Getting Importers’ Pulse About Food Safety Plans

By: Michael R. Taylor

My team and I took to the road again recently to reach out to the people who will be most affected by the food safety rules that FDA has proposed this year.

We traveled to Long Beach, Calif. – one of the world’s busiest ports – on Oct. 22 and 23 for a public meeting on the two rules that FDA proposed in July to help prevent contaminated foods from ever reaching U.S. ports. These rules – Foreign Supplier Verification Programs and Accreditation of Third-Party Auditors - would make importers more accountable for food safety and would strengthen our ability to monitor foreign food producers.

Members of the import community and food industry attended a public meeting on proposed rules designed to keep imported foods safe.

Earlier this fall, we had our first public meeting on the proposed import rules in Washington, D.C., that was attended by a diverse audience, including consumer and public policy representatives. In Long Beach, the audience was predominantly members of the import community and food industry around the world – including public and private officials from Japan, Thailand, Mexico, Canada and Barbados. Global impact was a thread that wove through all the discussions.

We were very pleased to have with us Sandra Schubert, undersecretary for the California Department of Food and Agriculture, who emphasized the importance of these rules to a large importing and exporting state like California. Across the country, the states will play a very important role in making the food-safety rules a reality.

We learned how the complexity of the global food supply chain could make implementation a challenge. For example, the owners of specialty food stores may have a comparatively small volume of food, but they use many different suppliers around the world. (One Italian foods retailer said that he uses 38 different suppliers in Italy.) They are concerned about the difficulty of requiring all of their small-scale suppliers to verify that the foods are produced in a manner consistent with U.S. standards.

Their complaint is similar to those voiced by small farmers facing a proposed rule that would create new safety standards for the produce industry. They too are afraid of being overwhelmed by logistics and expenses that could put them out of business. As with the produce rule, there are exemptions for small businesses and suppliers. However, some of the specialty importers feel that those exemptions should be expanded.

I was impressed that many of those who spoke at the meetings are thinking ahead to the nuts and bolts of implementation. They asked, however, how we will keep the playing field level – holding all importers and exporters to the same standards. They’ll be at a financial disadvantage if they’re following the rules and others aren’t.

We’ll consider that, and we’ll keep talking. There is clearly no “one size fits all” solution. We want to meet our safety goals with practical, feasible regulations that will work across the wide diversity of food operations.

From Long Beach we drove north to Bakersfield, where we met with growers to discuss the proposed produce regulations. These farmers produce an incredible diversity of crops, including citrus fruits, table grapes, almonds, carrots, leafy greens, green peppers and many more.

We learned a lot in this visit to California. Everything that we heard will be carefully considered as we work on the final version of these rules.

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

Personalized Medicine: The Future is Now

By Margaret A. Hamburg, M.D.

Margaret Hamburg, M.D.The difference between science and science fiction is a line that seems ever harder to distinguish, thanks in part to a host of astonishing advances in medical science that are helping to create a new age of promise and possibility for patients.

Today cancer drugs are increasingly twinned with a diagnostic device that can determine whether a patient will respond to the drug based on their tumor’s genetic characteristics; medical imaging can be used to identify the best implantable device to treat a specific patient with clogged coronary arteries; and progress in regenerative medicine and stem cell therapy using a patient’s own cells could lead to the replacement or regeneration of their missing or damaged tissues. Given these trends, the future of medicine is rapidly approaching the promising level of care and cure once imagined by Hollywood in futuristic dramas like Star Trek.

But these examples are not science fiction. They are very real achievements that demonstrate the era of “personalized medicine” where advances in the science of drug development, the study of genes and their functions, the availability of increasingly powerful computers and other technologies, combined with our greater understanding of the complexity of disease, makes it possible to tailor treatments to the needs of an individual patient. We now know that patients with similar symptoms may have different diseases with different causes. Individual patients who may appear to have the same disease may respond differently (or not at all) to treatments of that disease.

FDA has been playing a critical role in the growth of this new era for a number of years. Even before I became FDA Commissioner the agency was creating the organizational infrastructure and putting in place the regulatory processes and policies needed to meet the challenges of regulating these complex products and coordinating their review and oversight. It has been my pleasure to serve at FDA during this next exciting period and to help ensure that the agency continues to prioritize this evolution by anticipating, responding to, and encouraging scientific advancements.

I am very pleased to be able to present a new report by FDA as part of our ongoing efforts in this field. Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development describes many of the exciting developments and looming advances in personalized medicine, lays out the historical progress in this field, and examines FDA’s regulatory role: from ensuring the availability of safe and effective diagnostic devices, to addressing the challenges of aligning a drug with a diagnostic device, to post-market surveillance.

Outside collaboration and information sharing is essential for this field to flourish. On Tuesday, the American Association for Cancer Research and AdvaMedDX held a fruitful daylong conversation on personalized medicine to treat cancer. I was one of the speakers, participating in a conversation with Dr. Francis Collins, the head of the National Institutes of Health. Our discussion focused in part on current status of drug and diagnostic co-development and the challenges and potential of whole genome sequencing, where data can be collected on a patient’s entire genetic makeup at a reasonable cost in a reasonable amount of time.

FDA is committed to fostering these cooperative efforts, as it will require the full force of government, private industry, academia and other concerned stakeholders to maximize our efforts and fully realize the promise of personalized medicine. Our new report outlines that commitment, and helps chart the way forward so that more people can live long and prosper.

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

A New Plan for Drug Shortages to Build on FDA’s Success

By: Capt. Valerie Jensen, R.Ph. 

I’ve led FDA’s efforts to address hundreds of drug shortages for more than 10 years. During that time, we’ve made progress. Just last year, we cut the number of new shortages by more than half. But more work needs to be done. 

In an effort to enhance FDA’s current approach to drug shortages and bring new ideas to reduce the number of patients who are affected, we provided Congress today with a strategic plan aimed at enhancing efforts to prevent and reduce drug shortages. FDA is actively working, as required by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, to address the public health threat caused by critically needed medications being unavailable for patients. And we will continue that work and build on our progress. 

An important part of our work is understanding the impact on patients. I’ve talked with many patients and caregivers about the effects of drug shortages. It deeply saddens me to hear a mother talk about her new baby boy, born prematurely, who is struggling to survive due to the scarce supply of drugs to meet his nutritional needs. Or a husband whose wife has been battling cancer and her doctor says the hospital is running out of the medication needed to properly treat her. 

I’m often asked, “Why do drug shortages persist?” and “Why are so many lifesaving drugs in shortage?” The majority of these problems stem from quality and manufacturing problems. Therefore, the answers boil down to quality manufacturing. 

While “quality manufacturing” may sound like a simple concept, getting there is a complex process – and one in which FDA and outside stakeholders have important roles to play. 

The strategic plan includes a number of new ideas to address shortages. Many of these strategies focus on enhancing FDA’s response and communication when we become aware of quality or manufacturing issues that could lead to a shortage. Other strategies that FDA is considering include the development of new risk-based approaches to identify early warning signals for manufacturing and quality problems that could lead to production disruptions.

In addition, the strategic plan identifies some preventive measures companies can take that place a greater emphasis on manufacturing quality and stability of supply, thereby eliminating the root causes of most shortages. 

Better manufacturing quality will help eliminate drug shortages over the long-term. But when a manufacturing disruption is likely to occur, early notification by manufacturers is critical. Along with the strategic plan, therefore, FDA is today issuing a proposed regulation implementing the expanded early notification requirements included in FDASIA. This regulation would require that all manufacturers of certain medically necessary prescription drugs give FDA advance notice of a permanent discontinuance or a temporary interruption of manufacturing. It would also extend this requirement to manufacturers of biologic products. 

Advance notification of a potential shortage allows FDA to work closely with manufacturers on the underlying issues, and in many cases, we are able to prevent the shortage. 

FDA envisions all stakeholders coming together to ensure patients have access to the safe, effective, and high-quality medications they rely on and deserve, and we believe the strategic plan we presented to Congress today will make great strides in ensuring that happens.

Capt. Valerie Jensen, R.Ph., is the Associate Director of the Drug Shortages Program in FDA’s Center for Drug Evaluation and Research

 

Keeping Animal Foods Safe

By: Daniel McChesney, Ph.D. 

Animals are an important part of our lives. Whether we’re talking about a family’s pet or a farmer’s livestock, we at FDA are committed to doing all we can to keep the foods they eat free of contamination. 

To this end, we have proposed the Preventive Controls for Food for Animals rule to establish good manufacturing practices for facilities and personnel involved in manufacturing, processing, packing and holding animal food. It would require facility owners to have a food safety plan and to have controls in place to minimize any potential hazards. 

This proposed rule pulls together the work we’ve done over the past decade to craft a safety system for animal food and will give us new tools to do this important work. The research and findings of the agency’s Animal Feed Safety System Working Group helped create the foundation for the proposed regulations. 

Historically, we have put most of our efforts into responding to safety issues involving animal food as they arise. And while regulations have been crafted to address such threats as the brain-wasting bovine spongiform encephalopathy (aka “mad cow” disease), this regulation moves towards a comprehensive, risk-based regulatory framework to keep all animal foods safe. 

And you can see by looking at some of the crises in recent years this is clearly an important public health issue, one that affects both animals and people. 

Everyone still remembers the massive recall of pet foods in 2007 after melamine, a chemical used to make plastic, was intentionally added to ingredients produced in China, killing pets across the country. 

Just last year, 30,000 tons of dry dog and cat food were recalled following an outbreak of Salmonella tied to a South Carolina facility. The Centers for Disease Control and Prevention reported that 47 people in 20 states and two in Canada fell ill from coming in contact with the contaminated food. 

Globally, public health agencies have for years dealt with the presence of dioxin – linked to cancer and developmental problems in people – in animal food ingredients, and those episodes led to multiple food recalls. 

While FDA moved quickly in response to these and other crises tied to contaminated pet foods, the agency’s focus changed with the enactment in 2011 of the FDA Food Safety Modernization Act. Congress charged FDA to take a more preventive, risk-based regulatory approach. 

While FDA has proposed four other rules this year that were mandated by the food safety law, we chose to handle safety issues involving animal foods separately. Animal and human foods are produced differently, and animals and people are vulnerable to different hazards. 

Also, the rule deals with the nutrient content of animal foods to satisfy a need that is unique to animals. If humans eat a food that’s not particularly nutritious, we can choose something else later. Animals obviously don’t have that option, and they usually get the same food for every meal, so these foods must be complete, nutritionally balanced products.

The bottom line is that we want the foods that animals eat to be safe. We want you to be safe if you’re handling pet food or eating foods derived from animals. This rule will help us do that. You are welcome to read the rule and submit comments by visiting FDA’s official docket at www.regulations.gov or www.fda.gov/fsma

Daniel McChesney, Ph.D., is Director of the Office of Surveillance and Compliance at FDA’s Center for Veterinary Medicine.

As nanotechnology is being used to develop new drugs, FDA is working to ensure quality, safety, and effectiveness

By: Celia N. Cruz, Ph.D. 

Nanotechnology is a new and exciting field that offers scientists the opportunity to control matter at very small dimensions, opening many possibilities for making all kinds of new products. This technology operates on an incredibly small scale that measures things in units called nanometers. One nanometer is one billionth of a meter. It’s hard to even imagine how small that is, but here’s one way to do it: A human hair is about 100,000 nanometers wide. 

Wow, that’s small! But nanotechnology promises big things! There are already many products made using materials at the nanoscale, including new kinds of clothing, packaging materials, and light-weight, but strong, building materials. 

Why are we at FDA’s Center for Drug Evaluation and Research (CDER) writing about it? Because medical products can also be made using materials at the nanoscale. In fact some are already available, including certain sunscreens, in which the nanomaterials are used to provide UV protection while remaining transparent on the skin, and in drugs to treat cancer, including Doxil and Abraxane. Use of nanomaterials can enhance delivery of drugs to their biological target or help scientists customize them for a particular type of patient. 

Materials at the nanoscale can have different chemical, physical, or biological properties compared to their conventionally-scaled counterparts. Scientists can use these features to enhance the properties or the quality of a drug. But because such properties can affect the quality, safety, or effectiveness of a drug, FDA is studying these issues related the use of this powerful new technology in medical products. 

Recently, to help us better understand the potential impact nanotechnology could have on a drug’s quality, safety, or effectiveness, CDER’s Nanotechnology Risk Assessment Working Group (Nano Group) finalized a series of risk assessment and risk management exercises to identify potential risks associated with a drug product that contains nanomaterials. A key goal was to determine if our current regulatory processes are adequate to identify any potential risks and reduce those risks. 

Some members of the Nanotechnology Working Group in the CDER labs where characterization of gold nanoparticles is underway. Left to right, front row: Katherine Tyner, Ph.D. Office of Clinical Pharmacology; Celia N. Cruz, Ph.D. Office of New Drug Quality Assessment; middle row: Olen Stephens, Ph.D. Office of New Drug Quality Assessment: Don Henry, Office of Pharmaceutical Science; Abigail Jacobs, Ph.D. Office of New Drugs; back: Paul Brown, Ph.D. Office of New Drugs.

The CDER Nano Group consisted of a multidisciplinary team of scientists that could provide a complete evaluation of the use of nanomaterials in the types of drugs regulated in the Center. We first performed a thorough risk assessment of all stages in the lifecycle of a drug containing nanomaterials to capture any real or perceived hazards related to the nanomaterials. To complete the exercise, we evaluated the common ways a person could be exposed to nanomaterial in a drug product ― swallowing a drug, having it injected, applied to the skin, or inhaled. In addition, we evaluated unintentional and accidental exposure. 

Once all the potential risks were identified, we undertook a risk management exercise to examine the regulatory process we use to evaluate drugs. We then considered whether the identified potential risks in the first exercise could be sufficiently managed by the existing review processes we use to help protect patients from harm. 

Our risk management exercise determined that our current regulatory review processes indeed can adequately protect the public from potential risks associated with the use of nanomaterials in drug products. We also identified areas that could benefit from improvement. These areas include increased nanotechnology regulatory science research and up-to-date training of the review staff who evaluate marketing applications for drug products developed using nanomaterials. FDA does not make a categorical judgment that nanotechnology is intrinsically safe or harmful. Rather, for nanotechnology-derived and conventionally-manufactured products alike, FDA considers the characteristics of the finished product and, as applicable, its safety, effectiveness, or other product attributes. 

Historically, FDA has successfully adapted to novel technologies, and the robust review process we use will continue to capture the potential risks associated with this new technology. To share the findings of the nanotechnology risk assessment and management exercises, in January 2014, FDA will co-sponsor a workshop with the US Pharmacopeia, the International Society for Pharmaceutical Engineering, the American Association for Pharmaceutical Scientists, and the Society of Toxicology to review and share experience gained during the development and review of medical products containing nanomaterials. With these and other activities, FDA will continue to work to ensure that safe, effective drugs are available to the American public. 

Celia N. Cruz, Ph.D. is Senior Reviewer, Chemistry, Manufacturing and Controls, at FDA’s Center for Drug Evaluation and Research

Reaching Out to Europe on Food Safety

By: Michael R. Taylor

After trips to the Pacific Northwest and New England to connect with growers and state partners on produce safety, I traveled last week to Europe to talk with our regulatory counterparts and others about what the proposed rules under the Food Safety Modernization Act (FSMA) mean for countries that export food to the United States. In Europe, the focus was on all four of the rules we have proposed so far, including two rules proposed in July that implement the Congressional vision of achieving greater importer accountability for food safety.

The U.S. delegation meets with Dutch colleagues at the Port of Rotterdam, the largest seaport in Europe. Jack Vera (center), head of the Import Inspection Division, Netherlands Food and Consumer Product Authority, discusses with Mike Taylor and others procedures required by the European Union for conducting product checks and for sampling and testing product at the Border Inspection Post.

Food safety is a critical issue for all of us in today’s global food system. For consumers in the U.S., there’s a good chance that the food they are eating is imported. Fifteen percent of all the food we eat each year comes from other countries and the percentage is much higher for certain commodities, like fruits and vegetables, seafood and spices. American consumers want to know that imported food is as safe as food produced here.

U.S. food producers and processors also have a stake in the safety of food and ingredients from overseas and rightly want to know that there’s a level playing field – that imported food would have to meet the same safety standards as food produced in the U.S. under the new food safety rules. And it makes sense that European firms and governments are interested in the FSMA requirements we are developing because they want to maintain market access in the U.S.

Our first stop was in Grange, Ireland, just outside Dublin, where the European Union’s Food and Veterinary Office (FVO) is housed. FVO oversees the national food safety inspection programs conducted by the EU’s 28 member states. We had a full day of detailed discussion with FVO director Michael Scannell and his team about FSMA and the opportunity to collaborate on its implementation. The opportunities are great and are important for the U.S. and Europe if we’re to achieve both effectiveness and efficiency in food safety oversight.

There are some differences in how Europe approaches food safety oversight but what was striking to me was that many of the overarching principles that guide us are so similar. In the Netherlands, our second stop, a presentation by Dr. Ron Dwinger from that country’s Food and Consumer Product Authority emphasized basic principles that are very familiar to all of us – a focus on prevention, the importance of addressing food safety from farm to table, the need to base strategies on risk, and the importance of industry responsibility. It was obvious to me that all of us are talking the same language and that food safety reform is a global movement.

While in the Netherlands, my FDA colleagues and I visited the Port of Rotterdam, which is the largest seaport in Europe. The fact that it is a major gateway to the European market for food commodities from around the globe really showed the scale and complexity of today’s modern food system. We were briefed by Jack Vera, head of the Import Inspection Division, Netherlands Food and Consumer Product Authority, about their procedures and strong safety controls over what comes into the country, and we witnessed the sampling of frozen tuna from a large container that originated in Ecuador.

We moved on to Brussels for a critical meeting with our EU regulatory counterparts from DG Sanco, an arm of the European Commission that sets food safety policy and standards for the EU. FDA has had a very positive, ongoing relationship with Paola Testori, the head of DG Sanco. She is a strong leader for consumer protection and a staunch proponent of trans-Atlantic partnership on food safety, including FSMA implementation. Her direct and candid style will help ensure we fulfill our common vision.

We then held a public listening session in Brussels, where we found the same diversity of stakeholders and questions that we expect back home – from government, industry, and consumer groups. Those participating at the meeting represented both the EC and some of the EU member states.

Finally, after traveling to three countries in three days, we left Brussels for Geneva, where we visited our colleagues in the food safety program at the World Health Organization, who play a key role in assuring the scientific quality of international food safety standards, established by the Codex Alimentarius Commission of the United Nations, and in building the food safety capacity of developing countries.

The last stop of our trip was at the World Trade Organization (WTO) headquarters, which sits on the shore of the beautiful lake straddled by the “old” and “new” Geneva. We met there with Gretchen Stanton, who oversees implementation of WTO agreements related to trade in food, and her colleague Melvin Spreij. Trade is important to the economies of developed countries but also for less developed ones, many of which want to strengthen their food safety systems so they can export to markets in the U.S. and Europe. We discussed our international outreach efforts on FSMA and how to help developing countries build their food safety capacity.

With each visit, meeting and listening session we participate in, both in the U.S. or abroad, it becomes clearer and clearer how important partnerships will be to successful food safety reform and how many willing partners we have.

The aspiration for partnership is of course the easy part. Actually building meaningful operational partnerships is much more difficult and will require sustained investment of effort and significant resources. It will be worth it though if the end result is a modern food safety system suited for our global food economy and capable of maintaining the public confidence essential to trade in food, whether domestic or international.

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

Next Steps on Arsenic and Rice

By: Suzanne Fitzpatrick, Ph.D., DABT 

On Sept. 6, FDA announced the results of testing 1,300 samples of arsenic in rice and rice products and found that the arsenic levels in rice do not present an immediate or short-term health risk. 

As we said last week, the next step is to assess the potential health risk from long-term exposure to the arsenic in rice and foods made with this grain. 

And that is where my job starts. I am a scientist at FDA and I’d like to explain the scientific legwork that will be done over the next few months by some of the most preeminent arsenic experts in the country. 

This is a daunting task, with one complicating factor being the sheer volume of rice products. When we conducted the risk assessment on arsenic in apple juice that led to the proposed limit, or action level, of 10 parts per billion, we were essentially dealing with one product. With rice, there are different varieties and hundreds of products made with rice. We’ve already started the work. A thorough risk assessment is underway by FDA scientists at the Center for Food Safety and Applied Nutrition, in consultation with colleagues in FDA’s National Center for Toxicological Research and in other federal agencies, including the National Institute of Environmental Health Sciences and the Environmental Protection Agency. 

Scientists and medical experts of all kinds will be working together. I am a toxicologist and will be looking at the data on possible different adverse effects from arsenic exposure in rice. Nutritionists will be studying rice consumption patterns and epidemiologists will be looking for patterns of disease. There will be statisticians, experts on exposure to arsenic, and many others. 

We will use published research on people who have been exposed for years to elevated levels of arsenic in the drinking water. Importantly, we will be looking to see how arsenic may affect the youngest and most vulnerable among us. 

This analysis will take time. As it progresses, the rice industry, university researchers, and the U.S. Department of Agriculture are working to identify ways to reduce arsenic levels in rice during production. This is important because we want to minimize exposure to contaminants like arsenic in our foods whenever feasible. 

In the meantime, let me repeat FDA’s advice to eat and to serve your family a balanced diet that contains a variety of grains, including wheat, barley and oats. Consistent with advice long given by the American Academy of Pediatrics (AAP), we recommend that infants and young children eat a variety of grain cereals for good nutrition. According to AAP, there is no medical evidence that rice cereal has any advantage over other cereal grains as a first solid food. 

My colleagues and I are scientists, but we’re also consumers and parents ourselves. It is our responsibility – our mission –  to put forth the best possible science on this issue – to understand and minimize any long-term risk from the presence of arsenic in rice and foods made with rice. 

Dr. Suzanne Fitzpatrick is the Senior Advisor for Toxicology in FDA’s Center for Food Safety and Applied Nutrition

Thinking Globally to Strengthen Science and Public Health Locally

By: Margaret A. Hamburg, M.D.

There are many good reasons to go to Arkansas in September. To visit Little Rock, nestled in the rolling hills between the Ouachita Mountains and the Arkansas River, and recently chosen as America’s number one most livable city. To attend the Annual Eureka Springs Antique Automobile Festival or the Ozark Quilt Festival. Or to take in the William Jefferson Clinton Presidential Library in Little Rock or visit his childhood home in Hope. And yet, none of these were the prime rationale for why more than 100 scientists, researchers, government regulators, and students from around the world came to this state. Instead, these committed individuals traveled from places as far away as Brazil, South Korea, and Australia to attend the Third Annual Global Summit on Regulatory Science hosted this week by FDA’s National Center for Toxicological Research (NCTR). 

Margaret Hamburg, M.D.They were here to help plan and build an organization to ensure that at a time of growing global demands and pressures, we can more efficiently turn the extraordinary potential and promise of science and technology into real-world products and programs that matter and make a difference to the public health.

The concept at the heart of this gathering is an occasionally neglected but fundamental component of the scientific enterprise and of FDA’s work and mission, regulatory science. Regulatory science is critical to speeding innovation, improving regulatory decision-making, and strengthening our ability to better assess the safety, quality and efficacy of a wide range of products, including food, drugs and devices. It is the work of regulatory science that truly enables us to have the knowledge and tools needed to translate scientific discovery and innovation into the products that hold such great promise.

That’s why one focus of the meeting was how to build a training model for regulatory scientists. Because even when individual nations have high standards for scientific training, fully leveraging the opportunities in science today requires an added focus on the specific critical thinking skills necessary to design, implement, and interpret studies within the regulatory context.

A number of programs at FDA for instance, are helping to ensure that scientists – both at the agency and around the globe – have this foundation. For example, NCTR has been collaborating with various Arkansas universities for a number of years to offer research training opportunities through a fellowship program that offers research training to postdoctoral students, as well as a training program for summer interns at the undergraduate level. So far, these programs have helped train students from more than 47 countries, as well as within Arkansas and across the nation.

One program I am especially excited by is the Arkansas Center of Excellence in Regulatory Science (ACERS), a public-private partnership that grew out of a Memorandum of Understanding I signed with the State of Arkansas in 2011. The five research universities that are part of the MOU are working collaboratively to join their vast computing capabilities, bioinformatics training, and other resources, with the equally impressive capabilities of NCTR and FDA to develop a powerful public resource. And just this week, at the Governor’s mansion, I signed the Partnership Intermediary Agreement, which will further strengthen the work of the Center, by facilitating the transfer of NCTR technology to the private sector.

Another important forward-looking aspect of ACERS is the creation of the Program in Regulatory Sciences at the University of Arkansas for Medical Sciences. This curriculum will help provide both current graduate students – and their broader scientific communities — with the critical skills needed to apply their scientific expertise to the decision-making needed for regulatory science within their specialties. These students represent the shape of things to come and provide an important step toward achieving the global promise of scientific innovation.

All of this speaks to the second important principle at the center of this week’s gathering in Arkansas – strengthening opportunities for collaborations being built among scientists from different governments, academia, industry, and elsewhere. Quite simply, collaboration is a cornerstone of regulatory science.

FDA increasingly is required to act in an environment in which food and product safety and development know no global boundaries. To respond effectively we must strengthen collaboration among international partners. This will allow us to offer a unified focus on regulation in the name of science to help ensure the availability and safety of the supply of food, drugs, and other products around the world.

The discussions this week in Arkansas furthered the development of innovative technologies, approaches, and, perhaps most significantly, partnerships that enhance the use and translation of basic science into regulatory applications, as well as new collaborative systems for communication, education and training. These efforts offer extraordinary promise for the future of regulatory science in the global context and for the delivery of the kinds of innovative, safer and more effective products that patients and consumers expect and deserve.

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

Crafting better drug labeling to ensure safer use of opioids

By: Margaret A. Hamburg, M.D.

One of the FDA’s primary public health missions is ensuring that healthcare providers and their patients have all the information they need to help decide whether a medication is safe and appropriate to use.

Margaret Hamburg, M.D.Communicating the full risks and benefits of a drug becomes all the more important for those medications that are potentially deadly if used incorrectly. Extended-release long-acting(ER/LA) opioids fall into that category, and can sometimes cause serious harm, like addiction, even when used properly.

These medications, which include drugs such as morphine, oxycodone, and fentanyl, can improve the quality of life for many people who must live every day with pain. But ER/LA opioids often also contain a large amount of the active ingredient, sometimes in sufficient quantity to be lethal, and they are a prime target of drug abusers.

As part of FDA’s efforts to address the serious risks of ER/LA opioids, we looked more closely at the product labeling, known by many as the package insert, to determine whether this essential tool for conveying information about a drug should be revised to encourage safer use.

We closely reviewed medical literature and evaluated public input. We then came to the conclusion that if we improved what the labeling says about proper patient selection and the risks from these drugs, we might be able to reduce the frequency of bad outcomes.

And so today I’m pleased to announce new, proposed labeling changes for ER/LA opioid pain relievers, as well as new postmarket requirements that will include additional studies and clinical trials to better assess certain significant questions about the risks and safety practices of these drugs. The goal is to achieve safer and more appropriate use of these potent pain relievers.

These labeling changes better describe the risks associated with the ER/LA opioid medications and clarify the population for whom the benefits of these products outweigh their risks.

Rather than stating that these medications are indicated “for the relief of moderate to severe pain in patients requiring continuous, around-the clock opioid treatment for an extended period of time,” once final, the updated label will clarify that these products are indicated for “management of pain severe enough to require daily, around the clock, long-term opioid treatment and for which alternative treatment options are inadequate.”

And in the section of the label regarding limitations of use, we have added language plainly stating just how risky these drugs are — even at recommended doses.

In addition, we are requiring changes to the boxed warning for these products to give greater emphasis and prominence to the risk of Neonatal Opioid Withdrawal Syndrome that may occur in newborns due to prolonged opioid exposure during gestation.

We know that the way a patient characterizes pain is always going to be subjective: “moderate” pain for one patient may be “severe” pain to another. And we recognize that there are some women who have an appropriate need for opioids during their pregnancy.

The goal of all of these labeling changes is to help physicians work with their patients to determine whether these potent pain relievers are the most appropriate treatment for their specific situation and if so, to help them in managing their use.

While our intent is to encourage safer and more appropriate use of these products, simply changing the labeling won’t make an impact if these changes are not understood and integrated into practice by healthcare providers. So I am urging prescribers to spend some time going over this new labeling, when final, reflecting on what the language means to their practice, and communicating what they’ve learned to their patients.

The fact is, improving the safe and appropriate use of ER/LA opioids takes the help and commitment of all of us, including our partners in the healthcare community. We are committed to working together to help ensure that healthcare providers can prescribe ER/LA opioids properly and better monitor and educate their patients.

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

CFSAN: Pinpointing Priorities, Protecting the Public Health

By: Michael Landa 

When I started my first tour with FDA in 1978, I could not have foreseen the challenges we would face today in our mission to protect and promote the public health. 

Who could have predicted the expanding globalization of the food supply? Or the extent to which technology would transform the foods and cosmetics industries and the ways we regulate them? Who knew that today many consumers would be committed to eating fresh, minimally processed, locally sourced foods? 

As director of the Center for Food Safety and Applied Nutrition (CFSAN) at FDA, I have seen these and other developments in the shifting landscape of food and cosmetic safety. And I am responsible for helping to establish the priorities that will guide our work. 

To this end, I am pleased to share with you the CFSAN Plan for Program Priorities, 2013-2014. The two-year plan - which is well underway at this time – identifies six key program goals and details how we will achieve them. The goals are: 

  1. Reduce foodborne illness rates and cosmetic injury rates each year.
  2. Establish regulations, policies, guidances, and inspection and compliance strategies based on the best science and strategies for prevention and minimizing public health risk.
  3. Increase compliance with new controls focused on preventing foodborne illness and other health hazards. This includes promoting best agricultural practices to farmers, educating consumers on safe food handling practices, and ensuring that safety standards are consistent for both foreign and domestic foods and cosmetics.
  4. Implement science-based strategies that facilitate healthy diets.
  5. Develop and swiftly deploy the fastest, most effective methods for identifying, containing, and eliminating food and cosmetic hazards.
  6. Achieve optimal use of staff and resources. This includes strengthening leadership and management capabilities, enhancing relationships with other regulatory entities at home and abroad, and reviewing and clarifying administrative roles and responsibilities. 

This is not by any means an exhaustive list of all CFSAN initiatives. The Center is continuing other important work that includes reviewing manufacturer premarket notifications for infant formulas; carrying out pre- and post-market regulation of food ingredients and packaging; monitoring for the presence of chemical contaminants in regulated products; authorizing health and nutrient content claims on food products; seeing to it that violative product labeling for cosmetics is corrected; and reviewing premarket notifications for new dietary ingredients in dietary supplements.  

We remain focused on dedicating our resources – human and otherwise – to meeting all of these goals and responding to the challenges ahead.

I encourage you to look at the strategies we will use and the regulatory blueprints we will follow to ensure that the foods you eat and the cosmetics you and your family use are safe. 

Michael M. Landa is Director of FDA’s Center for Food Safety and Applied Nutrition