SCORE at Six Months: Meeting the Challenge of Complex Recalls

By: Stephen Ostroff, M.D., and Howard Sklamberg, J.D.

When a potentially contaminated food is on the market, time is of the essence to keep people from becoming ill. Yet there are times when it is difficult to determine what actions should be taken. This can happen when we do not have enough information to reach a clear decision.

Stephen Ostroff, M.D.

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

To better address these situations, in April FDA established a team of senior leaders that is brought in to make decisions in the most challenging cases. The team is called SCORE, which originally stood for Strategic Coordinated Outbreak Response and Evaluation, but it soon became clear that the scope of its work is broader than outbreaks. The team looks at cases in which recalls and other actions may be needed, even when there are no reports that people have fallen ill. So SCORE now stands for Strategic Coordinated Oversight of Recall Execution.

And we’re happy to report that SCORE is already making a difference, helping to overcome obstacles and streamlining processes to get potentially harmful foods off the market as soon as possible to reduce further consumer exposure.

In the last six months, SCORE has reviewed and directed operations in cases that include flour contaminated with peanut protein, (a major food allergen), facilities contaminated with Listeria monocytogenes, pistachios in which Salmonella was detected, and baby food that was not manufactured in compliance with infant formula regulations. All of these cases resulted in recalls and announcements issued by the firms and FDA.

Howard Sklamberg

Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

SCORE was launched, in part, in response to concerns raised by the Department of Health and Human Services’ Office of the Inspector General about FDA’s ability to ensure that companies initiate voluntary recalls in a prompt and effective manner. While FDA staff were already helping to facilitate thousands of prompt and successful voluntary recalls, we recognized the need for an enhanced response in certain, more complex cases.

In the cases brought to the team, we believe that SCORE has helped determine the right course of action and shorten recall timeframes, getting the products off the market faster. SCORE has helped improve tactical planning, leading to additional inspections and sampling assignments, and to getting the word out to more consumers about potentially dangerous products. In one case, FDA suspended a food facility’s registration after a reinspection and additional sampling requested by SCORE showed continued contamination. Suspension of registration effectively shuts a facility down until FDA determines that there is no longer a reasonable probability that foods produced there will cause serious illnesses or death.

We set individual deadlines and got prompt results in these, and other, instances. FDA staff are seeing these actions as a model for their efforts going forward.

FDA has been evolving over the past few years into an agency that speaks with one voice in its oversight of food safety. SCORE’s membership includes leaders from within the directorates of Foods and Veterinary Medicine and Global Regulatory Operations and Policy, in addition to the Office of the Chief Counsel. The spectrum of expertise covers inspections and investigations, compliance and enforcement, policy, legal, communications, outbreak response and, most important, science.

This team is in its infancy but the results it has achieved thus far signal an integrated approach to food recalls that will help ensure a swift response no matter what obstacles arise. The arrival of the compliance dates for the FDA Food Safety Modernization Act rules overseeing the safety of domestic and imported foods are putting additional food safety controls in place to help reduce food contamination. And the work of SCORE and its colleagues will continue.

SCORE’s goals for the next year include identifying and closing gaps that slow the process of determining whether a food is a threat to public health or interfere with identifying the right actions to take in response to potential contamination. Our ultimate goal is to continue to improve our ability to protect consumers from contaminated food.

Stephen Ostroff, M.D., is FDA’s Deputy Commissioner for Foods and Veterinary Medicine, and Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy.

Introducing FDA’s Emerging Sciences Idea Portal: Please Help Us Predict the Future

By: Donna L. Mendrick, Ph.D.

Gazing into the future to predict the next new things in science and technology is not just the work of a science fiction writer.

Donna MendrickGovernment and business engage in this forward thinking too– it’s called “horizon scanning,” a fairly recent practice that involves systematically gathering a broad range of information about emerging trends to help organizations develop the capabilities they need to deal better with an uncertain and complex future.

FDA set up its own intra-agency horizon scanning group in April 2015 called the Emerging Sciences Working Group, which I chair. Our 15-member group meets regularly and includes representatives from FDA product and research centers as well as relevant offices.

With the mission of leveraging scientific expertise and resources to conduct long-range horizon scanning, we advise Agency and product center leadership on how emerging issues and cross-cutting scientific advances may affect FDA preparedness and activities across government agencies.

The fact is, FDA’s ability to achieve its mission relies on awareness and preparing pro-actively to address emerging issues and scientific advances that will affect the products FDA regulates five or more years in the future – well in advance of formal FDA regulatory submissions.

What kinds of new science and technology will alter the way FDA does its work? We are not focused on evolving areas such as nanotoxicology, since nanoparticles are already in some approved products even though the field is still being developed and understood.  Our goal is to identify areas not yet addressed in current products like hibernation for surgery and brain-computer interfaces.

Once we have such information it can be used for science-based planning, programs, policies, reporting, and communication within and outside FDA.

It’s no surprise that FDA can’t possibly employ experts in every subcategory of scientific and technological knowledge. To cast a wide net, we are also seeking the advice of other government agencies that fund research, evaluate patent submissions, and develop scientific policy for the U.S. government — and that process has begun.

But it is clear that to fully horizon scan we must turn to experts in the private sector. That’s why today we are issuing a Federal Register notice asking science and technology experts outside of the government to submit their predictions on the next new things in their field of specialization.

To be clear, we’re not looking for advances that are already under discussion. We’re seeking information about scientific and technological advances that are so unknown they don’t show up – or barely show up – on a web search.

Your electronic submissions to our Emerging Sciences Idea Portal will be public so all confidential information should be submitted in writing. And there is no guarantee we’ll get back to you with a response – but we might if we’re sufficiently intrigued and want more information.

We look forward to your submissions. With your help, FDA will be ready to provide advice and to promptly review applications for products that truly represent the next new thing.

Donna L. Mendrick, Ph.D., is FDA’s Associate Director for Regulatory Activities at the National Center for Toxicological Research

New FDA/EMA rare diseases and patient engagement clusters underway

By: Jonathan Goldsmith, M.D., FACP, and Sandy Kweder, M.D., RADM (Ret.) US Public Health Service

Drug development and approval happens across the globe and we at FDA strive to collaborate with other countries and international regulatory agencies to ensure public health. One of our most valuable collaborators is the European Medicines Agency (EMA) — our counterpart agency for drug regulation in Europe that coordinates a network of 4,500 scientists and evaluates and supervises medicines for more than 500 million people in 31 countries.

Dr. Jonathan Goldsmith

Jonathan C. Goldsmith, M.D., FACP, FDA’s Associate Director Rare Diseases Program, Center for Drug Evaluation and Research, Office of New Drugs

For more than a decade, FDA and EMA scientists have collaborated to help solve some of our biggest challenges. We work with them in groups called “clusters.” The first cluster was initiated in 2004. Since then clusters have been formed to focus on treatments for children; establish effective measures for the development and use of biosimilar medications as cost effective alternatives to brand name biologic drugs; evaluate new treatments for patients with cancer; set standards to help develop medicines personalized to a patient’s genetic makeup, and much more. Both agencies have benefited from this joint work. The EMA summarizes these and our other clusters on its website.

We are excited about the initiation of our most recent cluster activity with our EMA colleagues. Just last month we established a cluster that will work to advance treatments for patients with rare diseases. This cluster’s primary goal is for FDA and EMA scientists to share valuable information about their work and to collaborate on certain review aspects of rare disease drug development programs. FDA’s core members of the cluster include experts from FDA’s Center for Drug Evaluation and Research’s Rare Diseases Program, the Office of Pediatric Therapeutics, the Center for Biologics Evaluation and Research’s director’s office, and the Office of Orphan Products Development, but other experts will be engaged on specific topic areas as the cluster evolves. Among many other important activities, our agencies will collaborate on:

  • Identification and validation of trial end points;
  • Potential trial designs when only small populations of patients are available for testing the safety and effectiveness of prospective new therapies;
  • Ways to apply flexibility in evaluation of drug development programs;
  • Expediting the review and approval of drugs to treat rare diseases to bring new drugs to patients in need as soon as possible.
Sandra Kweder

Sandra Kweder, M.D., Rear Admiral (Ret.) US Public Health Service, FDA’s Deputy Director, Europe Office, and Liaison to European Medicines Agency

Our work also builds on another exciting and recent development — a patient engagement cluster formed in June 2016 to incorporate the patient’s involvement and viewpoint in the drug development process. FDA and EMA are interested in understanding patient’s experiences and gaining input on their tolerance for risk and uncertainty, on current therapy and its benefits or shortcomings and on the benefits that patients seek. This cluster, among other valuable efforts, will:

  • Help each agency learn how the other involves patients in their work, and to develop common goals of expanding future engagement activities with patients;
  • Discuss ways for finding patients that can serve as spokespersons for their community;
  • Explore ideas to help train selected patients and advocates to effectively participate in agency activities, and;
  • Develop strategies for reporting the significant impact of patient involvement.

Given the focus of both of these new clusters, we expect they will address new areas of interest and also draw on expertise from all of the other clusters, such as oncology, pediatrics, and orphan diseases, contributing to more advanced and robust collaborations across both of our organizations.

Focusing on patients with rare diseases and working to advance patient input enhances the value of our cluster activities. With our colleagues at the EMA we look forward to accomplishing more than what we can individually.

Jonathan C. Goldsmith, M.D., FACP, FDA’s Associate Director, Rare Diseases Program, Center for Drug Evaluation and Research, Office of New Drugs

Sandra Kweder, M.D., Rear Admiral (Ret.) US Public Health Service, FDA’s Deputy Director, Europe Office, and Liaison to European Medicines Agency

Where We Are/What We Have Done – Two Years After Releasing Our FDASIA 907 Action Plan

By: Janice Soreth, M.D.

Since it’s been more than two years since FDA unveiled its Action Plan to advance the inclusion of diverse populations in clinical trials, we’d like to update you on how much we have accomplished, and acknowledge that continued commitment is critical in order to build on this foundation.

Janice SorethThe Congressional mandate under Section 907 of the FDA Safety and Innovation Act of 2012 required FDA to develop a report examining the extent to which various demographic groups were included in clinical trials and their outcomes reported in labeling for medical products for which applications were submitted to FDA. The legislation also required FDA to develop an Action Plan based on the report findings and input from stakeholders, issued in August 2014. The Action Plan identified 27 discrete actions for FDA to take within the three priority areas: improving data quality, encouraging greater clinical trial participation, and ensuring more data transparency.

As we discussed at our public meeting on February 29th, we have made progress on nearly every one of our action items and we continue to make strides.

In June 2016, FDA issued the draft guidance, “Evaluation and Reporting of Race and Ethnicity Data in Medical Device Clinical Studies.” We are also updating the 2005 “Guidance for Industry Collection of Race and Ethnicity Data in Clinical Trials.”

Our popular Drug Trials Snapshots, providing information about who participated in clinical trials supporting FDA-approved drugs and biologics, have now been posted on some 75 products. This innovative program developed by our Center for Drugs Evaluation and Research also highlights whether there were any differences in the benefits and side effects among sex, race, and age groups

We have significantly advanced efforts to raise clinical trials awareness. FDA’s Office of Women’s Health instituted a new initiative on “Diverse Women in Clinical Trials” that is disseminating consumer resources in English and Spanish and tools for clinical researchers in partnership with NIH’s Office of Research on Women’s Health. Our Office of Minority Health developed a tool kit and posted several public service announcements on FDA’s YouTube channel aimed at engaging patient participation. And we are currently reviewing the public comments from a range of organizations that we received to the public docket that was opened at the time of the public meeting.

Finally, I want to announce that I recently took over the chairmanship of the steering committee charged with implementing this plan. I am currently the Acting Associate Commissioner for Special Medical Programs, which has oversight of our advisory committee programs, combination products, and pediatric and orphan products programs among other responsibilities. Since joining FDA as a primary medical reviewer 25 years ago, I have served as CDER’s director of the division of Anti-Infectives and Ophthalmology and most recently spent five years in London as Deputy Director of the FDA Europe Office and Liaison to European Medicines Agency.

As we look back at our accomplishments, we believe that transparency in reporting about clinical trial inclusion will make a difference in encouraging broader demographic diversity and want to thank the former chair, Barbara Buch, M.D., of CBER, for her accomplishments. Going forward, I encourage you and all of our key stakeholders – patient and disease advocates, health professionals, and industry to continue partnering with us to advance this important work in ensuring demographic diversity and representation.

Janice Soreth, M.D., is Chair of the FDA Safety and Innovation Act Section 907 Steering Committee and the Acting Associate Commissioner for Special Medical Programs

Our 20th Patient-Focused Drug Development meeting: Enhancing the patient’s voice in FDA’s approach to drug review and development

By: Theresa M. Mullin, Ph.D.

Since the launch of the Patient Focused Drug Development program as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V), we have worked intensively to explore ways to enhance the patient’s voice in drug development. Recently we reached a particularly gratifying milestone in this important work — our 20th Patient-Focused Drug Development (PFDD) public meeting.

Theresa MullinThe PDUFA program provides much needed funding from the pharmaceutical industry to support FDA’s premarket review activities and the agency’s work to encourage drug development. Under PDUFA V, FDA committed to obtain patients’ views in at least 20 disease areas over the course of the program’s five year period, which ends in September, 2017. That means conducting a public meeting for each disease area to obtain patient perspectives on the impact of the condition on daily life and current treatment approaches. Our 20th PFDD meeting, with patients who have received organ transplants, took place on September 27th. With that meeting completed, we fulfilled our commitment — one year ahead of schedule.

The PFDD meetings have given us the opportunity to strengthen our understanding of the targeted disease areas and hear directly from patients, their families, and caregivers about the symptoms that matter most to them; the impact of the disease on daily life, and their experiences with currently available treatments. Having this kind of input is extremely valuable for us because hearing what patients care about can help us determine how best to facilitate drug development for a particular disease area. Hearing the patients’ perspectives also helps us understand how patients view the benefits, risks, and burdens of treatments for their condition.

While FDA plays a critical role in drug development, we are only one of the players in the process; other stakeholders, including healthcare providers and industry sponsors, who have attended the PFDD meetings to hear from patients, are also gaining valuable information. The  PFDD meetings have also helped  identify areas of unmet need within the patient population (e.g., the psoriasis meeting highlighted the need for treatments for the pediatric population living with psoriasis) and helped raise awareness and focus engagement within the patient community itself (e.g., in preparation for the narcolepsy meeting patient groups collaborated to form a coalition called Unite Narcolepsy). We’ve chronicled this and more in our Voice of the Patient reports, which provide a detailed account of the valuable input we’ve heard at each meeting.

The Voice of the Patient reports are intended to be useful to both our FDA colleagues conducting reviews and the broader community. These reports summarize what FDA heard through patient speaker panels, audience participation, the webcast, and submissions to the public docket. Each report faithfully captures this information as a valuable resource for the FDA review divisions and is distributed internally to the relevant review divisions for reference when advising sponsors on their drug development programs and when assessing products under review in that disease area.

As drug development advances in the 21st Century, sponsors are using increasingly sophisticated and vital forms of technology to generate the medicines of the future. But there is a critical part of drug development — gaining ever increasing importance in the process — that has little to do with advanced technology. Instead, it has to do with listening to patients and their personal experiences living with their disease and its treatment, and determining the best ways to reliably capture this perspective so that it can be better integrated into decision making.

We believe that the long-term impact of PFDD will be better, more informed FDA decisions and oversight both during drug development and during our review of a marketing application. We are extremely grateful to all of the hundreds of patients and their loved ones who have so generously and, in some cases, courageously, participated in our meetings and have shared their personal stories, experiences, and perspectives.

We may have met the letter of our PDUFA commitment, but we are not finished. Patient-Focused Drug Development is a priority for FDA. Beyond the 20 meetings we have already held, we plan to hold four more PFDD meetings by the end of FY2017. Additionally, we recognize that there are many more disease areas to address. To help expand the benefits of FDA’s PFDD initiative, FDA welcomes similar patient-focused meetings organized by the patient groups themselves. For this parallel effort to FDA’s PFDD initiative, interested patient groups can submit a letter of intent. More information is outlined on FDA’s website.

One of the most valuable things we can do as regulators at FDA is simply to listen. I’m reminded of that each time we hold a PFDD public meeting. FDA will continue to listen — and learn — and we look forward to continuing to gain the additional insights that only patients, their families, and caregivers can provide.

Theresa M. Mullin, Ph.D., is Director of FDA’s Office of Strategic Programs in the Center for Drug Evaluation and Research

precisionFDA’s Next Challenge? Conduct an App-a-Thon!

By: Zivana Tezak, Ph.D., and Elaine Johanson

FDA is increasingly harnessing the power of supercomputers, the creative and collaborative culture of the scientific community, and novel approaches to technology to help achieve advances in diagnostics, therapeutics, and analytics that will ultimately benefit patients.

Zevana Tezak

Zivana Tezak, Ph.D., is Associate Director for Science and Technology at FDA’s Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health

Perhaps no program personifies these efforts more than the online research portal precisionFDA, which was developed by FDA scientists with the help of leading minds from Silicon Valley as part of President Obama’s Precision Medicine Initiative (PMI).

The goal of the PMI is to help translate scientific knowledge about genomics into clinical care. As part of this initiative, precisionFDA’s task is to advance the use of a core technology behind the PMI known as next generation sequencing or NGS, which is capable of mapping the entire human genome. To achieve that, precisionFDA is drawing upon the latest computing and storage technologies to provide an open source cloud-based space where experts can share data, ideas, and methodologies. Today, it boasts more than 1,600 participants, including researchers, test developers, industry, academics, statisticians, and clinicians.

One way we’ve been learning and growing is through contests designed to spark the creative thinking of members on behalf of important NGS questions about data, analytics, and sequencing tools.

We are happy to announce the next challenge: an “App-a-Thon,” inviting software developers to get together with their peers, collaborators, and friends to add NGS software apps to the precisionFDA app library. Apps in this case are executable commands using the Linux operating system that are “wrapped” around NGS software.

Elaine Johanson

Elaine Johanson, is precisionFDA Project Manager and Deputy Director of FDA’s Office of Health Informatics

Apps can be existing, modified, or completely new. Ultimately this challenge, which closes Oct. 28, 2016, is a contest to engage the NGS community in the development of new genome sequencing analytical tools for use on precisionFDA. These apps can do a variety of useful activities such as simulations, benchmarking, data integration, mapping portions of the genome, or identifying genetic variants. Members of precisionFDA are encouraged to try out these apps by running them on the platform.

Our goal is to build a robust reference library of apps and files so that precisionFDA can provide developers with everything they need to support development work on their software pipeline or tests.

If you’d like to set up an App-a-Thon, FDA provides the framework and all the materials, storage, and compute capacity to hold an App-a-Thon on precisionFDA. We encourage you to choose a timeframe, invite your researcher/developer friends, and follow the directions in FDA’s ‘App-a-Thon in a Box’ toolkit. This toolkit even contains video and results from a precisionFDA App-a-Thon held at Stanford University.

The results of this challenge will be highlighted by FDA Commissioner Robert Califf at the World Precision Medicine Congress on Nov. 14, 2016 in Washington D.C. Participating will benefit the entire NGS community, but most importantly, it will advance public health and benefit the patients we collectively serve.

Zivana Tezak, Ph.D., is Associate Director for Science and Technology at FDA’s Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health 

Elaine Johanson, is precisionFDA Project Manager and Deputy Director of FDA’s Office of Health Informatics

Using Symbols to Convey Information in Medical Device Labeling

By: Antoinette (Tosia) Hazlett, MSN, RN, and Scott Colburn CAPT, USPHS

Symbols convey important messages for navigating everyday life; whether it’s a traffic sign or a graphic image indicating that no smoking is allowed in a building. Symbols in medical device labeling can also convey important information. However, to be an effective means of communicating information, it’s critical that symbols on medical devices are understood by the individuals who use them.

Tosia Hazlett

Antoinette (Tosia) Hazlett, MSN, RN, Senior Policy Analyst at FDA’s Center for Devices and Radiological Health

In June, FDA issued the Use of Symbols in Labeling final rule, which describes the circumstances in which manufacturers can use a stand-alone symbol in device labeling without any adjacent explanatory text. For example, if certain requirements are met under the final rule, manufacturers of sterile syringes could opt to use the symbol for “do not reuse” on a syringe package without adding the actual words “do not reuse” to the package.

Using Symbols

The “Use of Symbols in Labeling” final rule which went into effect on September 13, 2016, does not mandate the use of stand-alone symbols in device labeling. Under the final rule, device manufacturers have three options. They can choose not to use symbols, use symbols with adjacent explanatory text, or use stand-alone symbols that have been established in a standard if certain requirements are met, including providing an explanation of the symbols in a symbols glossary that is included in the labeling for the device.

Adding the option of stand-alone symbols is expected to reduce design costs for manufacturers because it is more consistent with how devices are currently labeled in Europe and other foreign markets. Replacing small and difficult-to-read text with a symbol will also help make some labeling more user-friendly and understandable. That is critical in medical device labeling, where space may be limited. The use of stand-alone symbols on a global scale may help promote better understanding through consistent labeling across products distributed in the U.S. and foreign markets.

Scott Colburn

Scott Colburn CAPT, USPHS, FDA’s Director, Center for Devices and Radiological Health Standards Program

Before this rule, FDA recognized five consensus standards that address the use of stand-alone symbols. On the same day this rule was issued, FDA updated its currently recognized consensus standards list and added three new standards containing more symbols in a published standards-recognition notice.

Symbols Glossary

The required symbols glossary is intended to help users become familiar with the meaning of the stand-alone symbols and serve as a reference for users to look up any definitions they may not recall.

The symbols glossary may be in a paper or electronic format as long as it is included in the labeling for the device. Additionally, the labeling on or within the package that contains the device must bear a prominent and conspicuous written statement identifying the location of the symbols glossary.

Symbol Statement “Rx Only” or only”

The rule also allows for the use of the commonly used symbol statement “Rx only” or “℞ only” in the labeling for prescription devices.

Learn More

On Monday, July 25, 2016, FDA conducted a webinar to help industry and patient groups learn more about this final rule and the new standards recognition notice. The slides, recording and transcript from the webinar entitled, “Final Rule: Use of Symbols in Labeling” is available on the CDRH Learn  and Webinar webpages.

Antoinette (Tosia) Hazlett, MSN, RN, is a Senior Policy Analyst at FDA’s Center for Devices and Radiological Health

Scott Colburn CAPT, USPHS, is FDA’s Director, Center for Devices and Radiological Health Standards Program

FDA’s Clinical Investigator Training Helps Support the Drug Development Process

By: Leonard Sacks, M.D., and Mili Duggal, Ph.D., M.P.H.

Though many people do not know it, FDA does much more to facilitate drug approval than evaluate new drug applications. We are also actively involved in drug development well before the application stage. One important way we do this is by training scientists who conduct the clinical trials for drugs in development. This helps ensure that the drug studies conducted by investigators meet the applicable regulatory requirements and that the applications submitted meet regulatory standards.

Leonard Sacks

Leonard Sacks, M.D., is Associate Director for Clinical Methodologies, Office of Medical Policy, at FDA’s Center for Drug Evaluation and Research

We are excited to announce our seventh annual Clinical Investigator Training Course, which will be held in collaboration with the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M-CERSI) from November 7-9, 2016, at the Civic Center, Silver Spring, Maryland. The course is designed for physicians, nurses, pharmacists, and other healthcare professionals who are involved in the design, conduct, and evaluation of clinical trials. Participants receive training by senior FDA experts and guest speakers from industry and academia, which enables them to learn the scientific, regulatory, and ethical aspects of clinical trials.

FDA has successfully conducted the Clinical Investigator Training Course since 2009, training more than 1,000 attendees from the U.S. and other parts of the world, including Germany, Spain, Zimbabwe, and China. Over the years, participants have included healthcare professionals from government organizations, regulatory bodies, academia, industry, and the healthcare sector.

Mili Duggal

Mili Duggal, Ph.D., M.P.H., is an ORISE Fellow, Office of Medical Policy, at FDA’s Center for Drug Evaluation and Research

FDA developed this course so that investigators could learn directly from our staff and interact with them. Clinical trial investigators play a critical role in the development of medical products. They are responsible for protecting the safety and welfare of study subjects and for acquiring adequate and reliable data to support regulatory decisions. FDA recognizes that investigators should be comprehensively trained to conduct trials efficiently. The course’s goal is to develop competence and expertise among clinical investigators, improve the quality of clinical trials, and support patient safety.

As we continue to build our program, FDA will work to integrate the latest scientific information and good clinical practices into our course. We anticipate a new round of exciting discussions with our attendees this year and we invite all who are interested and wish to attend to take a look at the course website for more details. We look forward to helping many more talented researchers hone their clinical investigator skills to advance new drug development for the American public.

Leonard Sacks, M.D., is Associate Director for Clinical Methodologies, Office of Medical Policy, at FDA’s Center for Drug Evaluation and Research

Mili Duggal, Ph.D., M.P.H., is an ORISE Fellow, Office of Medical Policy, at FDA’s Center for Drug Evaluation and Research

Making Sure ‘Healthy’ Means What It Says on Food Packages

By: Douglas Balentine, Ph.D.

With final rules on the Nutrition Facts label published, consumers soon will see an updated label on food packages that makes the calories and serving sizes of products easier to see and that gives them additional nutrition information, such as added sugars, vitamin D, and potassium.

Doug BalentineThe marketplace is teeming with rows and rows of foods – some new and some not; some healthier than others. Even for the well informed, choosing what to buy is challenging, especially if you want to choose a healthy diet for you and your families.

We know that many consumers use the Nutrition Facts label, especially when they are buying a food for the first time. Often, there are also a lot of other terms on food packages such as “healthy,” “low in fat,”or “good source.” We also know that many just don’t have the time to consider the details of nutrition information on every package they purchase. In fact, most purchase decisions are made quickly, within three to five seconds.

That’s why we’re looking at how we define the claim “healthy.” Companies can use this and other claims on the front of packages of foods that meet certain criteria to help consumers quickly identify nutritious choices.

As our understanding about nutrition has evolved, we need to make sure the definition for the “healthy” labeling claim stays up to date. For instance, the most recent public health recommendations now focus on type of fat, rather than amount of fat. They focus on added sugars, which consumers will see on the new Nutrition Facts label. And they focus on nutrients that consumers aren’t getting enough of, like vitamin D and potassium. By updating the definition, we hope more companies will use the “healthy” claim as the basis for new product innovation and reformulation, providing consumers with a greater variety of “healthy” choices in the marketplace.

We have started to consider the criteria or terms for an updated definition of “healthy” but don’t have all the answers. As a first step, we are asking for public input on a range of questions about what “healthy” should mean from a nutrition perspective and how consumers understand and use “healthy” food label claims.

For example, what current dietary recommendations should be reflected in the definition of “healthy”? What are the public health benefits of defining the term “healthy”? What do consumers expect of foods that carry a “healthy” claim? What factors and criteria should be used for the new definition of “healthy”? We are also planning to hold public forums to get additional input and inform us of what a broad range of stakeholders and consumers think. This may take some time, but we want to get it right.

While we are working on the “healthy” claim, we also will begin evaluating other label claims to determine how they might be modernized. We want to give consumers the best tools and information about the foods they choose, with the goal of improving public health. And, we will also engage with industry to explore other ways to encourage companies to change their products to have better nutrition profiles. The end result will be more healthy dietary choices for consumers, and that is a worthy goal.

Douglas Balentine, Ph.D., is Director, Office of Nutrition and Food Labeling at FDA’s Center for Food Safety and Applied Nutrition

First Major FSMA Compliance Dates: Landmarks and Learning Experiences

By: Stephen Ostroff, M.D., and Howard Sklamberg, J.D.

The phrase “where the rubber meets the road” is one that comes up in conversations about different subjects, from athletics to academics, when carefully laid plans are put to a crucial test. That’s where we are today with the arrival of the first major compliance dates under the regulations developed by FDA to implement the FDA Food Safety Modernization Act (FSMA).

Stephen Ostroff, M.D.

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

This is the day when larger businesses must comply with certain new standards under the preventive controls rules for human and animal food, two of the main rules developed to drive down the incidence of foodborne illnesses in our country. Larger human food facilities must meet preventive controls and modernized Current Good Manufacturing Practice requirements (CGMPs); larger animal food facilities must meet CGMPs. (The human and animal food rules have staggered compliance dates; animal food businesses have additional time to meet the preventive controls standards, as do smaller producers of human foods.)

The preventive controls rules were the first two of seven foundational FSMA rules to become final starting in September 2015. Human food facilities are required to have a food safety system in place that includes an analysis of hazards and risk-based preventive controls to minimize or prevent those hazards. The standards that animal food facilities must meet mark the first time that CGMPs have been broadly required for the safe production of animal food.

FSMA was signed into law in 2011 in the wake of mounting concerns by consumers and lawmakers about outbreaks of foodborne illness that kill thousands of people and animals every year. What followed was an unprecedented effort by FDA to involve the diverse landscape of food safety stakeholders, including growers, manufacturers, importers, distributors, consumer groups, and academic institutions, in the formulation of rules that are practical, flexible and effective for the food industry at home and abroad while protecting the public from contaminated food.

Howard Sklamberg

Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

Since FSMA was enacted in 2011, we have literally traveled the world to get input on the rules we proposed in 2013 and early 2014 to implement the law. FDA teams have been involved in approximately 600 engagements, including public meetings, webinars, listening sessions, farm tours, visits to manufacturing plants and extensive presentations and meetings with various stakeholder groups.

As a result of these conversations, we made significant changes in September 2014 to four of the FSMA proposed rules, including the preventive controls rules, to make them more feasible and, ultimately, more effective.

So what happens now? This is a new chapter for all of us. FDA is focusing on providing the support that companies need to comply with the new requirements with education, training and technical assistance. We will be looking at how facilities are working to comply with the new food-safety standards and protect consumers from unsafe food. Of course, our mandate is to protect public health and, when necessary, the agency will act swiftly to do so.

The conversations we had with stakeholders in creating the rules will continue as we move further into the implementation phase with the preventive controls and other rules. We will be sharing our thinking on how requirements should be met in guidance documents and asking for the public to continue to provide feedback. If necessary, changes will be made; aspects of the rules will be fine-tuned. This first wave of compliance dates is important to the entire spectrum of FSMA implementation; the lessons learned will be invaluable in the years ahead when smaller food facilities are held to the new standards.

So today, the rubber meets the road. But these compliance dates aren’t the beginning of the end of our work to make FSMA a reality. They’re the end of the beginning. The partnership that FDA has forged with food producers of all kinds, and with its state, local, tribal and international regulatory partners, will ultimately protect consumers for generations to come.

Stephen Ostroff, M.D., is FDA’s Deputy Commissioner for Foods and Veterinary Medicine; Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy