A Year Later, FDA Is Better and Stronger in Protecting Consumers from Unsafe Foods

By: William Correll and Douglas Stearn

We have made dramatic changes in our response to complex, potentially high-risk food safety situations that may be difficult to address quickly.

Bill Correll

William Correll is the director of the Office of Compliance in FDA’s Center for Food Safety and Applied Nutrition

Almost a year ago, we heard concerns that FDA was not doing enough to ensure that companies promptly and effectively initiate recalls of potentially dangerous food products in those rare instances in which a firm is not responding appropriately. FDA has always been committed to protecting the U.S. food supply, which is among the safest in the world, but we recognized the need to strengthen certain compliance and enforcement strategies in cases made more complex by factors that include the nature of the product, the scope of available evidence, and the company’s response.

And so, we took to heart issues raised by the Office of the Inspector General at the Department of Health and Human Services and have used them as a catalyst for change.

Doug Stearn

Douglas Stearn is the director of the Office of Enforcement and Import Operations in FDA’s Office of Regulatory Affairs

Not just change, but a culture change. At the heart of this change was the creation of SCORE, which stands for Strategic Coordinated Oversight of Recall Execution. We are the co-chairs of this group of senior leaders that gets involved in the most challenging food safety situations, working with field staff and district offices to evaluate the range of available options and deciding quickly what action to take. For example, SCORE can drive agency action if the company is not acting aggressively enough to recall their products, and can push for use of administrative or judicial remedies.

We now have FDA compliance, enforcement, and field leaders at the table, reviewing cases every week or more often, as needed. Science and medical officers are engaged in the conversation, as are field investigators, and lawyers.

What is the right action? What should FDA be doing? What should the company be doing? These are real time, high-level decisions, with the result being that field investigators are now empowered to immediately engage senior leaders in overcoming obstacles to the rapid removal from the marketplace of foods that are, or could be, contaminated. The process of raising a food safety issue up within the agency has thus been streamlined to put FDA leaders and field staff on the same page right away.

Among the thousands of product recalls that FDA oversees each year, SCORE has played a critical role in addressing the most significant risks to the public. SCORE’s involvement has ensured that multiple recalls involving high-risk products have been initiated, has improved tactical planning, and sped the use of enforcement tools when necessary.

In the past year, SCORE has been involved in cases that included lead contamination of dietary supplements, Salmonella contamination of powdered milk, E.coli O157:H7 in soy nut butter, and Listeria monocytogenes in hummus, soft cheese and smoked fish. In addition to facilitating recalls and import alerts for the detention of products entering the United States, SCORE initiated or expedited the process for suspending the registration of two food facilities, actions that block the facilities’ ability to distribute food.

The creation of SCORE is not the only change we’ve made. There is a new recall audit plan to assess the adequacy of a company’s recall efforts and more than two dozen procedural and policy changes that have either happened or are in the works. These include an expansion of public notification of recalls that may affect the most vulnerable consumers, including the very young and elderly.

Most companies readily initiate a voluntary recall when faced with evidence that their product is unsafe. But when there is an obstacle, we are determined to overcome it, using all of the tools we have available. We’ve always taken our job seriously and we’ve shown over the past year that we will use every opportunity to do it better.

William Correll is the director of the Office of Compliance in FDA’s Center for Food Safety and Applied Nutrition

Douglas Stearn is the director of the Office of Enforcement and Import Operations in FDA’s Office of Regulatory Affairs

FDA Commissioner Asks Staff for ‘More Forceful Steps’ to Stem the Opioid Crisis

By: Scott Gottlieb, M.D.

As Commissioner, my highest initial priority is to take immediate steps to reduce the scope of the epidemic of opioid addiction. I believe the Food and Drug Administration continues to have an important role to play in addressing this crisis, particularly when it comes to reducing the number of new cases of addiction.

Dr. Scott GottliebToday, I sent an email to all of my colleagues at FDA, sharing with them the first steps I plan to take to better achieve this public health goal. With this, my first post to the FDA Voice blog, I also wanted to share my plans with you.

I believe it is within the scope of FDA’s regulatory tools – and our societal obligations – to take whatever steps we can, under our existing legal authorities, to ensure that exposure to opioids is occurring under only appropriate clinical circumstances, and for appropriate patients.

Patients must be prescribed opioids only for durations of treatment that closely match their clinical circumstances and that don’t expose them unnecessarily to prolonged use, which increases the risk of opioid addiction. Moreover, as FDA does in other contexts in our regulatory portfolio, we need to consider the broader public health implications of opioid use. We need to consider both the individual and the societal consequences.

While there has been a lot of good work done by FDA to date, and many people are working hard on this problem, I have asked my FDA colleagues to see what additional, more forceful steps we might take.

As a first step, I am establishing an Opioid Policy Steering Committee that will bring together some of the agency’s most senior career leaders to explore and develop additional tools or strategies FDA can use to confront this crisis.

I have asked the Steering Committee to consider three important questions. However, the Committee will have a broad mandate to consider whatever additional questions FDA should be seeking to answer. The Committee will solicit input, and engage the public. I want the Committee to go in whatever direction the scientific and public health considerations leads, as FDA works to further its mandate to confront the crisis of opioid addiction.

The initial questions I have tasked the Steering Committee to answer are:

  1. Are there circumstances under which FDA should require some form of mandatory education for health care professionals, to make certain that prescribing doctors are properly informed about appropriate prescribing recommendations, understand how to identify the risk of abuse in individual patients, and know how to get addicted patients into treatment?
  2. Should FDA take additional steps, under our risk management authorities, to make sure that the number of opioid doses that an individual patient can be prescribed is more closely tailored to the medical indication? For example, only a few situations require a 30-day supply. In those cases, we want to make sure patients have what they need. But there are plenty of situations where the best prescription is a two- or three-day course of treatment. So, are there things FDA can do to make sure that the dispensing of opioids more consistently reflects the clinical circumstances? This might require FDA to work more closely with provider groups to develop standards for prescribing opioids in different clinical settings.
  3. Is FDA using the proper policy framework to adequately consider the risk of abuse and misuse as part of the drug review process for the approval of these medicines? Are we doing enough when we evaluate new opioid drugs for market authorization, and do we need additional policies in this area?

These are just some of the questions I will be asking this new Steering Committee to consider right away, given the scope of the emergency we face. In the coming days, I’ll continue to work closely with the senior leadership of FDA. I want to know what other important ideas my colleagues at FDA may have, so that we can lean even further into this problem, using our full authorities to work toward reducing the scope of this epidemic.

Despite the efforts of FDA and many other public health agencies, the scope of the epidemic continues to grow, and the human and economic costs are staggering. According to data from CDC and SAMHSA, nearly 2 million Americans abused or were dependent on prescription opioids in 2014, and more than 1,000 people are treated in emergency departments each day due to misusing prescription opioids.

Opioid overdose deaths involving prescription opioids have quadrupled since 1999. In 2015, opioids were involved in the deaths of 33,091 people in the United States. Most of these deaths – more than 22,000 (about 62 people per day) – involved prescription opioids.

We know that the majority of people who eventually become addicted to opioids are exposed first to prescription opioids. One recent study found that in a sample of heroin users in treatment for opioid addiction, 75% of those who began abusing opioids in the 2000s started with prescription opioid products.

This March, a study published in CDC’s Morbidity and Mortality Weekly Report, found that opioid-naïve patients who fill a prescription for a one-day supply of opioids face a 6% risk of continuing their use of opioids for more than one year. This study also found that the longer a person’s first exposure to opioids, the greater the risk that he or she will continue using opioids after one, or even three years. For example, when a person’s first exposure to opioids increases from one day to 30 days, that person’s likelihood of continuing to use opioids after one year increases from 6% to about 35%.

Working together, we need to do all we can to get ahead of this crisis. That’s why we’ll also be soliciting public input, through various forums, on what additional steps FDA should consider. I look forward to working closely with my FDA colleagues as we quickly move forward, capitalizing on good work that has already been done, and expanding those efforts in novel directions. I will keep you updated on our work as we continue to confront this epidemic.

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

Follow Commissioner Gottlieb on Twitter @SGottliebFDA

FSMA Collaborative Training Forum: ‘Educate Before and While We Regulate’

By: Donald Kautter Jr. and Stephen Hughes

“We will educate before and while we regulate.”

That’s been a mantra for FDA as the rules that implement the FDA Food Safety Modernization Act (FSMA) have taken shape. Making sure that food producers understand the new requirements and have the knowledge they need to meet them is key to the success of this effort to prevent illnesses caused by domestic and imported foods.

However, FDA recognized early on that one size won’t fit all when it comes to training and that a variety of training options and delivery formats would be necessary to meet needs shaped by product, region, size, and other factors.

Enter the FSMA Collaborative Training Forum, convened in partnership by FDA and the U.S. Department of Agriculture. The forum is made up of the agencies, centers, associations, universities and others funded by FDA and USDA through cooperative agreements and grants to develop and deliver FSMA training. Communication between them is important to minimize overlap and improve coordination and efficiency.

The forum held its first meetings in April. Participants laid the groundwork for a vibrant collaboration that will support diverse food producers who are preparing to meet the FSMA standards.

photo of various produceThe diversity of the food producers is matched by the diverse community of training providers. The forum includes representatives of the public-private alliances funded primarily by FDA as a resource for industry: the Produce Safety, Food Safety Preventive Controls and Sprout Safety Alliances. It also includes the National Coordination Center (NCC) and four Regional Centers that were created in a partnership between FDA and USDA’s National Institute of Food and Agriculture to provide training opportunities for farmers, small food processors, and small produce merchant wholesalers.

In addition, the National Farmers Union Foundation and the University of Arkansas-Fayetteville, which entered into cooperative agreements with FDA to develop training curricula and delivery for local and tribal food producers, respectively, are among the training providers. The National Association of State Departments of Agriculture, which is engaged in a cooperative agreement with FDA to plan implementation of the produce safety rule, is also a member of the forum.

Last, but not least, there’s the Joint Institute for Food Safety and Applied Nutrition (JIFSAN), a partnership between the FDA and the University of Maryland that is focused on increasing global knowledge of effective food safety practices.

These first meetings focused on the new produce safety standards, which set science and risk-based requirements for the production of fruits and vegetables. All of these training programs are up and running, although they’re at different stages of development. But no matter where they are in this journey, they’re working together. The NCC, for example, has been coordinating with regional centers monthly and, through forum discussions, is now including those working with local and tribal food producers.

Everyone wants to measure success and to determine that they’re reaching the right audiences. Examining metrics and coordinating data will be a priority going forward so that all training providers have the same sense of what’s working and what isn’t.

Group members shared their experiences and knowledge in these first meetings. For example, a common experience has been that growers don’t use online training as much as other food producers. Lack of access to the internet or insufficient bandwidth to run the programs are the issues for some. We’ll reshape how the training is offered based on feedback as more data are collected.

This is just the beginning. There are plans to work with forum participants to post resource materials in a way that’s accessible to food producers around the world.

This is a great example of good governance – working in partnership and communicating across organizational boundaries to support those who will do the important work of strengthening our food safety system. The forum will meet every few months to help ensure that training programs meet the needs of those who must understand the new FSMA standards, no matter their size, nature, or location.

Donald Kautter Jr. is a Consumer Safety Officer in FDA’s Division of Plant Products and Beverages.

Stephen Hughes is a Team Leader in FDA’s Produce Safety Network.

They are the FDA co-leads of the FSMA Collaborative Training Forum, and partner closely with USDA to facilitate the forum.

‘Radiating Shoe Sales’

By: Vanessa Burrows

Since the discovery of X-rays in the late 19th century, the technology has enhanced health care in a variety of ways. Like many cutting-edge scientific developments, however, it also has inspired uses of uncertain therapeutic value. That was the case with the shoe-fitting fluoroscope, the subject of the latest episode of FDA’s history video series.

Vanessa Burrons

Vanessa Burrows, FDA Historian, next to a shoe-fitting fluoroscope

Marketed as a scientific method for optimizing shoe fit, the fluoroscope appeared in shoe stores nationwide from the 1920s to the 1960s. But the machines not only didn’t do what they promised, they also exposed children, their parents, and store clerks to unhealthy doses of radiation.

In the late 1940s, scientists and regulators began to raise serious concerns about the dangerous levels of radiation. Over the next two decades, individual states gradually took action to either ban or restrict the use of the device.

By the 1970s, concerns grew about radiation emitted from common appliances, such as televisions and microwave ovens. And in 1971, FDA was given authority to regulate radiation-emitting devices. The agency continues this oversight, working to protect consumers from harmful novelty devices like the shoe-fitting fluoroscope. FDA also sets standards for medical imaging, surgical and therapeutic equipment, security systems, and consumer products – all for the protection of the health of American consumers.

We hope you enjoy your visit to FDA’s HistoryVault.

Vanessa Burrows is an FDA Historian

Reducing Preventable Harm from Medications: Too Big for FDA to Do Alone

By: John J. Whyte, M.D., M.P.H.

Sometimes a drug can be used exactly as FDA approved it, taken just the way a doctor prescribed it, and a patient can still experience adverse events. When it comes to drugs, not all risks are known – even after approval.

John WhyteSadly, however, harm from medications also may come from known risks that could have been prevented. The Institute of Medicine (now called the National Academy of Medicine) estimated that at least 1.5 million preventable adverse drug events occur within our health care system each year. It’s a complex system where safety issues can arise at any turn.

Among the many challenges, prescribers and other providers often struggle with the intricacies of today’s health care system, patients can have difficulty following detailed directions, and manufacturers must carefully package and label their products to avoid confusion and misunderstanding for how they are used.

Even giving a child a dose of acetaminophen, the commonly-used over-the-counter pain reliever and fever reducer, can lead to tragic results. The product was available in a strongly concentrated form for infants so they could take a very small amount, as well as a much weaker form for older kids to swallow by the teaspoonful. Unfortunately, over the years, some parents accidentally gave their infants a full teaspoonful of the stronger concentrated form, resulting in serious liver damage and even death. The Consumer Healthcare Products Association (CHPA) worked with their members to voluntarily remove the more concentrated form from sale and market a uniform less concentrated form. Their effort was instrumental in eliminating a preventable medication error.

Safe Use blog imageReducing preventable harm from medications is a big part of FDA’s mission. It requires teamwork across all of health care and the medication manufacturing, distribution, and delivery system.

As one of many ways we facilitate that teamwork, FDA’s Center for Drug Evaluation and Research’s Professional Affairs and Stakeholder Engagement Staff is hosting a one-day public meeting on June 15, 2017, called “Safe Use Symposium: A Focus on Reducing Preventable Harm From Drugs in the Outpatient Setting.”

We’ll gather with patients, caregivers, prescribers, pharmacists, manufacturers, distributors, and others to discuss sources of preventable harm from drugs in the outpatient setting. Attendees will consider situations such as the use of inappropriate medications in certain age groups, the use of drugs that interact with one another, and unintended exposures of dangerous medications to children.

Those attending will include representatives from:

  • Federal agencies such as the Drug Enforcement Agency, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services;
  • State regulatory bodies, including professional licensure and oversight boards;
  • Healthcare insurers; and
  • Patient advocacy organizations.

During this symposium, we want to generate ideas for specific solutions to reduce preventable harms and discuss how to evaluate the ideas’ effectiveness. These new ideas for future research can be funded by grants from FDA’s Safe Use Initiative. A variety of important research projects have been completed and FDA offers new opportunities on an ongoing basis.

There is no registration fee but early registration is recommended because seating is limited. More information about registration is available online.

We encourage all parties interested in the safe use of medications to attend. Some jobs, such as reducing the many forms of preventable harms from medication, are too big for one organization. It truly requires a communal and collaborative effort for success.

John J. Whyte, M.D., M.P.H., is Director of Professional Affairs and Stakeholder Engagement at FDA’s Center for Drug Evaluation and Research

Updated June 1, 2017

FDA and NIH Release Final Template for Clinical Trial Protocols

By: Peter Marks, M.D., Ph.D.

A little more than a year ago, FDA and NIH announced the availability of a draft template for investigators to use when organizing clinical trial protocols, which are essentially roadmaps for conducting a clinical trial.

Peter MarksToday, we are excited to announce that the NIH-FDA Joint Leadership Council has issued a final version of the template, a development which is likely to contribute important efficiencies to the process of protocol development, saving medical product development time and money.

The final version is intended for clinical investigators who are writing protocols for phase 2 and phase 3 NIH-funded studies requiring investigational new drug or investigational device exemption applications, but could also be helpful to other investigators conducting studies of medical products that are not regulated by FDA. It provides both instructional and sample text and reflects input from the public, consisting of nearly 200 comments from over 60 individuals. Importantly, it also has been harmonized with a separate protocol template that was recently developed by the private sector organization, Transcelerate Biopharma, for industry-sponsored research.

Clinical trial protocols are critical components of any medical product development program, describing trial objectives, trial design, methodology, statistical considerations, and trial organization.

Having a standard protocol format will facilitate review of protocols by regulators and others (e.g., institutional review boards). We believe that the template will help investigators prepare protocols that are consistent and well organized, contain all the information necessary for the clinical trial to be properly reviewed, and follow the International Conference on Harmonisation (ICH) E6 Good Clinical Practice guidelines. By clarifying expectations, the template will contribute important time and money-saving efficiencies.

Guidance is available from FDA on the content that should be included in a protocol to help ensure human subject protection and high data quality, but the guidance does not describe a standardized format for presenting this information. Placing relevant information in a standardized location in a clinical trial protocol can expedite the development and review of protocols thus enabling a quicker start of a clinical trial, potentially leading to more timely completion of studies and getting important new treatments to patients more quickly. What’s more, with the increased complexity of clinical development, such as use of combinations of different medical products, it is more important than ever that investigators understand protocol development expectations and capture important components right from the start.

NIH, which supports and conducts biomedical research, and FDA, which evaluates the safety and effectiveness of medical products and depends on high-quality research to inform its decisions, agreed that developing a protocol template would be an excellent opportunity to help improve the design of clinical trials. Our agencies believe that the availability of this template and accompanying instructional information will be very useful to investigators in creating well-organized, high-quality protocols — a benefit to everyone involved in medical product development.

Peter Marks, M.D., Ph.D., is the Director of FDA’s Center for Biologics Evaluation and Research