FDA Update on Traceback Related to the E. coli O157:H7 Outbreak Linked to Romaine Lettuce

By: Scott Gottlieb, M.D., and Stephen Ostroff, M.D.

The FDA continues to investigate the outbreak of E. coli O157:H7 infections associated with romaine lettuce from the Yuma growing region. Any contaminated product from the Yuma growing region has already worked its way through the food supply and is no longer available for consumption. So any immediate risk is gone. However, the FDA is committed to investigating the source of the outbreak and working with industry to help prevent similar events in the future.

Dr. Scott Gottlieb

Scott Gottlieb, M.D., Commissioner of the U.S. Food and Drug Administration

This is a serious and tragic outbreak. And we’re devoting considerable effort to identifying the primary source. We’ve made progress in recent weeks toward this goal. This outbreak of E. coli O157:H7 illnesses is the largest in the United States in more than 10 years. As of today, it has affected 172 persons in 32 states, and it is anticipated the numbers will be updated on Friday. Tragically, 45 percent of these ill people have been hospitalized, and one has died. And 20 of these people have developed hemolytic uremic syndrome (HUS), one of the most serious complications that can occur with E. coli O157:H7 infection.

These statistics reflect the severity of this particular foodborne illness. The kidney damage that’s associated with HUS can require temporary dialysis and the kidneys may never fully recover. For these reasons, anytime outbreaks caused by this pathogen occur, we need to find the root cause of the contamination and determine what went wrong. We need to relay these findings to industry so that measures can be put in place to prevent it from happening again.

The FDA’s investigators are actively searching for answers as to the source of this outbreak, and what steps can be taken to prevent it from recurring in future growing seasons. In the current outbreak, illness has generally been linked to the consumption of chopped romaine lettuce. The lettuce was generally consumed at restaurants or purchased at markets. In one cluster of illnesses at an Alaska correctional facility, the prison received and served whole head romaine lettuce rather than chopped and bagged romaine.

The FDA and our state partners have been involved in extensive traceback efforts of the romaine lettuce that was likely consumed by those who became ill. Traceback involves working backwards from the point of consumption or purchase of the product through the supply chain. It often includes investigating the multiple steps along the way. These steps can include suppliers, distributors and processors where the lettuce was chopped and bagged, and then back to the farm or farms that could have grown the lettuce that ended up in those bags. It’s a labor-intensive task. It requires collecting and evaluating thousands of records; and trying to accurately reproduce how the contaminated lettuce moved through the food supply chain to grocery stores, restaurants and other locations where it was sold or served to the consumers who became ill.

Stephen Ostroff, M.D.

Stephen Ostroff, M.D., FDA’s Deputy Commissioner for Foods and Veterinary Medicine

Our traceback efforts are designed to find points of convergence from several well identified clusters of illness with a common point of exposure, such as a restaurant or grocery store. This means that as we draw lines for each cluster from one point in the supply chain to another point, we look for places where the lines will intersect and lead back to a common location. This can then help clarify where the contamination may have taken place.

We usually do this for clusters of ill individuals that occurred in different parts of the country; since lettuce in one part of the country may not follow the same pathway as lettuce in another part of the country. When that point of convergence is identified, efforts can then focus on how the contamination occurred at that location.

We’ve conducted traceback activities for many of the illnesses identified in this outbreak. We’ve used this information to create a traceback diagram that we’re releasing today. The diagram does not include tracebacks for all 172 cases. Rather, it focuses on settings where there were several well-documented clusters of cases. As additional traceback information is received, we anticipate the diagram will be updated.

As can be seen in the diagram, in the current outbreak, and based on the information we have to date, there are still no obvious points of convergence along the supply chain. There is only one straight line back to a single farm. And that particular instance involves the whole head lettuce served in the Alaska correctional facility, since it was not processed and was not mixed with lettuce from multiple farms, as seen in other parts of the traceback.

In these other tracebacks in the diagram, there are different suppliers, distributors and/or processors. These pathways lead back to different farms, sometimes many farms, where possibly contaminated lettuce could have been harvested during the timeframe of interest. The only point of commonality in our traceback efforts to date is that all of the farms are located in the Yuma growing region. This region is where a large portion of the romaine lettuce supply in the United States comes from during the winter months.

What does this traceback diagram tell us?

It says that there isn’t a simple or obvious explanation for how this outbreak occurred within the supply chain. If the explanation was as simple as a single farm, or a single processor or distributor, we would have already figured that out. The traceback diagram does show us that the contamination with E. coli O157:H7 was unlikely to have happened near the end of the supply chain (such as at a distributor) because there are no common distributors among the places that received and sold or served contaminated lettuce. The contamination likely happened at, or close to, the Yuma growing area.

Our task now is to investigate what happened. We are actively evaluating a number of theories about how romaine lettuce grown on multiple farms in the same growing region could have become contaminated around the same time. It’s possible that contamination occurred on multiple farms at once, through some sort of environmental contamination (e.g., irrigation water, air/dust, water used for pesticide application, animal encroachment). Another possibility is that it happened just after the lettuce left the farm. We are examining all possibilities and as we investigate we learn more about a potential common source we will communicate this information with growers and consumers. But the source and mode of contamination may remain difficult to identify.

Our efforts are complicated by the fact that romaine lettuce is a perishable commodity with a short shelf life of a couple of weeks. None of the lettuce that likely made people sick was available for testing because of the time between the incubation period of E. coli O157:H7 (the time between exposure to the lettuce and the onset of illness) and the time it takes to seek health care and collect specimens from ill people, test those specimens, report the illnesses to public health officials, fingerprint the pathogen to make sure it is part of the outbreak, and interview the ill people to identify where and when they were exposed.  By that time, the lettuce they ate which could have made them ill is long gone.

Similarly, the lettuce growing and harvesting season in the Yuma growing region was essentially over by the time the outbreak was recognized in April, and harvesting has since ceased. That is why we, and our colleagues at the Centers for Disease Control and Prevention, have said that there’s no longer any romaine lettuce from the Yuma growing region available for purchase or consumption.

Romaine lettuce production in this area is now idle until later in the year. This makes it difficult to find places where the E. coli O157:H7 organism that caused the outbreak may have been hiding.

We have no evidence that romaine lettuce from other growing regions have been a part of this outbreak.

The FDA is looking at all possibilities for how the contamination may have caused such a large outbreak. This work will continue. In these efforts, we’re collaborating with outside experts who may have insights, ideas, or suggestions. This includes working with farmers, technical experts, the lettuce processing industry, state partners, and others. It also includes on-site assessments. Through such assessments we may be able to find a possible explanation so that steps can be taken to prevent this problem from recurring.

We’re committed to these efforts, and finding the root cause of this outbreak.

Romaine lettuce is one of the most popular types of lettuce in this country. We want American consumers to be confident in the quality and safety of the lettuce they consume. In addition to working to identify the source and mode of contamination, we will also continue working after the outbreak to evaluate what happened and how lessons learned can be used to provide feedback to industry on best practices and areas to work on. These include better tools to more efficiently and swiftly traceback commodities like lettuce through the supply chain, and better ways to standardize record keeping. We also want to explore the use of additional tools on product packaging that could improve traceability. For example, could QR codes be used to provide additional information that could help consumers more easily identify which lettuce should be avoided and which lettuce is ok to eat?

We’re also working with the leafy greens industry and technical experts to explore methods to grow and process lettuce in ways that further reduce the risk of outbreaks. We live in an era of unprecedented innovation and technology, and we want to bring more of that innovation and technology to bear to help solve this problem and ensure consumer confidence in healthy fruits and vegetables.

Food safety is one of the highest priorities at the FDA. This outbreak is a clear illustration of why that’s the case. It shows the terrible consequences when something goes wrong.

This outbreak marks the importance of moving forward with the Food Safety Modernization Act’s Produce Safety Rule. That rule is designed to implement practical measures to prevent contamination of fruits and vegetables at the farm. This rule is being implemented in close collaboration with our state partners and with our federal partners at the U.S. Department of Agriculture.

State partners will do the vast majority of routine inspections under the Produce Safety Rule. They are often the most familiar with their farming communities and growing and harvest practices. These inspections are slated to begin next year. We’re currently in the process of finalizing the guidance and training farmers throughout the country and those who ship produce to the U.S. on the rule’s requirements.

We believe that the measures outlined by the Produce Safety Rule, when fully implemented, will reduce the chance of an outbreak similar to the one we just experienced. That’s our goal, and our commitment, to the American public.

Scott Gottlieb, M.D., is Commissioner of the U.S. Food and Drug Administration

Stephen Ostroff, M.D., is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

Follow Commissioner Gottlieb on Twitter @SGottliebFDA

The FDA Issues Draft Guidance About the Absorption of Active Ingredients Being Considered for Inclusion in Over-the-Counter Drug Products Applied to the Skin and Marketed without Approved Applications

By: Theresa M. Michele, M.D.

All drugs have some risk — even over-the-counter (OTC) drugs available without a prescription — and the FDA is always taking steps to help ensure their safety. When you take a pill, you generally expect that some of the active ingredient gets into your body, but what about when you apply a topical product to the skin? How much of the product gets absorbed through the skin and enters the bloodstream, and is it safe? At the FDA, we’ve been working to better understand the absorption and safety profile of topical OTC products such as sunscreens and topical antiseptics. We are particularly interested in learning how these products affect vulnerable populations such as children, the elderly, and pregnant and breastfeeding women.

Theresa Michele, M.D.Until recently, there was little data available to demonstrate the extent to which topical OTC drugs are absorbed into the bloodstream after application, and whether there are any long-term consequences of this. In fact, many topical OTC products were first marketed when these products were thought not to be absorbed through the skin and when there were no effective methods available to measure absorption. Now, better measurement tools are available, and research indicates that topical drugs can indeed be absorbed into the body through the skin.

Consequently, the FDA has been generally encouraging manufacturers to collect data on the potential risks of a topical drug when used according to the maximum limits of the product’s instructions, what we call Maximal Usage Trials or MUsT studies. Most recently we included MUsT studies among the list of safety and efficacy studies recommended for sunscreen active ingredients being evaluated under a new marketing pathway established by the Sunscreen Innovation Act in a final guidance for industry in November 2016. Now we are issuing draft guidance that, when finalized, will provide recommendations to industry on how to design and conduct MUsT studies for topical active ingredients that are under consideration for inclusion in an OTC monograph.

The draft guidance includes discussions about how to study the topical active ingredient’s effects on specific subgroups of vulnerable patients like children and the elderly. The studies require a relatively small sample of patients for a short period of time and should not be overly burdensome. In fact, this draft guidance reflects the same safety and efficacy standards that have applied to all drug products marketed under the OTC Monograph System for more than 40 years.

Absorption studies have contributed significantly to the FDA’s knowledge of the safety of topical prescription products. Applying a similar level of safety research to active ingredients being considered for inclusion in an OTC monograph to that which currently exists for prescription products can help the FDA determine whether these ingredients should be included in OTC products marketed without approved applications.

Theresa M. Michele, M.D., is the Director of the Division of Nonprescription Drug Products, Office of New Drugs, at the FDA’s Center for Drug Evaluation and Research

Addressing Needs of Patients While Stemming the Tide of the Opioid Crisis

By: Scott Gottlieb, M.D.

The biggest public health crisis facing FDA is opioid addiction. Not a day goes by in my role at FDA without hearing stories of the emotional, physical, and financial toll this epidemic is taking on Americans.

Dr. Scott GottliebFDA is committed to making every possible effort to stem the tide of this crisis. A little over a year ago, I announced a redoubling of that commitment through the formation of the Opioid Policy Steering Committee (OPSC). This group, comprised of the agency’s most senior leaders, was tasked with developing new approaches to impacting this crisis. One overarching goal of the committee was to develop new policy solutions to reduce overall exposure to opioids, prevent new addictions, and support the development and use of better FDA-approved medications to treat those with opioid use disorder.

Part of this effort resulted in two important actions led by the OPSC. In September 2017, FDA solicited public input on how the agency’s authorities could be used to address the crisis. A meeting in 2018 was held to solicit specific input on how FDA’s actions could assist more appropriate prescribing.

These actions generated a wide range of feedback, and they included the important voices of the patients. The feedback we received affirmed for us that as we address this crisis, we wouldn’t lose sight of the needs of Americans living with chronic pain or coping with pain at the end of life.

We’ve heard the concerns expressed by these individuals about having continued access to necessary pain medication, the fear of being stigmatized as an addict, challenges in finding health care professionals willing to work with or even prescribe opioids, and sadly, for some patients, increased thoughts of or actual suicide because crushing pain was resulting in a loss of quality of life.

We’re focused on striking the right balance between reducing the rate of new addiction while providing appropriate access to those who need these medicines. In some medical circumstances, opioids are the only drugs that work for some patients. This might include patients with metastatic cancer or severe adhesive arachnoiditis. Today, to address these goals and challenges, we announced an upcoming meeting focused solely on the needs of those suffering from chronic pain.

This public meeting is an opportunity for FDA to hear directly from patients, including adult and pediatric patients. We want to hear their perspectives on the impacts of chronic pain, their views on treatment approaches for chronic pain, and the challenges or barriers they face accessing treatments. 

As FDA learns more about the types of chronic pain that are managed with analgesic medications such as opioids, acetaminophen, NSAIDs, antidepressants, other medications, and non-pharmacologic interventions or therapies, we gain valuable insight into strategies FDA can adopt to help strike the right balance between policies that allow appropriate prescribing for those in true need of these medicines and preventing unnecessary exposure to opioids that can increase the rate of new addiction.

For example, one idea FDA is considering is the development of a strategy for encouraging medical professional societies to develop evidence-based guidelines on appropriate prescribing for different acute medical indications, how to assess the scientific support for these guidelines and impact on prescribing behavior, and considering the possibility of incorporating new prescribing information in opioid analgesic labeling. We believe such guidelines could encourage the use of an appropriate dose and duration of an opioid for some common procedures and promote more rational prescribing, including that patients are not being under prescribed and patients in pain who need opioid analgesics are not caught in the cross hairs. In short, having sound, evidence-based information to inform prescribing can help ensure that patients aren’t over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments. We will take the first steps toward developing this framework in the coming months, with the goal of providing standards that could inform the development of evidence based guidelines.

We’re also going to be creating a new series of guidance documents focused on laying out an efficient, modern pathway for development of drugs targeted to the treatment of various types of pain. These will be up-to-date policies that focus on the treatment of specific areas of pain. This will allow us to tailor our requirements to the indications for which pain treatments are being developed. The aim will be to modernize FDA’s current guidance on analgesic drugs, to promote more new drug innovation.

As we address the opioid crisis with new approaches, and take more vigorous steps to confront addiction, we can’t lose sight of patients who have appropriate needs for these medicines. This meeting is one of many steps we’re taking to make sure we protect the needs of patients with chronic and acute pain even as we take new actions to reduce overall prescribing and dispensing of opioid medicines.

Scott Gottlieb, M.D., is Commissioner of the U.S. Food and Drug Administration

Follow Commissioner Gottlieb on Twitter @SGottliebFDA

Emerging issues of misuse and abuse of OTC loperamide challenge FDA to address a new turn in the opioid addiction crisis, while maintaining access for patients

By: Scott Gottlieb, M.D.

The opioid epidemic has reached tragic proportions. Yet it continues to take many new, and troubling turns. If there’s one lesson we’ve learned from this crisis, it has been the ability of the mounting abuse and misuse to evade our interventions. This history challenges us to deal more quickly and aggressively when new aspects of the addiction crisis emerge. For example, we’re seeing a crisis that began largely with the misuse of prescription opioids evolve into an epidemic that’s increasingly being driven by an influx of street drugs like illicit fentanyl and heroin. We must be alert to these new patterns of abuse and misuse of different drugs.

Dr. Scott GottliebOne such concern relates to the inappropriate use of loperamide – an FDA-approved drug to help control symptoms of diarrhea, including travelers’ diarrhea. Loperamide is sold under its over-the-counter (OTC) brand name Imodium A-D, as store brands and as a prescription drug. Loperamide is an opioid agonist, and it’s safe and effective at its approved doses. The drug acts locally, inside the gut, to treat the symptoms of diarrhea.

But when loperamide is abused and taken at extremely high doses, some of it can cross the gut lining, giving users an opioid like “high.” We’re aware that those suffering from opioid addiction see loperamide as a potential alternative to manage opioid withdrawal symptoms or to achieve euphoric effects. But at these very high doses, it’s also dangerous. We’ve received reports of serious heart problems and deaths, particularly among people who intentionally misuse or abuse high doses. Sometimes people are using as much as 100 times the recommended dose.

As with other new patterns of abuse and misuse related to the opioid crisis, the FDA acted with urgency to address the issues related to loperamide. We’ve issued a Drug Safety Communication and worked with sponsors to revise both prescription and OTC drug labeling to warn about serious heart problems associated with high doses of loperamide. We’re also encouraging changes to packaging of the OTC products to help deter abuse, such as the use of blister packs. And we’ve reached out to online sellers of these products to inform them of the public health risks and ask for their attention to the issue and their commitment to stop selling large quantities of the product.

At the same time, we’re very mindful of balancing benefit and risk and the needs of patients in our mission to promote and protect public health. We recognize that there are important and legitimate uses of loperamide, including for patients suffering from chronic diarrhea in adults associated with inflammatory bowel disease (IBD), including Crohn’s disease. We need to take the additional steps I outlined to address the abuse and misuse of loperamide. But preserving appropriate access to this treatment for patients who need it is something we take seriously. So we’re seeking input from the patient community on how best to strike this careful balance. In order to ensure that we don’t create access issues for such patients, we’re proceeding in a step-wise, deliberative fashion to ensure that the actions we take in relation to OTC loperamide use are reasonable and scientifically sound, and that these actions are necessary to achieve safe use of the drug and to address the issues of abuse and misuse.

It’s also the case that loperamide is available by prescription for patients who require maintenance therapy for chronic disease and are under the care of a health care provider.  We’ve also heard concerns that the changes to packaging could drive up the price. Affordability of medicines is one of my key concerns. We’re carefully evaluating the impact that our actions could have on the cost of this medicine. Based on our analysis to date, we don’t expect that the steps we’re taking will have much, if any, impact on cost, given that loperamide is available as a generic drug and manufactured by a range of competitors.

OTC loperamide is currently approved in packages of 8 to 200 tablets, which are often sold in multipacks of more than 1,000 tablets at a time. This is more than a three-year supply if the drug is taken according to the product label. Evidence suggests that reasonable packaging limitations and unit-of-dose packaging may reduce medication overdose and death.

Therefore, as we announced in January, the FDA has sent letters to the OTC brand manufacturers requesting that they implement packaging changes. We’re currently evaluating the maximal package size appropriate for OTC use, and plan to take into account data manufacturers provide on consumer use and needs; current OTC labeling and indications; the dose-response relationship of loperamide to cardiac events and known adverse event data; and importantly, the feedback of patients who rely on this medicine.

The agency is discussing implementation timeframes to ensure that manufacturers can continue to meet consumer need while package reconfiguration is taking place.

I also recently wrote to online distributors asking them to take two voluntary steps to help reduce the risks of loperamide abuse and misuse. First, I asked them not to sell bundled amounts of loperamide that contain more than one package of the drug. And second, I asked them to ensure that consumers can easily access and read the product labeling and warnings for drugs sold on shelves or on websites before purchase.

We appreciate the responsiveness from both the manufacturing and retail industry. Several companies are already committing to implement these packaging changes or purchasing safeguards. For example, Walmart has already taken a number of concrete steps to address the FDA’s request. These include ensuring that all loperamide products sold by Walmart/Sam’s Club have the product labeling clearly visible on the website; limiting purchase of 200 count tablet products in stores or online to a single bottle; and, moving the sale of bundled products at Sam’s Club behind the pharmacy counter and limiting sale to a single package. Walmart is also working to remove all loperamide “marketplace products” (i.e. products sold on their website by a third-party vendor) from their website. These vendors appear to be the primary source of bundled products and products that do not display product labeling on the Walmart site.

Amazon also has already taken some steps to address our recommendations and eBay has stated publicly that they also intend to follow our recommendations. We continue to work with other retailers to encourage them to take steps to help prevent abuse and misuse of loperamide.

All of us must do our part to address the public health challenges posed by the opioid addiction crisis.

The FDA will continue to assess the loperamide safety issue, and monitor adverse events, scientific literature, and data submitted by the public. We want to ensure that the steps we’re taking improve the safety of loperamide without limiting OTC access for consumers using the product according to labeling. The FDA’s actions to address drug misuse and abuse must be informed by an understanding of the complex social environment in which changing patterns of drug consumption occur. The agency is committed to addressing emerging issues of abuse and misuse while taking steps to safeguard the needs of patients who depend on these medicines.

Scott Gottlieb, M.D., is Commissioner of the U.S. Food and Drug Administration

Follow Commissioner Gottlieb on Twitter @SGottliebFDA

Spring Unified Agenda: FDA’s Anticipated Upcoming Regulatory Work

By: Scott Gottlieb, M.D.

Today, the federal government published the Spring 2018 “Unified Agenda of Federal Regulatory and Deregulatory Actions” (Unified Agenda), which provides federal agencies with the opportunity to update the American public on our government’s regulatory priorities.

Dr. Scott GottliebFor its part, the U.S. Food and Drug Administration (FDA) continues to make swift progress on our regulatory agenda, which reflects the key strategic priorities of the FDA and the Administration. Our regulatory agenda reflects our adherence to science based decision making and our commitment to our mission to protect and promote public health.

I provided a detailed overview of many of our proposed regulations for 2018 around the release of the Unified Agenda last fall – most of which we continue to take forward. I’d like to take this opportunity to highlight for you some of FDA’s new contributions to the Spring Unified Agenda.

Addressing the Nicotine Addiction Crisis

Smoking remains the leading cause of preventable death and disease. And too many young people are still being initiated on tobacco products, and becoming addicted to nicotine.

We’ve taken steps to address the morbidity and mortality associated with tobacco through the comprehensive plan that we announced last summer. We’re considering regulating the nicotine levels in combustible cigarettes, to render cigarettes minimally or non-addictive.

At the same time, we’re continuing to advance our framework for how we’ll regulate both novel nicotine delivery products, such as e-cigarettes, and traditional tobacco products. One goal of our efforts is to encourage innovation of less harmful products. We will ensure that all tobacco products, whatever their nicotine content or delivery mechanism, are put through an appropriate series of regulatory gates to maximize any public health benefits and minimize harms.

To that end, we will be proposing a new regulation to establish product standards for electronic nicotine delivery systems or ENDS. The proposed standard will, among other things, address the levels of toxicants and impurities found in nicotine, propylene glycol, and vegetable glycerin e-liquid, as these toxicants and impurities can cause death or other adverse health effects.

As part of our comprehensive plan, we’re also working hard to prevent access to products we believe are adulterated or misbranded. We recently joined with the Federal Trade Commission to issue 13 joint warning letters to companies that misleadingly labeled or advertised nicotine-containing e-liquids as kid-friendly food products (juice boxes, candies, and cookies).

As part of our comprehensive approach, we’ll also be proposing new regulations to establish requirements for the administrative detention of tobacco products encountered during an inspection that an officer or employee believes to be adulterated or misbranded. These steps will allow us to more effectively block the distribution and use of products that are ultimately found to be violative, including products that are misbranded because their labeling or advertising causes them to resemble kid-friendly foods.

Modernizing and Harmonizing Standards

As part of our efforts to continue to ensure efficiency of existing regulations, we will be taking another step to modernize medical device regulation, by proposing a new regulation to replace certain aspects of existing Quality System regulations with specifications of an international consensus standard for medical device manufactures (ISO). This rule, if finalized, will harmonize domestic and international requirements and modernize the regulation to make it more efficient for manufacturers of medical devices seeking to sell their products globally, while also continuing to ensure they adhere to high, internationally-accepted quality systems.

Enhancing Clinical Trial Processes

The Spring Unified Agenda also will propose rules to support the clinical trial process, for instance regarding the requirements for cooperative research. We’re proposing a new rule that would, in most cases, allow any institution located in the U.S. that is participating in a multisite cooperative research to be able to rely on approval from a single institutional review board.

We also will be issuing a proposed rule to update the agency’s investigational new drug application regulations to define and clarify the roles and responsibilities of the various persons engaged in clinical investigations to enhance protection of the rights, safety, and welfare of subjects and better ensure the integrity of clinical trials.

In addition to the new proposed regulations I’m highlighting here, FDA will continue to pursue a multitude of other important rules across the Agency, such as taking forward our compounding policy priorities and advancing food and drug safety initiatives. Moreover, we continue to remove outdated rules or reconsider proposed rules in light of our evolving policy priorities. I want to note, however, that some previously identified regulations that weren’t included in this Unified Agenda may still remain FDA priorities. Just because you don’t see them here, doesn’t mean that we don’t intend to continue advancing some prior policy proposals.

While we continue to have a robust regulatory agenda for the coming year, regulation is only one way in which we can foster our mission and improve public health. We’ll continue to tackle many additional priority areas through guidance documents and other policy efforts. These areas will include efforts to reduce the cost of drugs by encouraging competition – including in biosimilars; spurring innovation across medical products; battling obesity through our various nutrition initiatives; and, continuing to attack the opioid addiction crisis facing our country.

I look forward to keeping you updated as we progress toward these goals.

Scott Gottlieb, M.D., is Commissioner of the U.S. Food and Drug Administration

Follow Commissioner Gottlieb on Twitter @SGottliebFDA

The FDA is Asking for More Information on Application Forms — Here’s Why That’s Good for Innovation and Improving Health

By: Christopher Leptak, M.D., Ph.D.

To be most effective, electronic health records (EHRs) use a systematized and standardized nomenclature for the hundreds of thousands of clinical terms that characterize patient care. This helps to ensure consistency from EHR to EHR and allows these records to be usable from healthcare entity to health care entity, a concept known as interoperability. This nomenclature, used by both industry and the federal government, is called SNOMED CT.

Christopher LeptakRecognizing the value of such a comprehensive and standard clinical healthcare terminology, the FDA is also embracing the use of SNOMED CT to characterize disease names for its drug development pipeline and for FDA-approved products. The forms drug developers submit in their product applications now request use of this nomenclature. Forms for Investigational New Drugs (INDs) (FDA Form 1571) and New Drug Applications (NDAs), Biologic License Applications (BLAs) and Abbreviated New Drug Applications (ANDAs) (FDA Form 356h) have been revised to request additional supplemental systematized information using the SNOMED CT nomenclature to state for what disease or diseases the drug in the application is indicated.

Here’s why the new nomenclature is good for innovation and improved health: By clearly identifying the intended uses or indications for a potential new drug, SNOMED CT enabled metrics will better inform review activities and aid in consistency in the FDA advice for applications with similar indications. Newly systematized indication information will allow the FDA to better identify areas of unmet medical need for future drug development. This information will also help inform policy development, and with it, allow FDA to become more proactive about developing guidances and gathering public feedback. Additionally, using SNOMED CT will make it possible for the FDA to link its internal data with other data sources coded to SNOMED CT (e.g., EHRs).

To help industry understand what to do, we just released an online tutorial for industry explaining the newly revised forms in detail.

We look forward to working closely with industry to make sure applicants understand the revised forms and how to fill them out. We encourage industry to watch the tutorial, learn the coding system, and partner with the FDA on improving public health.

Christopher Leptak, M.D., Ph.D., is Director, Office of New Drug’s Regulatory Science Program in the FDA’s Center for Drug Evaluation and Research.

Food Information That’s Pro Market and Pro Consumer

By: Scott Gottlieb, M.D.

Information about how healthy our food is gives us the chance to make better choices about our diets. This same information also inspires competition among producers to formulate food in ways that make it more healthful.

Dr. Scott GottliebThese core principles are at the heart of FDA’s recent initiative to expand opportunities for food manufacturers to make voluntary claims on food products about the healthy attributes of their merchandise. Easier access to this information is something both consumers and manufactures want. More Americans are looking for healthier food options. At the same time, food producers should be able to compete on the ability to develop foods that are healthier, and make reliable, science-based claims about these attributes to consumers.

So at FDA, we’re reforming our policies to make it more efficient to develop these claims. This clarity may encourage more manufacturers to invest in making foods healthier.

These same principles also underlie our efforts to promote the disclosure of basic information about calories on chain restaurant menus. Americans drink or eat about one-third of their daily calories outside the home. While we all want to be able to share a good meal with our families, our hectic lives often have us looking to chain restaurants or take-out meals for convenience and value. Food options aren’t always healthy. But there’s no reason that convenient, affordable food can’t also be wholesome.

America is the world’s breadbasket, with some of the most innovative manufacturers. Whether companies are formulating food to be sold at grocery stores for meals we prepare ourselves — or served in restaurants or grab-and-go establishments — they should have the same incentives to compete on delivering healthy, inexpensive food options that are also tasteful. And food producers and retailers should have the same ability to make claims about the healthy attributes of their products.

Driving this “healthy” competition depends on transparency and a level playing field.

This is why FDA is implementing efficient rules to make sure that consumers are provided with some basic information about the nutritional features of food provided both through our nutrition facts label that consumers see on food sold in stores, as well as through the new restaurant menu label rule that goes into effect next week.

Over the past year we’ve worked hard to make sure this new rule can be implemented in a way where the information will be maximally beneficial to consumers and the new requirements will be minimally burdensome to restaurants and retail establishments.

National menu labeling could help make a big difference in America’s obesity rates, one of our most vexing public health challenges. Today, about 40 percent of all Americans are obese, and obesity increases the chances of developing heart disease, diabetes, and some types of cancer. Weight-related diseases and conditions reduce productivity and shorten lives due to decades of metabolic damage. Obesity also is a big driver of chronic disease.

Starting next Monday, consumers will be able to walk into any large chain restaurant and other chain establishments in the country and know, at a glance, how many calories are in the foods a restaurant offers. Surveys show consumers overwhelmingly want this information. And many use it to improve their diets and health.

Studies show that menu labeling can make an important difference in every day food choices that add up over time. Recent research shows that smart menu labeling reduces the average number of calories ordered by 30 to 50 calories per visit.

That may sound like a small amount. It comes out to less than a cookie a day. But over a year, based on that sort of reduction, you could end up consuming 10,000 to 20,000 fewer calories, making you three to five pounds slimmer. Consuming just 64 fewer calories per day, on average, would help the nation meet the government’s goal of reducing youth obesity by 2020. Better information that prompts people to cut 50 calories a day out of their diets can go a long way. And, over time, this can drive population-wide changes.

Creating a level playing field for menu labeling is only one of the steps FDA is pursuing to leverage diet as a way to help Americans reduce their burden of chronic disease.

We’re also taking final steps to implement the new Nutrition Facts label. This is the first overhaul of food labeling in more than 20 years. Consumers will soon have access to an updated food label that’s based on current science. It provides more easily understandable information to help Americans to build healthy, home-cooked menus when they’re shopping in grocery stores.

And FDA is taking new steps to modernize our approach to food claims. Claims can show that a food component may reduce the risk of a health-related condition, such as the relationship between folate and the reduction in risk of a child being born with certain birth defects, or high fiber and low fat diets reducing the risk of developing some types of cancer. Claims can also help consumers quickly identify foods that are lower in a food component that they are trying to avoid like sodium.

Combining food claims and enhanced labels can allow families to mix and match foods and meals that contain essential nutrients, while staying within caloric guidelines. Consumers also will have an easy to use and consistent baseline for the nutrition information that they need to better manage their health. These efforts were outlined in a nutrition initiative that I announced last month. Our goal is to leverage diet as a way to reduce death from chronic disease.

Consumers already are demanding more information about their diets, becoming smarter shoppers, and seeking out healthier options. In a 2016 survey of more than 1,500 consumers, virtually all responded that it’s important that the brands and manufacturers they buy from are transparent about what is in their food and how it is made. It’s in everyone’s interest to have meaningful nutrition information and claims that consumers can understand and trust.

We’ve already seen healthy changes in the restaurant market supported by consumers, like coffee chains shifting their recipes from whole milk to two percent milk. You can still order whole milk, but now the default option is better for your health and your waistline. Many kid’s meals now come with the option of apple slices instead of fries. These are changes for the better without taking away anyone’s choices. This is how information drives competition by producers to make food more healthful, and also make consumers more discerning. Armed with reliable information, consumers are making these choices.

I know not everyone has supported restaurant menu labels. Not every chain wants to display calorie information. But consumers want this data. And FDA has taken steps to make it easy for manufacturers and restaurants to provide this information in cost effective ways already found in many chains. In addition, firms won’t need to deal with a patchwork of different requirements for calorie labeling across the country.

In the guidance we’ll soon release, we took the concerns of the industry to heart, particularly that it could be costly to display calorie information. So, we lay out flexible options for complying with the requirements ranging from low-tech paper menu handouts to utilizing the electronic kiosks that are becoming commonplace in food establishments around the country. These options won’t require costly changes to existing infrastructure.

Further, we’ve made clear that materials used for marketing don’t have to have calorie counts on them. That picture of a delicious cheeseburger doesn’t require a calorie declaration. And when it comes to build-your-own foods, like choose-your-topping pizzas, calorie ranges can be used to make the various combinations fit on a standard-size menu board. We also provide more flexibility when it comes to the calories information that restaurants need to disclose. We know that prepared food can diverge from one entree to the next. So we allow room for that variability.

Pizza makers don’t need to worry about that extra slice of pepperoni.

America’s food industry is ripe for innovation. Consumers want healthier options and food producers want to develop these choices and make claims about these attributes. We support those innovations. And science-based regulations and transparent labels make it easier for consumers to understand the impact that day-to-day food choices have on their long-term health. They also make it practical for producers to compete on these features.

Consumers also want to have the chance to make informed choices about the meals they eat out based on access to nutritional information. Our goal is to establish a menu labeling framework that allows our broad food industry to meet these desires in an efficient and cost-effective manner that also accommodates the industry’s diverse business models.

Scott Gottlieb, M.D., is Commissioner of the U.S. Food and Drug Administration

Follow Commissioner Gottlieb on Twitter @SGottliebFDA