By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs
It has been a year like no other in recent memory for public health. At the U.S. Food and Drug Administration, much of our focus has been dominated by our response to the COVID-19 pandemic. We’ve continued to make important scientific progress, with each day bringing new knowledge and understanding of the SARS-CoV-2 virus and the disease it causes, leading to the issuance of Emergency Use Authorizations (EUA) for two vaccines, and to increased availability of testing and treatment options.
The efforts by FDA staff in response to the virus involved a significant increase in the agency’s workload. But throughout, our workforce continued to make unparalleled contributions and demonstrated unwavering commitment to our many essential public health responsibilities.
In many ways, the year 2020 was shaped by the global pandemic and our response to it. Toward that end, this year also saw a number of cross-agency initiatives and achievements that both support and apply lessons learned from COVID-19 to adapt and strengthen our work, and to increase coordination of scientific leadership, agency operations, communications, and programming. For instance, we launched the COVID-19 Pandemic Recovery and Preparedness Plan – or PREPP – to support real-time adjustments on the basis of rapidly evolving data, to scale and sustain the FDA’s response, and to increase our capacity and resilience to respond to future health emergencies.
When I first joined the FDA, I established three strategic priorities for the agency: 1) unleashing the power of data, 2) empowering patients and consumers, and 3) promoting innovation, choice, and competition to advance scientific and medical progress. As you can see below, through our work on COVID-19 and our regular mission critical public health work, we have made significant progress on those priorities in 2020. What follows is just a sampling of the FDA’s achievements over the past year, representative of contributions that FDA staff continue to make – from all parts of the agency – day in and day out. But even this partial review reveals an incredible record of accomplishments and the hard work and dedication of FDA staff, including our U.S. Public Health Service Commissioned Corps officers, who play such a vital role in our public health mission.
The New Era of Smarter Food Safety, First Dual Use Animal Biotechnology Product
In a year when we’ve worked to mitigate temporary food supply chain issues and worked to help employees and employers in affected food industries continue or resume operations safely, we’ve also been able to advance a number of important new food safety initiatives.
In July, we released the New Era of Smarter Food Safety Blueprint, which outlines the steps the FDA will take over the next decade to create a more digital, traceable and safer human and animal food system. We also outlined a collaborative, action-oriented approach to enhancing the safety of leafy greens and help prevent the recurring outbreaks of Shiga-toxin producing E. coli, the 2020 Leafy Greens STEC Action Plan.
Our Center for Food Safety and Applied Nutrition launched two new consumer education campaigns this year, one involving the New Nutrition Facts label to help consumers use the updated Nutrition Facts label on food packages to make healthier food choices, and another called Feed Your Mind, in partnership with the U.S. Department of Agriculture and the U.S. Environmental Protection Agency (EPA), to provide science-based information on genetically engineered foods, commonly called GMOs.
Our Center for Veterinary Medicine (CVM) made history this month with the approval of the first animal biotechnology product for both food and biomedical use, a tremendous milestone for scientific innovation. The FDA is committed to continuing its close work with developers to facilitate safe advancements of animal biotechnology. This is also the first approval of an animal biotechnology product from a sponsor participating in our new Veterinary Innovation Program, which focuses on providing greater certainty in the regulatory process, encouraging development and research of innovative public health products, as well as supporting an efficient and predictable pathway to the approval of Intentional Genomic Alterations – or IGAs – in animals.
Among the other 28 pioneer and generic approvals issued this year by CVM are several products to treat, manage or prevent serious diseases in animals, including certain mast cell tumors in dogs, weight loss in cats suffering from chronic kidney failure, and severe asthma in horses.
We’ve also provided important guidance to both animal drug sponsors and to the animal food industry to promote innovation by issuing four key guidances to help facilitate the development of New Animal Drugs and one guidance on Animal Food Additive Petitions.
We continue to monitor the marketplace through our compliance and enforcement actions, also continue to inform the public about recalls of food, drug or device products with the potential to impact the health of animals or the humans who care for them.
Addressing the Harms of Tobacco, Especially Use of e-Cigarettes Among Our Youth
Just over a decade after the Center for Tobacco Products (CTP) was established, the FDA’s newest center continues taking a science-based approach to regulate an evolving tobacco landscape and protect the public – especially kids – from the harms associated with tobacco product use.
In March, CTP issued a final rule to require new health warnings on cigarette packages and in cigarette advertisements. Once implemented, these warnings will be the most significant changes to cigarette labels in more than 35 years and will considerably increase public awareness of lesser-known, but serious negative health consequences of cigarette smoking.
The FDA is continuing to address the alarming increase in the use of e-cigarettes among our youth, and the significant health implications of nicotine addiction and tobacco use more broadly. CTP marked a milestone this fall in the public health effort to combat youth e-cigarette use: the premarket review submission deadline for certain deemed tobacco products, including e-cigarettes. Applications are now undergoing a robust scientific evaluation to determine if products meet the criteria for receiving FDA authorization, such as whether marketing the product is appropriate for the protection of public health.
Also this fall, the FDA, in partnership with the CDC, released the 2020 National Youth Tobacco Survey, which shows 1.8 million fewer U.S. youth currently using e-cigarettes compared to 2019, as well as reductions in youth current use of cigarettes, cigars, smokeless tobacco, and tobacco products overall. This is good news, but the FDA remains concerned about the 3.6 million U.S. youth who currently use e-cigarettes and the nearly 5 million youth who currently use any tobacco product. The data also shows a surge in youth use of disposable e-cigarettes and that more than 8 out of 10 youth e-cigarette users report use of flavored products. And, CTP’s compliance actions against products targeted to young people continued throughout the year.
Inspections and Investigations, Operation Quack Hack, and Lab Safety During the Era of COVID-19
To respond to new pandemic-related complexities to our normal operations and sustain our performance, we are prioritizing our work and incorporating mechanisms that optimize the agency’s inspection operations. These include alternative inspectional approaches and novel assessment technologies that provide us with useful information to help ensure the safety and quality of the products consumers need. We also implemented the COVID-19 Advisory Rating system using real-time data to inform our investigators when and where it is safest to conduct prioritized domestic inspections.
We’ve continued to make important strides in preventing the distribution of fraudulent products, including many new efforts to exploit consumers through the sale of unproven medical products, illegitimate test kits, and substandard or counterfeit respirators being offered for sale on the internet.
To proactively identify and neutralize these threats to consumers, and particularly to protect consumers from fraudulent FDA-regulated products during the COVID-19 pandemic, the FDA launched Operation Quack Hack in March 2020.
To date, the FDA has identified more than 1100 fraudulent and unproven medical products related to COVID-19, and Operation Quack Hack initiatives have led domain registrars and online marketplaces to review and take down numerous websites or listings illegally selling unproven FDA-regulated products. This is in addition to our normal enforcement efforts by our Office of Criminal Investigations, which last year initiated more than 600 criminal investigations targeting violations related to FDA-regulated products.
Our Office of Regulatory Affairs (ORA) continued to work together this year with states and the CDC to investigate the outbreak involving thousands of lung injuries and multiple deaths associated with vaping.
A cornerstone of the FDA’s scientific work is to ensure that we operate our laboratories in a safe and secure manner. For example, we continued our multi-year lab revitalization effort with the relocation of the Kansas City Laboratory to a new state-of-the-art facility to continue our own independent scientific testing to support both risk assessment and regulatory programs for the foreseeable future. Our work in this area depends on the collaborative efforts of the FDA’s centers, ORA, our Employee Safety and Occupational Health, and the Office of Laboratory Safety to protect FDA staff.
In 2020, our biosafety and biosecurity professionals were integral to addressing the conditions for FDA staff to return to work safely, including laboratory staff doing SARS-CoV-2 research, given the new challenges and constraints posed by the transmission characteristics of SARS-CoV-2. They also played an important role in ensuring public safety. For example, ORA investigators and ORA laboratories worked together with the Center for Drug Evaluation and Research (CDER) to collect and analyze hundreds of hand sanitizer samples associated with an outbreak of illnesses and multiple deaths. While ORA adjusted inspections during the pandemic to protect our employees, we have made considerable progress in other priority areas.
We expanded our working relationship with the U.S. Customs and Border Protection (CBP), and the U.S. Immigration and Customs Enforcement, Homeland Security Investigations with a new memorandum of understanding that will allow our agencies to maximize inspections, investigations and detection capabilities to prevent harmful medical products as well as other illicit prescription drugs, cosmetics and foods from entering the U.S market at our nation’s International Mail Facilities (or IMFs) and Ports of Entry. It also includes the establishment of a satellite laboratory, bringing scientists with special training and advanced tools for rapid testing to these points of import entry. The first of these laboratories is in operation at the IMF in Chicago.
Our consumer safety officers at ports of entry have continued to examine imported products. In Fiscal Year 2020, we intercepted 20% more international mail than last year that contained illegal, and potentially dangerous, products. Working with CBP, investigators discovered shipments of sub-potent and dangerous methanol-containing hand sanitizers from Mexico. Due to the massive increase in the number of new hand sanitizer manufacturers and importers, ORA initiated “Operation Dirty Hands” to increase screening of potentially adulterated shipments of sanitizers.
In addition, ORA inspected seven cargo flights of medical products donated to the U.S. by six foreign governments. Before each flight, ORA coordinated with the U.S. Department of State, Federal Emergency Management Agency (FEMA), CBP, EPA, and other FDA headquarters and Center staff to discuss the diplomatic and logistical issues and inspection strategy. When the flights arrived, ORA inspected the cargo to ensure that the quantities and products matched what was declared and that all cargo complied with applicable regulations. FEMA distributed most of these medical products to hospitals, nursing homes, and long-term care facilities throughout the country.
53 Novel Drug Approvals, Emergency Use Authorizations for Medical Devices, Supporting COVID-19 Vaccine Development
During 2020, our medical product centers have been especially focused on addressing the challenges of this public health emergency while continuing to fulfill our normal essential responsibilities.
On the COVID-19 front, the FDA issued a new guidance for conducting clinical trials during COVID-19, to facilitate changes in conduct that would protect participant safety and maintain data integrity. CDER, in collaboration with the Center for Biologics Evaluation and Research (CBER) formed the Coronavirus Treatment Acceleration Program, designed to help bring new COVID-19 therapies to market as soon as possible. Currently, there are more than 590 COVID-19 drug development programs relating to COVID-19 in the planning stages, more than 390 trials that have been reviewed by the FDA, eight treatments for use during the COVID-19 pandemic authorized through Emergency Use Authorizations (EUAs) in collaboration with the Office of the Chief Scientist (OCS), and we approved the first drug to treat certain patients with COVID-19.
In 2020, CDER has approved 53 novel drugs as well as many new uses for already FDA-approved drugs to treat a wide range of medical conditions, including infectious, neurological, cardiovascular, endocrine, and autoimmune diseases, rare diseases, and cancers. Thirty-one (58%) of these novel approvals will help patients with rare diseases – many for which no previous treatment had been FDA-approved.
Of the many novel drugs and biologics approved over the past year, 16 relate specifically to cancer, including treatments for RET-fusion positive lung cancer, refractory multiple myeloma, initial treatment of MSI-high colon cancer, and refractory gastrointestinal stromal tumors, to name a few. Of these, 9 were reviewed under the Oncology Center of Excellence’s Project Orbis.
We’ve continued our important work to ensure access to cost saving drugs and needed medications. As of November 30th, the FDA has approved or tentatively approved more than 800 generic drugs, including 65 first generics, such as a new approval for the treatment of severe hypoglycemia (very low blood sugar), one for a widely used albuterol inhaler to treat breathing conditions, and another to treat a parasitic infection. We have also worked to help improve patient access to insulin, issuing draft guidance that describes our recommendations regarding a streamlined approach to demonstrating biosimilarity and interchangeability for certain insulin products.
CDER also took action to remove from the market a variety of drugs containing potentially cancer-causing nitrosamines. We announced the results of research concerning sunscreen safety, took steps to implement a new law that modernizes the way over-the-counter (OTC) drugs are regulated, required for benzodiazepines to have stronger risk warnings, required new safety warnings for nonsteroidal anti-inflammatory drugs, and issued guidance to industry to further help those who compound medications identify and prevent insanitary conditions at their facilities.
We’ve also made numerous decisions to address drug shortages. For example, we facilitated manufacturers’ extensions of expiration dates, prioritized review and approval of many generic drugs to help ease shortages, and issued guidance on the production of alcohol-based hand sanitizer to help boost supply.
Our Center for Devices and Radiological Health (CDRH) has made enormous contributions to the COVID-19 response, including working with OCS to authorize over 600 medical devices – a ten-fold increase over the number authorized in all prior national emergencies combined. To date, the FDA has authorized over 300 tests and sample collection devices. This includes a wide variety and volume of tests, including 233 molecular tests and sample collection devices, 62 antibody tests, and 11 antigen tests, with tests that can be used in laboratories, in doctors’ offices and other point-of-care settings, and at home.
The diagnostic tests, personal protective equipment (PPE), infusion pumps, ventilators, and other devices authorized under EUAs have been instrumental in the public health response to the pandemic. CDRH also implemented a coordinated response to help address potential device shortages given the increase in global demand and supply chain disruptions resulting from COVID-19. In order to expand access to critical PPE supplies for health care personnel, such as respirators, CDRH issued guidances for immediate implementation, communicated conservation strategies, and issued many Emergency Use Authorizations. As one of its actions to address testing supply shortages, CDRH, in partnership with the Biomedical Advanced Research and Development Authority and the Department of Defense, helped to coordinate a series of military airlifts of millions of swabs in northern Italy, where they were manufactured, for nearly six weeks starting in mid-March.
This year, CDRH also launched the Digital Health Center of Excellence, an important step in furthering the agency’s overarching dedication to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when they are a medical device, and technologies used to study medical products.
CDRH continues to work toward achieving its goal of ensuring that patients in the U.S. have first in the world access to high-quality, safe, and effective medical devices of public health importance. In 2020, CDRH authorized more than 100 novel devices, including the first game-based digital therapeutic to improve attention function in children with attention deficit hyperactivity disorder and the first cardiac ultrasound software that uses artificial intelligence to guide the user to capture high-quality diagnostic images.
CBER has had a busy year supporting the agency’s response to the COVID-19 pandemic, with a significant focus on work with manufacturers on the development and availability of vaccines for the prevention of COVID-19. As part of this effort, CBER issued two guidances for industry. The first provided recommendations to sponsors regarding the scientific data and information needed to support the development and licensure of safe and effective vaccines to prevent COVID-19. The second provided recommendations to vaccine sponsors regarding the scientific data and information that would support the issuance of an EUA for an investigational vaccine intended to prevent COVID-19, including chemistry, manufacturing and controls information, nonclinical and clinical data, and regulatory and administrative information.
Most recently, CBER issued two EUAs for COVID-19 vaccines, and other COVID-19 vaccines are in development. We held two meetings of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to seek input from independent scientific and public health experts on each of the vaccine candidates, underscoring our commitment to being as open and transparent as possible about the data and information needed to support authorization of these vaccines. This input, along with the careful and thorough evaluation by CBER’s career scientists, will give the public and medical community trust and confidence that these vaccines meet the FDA’s rigorous standards for safety and effectiveness.
CBER also continued to fulfill its many routine responsibilities, including ensuring the safety of the nation’s blood supply. The Center also licensed (approved) a number of important biological products, including a CAR-T product to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL); a new vaccine for the prevention of invasive meningococcal disease; a coagulation factor VIIa to treat and control bleeding episodes in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors; and a peanut allergen powder (oral immunotherapy) to mitigate allergic reactions - including anaphylaxis – that may occur with accidental exposure to peanuts.
It is a remarkable achievement that the agency has maintained the same pace of meeting its goals on the review of applications for medical products during the pandemic relative to recent years.
Advancing FDA’s Public Health Mission Globally
The FDA’s work to advance our vital public health mission through global engagements is yet another reminder of the sheer scope of the agency’s reach. The importance of the FDA’s global engagements has been affirmed through the collaborations to support its COVID-19 pandemic response efforts, including our Europe Office supporting the first global regulatory workshop on COVID-19 vaccines, under the auspices of the International Coalition of Medicines Regulatory Authorities, to discuss strategies to facilitate the development of SARS-CoV-2 vaccines and promote regulatory convergence to the extent possible. This year also saw the historic finalization of an equivalence determination that will facilitate the opening of markets in raw molluscan shellfish that have been closed to trade between the U.S. and the European Union since 2010. In addition, Project Orbis launched by the Oncology Center of Excellence strengthened international collaboration through a partnership with six foreign regulatory authorities to accelerate patient access to innovative cancer therapies across multiple countries. Also this year, CVM included veterinary pharmaceuticals as part of the FDA’s Mutual Recognition Agreement (MRA) for Pharmaceutical Good Manufacturing Practice Inspections with the European Union to strengthen the use of each other’s animal drug inspection expertise and resources and increase efficiencies.
Lessons Learned from 2020, The Path Forward
Throughout 2020, we continued to optimize our regulatory policies and procedures. For example, we streamlined many processes to make it easier for developers and scientists to send inquiries and requests related to the pandemic response and facilitated the timely availability of guidance documents for industry. We also continue to modernize how clinical trials can be designed and conducted to expand the data sources to aid our evaluation of medical products.
We made important progress in 2020 in our ongoing efforts to increase the diversity of participants in clinical trials, issuing a final guidance with recommendations on designing and executing clinical trials of drugs and biologics that include people with different demographic characteristics. This will help ensure that the products we approve are safe and effective for those who will use them and better meet the health needs of all patients. This is especially important when trying to find treatments and cures for new diseases like COVID-19, in which certain segments of the population, including older adults, pregnant women, children, and racial and ethnic minorities, have been affected differently. It is one more piece of our long-term focus on advancing health equity. This year also marked our Office of Minority Health and Health Equity’s 10-year anniversary and their important work to reduce health disparities among diverse populations.
We also took important action to help ensure the American public is more prepared and protected against future outbreaks of emerging infectious diseases, such as COVID-19, as well as chemical, biological, radiological and nuclear threats, by identifying a list of 227 drug and biological product medicines and 96 device medical countermeasures that are medically necessary to have available at all times.
COVID-19 has added new urgency to ongoing work at the FDA to apply new data sources, including real-world data, to inform our decision-making. Early in the pandemic, the FDA recognized that a diverse set of data sources would be needed to provide rapid, actionable information. The FDA developed research projects that combine new sources of data with rigorous analytical techniques to better understand COVID-19 symptoms and the patterns of use of therapeutics and diagnostics, among many other research questions. Through our groundbreaking work with the COVID-19 Evidence Accelerator, a new community of data researchers from government, academia, and industry grew around a common goal: deploying rigorous, novel, and transparent methods of applying data to inform the response to the pandemic.
COVID-19 accelerated the agency’s use of novel data sources and rigorous analytical techniques to inform science-based decision-making, and this work has shown us how important it is to have the tools and expertise needed to apply data in modern ways. To this end, the FDA has continued its technology and data modernization initiatives by revamping the way we develop and deploy information technology at the agency and by building modern data infrastructure and expertise. In June 2020, we heard stakeholder input on these topics in a public meeting on Modernizing FDA’s Data Strategy and we are looking forward to ongoing public engagement in this area.
Finally, another way we are working to increase access to critical medical products, as well as to lower production costs and decrease the risk of supply disruption, is through the adoption of innovative technologies, such as advanced manufacturing.
In a challenging year, we’ve seen the FDA respond with diligence and effectiveness. While there are many examples of the resourcefulness of our workforce, an action by the ORA’s Office of Enforcement and Import Operations (OEIO) relating to one of the COVID-19 vaccines captures it well.
Authorities in Belgium (where the Pfizer-BioNTech COVID-19 Vaccine was produced), would not allow the vaccine to be shipped to the U.S. until it was authorized. The OEIO staff quickly coordinated global communications among the parties, and within 24 hours, the vaccines were on a plane headed to a secure U.S. foreign trade zone site in Michigan for storage and staging in advance of the potential EUA.
ORA investigators from OEIO and the Office of Biological Products Operations then carefully examined the vaccines to ensure they had arrived secure and intact, and verified that storage conditions complied with current good manufacturing practices. Swift, decisive, and dedicated action by these investigators ensured that this critical vaccine could reach Americans safely and quickly.
This kind of work ethic and dedication to the FDA mission – effective, efficient, and focused on protecting and promoting public health on behalf of the American patients and consumers we serve – is evident across the FDA. I commend the entire FDA team for working so hard on behalf of the American public. I know this same focus and diligence will lead us into a successful and productive 2021.