FDA: A Great Place for Science…and for Scientists on the New Frontier of Regulatory Science

By: Robert M. Califf, M.D.

Robert CaliffAs FDA Commissioner, I’m proud of our agency’s extraordinary commitment to using the best available science to support our mission to protect and promote the health of the American public. This is especially critical today, as rapid scientific and technological advances are helping to expand our understanding of human biology and underlying disease mechanisms and to identify the molecular profile of a food contaminant.

These breakthroughs offer unprecedented opportunities for us to develop new treatments and cures and to protect our food supply with a robust system that meets the challenges of globalization.

But there’s another benefit that derives from our application of cutting-edge science to the challenges we face, which has become increasingly evident to me through my conversations with some of FDA’s more than 10,000 scientists. And that’s the deep personal and professional satisfaction gained from working in FDA’s state-of-the-art laboratories on front-line issues that make a real difference in the lives of all Americans. As one FDA scientist commented, “At FDA, your work is really at the crossroads of cutting-edge technology, patient care, tough scientific questions, and regulatory science.”

Being Part of a Vibrant Collaborative Scientific Environment

Whether you’re a biologist, chemist, epidemiologist, pharmacist, statistician, veterinarian, nurse, physician, or an engineer and whether you’re a recent graduate or a seasoned scientist, FDA offers an unmatched opportunity to be a part of a vibrant, collaborative culture of regulatory science.

FDA scientists gain a bird’s eye view of the pharmaceutical and food industries, and develop a thorough familiarity and understanding of the regulatory structure that guides these industries. As one young FDA scientist recently commented, “We see a tremendous breadth of different products here, which helps us learn quickly and makes our jobs interesting and challenging.” Another newly trained FDA scientist shared, “We have the chance to work with highly trained colleagues, within and across disciplines, to build and keep our scientific training cutting-edge.”

While the work of FDA scientists helps to advance scientific understanding, it goes much further than that. That’s because our work is directly tied to regulatory decisions. As such it has a powerful and immediate effect on the health of millions of Americans. As another FDA scientist explained, “We get to see how these basic science and clinical advances get applied to producing medical treatments and devices and how these can make differences in people’s lives.”

FDA offers a number of fellowship, internship, graduate, and faculty programs through which newly-minted scientists can join FDA and continue to apply and develop their skills. Many of these individuals remain on as full-time FDA scientists. One former FDA Fellow said they appreciate how “FDA makes room for and respects voices of young, qualified scientists.”

Tackling the Most Challenging Scientific Issues

So, although I may frequently boast about FDA’s responsibility and ability to do rigorous scientific research and its importance for the American public, I’m speaking as much about our scientists as our science. And I hope that when other young talented scientists consider these testimonies from our multifaceted scientific workforce they will be encouraged to join us.

I want to see more professionals take advantage of the opportunities FDA offers to collaborate on some of the most transformative scientific issues of our times – both for their benefit and for the nation’s. We need the best scientific minds to tackle the challenges of food safety, medical product development, and to evaluate how emerging technologies are affecting FDA-regulated products so that our reviewers can make science-based decisions about a product’s benefits and risks.

That’s why we’ve successfully added thousands of qualified new employees over the last several years and worked hard to fill mission-critical positions. It’s also why we continue to seek more hiring flexibilities and other ways that enable us to be more competitive with private-sector salaries for these positions.

The career opportunities at FDA are enormous, and I look forward to welcoming the next generation of scientists of every stripe to help us fulfill our mission. It’s not only good for science and essential to FDA’s ability to protect and promote public health; it’s a unique opportunity for these talented scientists and their careers.

FDA Scientists Discuss Their Cutting-Edge Research in FDA Grand Rounds Webcasts

Robert M. Califf, M.D., is Commissioner of the U.S. Food and Drug Administration

FDA Celebrates the 40th Anniversary of the Medical Device Amendments

By: Jeffrey Shuren, M.D., J.D.

In 1976, Steve Jobs and Steve Wozniak founded Apple and a gallon of gas was $.59. And in another action that has had long term impact, President Ford signed the Medical Device Amendments that closed the dangerous gap between what he called FDA’s “horse and buggy authority” and “laser age problems.”

Jeffrey Shuren, M.D., J.D.

Jeffrey Shuren, M.D., J.D., FDA’s Director of the Center for Devices and Radiological Health, speaking at FDA’s Celebration of the 40th Anniversary of the Medical Device Amendments

Unlike the pharmaceutical industry, which was born from large chemical companies that discovered medical uses for the products they made, the device industry sprung to life as a scrappy sibling—mostly mom-and-pop businesses addressing the needs of individual patients and physicians through invention.

Although Congress had first given FDA explicit authority over medical devices in the 1938 Food, Drug, and Cosmetic Act, the focus was on fraudulent products. Efforts to extend FDA’s oversight on medical devices failed in 1962 and again in 1970.

Then in 1975, reports emerged that thousands of women had been harmed, some even died, from pelvic inflammatory disease, as the result of using the Dalkon Shield, an intrauterine device for contraception. Congress responded the following year by enacting the Medical Device Amendments, which authorized FDA to classify all medical devices based on risk into one of three classifications, to require premarket approval for Class III devices, and for devices to comply with reporting and GMP requirements.

The law ushered in a new era for medical technology innovation, patient access, and patient safety, but also created a tension, contributing to a political environment where the pendulum continues to swing between these objectives, defining and driving the medical device ecosystem ever since.

In signing the legislation, President Ford noted that, when “well designed and well-made and properly used” medical devices “support and lengthen life.” But when medical devices are “poorly designed, poorly made, and improperly used” they can “threaten and impair” life.” His words still ring true today.

The initial Medical Device Program started with about 180 people. Today, FDA’s Center for Devices and Radiological Health (CDRH) is 1,700 strong; a vibrant family of individuals with a wide range of scientific, clinical, engineering, legal, and other expertise, who hail from a variety of backgrounds, and who are ready to tackle the latest scientific advancement.

And the mom and pop industry has transformed into a world of sophisticated software algorithms, miniaturization, combination products, wearable sensors, non-invasive procedures and diagnostics, robotics, and artificial intelligence.

Along the way, CDRH has adapted its expertise and regulatory approaches to meet the needs of such rapidly evolving innovation. While we will continue to adapt, more importantly, we are focusing on proactively anticipating where we need to be so that regulatory innovation is out in front of medical device innovation. We’re doing this now in the digital health space, by designing regulatory frameworks around the type of technology and its unique evidence generation and innovation cycle rather than applying a one-size-fits-all approach.

We are implementing new models for evidence generation. They include the establishment of a National Evaluation System for health Technology, or NEST, that could transform the historical tension between device innovation, patient access and patient safety into an alignment of interests to drive the development and more timely access to life-saving, life-enhancing, and life-advancing devices. This is consistent with our vision: That patients in the U.S. have access to high-quality, safe and effective medical devices of public health importance first in the world.

And we are also going to new places with patients by establishing a foundation for engaging with them as our partners and routinely incorporating their perspectives in our decisions. And that’s fitting because improving the health and the quality of life of patients by assuring they have timely access to medical technologies that will benefit them is at the heart of who we are and what we do.

As we look ahead to the future, it is our work, our care and our dedication that will allow us to reach our vision.

Jeffrey Shuren, M.D., J.D., is FDA’s Director of the Center for Devices and Radiological Health

For more information read: Remarks at FDA’s Celebration of the 40th Anniversary of the Medical Device Amendments, by Jeffrey Shuren, M.D., J.D.

Important steps toward streamlining access to investigational drugs for patients in need

By: Richard A. Moscicki, M.D.

FDA is only too aware that there are many patients who have a serious or life-threatening medical condition for which there is no available FDA-approved therapy. For such patients, one option may be to obtain access to an investigational drug that has not yet been approved by FDA. To do this, a physician submits an application to the FDA requesting authorization to use the investigational drug in the treatment of their patient. This is called expanded access to investigational drugs.

Dr. Richard MoscickiWhile FDA has been helping physicians navigate the system for many years, we are aware there have been physician and patient concerns about this process, which can be time consuming and difficult to understand. Consequently, FDA has recently made significant changes to streamline and simplify the process for single patient expanded access requests.

To make the expanded access process more efficient, we’ve just introduced a much simpler application form called the Form FDA 3926, which will be the form doctors now will typically fill out when they want to provide an investigational drug for a patient through expanded access. While the Form 1571 had 26 information fields and seven attachments, the new Form 3926 has fewer fields (11) and only one attachment. With this streamlined format, we estimate that physicians will be able to complete the form in just 45 minutes, as compared to the more difficult and time consuming effort required previously.

Also, as part of our commitment to streamlining the expanded access process, on May 16, 2016, the FDA and the Reagan-Udall Foundation held a meeting with interested stakeholders to explore additional options that might help patients and their physicians understand the process to request access to unapproved drugs. A common theme of the meeting was that navigating the expanded access process really does take a village. The physician, the drug company, FDA, and the institutional review board (IRB) all have important roles and must work together for the expanded access process to succeed.

The FDA and Reagan-Udall Foundation convened this forum to listen to the public express their needs about expanded access and to discuss ideas with stakeholders on ways that the complex process can be made more efficient and effective. Much work on the details remains, but in general there was agreement on the need for a central repository or clearinghouse where useful and relevant information could be stored in one place — a sort of “one-stop-shop” for physicians and patients to seek information about the expanded access process. As our thinking about this resource develops, we’ll keep the public informed.

For physicians seeking more information about expanded access to an investigational drug, we have developed an educational webinar to help them become familiar with the new application form. This live webinar will occur on July 12 at 1:00 PM EDT and will offer one hour of Continuing Education (CE) credit. The webinar will be recorded for viewing without CE credit. We also have released a guidance regarding Form FDA 3926, a guidance with Questions and Answers on expanded access, as well as a guidance directed at industry addressing questions regarding charging for investigational drugs.

Expanded access is designed for seriously ill patients who have exhausted other options.  The last thing a patient suffering from a serious or life-threatening condition needs is red tape. For many years, FDA has dedicated staff to assist physicians and patients in navigating our system. We expect these important steps will help us continue our efforts to serve patients in need and to advance public health.

Richard A. Moscicki, M.D., is FDA’s Deputy Center Director for Science Operations, Center for Drug Evaluation and Research

CBER Laboratories in the Life Sciences-Biodefense Complex

By: Carolyn A. Wilson, Ph.D.

Wise management of research programs means more than selecting projects that will yield the most scientific information but also making sure that we are making wise use of the dollars we allot for research.

Carolyn A. WilsonThat’s why FDA’s Center for Biologics Evaluation and Research (CBER) thinks strategically when it plans research programs by the more than 70 principal investigators who work in our two-year-old laboratories in the Life Sciences-Biodefense Complex at FDA’s White Oak campus.

We ask ourselves how we can most efficiently – and cost-effectively – obtain the answers to our scientific questions that our regulators will need to achieve their mission of ensuring the safety, purity, and potency of biological products.  Products regulated by CBER include vaccines, allergenics (allergy diagnostics and treatments), cellular, tissue, and gene therapy products, and blood and blood products.

To sharpen our research planning we recently undertook a major evaluation of our center’s scientific and administrative strategies and programs with the assistance of an outside consulting firm.

The findings have enabled us to refine  our strategies for wringing the most new knowledge from every dollar we spend on regulatory science – the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products. These refinements to CBER’s research strategy include:

  • A Resource Committee that manages CBER’s annual budget, as well as a Regulatory Science Council that develops center-wide goals, guides office-level objectives, and oversees all research activities. These two councils will increase overall transparency of decision-making, make sure that research is prioritized, and aim to make budget planning more timely and responsive to our mission.
  • More direct control of funds by individual CBER offices and earlier allocation of that funding, and annual peer review of 25 percent of existing and new projects to ensure accountability for how they are run.
  • Systems to increase the transparency of CBER research and research funding, enhance management decisions, and facilitate tracking of funding allocated to activities and projects.
  • Elevating the culture of science through monthly presentations highlighting the public health impact and mission relevance of CBER research; biannual CBER-wide Science Symposium, providing opportunities for communication and potentially improved collaboration across all CBER research projects; and, enhanced prominence of CBER research fellows in the research enterprise.
jars of vegetables

Faulty home food preservation is one potential source of botulism. FDA scientists are developing methods that will help manufacturers to make a vaccine that will prevent this bacterial illness.

These research and administration refinements are helping us better identify and prepare for tomorrow’s needs.  And when you consider the approximately 70-80 research programs we have underway, we’re doing a lot. A few examples include:

  • Studying botulism toxoids (inactivated illness-causing chemicals released by bacteria) to support development of the first vaccine to prevent this potentially fatal infection. CBER scientists are designing new tests to predict what vaccine approaches may be protective. These tests may also help screen vaccines that protect against other toxins such as those from anthrax, as well as the plant-derived toxin ricin.
  • Determining the critical immune events that provide protective immunity to intracellular microbes (bacteria and parasites that live inside human cells). Based on this, FDA scientists will develop new measurements to predict protection that may help evaluate new vaccines for these microbes.

    Girl sneezing in a field of flowers.

    Allergies can turn nature walks into annoying sneezing fits. FDA scientists are developing new tools to help manufacturers produce more potent allergy shots and enhance their safety.

  • Developing new tools and data to help manufacturers produce more potent allergy shots and enhance their safety.
  • Helping to develop a test for cow intestine to ensure heparin harvested from this tissue is not contaminated with the agent causing the bovine transmissible spongiform encephalopathy (TSE, also known as “mad cow disease”), a known risk to humans. This would help to ensure a safe, reliable, domestic source of heparin, which is now obtained mostly from China.
  • Developing new methods and technologies for rapid-testing detection and characterization of emerging infectious pathogens that threaten the safety of tissue and tissue-based products. In the course of developing these technologies, the lab has found previously unidentified microbial contaminants in archived tissues used for these studies. These findings provide preliminary evidence to support the potential for application of rapid test technologies in evaluation of emerging infectious disease transmission risks associated with the implantation, transplantation, infusion, or transfer of human tissue.

As CBER continues to advance regulatory science in its Life Sciences-BioDefense Complex, our projects will adapt to new challenges that the science of biologics will inevitably pose to FDA. And CBER will address those challenges, keeping in mind both the public health and our fiduciary responsibility to make every research dollar count.

Carolyn A. Wilson, Ph.D., is Associate Director for Research at FDA’s Center for Biologics Evaluation and Research

A Tale of 3 Countries: Applying FSMA Standards Globally

By: Stephen Ostroff, M.D., and Camille Brewer, M.S., R.D.

Over the past two months, we have been part of FDA delegations visiting three very diverse countries—Canada, China and Mexico—to discuss food safety. As we are doing in the United States with the FDA Food Safety Modernization Act (FSMA), each country we visited is addressing their national food safety objectives in unique and creative ways.  And each has committed to taking a strong role in supporting compliance with the new food safety regulations mandated by FSMA.

Stephen Ostroff, M.D.

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

Looking at how these nations are different – and how they are the same – opens a window on the challenges and opportunities presented by FSMA implementation on a global scale. The seven foundational FSMA rules are now final and they will have a profound effect on foreign food producers that want to export their products to the United States.

We visited Canada on May 10 and 11 for public meetings on FSMA in Toronto and Ottawa. Canada is modernizing its own food safety system under the Safe Foods for Canadians Act, which, like FSMA, places a strong emphasis on preventive controls. Our nations have a strong interest in achieving as much convergence as possible on food safety standards.

We had the opportunity to explain that the recently signed systems recognition arrangement with Canada does not create a “green lane” for foods shipped to the United States. Instead, it is a reciprocal regulatory cooperation tool that will foster greater risk-based targeting of resources and will foster cooperation in many areas, such as risk assessment and research. The systems recognition arrangement with Canada, signed on May 4, affirms that while our countries’ domestic food safety systems are not identical in all aspects, they currently do achieve a comparable degree of food safety protection.

In addition, considerable interest was expressed in the Voluntary Qualified Importer Program (VQIP), which does provide facilitated entry for food shipments to the United States.

Camille Brewer

Camille Brewer, M.S., R.D., Director of International Affairs at FDA’s Office of Foods and Veterinary Medicine.

In late April, our public and private meetings in Mexico strengthened what has become a true partnership between our two countries. In 2014, we started the Produce Safety Partnership with the National Service for Agro Alimentary Health, Safety and Quality (SENASICA), and the Federal Commission for the Protection from Sanitary Risks (COFEPRIS)—our regulatory partners in Mexico—to help prepare growers and packers there to comply with the FSMA requirements. This flagship program forms the basis for extensive collaboration on produce issues.

Mexico continues to modernize and strengthen its own regulatory regime for food safety. Our strong and growing relationship with the Mexican government is a model for partnerships we’d like to forge with other nations. One of our central FSMA themes is working closely with foreign governments that share our food safety goals, and whose own food safety efforts can contribute to the safety of imported food. Our FDA office in Mexico helps to build and sustain our mutual food safety goals.

This is a priority for both Mexico and the United States because of the large volume of produce we trade and the importance of produce safety from a public health and confidence standpoint. Much of the produce we eat in the U.S. is grown in Mexico, including produce that would otherwise be hard to find in the winter months. A lot is at stake for both sides, and our meetings in Mexico reinforced our shared commitment to food safety.

A week before the Mexico trip, we traveled to Beijing for a FSMA public meeting and meetings with our regulatory counterparts in China—the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), the China Food and Drug Administration (CFDA), and the China National Center for Food Safety Risk Assessment (CFSA). China also has new food safety laws. The interest in meeting FSMA requirements is so intense that the public meeting was shared across China by webinar, with more than 5,200 participants in government agencies, academic institutions, and industry.

There were meetings with Chinese officials about issues of mutual interest and strategic importance, in addition to subjects unique to China, such as the regulation of ceramic tableware and traditional Chinese medicine.

Like FDA, government regulators in China have been working to refine the food-safety infrastructure based on new laws. The sheer vastness of the country and the rapid pace of economic development and change  are key factors that government officials are taking into account as they refine their laws to control and monitor food production.

Progress is being steadily made and the FDA Office in China continues to work effectively with Chinese authorities to identify points of synergy. The visit culminated in a meeting of representatives of China, the European Union and FDA to discuss core food safety principles and other subjects.

So you can see our partnerships take on different forms. What we learned in our travels to Mexico, China and Canada is that each nation has a strong resolve to make their food supply safer for their own citizens and for export to other nations.

We will continue traveling to countries willing to partner with us in this mission. No matter where you live, no matter where you govern, everyone wants safe food.

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

Camille Brewer, M.S., R.D., is the Director of International Affairs at FDA’s Office of Foods and Veterinary Medicine

Be A Champion for Clinical Trial Diversity

By: Jonca Bull, M.D.

The FDA is launching a campaign to encourage minorities to participate in clinical trials for all medical conditions.

Jonca Bull, M.D., is Director of FDA’s Office of Minority HealthThe first part of the campaign will be launched on June 19, 2016, World Sickle Cell Day, observed annually to help increase public knowledge and raise awareness of Sickle Cell Disease, which primarily affects people of African and Hispanic descent. We want to encourage diverse communities to learn more about how they can become a part of the research process to bring new therapies to the market.

Clinical trials are a critical step in making new medical products available. Medical products—from vaccines to drugs for blood pressure or diabetes management — are tested in clinical trials.

Although FDA generally does not conduct clinical trials, we do the critical work in reviewing the data to assess the safety and efficacy of medical products before they can be used in medical practice. None of this is possible without clinical trials and the patients who go the extra mile by being research participants.

In order to help ensure that medical products are safe for everyone, we need a diverse pool of research participants—racial and ethnic minorities, women, even the elderly.

We know that certain diseases impact some populations differently. For example, diabetes occurs  more frequently in blacks and Hispanics, high blood pressure and heart failure occurs more frequently and severely in blacks; and, Asian American communities experience more hepatitis B.

Clinical trials participants need to more closely mirror the patients who will ultimately use the medicine. This is especially important when considering health disparities — diseases that occur more frequently or appear differently in non-white populations. But most clinical trials participants are white and male. That means we may miss vital data that could be used to be make better evidence-based, regulatory decisions. If we do not develop a more diverse pool of research participants, health disparities may persist because we will not know if a medical product is safe and effective in the actual population that will ultimately use it.

And that’s why we’re launching our campaign, which includes a series of educational aids such as videos, a blog, and an infographic. In these videos Shirley Miller, who lives with sickle cell disease, talks about her experience participating in clinical trials and encourages her peers to learn more about research studies.

In another video Dr. Luciana Borio, FDA’s Acting Chief Scientist, discusses why clinical trial diversity matters from FDA’s perspective.

This campaign is taking us one step closer to a world where health equity is a reality for all. It supports FDA’s initiative: “The Year of Clinical Trial Diversity.”

It is a part of our larger effort to improve clinical trials diversity — we also work with stakeholder groups, support research, develop multi-lingual resources, and use social media to promote a community of “Clinical Trials Champions.”

You can be a “Champion” by watching and sharing the videos and related resources.

Everyone has a stake in the game —health care providers, researchers, and patients. Share these videos and other materials. Start a conversation today.

Videos:

More information about this campaign and FDA’s OMH can be found here: www.fda.gov/minorityhealth

Follow us on Twitter @FDAOMH

Dr. Jonca Bull is FDA’s Assistant Commissioner for Minority Health, Office of Minority Health

Our Goal in Enforcing Food Safety: A Rapid, Science-Based Response

By: Stephen Ostroff and Howard Sklamberg

Recalls of potentially unsafe foods are an important food safety tool. The FDA most often works with companies to bring about voluntary recalls, with the goal of getting the product out of the marketplace as quickly and efficiently as possible.

Stephen Ostroff, M.D.

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

The FDA Food Safety Modernization Act (FSMA) empowers the FDA to act when a company does not voluntarily cease distribution and recall a potentially dangerous food product. The enforcement tools provided by FSMA include mandatory recall.

Because the vast majority of companies choose a voluntary recall when presented with science-based evidence that their products are unsafe, or reasonably likely to be unsafe, the FDA has only rarely needed to use its mandatory recall authority. In most instances, companies choose to initiate a recall when faced with the prospect of an enforcement action.

The HHS Office of the Inspector General (OIG) has raised concerns about the sufficiency of processes and procedures the FDA has in place to ensure that firms take prompt and effective action in initiating voluntary recalls. To consumers hearing about the OIG alert, we want to be clear that the FDA is totally committed to its public health mission of ensuring the safety of the food supply. The United States has one of the world’s safest food supplies. The work we do—performing facility and site inspections, conducting surveillance sampling both domestically and at the border, and using laboratory and other analyses to help determine prevalence of food-borne risks—contributes to its safety each and every day.

Howard Sklamberg

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

As a public health agency, the FDA continually works to improve its processes and appreciates the input from the OIG. In fact, the agency is now expediting changes already underway to strengthen its compliance and enforcement strategies, including voluntary and mandatory recalls. This includes, in individual situations, specifying timeframes for voluntary action by the firm and, if necessary, enforcement action by the agency.

But before we get into those changes, it’s helpful to consider what generally occurs before a voluntary recall takes place. The FDA’s actions have to be based in science and we go where the evidence leads us. The scope of a contamination must be ascertained to determine how much of a product must be recalled. The time needed to collect evidence can vary, but to request a recall without evidence risks recalling the wrong product and leaving consumers vulnerable to contaminated food that is still on the market.

Because the FDA acts on science-based evidence, it has credibility with food producers (and their internal and external legal teams) and consumers. Companies know that when they are approached by the agency, the danger is real and must be acted upon promptly. So the FDA, time and again, is able to protect consumers by engineering timely voluntary recalls.

The OIG’s concerns about the FDA’s food recall process are based on their selection of a “judgmental sample” of 30 voluntary recalls between October 1, 2012 and May 4, 2015 chosen based on their risk factor. The alert focuses in particular on two recalls in which the companies did not initiate recalls of all affected products for months despite the fact that FDA notified them as soon as the agency had evidence of a contamination. This finding is unacceptable–no question about that. It bears noting, however, that in those three years, the FDA worked with companies to successfully bring about thousands of recalls to keep unsafe food out of the market and homes of consumers with an average recall initiation time of less than a week.

We fully agree with the OIG that we must move as expeditiously as possible. We also agree that timeframes should be set, but they must be done on an individual basis rather than by setting arbitrary deadlines. The complexities surrounding recall events make it difficult for the FDA to establish a single timeline applicable to all situations.

To speed the FDA’s response when regulated foods are tied to real and potential public health risks, including outbreaks of human illness, the agency has recently established a new process to help streamline and strengthen decisions about compliance and enforcement actions.

We have established the Strategic Coordinated Outbreak Response and Evaluation (SCORE) team, a decision-making body of key senior leaders that will be co-chaired by those responsible for directing compliance and enforcement activities in the foods program and field operations. Team members are from FDA’s Foods and Veterinary Medicine program, the Office of Regulatory Affairs, and the Office of the Chief Counsel. They are advised by senior scientific, medical, communications, and policy experts. This builds on FDA’s establishment of the Coordinated Outbreak Response and Evaluation (CORE) network in 2011 to coordinate and streamline outbreak response, working with state and local authorities and other federal agencies.

What this team brings to the table is an integrated approach to identifying timely and efficient measures to help mitigate public health risks, goals shared by the OIG. It will review investigations that have, or may have, a link to specific foods or a food facility when there is a serious human health risk. It will also be involved when the case involves complex policy questions, when additional expert support is needed, or when response timelines have not been met. The SCORE team’s involvement will speed the FDA’s response by evaluating the whole range of options for use of compliance and enforcement authorities as quickly as possible.

The SCORE team has only recently been established, and we will be reviewing how it works, refining its functions and performance as needed.

There are other ways in which our enforcement strategy is already being strengthened. Since 2014, we have been using whole genome sequencing in the laboratory as a regulatory tool to more rapidly identify foodborne contaminants and trace them to their source with unprecedented speed and precision. This technique has already proven to be a game-changer in outbreak response, and will be increasingly valuable in the future.

Looking ahead, protections will be further strengthened by the FSMA-mandated preventive controls rules for human and animal food, which require covered food facilities to identify potential hazards and take steps to minimize or eliminate risks. They are also required to have a recall plan. Compliance dates begin for certain firms in September 2016.

Our stated mission to protect public health is more than just words on paper. We are always working to be better at our job and will use the OIG’s input as it was intended–to further strengthen our protection of the food supply.

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

Globalization and FDA’s New Partnerships to Ensure Product Safety

By: Howard Sklamberg

Globalization is posing challenges for public health. For FDA, part of that challenge is the ever-increasing volume and complexity of FDA-regulated products coming to America’s shores.

Howard SklambergIn fiscal year 2015, there were more than 34 million shipments of FDA-regulated products into the United States, up from just 15 million shipments a decade ago. These products are handled by 130,000 importers, and are manufactured, processed, or packaged at more than 300,000 foreign facilities.

We know this global trade expansion has ramifications for our nation’s public health. We also know we cannot be the inspectors for the world. Hence, we need to effectively direct our resources in a risk-based manner as we grapple with this tremendous volume of imported goods.

How? One way is to identify foreign regulators whom we can rely upon to partner with in verifying that safety standards are being met and then construct an approach that will meet the requirements of multiple regulatory jurisdictions. We are currently engaged in three innovative programs that meet this challenge.

The Medical Device Single Audit Program

The Medical Device Single Audit Program, or MDSAP, is an international approach to the auditing and monitoring of the manufacture of medical devices to ensure their safety and efficacy. This audit program will allow a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.

Currently, five nations – Australia, Brazil, Canada, Japan, and the U. S. – are participating in the MDSAP Pilot. It began 18 months ago and will run through the end of 2016. The program’s goals include:

  • Enabling regulatory oversight of medical device manufacturers’ quality management systems;  and,
  •  Promoting more efficient use of regulatory resources through work-sharing and mutual acceptance among regulators.

Mutual Recognition Agreements

In 2014, FDA launched the Mutual Reliance Initiative (MRI), a strategic collaboration between the FDA and the EU Member States. The goal of the program is to determine if the FDA and EU can agree to recognize each other’s drug Good Manufacturing Practice (GMP) inspections, a potentially time-saving approach.

If successful, we could rely upon EU experts to inspect facilities within their own borders, a more practical way of overseeing the large number of drug manufacturing sites outside of the United States. And it would be similarly more practical if the EU relied on FDA experts to inspect facilities within the United States.

Both the EU and the FDA are in the process of evaluating each other’s processes. The EU has visited several of FDA’s district offices in the United States and one drug laboratory and evaluated the work they do. The FDA has a different challenge since each country in the EU has at least one inspectorate, and in Germany, each state has their own inspectorate. To date, FDA has observed eight audits – in Sweden, Greece, Croatia, Germany, Hungary, Italy, the Czech Republic, and the United Kingdom – and will continue to observe audits of other Member States this year and in 2017.

Food Safety Systems Recognition

Preventing problems at relevant points along the global food supply chain can be a daunting job. FDA is soliciting help by leveraging foreign food safety systems that are similar to our own.

The agency’s Systems Recognition program determines whether another country has comparable regulatory programs and public health outcomes to what we have in place in the U.S.

A major advantage of Systems Recognition is that it allows FDA to be more risk-based in its oversight of imported food and we can more wisely plan our overall inspection activities, including foreign facility inspections, import field exams, and import sampling.

Thus far, we’ve completed: New Zealand and the U.S. signed a Systems Recognition Agreement (in 2012) and recently another agreement was signed with the Canadian Food Inspection Agency.

What’s Next? 

The three initiatives I’ve briefly outlined represent the best of FDA innovation and expertise in grappling with the increasing amount of imported FDA-regulated products. Our work will focus on a continued careful reliance on trusted foreign partners; a move away from duplicative work; more risk-based inspections; better data; and the minimization of public health risks globally.

Howard Sklamberg is FDA’s Deputy Commissioner for Global Regulatory
Operations and Policy

Marking the Beginning of a New Era in Food Safety

By: Stephen Ostroff, M.D.

The promises embodied in the FDA Food Safety Modernization Act (FSMA) add up to this: The foods that we eat and serve our families must be as safe as we can make them.

Stephen Ostroff, M.D.These promises mandate that food be produced, packed and transported with an awareness of potential hazards and a commitment to taking whatever systematic steps are necessary to eliminate or greatly reduce any risks. They envision a world in which families can share foods produced halfway around the world, knowing that they are held to the same rigorous safety standards as those produced in the United States.

The past nine months have seen the finalization of the seven rules that make FSMA’s promises a reality – for both domestic and imported foods. The last of those rules, one that adds protections against intentional adulteration, became final on May 27. Together, and individually, these rules represent a paradigm shift from simply responding to outbreaks of foodborne illness to preventing them from happening in the first place.

There’s a lot of work to be done in the implementation phase. But even as we look forward, it’s important to recognize that getting to this point with rules that are final is a spectacular achievement, and that many deserve the credit.

Members of Congress joined together to pass FSMA in 2010 because of widespread concern over multistate outbreaks, and lawmakers like Sen. Jerry Moran of Kansas and Rep. Rosa DeLauro of Connecticut have been unwavering in their support since then. Consumers, such as activists in STOP Foodborne Illness, who became sick themselves or who lost loved ones to contaminated food, put their sorrow aside and became champions for the greater good. Public policy organizations like the Pew Charitable Trusts have been steadfast partners throughout the rulemaking and budget processes.

The food industry mobilized to help FDA find the most effective, practical ways to implement these regulations. We worked with national associations that include the Grocery Manufacturers Association and groups with a more regional focus, such as the New England Farmers Union. Farmers, manufacturers, distributors, retailers and many others whose livelihood is directly affected by these rules brought their concerns to the table and worked with us to make the rules as feasible as possible.

We found dedicated partners in other government agencies at the federal, state and international levels. Leanne Skelton of the U.S. Department of Agriculture has been part of the FDA team. The National Association of State Departments of Agriculture is playing an important role in helping FDA meet the challenges of implementing the produce safety rule. State agriculture leaders like Chuck Ross in Vermont, Katy Coba in Oregon and Steve Troxler in North Carolina became a bridge between FDA and the food producers in their states. Our regulatory counterparts in other nations, such as SENASICA and COFEPRIS in Mexico, have joined the fight to increase food protections worldwide.

The people of FDA, under the leadership of Michael R. Taylor, worked tirelessly to find the right intersection between science and policy; to develop innovative and practical solutions to complex challenges; and, to engage in open and meaningful discussions with the many communities within the diverse food supply system. I recently succeeded Mike as deputy commissioner, and I want to acknowledge the importance of his dedication to public health and food safety.

The FDA teams who drafted and revised the rules worked in tandem with teams laying the groundwork for eventual implementation. They have traveled the nation, and the world, to meet with food producers and government officials. They have worked 24/7 on these rules since FSMA became law.

The road ahead towards full implementation of FSMA is a long one. There are miles to go, but thanks to the commitment and hard work of all those who are making this journey, we will keep the promises of FSMA.

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

A New Partnership with Canada on Food Safety

By: Caroline Smith DeWaal

With a shared border that is more than 5,500 miles long, Canada and the United States have a lot in common — including a shared food supply. So it is no surprise that Canadian food safety agencies and the U.S. Food and Drug Administration (FDA) have signed a “systems recognition arrangement” to mark an important new food safety partnership.  Notably, this is only the second arrangement of this type. The first was signed in December 2012 between FDA and New Zealand’s food safety authority.

Caroline DeWaalSystems recognition not only allows FDA to better plan its oversight of high risk foods, it also increases our reliance on regulators in other parts of the world that have demonstrated they provide a similar system of food safety protection. This is one tool that we use to help ensure that consumers have confidence that their food is safe, whether produced in the U.S. or elsewhere.

Under this arrangement between FDA and Canadian food safety authorities signed on May 4, 2016, FDA recognizes that Canada operates a national food safety control system with regulatory programs comparable to ours. A major advantage of this arrangement is that it allows FDA to be more risk-based in its oversight of imported food.

With systems recognition in place with Canada and New Zealand, FDA can plan more wisely its overall inspection activities, including foreign facility inspections, import field exams, and import sampling. In this reciprocal arrangement, both countries benefit.  Systems recognition advances cooperation and confidence building between our two regulatory systems and it paves the way for sharing information related to food safety.

Systems recognition is a very high bar to reach. Why? For one, the strength of food safety regulatory systems varies widely around the globe. At FDA, systems recognition is an option for countries with domestic food safety systems that have preventive, risk-based programs in place. We understand that any country can have a food safety incident.

For systems recognition to work well, we want to know that the country’s regulatory authorities have the ability to swiftly track down the source of a foodborne illness and take action to stop contaminated food in its tracks –and to follow up to prevent such events from happening again. While systems recognition arrangements are entirely voluntary for the two countries that enter into them, they mark a high degree of trust in participating countries’ abilities to both prevent and respond to food-related outbreaks and contamination events. Following a rigorous review, we are confident that Canada has systems in place to accomplish this.

Before entering into a systems recognition arrangement with Canada, FDA undertook an evidence-based assessment of Canada’s domestic food safety system. We used the International Comparability Assessment Tool (ICAT) to evaluate all aspects of the system, from the regulatory foundation, to the training, inspection, and compliance programs, to the investigation of outbreaks and trackbacks to find contaminated food sources. Onsite reviews were an important part of the assessment process; those reviews allowed FDA to see first-hand how Canada implements the programs they’ve described in the ICAT and Canada conducted a similar review of the way FDA operates its food safety programs.

Systems recognition is intended to facilitate discussions that lead to a continuous improvement process for regulators on both sides of the border. For example, in recent years, new legislation was adopted in each country that emphasizes preventive control systems and import safety: The FDA Food Safety Modernization Act became law in 2011 and the Safe Food for Canadians Act was passed in 2012. As our respective food safety systems, regulatory frameworks, programs and oversight continue to improve, we are committed to this partnership with Canada for the benefit of consumers on both sides of the border.

Caroline Smith DeWaal is the International Food Safety Policy Manager on the International Affairs Staff at FDA’s Center for Food Safety and Applied Nutrition