New Era of Smarter Food Safety Blueprint | FDA

New Era of Smarter Food Safety Blueprint | FDA

New Era of Smarter Food Safety Blueprint Released

On July 13, 2020, FDA Commissioner Stephen Hahn, M.D., and Deputy Commissioner for Food Policy and Response Frank Yiannas, introduced the New Era of Smarter Food Safety Blueprint that defines the course the FDA will take over the next decade to create a more modern, technology-driven and cooperative approach to food safety.

The New Era supports increased use of partnerships and dialogues between governments, standards bodies, industry groups, and public health organizations to reach achievable goals that enhance traceability, improve predictive analytics, respond more rapidly to outbreaks, address new business models and foster the development of stronger food safety cultures around the globe. What is it? This new approach to food safety will leverage leading-edge technology and digital tools to create a better-traceable and safer food system. The Blueprint also recognizes the need to address the underlying psychology of a food safety mindset as critical for all players along the production and delivery chain. Four core elements represent the foundational pillars of the New Era of Smarter Food Safety Blueprint, covering the range of technologies, analytics, business models, modernization and values that are its building blocks:

Tech-Enabled Traceability Smarter Tools and Approaches for Prevention and Outbreak Response New Business Models and Retail Modernization Food Safety Culture The underlying goal of the Blueprint is to bend the curve of foodborne illness by reducing the number of illnesses. “Smarter Food Safety to me means always looking to the future. Our destination − safe food for our families, our children and our animals − is unchanged,” said Dr. Hahn.

How has this evolved and where do we go from here? Last year in April, the FDA announced the New Era of Smarter Food Safety initiative. Three months later, FDA’s Foods Program leadership took the first step, selecting experts within the agency to provide their insights on how to develop the initiative. To keep pace with continually evolving food production and safety practices and technologies, the FDA is looking at emphasizing technology-driven approaches and processes. With short- and long-term activities, the Blueprint is a living document intended to keep pace with new food technologies, methods of food production and delivery. The Office of Global Policy and Strategy (OGPS), including directors from our offices around the globe, will meet virtually this month with staff in the Office of Food Policy and Response to discuss FDA’s global approach to the New Era Blueprint, and OGPS’s role in supporting global deliverables. OGPS is in the perfect position to do this: our staff already work with international regulatory partners and rely on strong partnerships with foreign governments and organizations to support the goals of the FDA. Why is this important? About 13 percent of all foods consumed by Americans originate from outside of the United States. That number jumps significantly if we consider some of our most basic foods: 53 percent of fresh fruits, 29 percent of vegetables and 93 percent of seafood! The safety of the global food supply chain is thus vitally important to Americans. With expanding implementation of Blueprint-supported modern technologies – like artificial intelligence, predictive modeling, digital tracking, sensor technologies and whole genome sequencing – to enhance food growing and production practices and decisions, Americans can have greater confidence in the safety of food from the U.S. and abroad. Watch the video.

Webinar Reveals Why Pharmaceutical Quality is a Global Priority

The Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ), CDER Small Business and Industry Assistance (SBIA) and the OGPS India and China offices recently hosted a first-of-its-kind, nighttime, online, interactive event to help further FDA’s global commitment to pharmaceutical quality. The July 23 webinar kicked off at midnight EDT so it would take place during the working hours of many of our international stakeholders.

With a significant portion of the finished drugs and active pharmaceutical ingredients used in the U.S. coming from abroad, engaging international stakeholders is essential to furthering the FDA’s overall commitment to pharmaceutical quality. Since previous SBIA conferences have drawn a large number of attendees from China and India, OPQ’s Adam Fisher decided to schedule an extended webinar that could best meet the schedules of stakeholders from those countries. The organizers were thrilled that SBIA was able to accommodate and deliver on this concept. After numerous discussions, it was unanimously decided that midnight to 5 a.m. EDT would be the best time for all parties involved. Fisher coined the phrase “Midnight Madness” even though the webinar was advertised under the formal name of “A Pharmaceutical Quality Webinar for Global Stakeholders.” Attendance statistics showed 791 unique logins – however, this may be a conservative number as one login may in fact have supported multiple viewers.

CDER’s Acting Center Director Patrizia Cavazzoni, M.D., and OPQ Director Michael Kopcha, Ph.D., RPh, provided the keynote addresses while other FDA experts presented on specific topics of interest to an international audience. Two OGPS staffers, Lane Christensen, Ph.D., international program and policy analyst with the OGPS China Office (CNO), and Chris Middendorf, international relations specialist for pharmaceuticals in the India Office (INO), were among the speakers.

Christensen's webinar topic was FDA’s International Mission and the Global Manufacturing Landscape. He explained CNO’s mission and why its presence is important in China. Workload for the office is up due to COVID-19, he said. In China alone, the total of drug facilities registered “has more than doubled” from the inventory registered at the beginning of the year, which Christensen attributes in large part to world-wide interest in the manufacturing of alcohol-based hand sanitizers.

INO’s Chris Middendorf, who recently moved from the CNO to our office in New Delhi, discussed FDA’s International Office and the Pharmaceutical Quality Mission. "Because we are in-country, we have a close relationship with our stakeholders,” he said. India has the largest number of FDA-registered drug manufacturing facilities outside of the United States and is one of the largest exporters of drug products to this country. FDA has strong collaborations with the Government of India, stakeholders and industry, helping to ensure a safe and reliable supply chain.

In February, Middendorf said, the Government of India and the FDA joined in establishing a Memorandum of Understanding on the safety of medical products. Included in the agreement are information-sharing, observing each other’s inspections, collaborations with other entities (between agencies, state and local authorities, industry and other non-government organizations) and meetings/other engagements. Other webinar topics included Quality Management Maturity: FDA Vision & Expectations, Major Issues and Facilities in Drug Master Files, and Pharmaceutical Quality Policies: What You Need to Know, among others. The entire webinar can be viewed in segments, here.

FDA’s Actions to Protect the Public from Unsafe Hand Sanitizers

The FDA has been actively working to protect the American public from the dangers of certain alcohol-based hand sanitizers and OGPS has been playing an important role in these efforts. Hand hygiene has been an important part of the U.S. response to the COVID-19 pandemic. If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommends consumers use an alcohol-based hand sanitizer that contains at least 60 percent alcohol (also referred to as ethanol or ethyl alcohol).

Unfortunately, FDA has seen a sharp increase in hand sanitizer products that do not meet quality standards. Some contain dangerous substances while others are sub-potent. One example are products labeled to contain ethanol but actually contain unacceptable amounts of methanol (also known as wood alcohol) that can be toxic when absorbed through the skin and life-threatening when ingested. Staff in our foreign offices have helped investigate the source of these products in the supply chain. Our Latin America Office staff worked closely with regulatory agency officials in Mexico to identify the source of methanol in hand sanitizer products and to take measures to promptly alert the public. Since June, the FDA has compiled a list of over 160 hand sanitizers that consumers should not use. On August 18, OGPS assisted in organizing a teleconference with international regulators, to discuss the ongoing problem. The teleconference was moderated by Bruce Ross, director of our Office of Global Operations. Other participants included Dr. Theresa Michele, director of the Office of Nonprescription Drugs in CDER’s Office of New Drugs; Francis Godwin in the Office of Manufacturing Quality, which is part of CDER’s Office of Compliance; and Leigh Verbois, director of the Office of Drug Security, Integrity and Response, which is also part of CDER’s Office of Compliance. As Ross said in opening remarks, the FDA decided to hold the briefing to further amplify FDA's concerns and engage with regulators to better understand how the effects of the COVID-19 public health emergency are impacting international hand sanitizer product quality and supply chains. Vashti Klein on the OGPS Communications Team was responsible for facilitating the successful teleconference. Australia’s Plain Packaging Tobacco Measures Reaffirmed by WTO

On June 10, the World Trade Organization (WTO) reaffirmed its decision that Australia’s plain packaging measures for tobacco products and packaging were consistent with WTO rules. In doing so, the WTO rejected appeals from the Dominican Republic and Honduras.  WTO members must ensure that their technical regulations are not more trade-restrictive than necessary to fulfill a legitimate objective, taking account of the risks non-fulfillment would create. The WTO ruled that Australia’s measures make a meaningful contribution to Australia’s legitimate objective of reducing the use of, and exposure to, tobacco products. Further, the public health consequences of not fulfilling this legitimate objective are particularly grave; and the complainants did not demonstrate that proposed alternative measures would be less-trade restrictive or would make an equivalent contribution to Australia’s legitimate objectives.

In 2012, Australia became the first country in the world to require plain packaging for tobacco products, directing that brand images, display logos and promotional text be removed from cigarette packages and to instead display required text and graphic health warnings. Australia introduced these measures to reduce the appeal of tobacco products, make health warnings more effective, and remove misleading information on packaging. The plain packaging measures formed part of Australia’s tobacco control scheme, which included taxation measures and educational campaigns.     Transitions

Farewell

William “Bill” Sutton, assistant country director for the China office, retired from the federal government on August 15 after 37 years of public service. His FDA career began in 1983 with the Center for Devices and Radiological Health’s (CDRH) Office of Device Evaluation (now part of the Office of Product Evaluation and Quality). He worked first in a series of administrative positions there before joining the Office of Health Industry Programs, now the Office of Communication and Education and the mandated industry and international assistance program in the Division of Small Manufacturers Assistance, now the Division of Industry and Consumer Education (DICE), where he spent over twenty years.

During his tenure in DICE, Bill focused on educating industry on the center’s total product lifecycle of regulatory programs for medical devices and radiation-emitting electronic products. He also served as deputy division director of DICE where he led the division in the strategic development of regulatory education on medical devices spanning premarket and postmarket policy. Sutton took on advanced responsibilities, including chair of FDA’s Third-Party Recognition Board (TPRB), which administered both the Accredited Persons (AP) for 510(k) review and AP for Inspection programs. In 2016, Bill joined the Office of International Programs, now the Office of Global Policy and Strategy, to work in the China Office. In this role, he served as a liaison between China and FDA in facilitating the distribution of safe and effective medical devices into the United States. Since the COVID-19 pandemic began, Bill took on a significantly increased role, due to the large volume of personal protective equipment and Class I medical devices being exported from China into the U.S.

Welcome

Anabela Marçal is the new European Medicines Agency (EMA) Liaison Official to the FDA. Her work involves supporting scientific and regulatory collaboration between the EMA and the FDA, in the context of their  confidentiality arrangements. Marçal has held various positions during her 20 year tenure at the EMA, including Head of Committees and Inspections, responsible for coordination of Good Manufacturing Practices, Good Clinical Practice, Good Laboratory Practice and Pharmacovigilance Inspections for the EMA; and Head of Community Procedures, responsible for the handling of European reviews initiated on the basis of new information on quality, safety or efficacy of authorized medicinal products that might lead to regulatory actions such as a suspension of a marketing authorization.

Although she is currently working remotely in Europe, Marçal will soon relocate to the White Oak campus of the FDA in Silver Spring, Md. Marçal obtained her degree in pharmacy at the University of Lisbon and received a professional certification in hospital pharmacy. She started her career at the Portuguese National Medicines Agency (INFARMED) before moving to the United Kingdom to join the EMA in 1999. In 2019, she relocated with EMA to Amsterdam.