everyone at FDA when I say that our hearts go out to the many victims, including those still struggling with this devastating infection, and their loved ones.

Margaret Hamburg, M.D.While our investigation of this deadly outbreak has been a top priority, our responsibility at FDA is also to help make sure this doesn’t happen again. We are currently deploying resources to work with states to inspect certain state-licensed pharmacies that produce sterile drug products that we believe may present the highest risk. Over the past two months, we have inspected over 30 facilities and will continue to work to protect public health. 

But our authorities are limited and not the right fit for FDA to provide appropriate and efficient oversight of this growing industry. There should be legislation that establishes appropriate, minimum federal standards for firms that compound sterile drug products in advance of or without a prescription and ship them interstate.  FDA must have clear authority to proactively inspect pharmacies to determine the scope and nature of their operations.  Even during this time of heightened awareness, our inspectors are being delayed in their work or denied full access to records at some of the facilities we are inspecting.

And serious problems at compounding pharmacies continue to occur. Just this week there have been two recalls of sterile compounded and repackaged drug products. In one recall, the presence of floating particles, later identified to be a fungus, were reported in five bags of magnesium sulfate intravenous solution, resulting in a nationwide recall of all sterile drug products produced by the pharmacy. In the other recall, all sterile drug products from a second pharmacy were recalled as a result of reports that five patients were diagnosed with serious eye infections associated with the use of repackaged Avastin. 

There is a legitimate role for traditional pharmacy compounding. Every day, thousands of pharmacists practice traditional pharmacy compounding—mixing a drug in response to a valid prescription for an individual patient’s need. For example, these drug products could be liquids for patients who can’t swallow pills, or they could be made without certain allergens. These operations are licensed and primarily regulated by the states.

However, a new breed of specialty pharmacy compounding has evolved that has outgrown the law, and can pose a threat to the health of the public.  New legislation is needed that specifically addresses such compounding and the now-established safety concerns.

These pharmacies produce medications in advance of or without obtaining a prescription and distribute them across the country. They make drug products that are intended to be sterile and must be made to exacting standards to prevent dangerous contamination. The magnitude and complexity of these operations have outpaced the current patchwork of state laws that differ in prescription requirements and quality control rules.

I firmly believe that new legislation is necessary to help FDA effectively oversee firms engaged in widespread distribution of sterile compounded drug products in advance of or without receiving a prescription. To that end, FDA is working with Congress, states, industry, and all interested stakeholders to develop a basic framework to protect public health. The Senate committee with jurisdiction over this issue has been working hard on a bipartisan basis to craft such a framework, and we are hopeful that their efforts will yield strong legislation for patients across the nation.

In the new framework, FDA believes that certain high-risk sterile compounding facilities should be subject to federal oversight to ensure that the compounding of sterile drug products at those facilities can be done without putting patients at undue risk, including: 

  • requiring compliance with federal quality standards that are appropriate for the compounding of riskier products and exposure of larger numbers of patients,
  • requiring federal registration of the compounding facilities that will be subject to federal quality standards so FDA knows where they are and what drug products they are making, and
  • requiring these higher-risk compounding pharmacies to report to FDA serious adverse reactions to their drugs of which they become aware so that we can act before potential problems get out of hand. 

And for all pharmacy compounding, FDA believes certain basic protections should be in place. These include: 

  • clear authority to examine a pharmacy’s records to more quickly locate the cause of an outbreak or other violations of the law, and
  • prohibiting compounding of the most complex and highest risk products—drugs and biologics that should only be made for patients by an FDA-registered drug manufacturer under an approved new drug application. The manufacturer will have demonstrated in this application that the product is safe and effective and can be safely made according to the highest quality standards.  

FDA supports and would like to explore with Congress several other ideas, such as requiring compounded drug products to have clear label statements identifying the nature and source of the product. The labeling statements would provide prescribers and consumers with valuable information about the products they are using or taking so that they can make informed judgments about their use. Of course, funding will be necessary to support the inspections and other oversight activities outlined in this framework.  We look forward to working with Congress to explore funding mechanisms, which could include registration or other fees, as Congress has authorized and FDA has successfully implemented in other settings. 

Protecting Americans from unsafe and contaminated drugs is not just an important responsibility for FDA—it is part of our core mission. We must be able to identify dangerous practices before they result in actual harm and, when necessary, intervene to minimize the damage and prevent such tragedies in the future.

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

Keeping Up With Mobile App Innovations

By: Christy Foreman

A smart phone that can perform an electrocardiogram (ECG)—measuring the electrical activity of a person’s heart to determine whether he or she is having a heart attack—is in my opinion an extremely smart phone. That is just one example of how mobile medical applications are transforming health care.

As we testified today before Congress, FDA has no intention of stifling innovation in this exciting and rapidly growing field. The fact is, only a fraction of mobile apps would require FDA review. However, when a mobile app is doing the job of a medical device that requires FDA clearance or approval, it’s only logical that both should be governed by the same rules. These are the small percentage of mobile apps that pose a risk of serious illness or death to patients. With these considerations in mind, FDA in coming weeks will be issuing a final guidance document that will help companies determine whether their product will require FDA clearance or approval.

They would be limited to mobile apps that meet the definition of device and are intended for use: 

  • to transform a mobile device into a medical device already regulated by FDA
  • as an accessory to a medical device already regulated by FDA

In addition to the smart phone that performs an ECG, other examples include a mobile medical app that controls the delivery of insulin; another that acts as a stethoscope; a mobile medical app that takes patient-specific information and provides a clinician with radiation dosage calculations, and mobile medical apps that allow doctors to view X-rays or other imaging on smart phones and tablets.

These examples show why FDA has a public health concern about the potential consequences of a malfunctioning mobile medical app. 

FDA’s Center for Devices and Radiological Health has been reviewing mobile medical apps for more than 10 years and in that period we have reviewed about 100 applications and each review has taken about 60 days to complete. We’re confident that the center has the expertise to continue the timely review of the small number of submissions we expect to receive from mobile app developers.

Our final guidance will be informed by some 130 public comments, most of which were overwhelmingly supportive of our risk-based, narrowly-focused approach proposed in the draft guidance. Once the guidance is released, we are confident that the public will see that it represents a careful balance between the need to encourage innovative technology with our mission of providing reasonable assurance that medical products are safe and effective.

Christy L. Foreman is Director, Office of Device Evaluation, at FDA’s Center for Devices and Radiological Health

Saluting Dr. Janet Woodcock: an FDA Advocate for Arthritis Sufferers

By: Margaret A. Hamburg, M.D.

Physicians who work at FDA have typically trained in one or more medical specialties — areas of concentration which shape their interests and inform the regulatory work they do here to protect and promote the public health.

Margaret Hamburg, M.D.In my own case, I earned a degree in internal medicine and then focused on infectious diseases, eventually advocating for reforms to confront the dangers of modern bioterrorism, and looking for ways to counter the threat of naturally occurring infectious diseases, such as HIV, pandemic flu, and drug resistant TB.

So, too, it is with the inimitable Janet Woodcock, M.D.

Dr. Woodcock first joined FDA in 1986, and in her years at this agency has served in numerous capacities, including FDA deputy commissioner and chief medical officer. Today, she is director of the agency’s highly-respected Center for Drug Evaluation and Research.

At its recent annual Advocacy Summit, the Arthritis Foundation presented Dr. Woodcock with its Floyd B. Odlum Making a Difference Award, which honors an individual, organization, corporation, or government agency that has helped to make a difference in the lives of people and families with arthritis.

Striking one in every five adults, arthritis is the nation’s leading cause of disability. And it’s not just a disease of old age. Two-thirds of people with arthritis are under the age of 65, including 300,000 children.

Those numbers are not lost on Dr. Woodcock, who began her medical career as a rheumatology specialist, and ever since has been helping to shape and inform the advancement of arthritis treatments.

Dr. Woodcock has been a key figure in the revolution of rheumatoid arthritis therapies, from drugs that broadly address arthritis inflammation to today’s highly-effective, targeted, treatments. She is also helping to shape FDA’s regulatory framework for an abbreviated path to market for biosimilar drugs, those that are shown to be, among other things, highly similar to an already-approved biological product.

Once these drugs become available, they could increase choices for patients and reduce what those patients pay for certain arthritis therapies. Throughout her tenure, Dr. Woodcock has been an active liaison with the rheumatology community, crafting guidance on the development of arthritis medications, partnering on ways to measure a product’s safety and effectiveness, and studying products once they go to market.

In ensuring that safe drugs continue to be developed and become available to the many arthritis sufferers across the country, Dr. Woodcock has remained constant in her dedication to alleviating the pain and suffering of arthritis patients, and so many others. She has insisted upon scientific rigor in the work FDA does.

She has herself said, “I am continually challenged to make sure that FDA’s regulatory process remains the world’s gold standard for drug approval and safety.”

Those who know Dr. Woodcock would agree with me when I say she is a force to be reckoned with. We thank her for that, and along with the Arthritis Foundation, we salute her for all that she does to advance public health.  

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

Students Bring Energy and Good Ideas to the Table

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

Graduate students who won a faculty-judged “America’s Got Regulatory Science Talent” competition at the University of Maryland recently filled my office with some of their ideas and energy.

Their winning ideas, and their commitment and excitement, bode well for the future of the sciences involved in ensuring that medical products are safe and effective. Perhaps above all, the problems that inspired their ideas provided powerful reminders that consumers should be engaged by health professionals and involved in their own care, including understanding the names and purposes of any medicines they are taking.

Jane Kalinina and Neha Patel, who are both pursuing degrees in law and pharmacy, saw the need for better patient awareness and understanding while working in pharmacies.

“Patients regularly called and asked, ‘What am I taking this for?’” said Kalinina. Citing a typical example, she described a patient who had been confusing her hypertension and diabetes medicines, and thus had been taking the wrong amount of each.

Such problems, they noted, are particularly problematic among the elderly, who often take multiple medicines and may see multiple doctors who may not always be aware what their colleagues have already prescribed.

Kalinina and Patel’s idea to help potentially better inform patients include the name of the condition a prescription medicine treats right on the bottle. In researching this idea, they learned that the State of California recently implemented just such an approach, with plans to evaluate potential benefits due in 2014. Kalinina and Patel plan to track this program and its evaluation and, if benefits are confirmed, hope to see the approach adopted nationally. Their idea won third place in the competition sponsored by the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M-CERSI).

Second place was awarded to five doctoral students in Pharmaceutical Health Services Research: Patience Moyo, Mehmet Burcu, Sarah Dutcher, Xinyi Ng and Dinci Pennap. Their proposal was aimed at reducing the risk of harmful drug interactions through enhancing links among doctors, health systems and pharmacists, so that pharmacists have access to complete records of medicines being prescribed.

First place went to Curtis Gallagher, a doctoral student in molecular medicine at the University of Maryland, Baltimore, who researched “untapped opportunities” to facilitate reporting and monitoring of potential drug side effects and other unanticipated problems.

He noted that about 150 million Americans take at least one prescription. Based on personal experience and a 100-person survey, he found most people did not know about MedWatch, the FDA program where negative events can be reported and are tracked for trends, or found reporting too time consuming. His suggestion was for FDA to develop easier-to-use pull down menus of potential side effects, based on a drug’s FDA labeling, and allow consumers to file through FDA or through other websites consumers typically find when doing a computer search for information on a drug or condition. His ideas are being discussed at FDA.

As our health care system works to develop and refine many new approaches to enhancing the safe use of medications, this advice to consumers remains critical: know what you are taking, and why.

Jesse L. Goodman, M.D., M.P.H., is FDA’s chief scientist. In addition to being responsible for FDA’s cross-cutting scientific and public health efforts, he also provides strategic leadership for FDA’s regulatory science and innovation initiatives.

A Key FDA Resource for Industry and the Public: Working with the FDA Office of the Ombudsman

By: Andrew Moss and Laurie Lenkel

Like many Federal agencies, FDA has a robust ombudsman program that addresses concerns and complaints from regulated industry and the public. At FDA, most product evaluation centers house their own ombudsman staff that address center specific issues. The FDA Office of the Ombudsman, as part of the Office of the Commissioner, provides this function for the agency as a whole.   

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While some think of an ombudsman as a type of court of last resort or legal adviser, the FDA Office of the Ombudsman rather acts primarily as a counselor or informal mediator. An ombudsman may be called upon by interested parties to provide guidance and assistance at any stage in a dispute, complaint, or other problem that relates to the work of the agency—not only when a matter reaches an impasse. Addressing problems early can often aid in their resolution.

The FDA Office of the Ombudsman employs some basic guiding principles that allow it to serve in this mediating role: 

  • Neutrality—we engage in matters free from bias and independently from the agency components involved; 
  • Transparency—we strive to be as clear and open as possible about the steps we are taking to provide assistance and about what we can and cannot do to help; 
  • Confidentiality— we maintain the confidentiality of all information provided consistent with applicable laws and regulations.

The FDA Office of the Ombudsman handles inquiries about the resolution of consumer complaints as well as inquiries from regulated industry regarding, among other things, agency action or delays in action, compliance activities, import issues, and actions of FDA field offices. We play an important role in assisting small businesses. Although small businesses are generally subject to the same regulations as any other entity, we can help to draw attention to the special needs and concerns of these companies. If nothing else, we can help small businesses to understand messages from the agency and to better communicate with FDA offices and staff, thereby helping companies to satisfy FDA requirements, which are designed to protect consumers and patients.

The tools we use to assist individuals and companies vary from situation to situation.  Sometimes we help them to better understand actions taken by FDA. At other times we can be helpful in calling attention to and moving forward action that has been delayed.  In many instances, we are able to facilitate a productive meeting between key FDA officials and the interested party to discuss and help move toward resolution of issues of concern. 

A new role for the FDA Office of the Ombudsman is in shepherding the consideration of scientific disputes raised by FDA employees that are not resolved elsewhere and rise to the level of the Commissioner, the head of the FDA. While there are often multiple legitimate ways to view different findings and to make regulatory or policy decisions, FDA is committed to the integrity of the underlying science and a science-based approach to its decision making, and places great value on ensuring that divergent scientific opinions are fully and fairly heard. Any FDA scientist can first raise a scientific dispute or disagreement within the center where they work through well defined processes, with the final arbiter being the Director of that FDA center.  However, if they are ultimately not satisfied that their views have been fully heard and considered by the Center, they can bring the matter to the Office of the Commissioner via the FDA Office of the Ombudsman for review of the process.    

Whatever the issue, question, or problem, the FDA Office of the Ombudsman stands ready to provide guidance and assistance. We are here to help. And if we can’t directly assist you in a given matter, we will identify the FDA component that can. You can contact us anytime at ombuds@oc.fda.gov, or visit us on the web

Laurie Lenkel is Ombudsman and Andrew Moss is Deputy Ombudsman in FDA’s Office of the Commissioner

Public Meeting on Food Safety Highlights First Two Proposed Rules

By: Michael R. Taylor

Last week, we kicked off a series of public meetings—with about 400 people participating—to stimulate dialogue and gain input on FDA’s first two proposed rules to implement the FDA Food Safety Modernization Act. In her opening remarks, Dr. Hamburg noted how her appointment as FDA Commissioner by President Obama, coming on the heels of the illnesses and deaths attributed to contaminated peanut products, helped make food safety a high priority for her and the Administration.

Michael R. Taylor, J.D.It was fitting that we held our first meeting in a USDA auditorium in Washington, D.C., because we have worked closely with USDA and with other government partners at the state and local level, as well as with industry and consumer groups, to get the rules right.  That means holding a lot of meetings to explain the proposed rules, visiting farms and facilities, and opening dockets for comments from interested parties, to receive as much input from the public as possible before we finalize the rules.

The diversity of those who signed up to make public comments at the meeting shows how important food safety is to all of us, from victims of foodborne illness to farmers and food manufacturers. First up was 15-year-old Dana Dziadul, who was three years old when she became ill from Salmonella in cantaloupe. The compelling stories from Dana and other victims of foodborne illness, and their families, remind us all that first and foremost, we have a public health obligation to address the harsh reality that each year, 3,000 people die and more than 100,000 are hospitalized because of foodborne illness. Our first obligation is to do everything we can to reduce these numbers.

We also know that improving food safety helps avoid the disruptions in the marketplace that result from illness outbreaks and recalls of food and maintain consumer confidence in healthful foods, such as the produce that the proposed rules cover. This convergence of interests has made our current food safety initiatives a real community effort, with industry, consumers and government coming together around the common goal of modernizing our food safety system to better prevent problems. We all have a responsibility, and we all have a role, in making and keeping food safe.

The work ahead may sound simple—having the right standards in place that are based on the best information we have on how to prevent hazards, and making sure these standards are met. But we have much yet to accomplish. We have to make sure the standards are flexible enough to address the diversity of operations across the country—from small farms to large facilities, from Maine to California. We also need to be sure FDA is ready to operate under this new, prevention-oriented framework, which will require employee training and ensuring our resources are focused on the greatest risks. And we are committed to providing technical assistance so that industry, especially small operations, can meet the new requirements when they are finalized.

These two proposed rules we have announced are very important, but we have three additional rules coming to further form our food safety framework. To address the safety of imports, we will soon be proposing a rule that requires that importers based in the United States verify that their overseas supplies are following prevention-based standards that provide the same level of public health protection as those that are in place here. Also addressing imports is a proposed rule on the accreditation of the third party auditors that industry uses to help them determine if food safety standards are being met. The third proposed rule coming addresses preventive controls for animal food, including pet food.  Preventive controls are steps that firms must put in place to control hazards such as microbial contamination that could occur in a food facility.

We will be holding two more public meetings—one in Chicago and one in Portland, Oregon. You can find more information on our web site at fda.gov/fsma. Six meetings in various states across the country also are scheduled. Your comments are important to us, and I encourage you to submit comments at regulations.gov before the May 16th deadline. 

The road ahead is a long one, and it will take years, and sustained commitment, to have our framework fully in place. But, for America’s families and our vibrant food system, the hard work is absolutely worth it!

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


Don’t Get Scammed: Beware of Health Fraud

National Consumer Protection Week runs March 3–9, 2013. This coordinated campaign by federal, state, county and local government agencies, and non-profit partner organizations encourages consumers nationwide to make better-informed decisions.

In this video, the Commissioner of Food and Drugs Margaret A. Hamburg, M.D., and the FDA National Health Fraud Coordinator Gary Coody, R.Ph., discuss health fraud scams and give tips to consumers.

For More Information:

Help Shape the Future of Health IT

By: Bakul Patel, MS, MBA

Calling all movers and shakers in health care information technology!

We’re on a mission to help pave the way for innovative advances in safe and effective health information technology (HIT).

Who are “we”?

Under recent legislation, Congress charged FDA—in consultation with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission—to develop a report with a strategy and recommendations relating to a risk-based regulatory framework for HIT that would promote innovation, protect patient safety, and avoid regulatory duplication.

Congress also provided that the agency could assemble a working group that is geographically diverse and consists of experts and interested persons from all stakeholders in the HIT community to help develop the required strategy and recommendations. We put out a call for nominations with a deadline of March 8 on the ONC’s website, so the deadline is fast approaching.

Please take a look at the list of areas of expertise we’re seeking for the working group’s membership.  

The response so far has been gratifying, but our mission is large and if you haven’t already submitted a nomination—for yourself or someone you admire in your field—we urge you to do so now.  We’ll be looking in particular for people who represent a large segment of our stakeholder community.

I’m a technology guy, so I get fired up when it comes to thinking about the possibilities in this rapidly evolving field. But if your eyes glaze over when you hear the phrase “health information technology,” here’s why you should be interested, too:

We live in exciting times. Electronic health records, patient-to-doctor Skyping, smart phones, efficient workflow systems, and ingenious mobile apps provide us with vast reservoirs of health-related information—literally at our fingertips—in seconds.

For example, the National Institutes of Health’s LactMed app gives nursing mothers information about the effects of medicines on breast milk and nursing infants, and there are other apps aimed at helping health care providers improve and facilitate patient care.

But ready access also offers safety challenges. How can we best protect patient privacy? How do we make sure the information is accurate? How can we foster efficiency and curtail costs in the way this information is disseminated in, say, the interpretation and transmittal of radiological images from a medical imaging center to an electronic tablet in a pediatrician’s office to a hospital overseas?

Our working group will be tackling these issues and a host of others. And we want the group to be as varied, wide-reaching, and forward-thinking as possible.

Whether you’re a venture capitalist looking to fund innovative projects; a health care professional who works in a hospital or in private practice; an expert in another area of information technology; or a consumer who wants to ensure the privacy of your own data, we seek and value your participation.

Please, put your name in the hat. It’s a rare opportunity to help shape the future of how health care is provided for generations to come.

Bakul Patel, MS, MBA, is a Policy Advisor in the Office of the Center Director in FDA’s Center for Devices and Radiological Health

FDA joins with health professional organizations in encouraging prescribers to seek training to safely prescribe opioid pain medicines

By: Margaret A. Hamburg, M.D.

More than 15,500 people died in the United States in 2009 after overdosing on narcotic pain relievers. That’s a 300 percent increase over the last 20 years. And for each death, there are an additional ten treatment admissions, 32 emergency department visits and 825 nonmedical users of these drugs.

Margaret Hamburg, M.D.FDA is extremely concerned about the inappropriate use of opioids, which has reached epidemic proportions in the U.S., becoming a major public health challenge. While much of the problem is attributable to illicit use which can include sharing medication with family and friends or theft of the drug from home medicine cabinets, legitimate use of medications for pain may also lead to unnecessary adverse events, addiction, and death for some patients. Our nation’s front-line health care professionals, especially physicians and other prescribers can play an important role in efforts to reduce this trend.

FDA believes it is critically important to facilitate prescribers’ education about the best uses of opioids, including knowing when and for which patients they should be used.

Therefore, today, FDA issued an open letter to prescribers urging them to take advantage of educational programs designed to promote responsible opioid prescribing, improve pain management, and minimize prescription drug abuse and diversion.

And I’m pleased to announce that the American Medical Association (AMA), the American Academy of Family Physicians (AAFP), the American Academy of Physician Assistants (AAPA) and the American Academy of Pain Management (AAPM) have graciously agreed to distribute the open letter to their members. All are actively engaged in activities, including training, aimed at reducing the misuse and abuse of opioid medication, as are many others.

FDA will also distribute this open letter to our expansive health care news lists and urges all health care professionals to not only read, but also pass the letter along to all of their prescribing colleagues.

Prescriber training is one element of a risk management plan known as a Risk Evaluation and Mitigation Strategy (REMS) required by FDA, and approved in July 2012, to address the misuse, abuse, and addiction related to extended-release (ER) and long-acting (LA) opioid pain medicines.

New educational programs mentioned in the letter address ER/LA opioid prescribing. They are based on a blueprint developed by FDA with input from many stakeholders and will be provided at little or no cost through accredited continuing education activities supported by independent education grants from drug manufacturers. The first prescriber training program is available starting today and others will follow.

FDA sought the REMS for ER/LA opioids because these types of pain medicines have clearly emerged as those with the highest potential for harm from misuse, abuse, and unintentional overdose. These widely-used products often contain large amounts of opioids in a single dosage form, sometimes in sufficient quantity to be lethal, especially for a child, and they are a prime target of drug abusers. And that’s why it is so important for physicians and other prescribers to participate in these training programs to enhance their understanding of how to appropriately prescribe these powerful medications to patients that need them – while also keeping them out of the hands of those who could misuse or abuse them.   

According to estimates, more than 320,000 prescribers who are registered with the Drug Enforcement Administration wrote at least one prescription for an ER/LA opioid pain medicine in 2011, so we have a lot of prescribers to reach. However, working together to ensure appropriate use of opioids, I am confident we can make great strides in reducing this epidemic.

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