Goal 2: Protect the Health of Americans Where They Live, Learn, Work, and Play

Responders from HHS’s National Disaster Medical System care for a patient arriving via airlift in the wake of Hurricane Michael.

HHS’s work to protect the health of Americans extends from addressing the most pressing public health threats in our local communities, including the opioid crisis, HIV, and other infectious diseases, all the way to supporting global planning and infrastructure to address and prevent health threats around the world.

In this page:

• Combating the Opioid Crisis
• Strengthening Global Health Security
• Battling America’s HIV Epidemic
• Fighting Infectious Diseases at Home
• Combating Anti-Microbial Resistance
• Responding to Natural Disasters
• Defending against Chemical, Biological, and Radiological Threats
• Providing Epidemiological Assistance Here and Abroad
• Combating Nicotine Addiction
• Promoting Health through Physical Activity
• Modernizing Food Safety and Nutrition
• Advancing Drug Safety
• Improving Mental Health Treatment

Combating the Opioid Crisis

In one of his first speeches in office, Secretary Azar laid out his approach to the opioid crisis as one of his four priorities, with a specific emphasis on relying on the best science possible. In March 2018, he named Admiral Brett Giroir, Assistant Secretary for Health, as senior advisor to oversee opioid policy and coordinate opioid-specific efforts across the department.

In 2018, under Admiral Giroir’s leadership, HHS updated its strategic framework for tackling the opioid crisis, using science as the foundation for the department’s comprehensive strategy. These updates built on the five-point strategy to combat the opioid crisis that was developed by the Office of the Assistant Secretary for Planning and Evaluation (ASPE) and introduced by HHS under President Trump in 2017.

Dedicated efforts from the federal government to communities and individuals have begun to show promising signs: From 2016 to 2017, according to the HHS-run National Survey on Drug Use and Health, the number of Americans initiating heroin use dropped significantly. From January 2017 through November 2018, there has been a:

• 26 percent decrease in total morphine milligram equivalents dispensed monthly by pharmacies.
• 338 percent increase in naloxone prescriptions.
• 22 percent increase in number of patients receiving buprenorphine, one form of medication-assisted treatment (MAT) for opioid addiction, per month.
• 47 percent increase in number of naltrexone prescriptions, another form of MAT, per month.

Better Access to Treatment, Prevention, and Recovery Services

Historic levels of grant funding: Thanks to legislation passed by Congress and signed by President Trump, HHS awarded more than $2 billion in 2018 to address the opioid crisis. This included:

• The Substance Abuse and Mental Health Services Administration (SAMHSA) awarded $500 million in the second year of the Opioid State Targeted Response (STR) program to help states develop prevention, treatment, and recovery systems to address the opioid crisis. Thanks to STR in 2018, over 121,000 clients received services, 396,000 individuals were trained, and 1,300 funded organizations offered at least one form of MAT.
• SAMHSA awarded $1 billion through the State Opioid Response grant program, building upon the success of STR.
• HRSA awarded more than $350 million to over 1,200 health centers nationwide to implement and advance evidence-based strategies to expand access to integrated substance-abuse and mental health services.
• The CDC awarded $155 million to increase support for states and territories working to prevent opioid-related overdoses, deaths, and other outcomes, which will advance the understanding of the crisis and scale up prevention and response activities. CDC also awarded $12 million in funds to support 11 Tribal Epidemiology Centers and 15 tribal entities, to improve opioid overdose surveillance and improve prevention strategies, and distributed an additional $27 million to nine non-governmental organizations, which will support states and territories with staffing, procurement, and training to enhance local public health capacity.

A historic opportunity to test comprehensive interventions: In 2018, the National Institutes of Health (NIH) began accepting applications for the HEALing Communities study, which will provide generous resources and comprehensive support for up to three communities with especially high rates of overdoses, helping them test an integrated set of evidence-based practices for prevention and treatment. HEALing Communities will constitute the most ambitious such undertaking in the history of the study of addiction, while aiming to decrease opioid overdose fatalities in these communities by 40 percent.

A new emphasis on MAT: In one of his first major speeches, Secretary Azar told America’s governors that he would make MAT, the gold standard for addiction treatment, a key element of HHS’s strategy for battling the opioid epidemic. Toward this end:

• The new SAMHSA SOR grants included a requirement that states make MAT available to all patients served through the grants.
• HRSA-funded community health centers saw a 64 percent increase in MAT patients and 75 percent increase in MAT providers from 2016 to 2017.
• The Office of the Assistant Secretary for Health (OASH) alerted healthcare providers to how they can be expanding access to MAT through telemedicine.
• FDA issued two draft guidances on developing buprenorphine depot products, an extended-release form of MAT, and on endpoints for demonstrating effectiveness of MAT drugs.
• SAMHSA developed the first survey of practitioners who are waived to prescribe buprenorphine to better understand barriers to prescribing and the extent to which these constraints can be addressed.
• In 2018, SAMHSA’s Medication Assisted Treatment—Prescription Drug and Opioid Addiction program achieved a 62 percent abstinence rate at 6 month follow-up, exceeding its target rate.

Demonstrations to help states use Medicaid to fight addiction: CMS approved 14 substance-use-disorder (SUD) demonstrations in 2018, bringing the total of such demonstrations approved to 21. These demonstrations provide states with new flexibility around the IMD exclusion (Medicaid’s statutory restriction on funding inpatient treatment for mental illness) to support effective and timely access to treatment for SUD, including opioid use disorder.

A new assessment of such a demonstration, launched by Virginia in 2016, found a number of positive results: The state saw a 39 percent decrease in opioid-related emergency-room visits, and a 31 percent decrease in substance-use-related ER visits overall. The number of residential treatment centers expanded dramatically, as did the number of opioid-specific treatment programs.

Two new payment models: CMMI launched two new innovative models to focus on vulnerable populations—children and pregnant women—in fighting the opioid crisis.

• The Integrated Care for Kids (InCK) model helps prevent and treat behavioral and mental health conditions, including substance-use disorder, in children and young adults. Under the InCK model, when mental and behavioral health challenges arise, there is a full set of crisis services available to handle the needs of kids and their families.
• The Maternal Opioid Misuse (MOM) model allows state Medicaid agencies, front-line providers, and healthcare systems to coordinate clinical care and integrate support services for pregnant and postpartum women with opioid use disorder and their infants.

Supporting rural communities and coalitions: HRSA awarded 95 planning grants to rural communities to identify key needs for prevention and treatment of substance abuse; funded 36 grants to rural communities to combat the opioid epidemic through direct service provision; and awarded $34.6 million to expand the opioid workforce and increase access to evidence-based prevention and treatment services in rural and underserved communities nationally.

Surgeon General’s spotlight on the opioid crisis: Surgeon General Jerome Adams’s spotlight on the opioid crisis calls for a cultural shift in the way Americans talk about the opioid crisis and recommends actions that can prevent and treat opioid misuse and promote recovery. The Surgeon General also released a digital postcard, highlighting tangible actions that all Americans can take to raise awareness, prevent opioid misuse and reduce overdose deaths.

FDA approvals: The FDA approved the first non-opioid treatment for the mitigation of withdrawal symptoms associated with abrupt discontinuation of opioids; the first generic versions of Suboxone sublingual film; new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence; and the first sublingual formulation of sufentanil.

FDA pathways for new treatments: The agency launched an innovation challenge to spur the development of medical devices, including diagnostic tests and digital health technologies (mobile medical applications) to help combat the opioid crisis and achieve the goal of preventing and treating opioid use disorder. FDA received more than 250 applications from medical device developers and 8 participants were selected based on the criteria.

New, localized and evidence-based approaches to technical assistance: SAMHSA reconfigured its approach to technical assistance and training, with a new focus on addiction, mental health and substance abuse prevention and making training and technical assistance available to all providers and communities, rather than the former focus just on SAMHSA grantees. SAMHSA also began a first-ever collaboration with the Department of Agriculture, awarding an $8 million effort to develop training and technical assistance centers to address the needs of rural America.

To promote broader use of practices with solid scientific evidence, SAMHSA also established a new National Mental Health and Substance Use Policy Laboratory, which enhances SAMHSA’s ability to develop and implement evidence-based resources. SAMHSA introduced its new Evidence-Based Resource Center, replacing an old system which provided little usable information on the establishment of evidence-based practices.

FDA work to reduce illicit marketing and distribution of opioids: As part of implementing FDA’s Opioid Policy Work Plan, the agency issued warning letters to the marketers and distributors of 12 fraudulent opioid cessation products and to 17 online networks, operating about 370 websites that were illegally marketing unapproved opioids. In June, FDA held the first Online Opioid Summit to discuss ways to reduce the availability of illicit opioids online. In attendance were many key internet stakeholders, including Twitter, Facebook, Microsoft and Google, as well as government agencies, academic researchers and patient advocates.

FDA expands criminal enforcement against illicit opioids: FDA’s Office of Criminal Investigations (OCI) established a new Enforcement Task force in partnership with Customs and Border Protection and U.S. Postal Service, while hiring new FDA special agents to step up enforcement. In 2018, OCI made 91 arrests that led to 73 convictions related to the inspections at ports of entry, and increased the use of the TruScan device, a rapid identification tool, to identify counterfeit pharmaceuticals and tainted supplements.

Secretary Azar and Assistant Secretary for Health Brett Giroir participate take a tour of “Prescribed to Death” – an exhibit aimed at changing Americans’ attitudes toward opioids.

Better Data on the Epidemic

Improving data analysis and dissemination through AHRQ: AHRQ released a new online statistical resource in March that, for the first time, provides county-level comparisons of hospitalization rates for substance use, including opioids, alcohol, stimulants, and other drugs. This resource helps communities better understand local challenges and support community efforts to formulate the most effective remedies to reduce substance abuse, including opioid use disorder. AHRQ also published a number of statistical briefs that shine a light on the opioid crisis and its effect on the U.S. healthcare system. AHRQ also expanded its online resource guide on integrating behavioral health and primary care to include a section devoted to addressing opioid and substance abuse in primary care. In addition to highlighting resources from across HHS, the site includes a collection of over 250 practical tools and resources available to providers, patients, and communities to help implement MAT in primary care settings.

Faster counting of overdose deaths: CDC increased the percentage of mortality records collected electronically from the states within 10 days of death from seven percent in 2014 to an estimated 63 percent in 2018, providing faster data to improve decision-making and target resources. CDC also published its first full year of provisional drug overdose death data nationally, for each jurisdiction and specific drugs or drug classes, on a six-month lag, down from a more than 12-month lag.

Indian Health Service Principal Deputy Director Michael Weakhee participates in a discussion during the National Town Hall on Combating Opioids and Substance Abuse in Tribal Communities.

Advancing prescription drug monitoring programs: CDC supported states to implement important opioid overdose prevention strategies, such as improvements to Prescription Drug Monitoring Programs (PDMPs). With CDC help, Illinois, for instance, is now integrating PDMP data with more than 800 sites, has completed nearly 4.4 million PDMP requests, and is connected to 25 other state PDMPs to improve usability and state interoperability.

Working toward interoperability of PDMPs: ONC supported the goal President Trump set forth to build a national network of prescription drug programs, through including standards to support PDMP integration in the Interoperability Standards Advisory, a process through which ONC coordinates health IT standards and implementation specifications that stakeholders use.

Revolutionizing use of HHS data: Following the HHS Opioid Code-a-Thon in December 2017, HHS released publicly current state assessments about the challenges to data sharing across agencies within the department, including an overview of the relevant legal and privacy landscape—the first of its kind. Born from a winning solution at the HHS Opioid Code-a-Thon, Google will incorporate drug disposal site data into Google Maps, making it easier to find disposal options for unused prescription drugs.

Better Targeting of Overdose Reversing Drugs

Surgeon General’s Advisory on Naloxone: The Surgeon General released the first Surgeon General’s advisory in 12 years, urging more Americans to carry a lifesaving medication that can reverse the effects of an opioid overdose. Naloxone is already carried by many first responders, such as EMTs and police officers, but the advisory recommends that more individuals, including family, friends and those who are personally at risk for an opioid overdose, also keep the drug on hand. Industry-provided data indicated that there was a 27 percent increase in the number of retail-dispensed prescriptions for naloxone immediately following the release of the advisory and a 70 percent increase in weekly dispensing rates 12 weeks after the release of the advisory.

Secretary Azar visits with a client of Brigid’s Path, an inpatient medical care center for drug-exposed newborns.

New HHS naloxone guidance to enhance co-prescribing: Assistant Secretary for Health Brett Giroir issued a guidance recommending that clinicians prescribe or co-prescribe naloxone to individuals at risk for opioid overdose, including individuals who are on relatively high doses of opioids, take other medications which enhance opioid complications, or have other underlying health conditions.

Equipping first responders: SAMHSA grants to expand access to naloxone for first responders resulted in the distribution of more than 31,000 naloxone kits during 2018.

Better Pain Management

FDA efforts to improve prescribing and pain management: The FDA awarded a contract to the National Academies of Sciences, Engineering, and Medicine to help advance the development of evidence-based guidelines for appropriate opioid analgesic prescribing for acute pain resulting from specific conditions or procedures.

The agency also approved the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS), which for the first time applies to immediate-release opioid analgesics intended for use in an outpatient setting. Previously, the REMS had covered only extended-release/long-acting opioid analgesics. Also for the first time, the opioid REMS will require that training be made available to health care providers who are involved in the management of patients with pain, and not only to prescribers.

Overseeing prescribing in Medicare: The HHS Office of the Inspector General (OIG) published a new report analyzing Medicare Part D data to identify opioid prescribing patterns. While risky prescribing was down from 2016 to 2017, OIG found that about 15,000 beneficiaries appeared to be “doctor shopping” and that almost 300 prescribers engaged in questionable opioid prescribing by ordering opioids for beneficiaries at serious risk of opioid misuse or overdose.

NIH Director Francis Collins and Secretary Alex Azar participate in a Twitter chat on Pain Awareness Month.

Better Research on Pain and Addiction

Helping to end addiction long term: In 2018, NIH launched the Helping to End Addiction Long-term (HEAL) Initiative, to accelerate scientific solutions to address the opioid crisis, with regard to both pain and addiction.

With regards to pain, HEAL builds on extensive, well-established NIH research to:

• Develop new tools and biomarkers to detect changes in the brain associated with the transition from acute to chronic pain.
• Develop tailored interventions to control pain and restore function.
• Develop new, effective, and non-addictive approaches for pain management.
• Define and support best practices for pain management.

On addiction, HEAL will also seek to:

• Develop flexible and complementary treatment options for opioid use disorder to reduce drug use, prevent overdoses and support recovery.
• Develop new agents to prevent and reverse opioid overdose that are capable of reversing overdose from highly potent synthetic opioids such as fentanyl and carfentanil.
• Enhance treatments for pregnant women with an opioid use disorder and for newborns with neonatal opioid abstinence syndrome (NAS).
• Develop and test additional medication-assisted treatment options.
• Test strategies for translating research into practice, and advance implementation of evidence-based treatments in real-world settings.

A new initiative on NAS: HHS held the department’s first-ever national convening on NAS, which brought national experts together to provide their individual perspectives on a new HHS initiative to study and address the needs of infants born with NAS.

HHS-supported research advances: In 2018, NIH-supported studies that pertain to pain and opioid addiction included the following:

• Researchers demonstrated in the Journal of Pain that disability is as likely in the chronic pain population as it is in those with kidney failure, emphysema or stroke—reflecting the challenges faced by 11 million U.S. adults with High Impact Chronic Pain (HICP), a new concept that describes those with pain lasting three months or longer and accompanied by at least one major activity restriction.
• A study published in Science, funded in part by the National Institute on Aging, found that clinicians were more likely to reduce the number and dose of opioid drugs they prescribed after learning that one of their patients had died from an overdose from a controlled substance than those not notified.
• An NIH-funded study found that treatment of opioid use disorder with either methadone or buprenorphine following a nonfatal opioid overdose is associated with significant reductions in opioid-related mortality
• Researchers have shown that pain-induced changes in the rat brain’s opioid receptor system may explain the limited effectiveness of opioid therapy in chronic pain and may play a role in the depression that often accompanies it, showing the clear impact of chronic pain on the brain and its relation to depression.
• New research published in Neuron, funded by the National Institute on Drug Abuse, found that opioids used to treat pain, such as morphine and oxycodone, produce their effects by binding to receptors inside neurons, contrary to conventional wisdom that they acted only on the same surface receptors as endogenous opioids, which are produced naturally in the brain.

Understanding opioid use among Americans with disabilities: ACL’s National Institute on Disability, Independent Living and Rehabilitation Research (NIDILRR) launched two projects in 2018 to better understand opioid use and abuse among Americans with disabilities: One will lay the groundwork for primary care providers and specialists to accurately assess for opioid use disorder in people with disabilities who are taking opioids long term to manage musculoskeletal pain, and the other will contribute to evidence-based policy and practice on behalf of people living with disabilities and opioid use disorder.

Promoting and improving best practices: In December, the Pain Management Best Practices Inter-Agency Task Force, hosted by OASH, issued its draft report, calling for individualized, patient-centered pain management to improve the lives of millions of individuals who experience acute and chronic pain. The report will be finalized in 2019.

Strengthening Global Health Security

Launching a new global strategic plan: At the 2018 U.N. General Assembly, a U.S. delegation, led by Secretary Azar and supported by HHS’s Office of Global Affairs successfully negotiated a resolution on the International Health Regulations (IHR), resulting in the approval of the IHR Global Strategic Plan, a key piece of strengthening global health security around the globe.

Taking the next steps for global health security: At the 5th Global Health Security Agenda Ministerial Meeting in Indonesia, with HHS Deputy Secretary Hargan as head of delegation, HHS led an international working group to further President Trump and Secretary Azar’s priorities for the Global Health Security Agenda (GHSA), a multinational coalition for global health security. This work resulted in the development and successful international launch of the next five-year phase of GHSA, known as “GHSA 2024,” and its guiding framework.

Addressing regional health crises and security: Secretary Azar convened an Americas ministerial roundtable discussion to discuss needs and solutions to the regional health crisis stemming from the collapse of the Venezuelan healthcare system and the mass migration out of the country, which has demonstrated the need for regional partners to cooperate on global health security.

Health security at the southern border: HHS worked to realign the activities of the U.S.-Mexico Border Health Commission according to the administration’s infectious disease global health priorities by redirecting FY 2018 and 2019 funding to projects on the border, which advance administration objectives on both global health security and antimicrobial resistance.

National Disaster Medical System teams in training.

Battling America’s HIV Epidemic

CDC expands surveillance work: In 2018, the CDC implemented a new integrated HIV surveillance and prevention program to prevent new HIV infections and achieve viral suppression among persons with HIV, enabling health departments to better match resources to geographic burden of HIV. This program builds on CDC’s flagship HIV program, a chief contributor to HIV prevention success in the U.S., including increases in awareness of status, and reductions in perinatal HIV infections and new HIV diagnoses.

A new record for results from the Ryan White program: In 2018, 85.9 percent of patients receiving medical care through HRSA’s Ryan White Program were virally suppressed, compared with a viral suppression rate of 59.8 percent among the general population of people diagnosed with HIV. Higher rates of viral suppression mean not just better health for those living with HIV, but also substantially reduced likelihood of their transmitting HIV.

New focuses for the Ryan White program: HRSA revamped the Ryan White HIV/AIDS Program (RWHAP) Part C funding methodology to better align with where the epidemic is most concentrated. The new methodology allowed HRSA to fund ten new RWHAP Part C geographic service areas, including six in the South, where there is the greatest burden of infection, illness, and deaths from HIV.

A promising sign about viral suppression: HIV was suppressed for more than 15 weeks through antibody infusions, after stopping antiretroviral treatment, in a pilot clinical trial of a small group of people living with HIV who were sensitive to two anti-HIV antibodies. The trial was supported by NIH, the Gates Foundation, and others.

Fighting Infectious Diseases At Home and Abroad

Promoting innovation in the fight against Lyme disease: The HHS CTO organized and led the first-ever Lyme Innovation Roundtable at HHS to harness the power of collaboration, data-driven Innovation, and emerging technologies for Lyme and other tick-borne diseases. The HHS CTO announced and led the 14-week tech sprint to create value from federal open data related to health priorities like artificial intelligence for improving experimental therapies, matching clinical trials, and responding to Lyme disease. The sprint uses methods pioneered by the Census Bureau for lightweight public-private collaborations that tackle complex challenges with open data, emerging technology, and agile methods.

Taking the lead on fighting to end tuberculosis: HHS led the U.S. Government’s participation in the U.N. High-Level Meetings on Tuberculosis (TB) at the U.N. General Assembly, at which the U.S. stance on multi-stakeholder approaches to these challenges as well as a strong commitment to protection of innovation were achieved in the high-level meetings’ accompanying declarations. Together, OGA, CDC, NIH, and FDA are working to develop a whole-of-HHS initiative to accelerate TB elimination in the United States and around the world.

Combating Anti-Microbial Resistance

Securing global cooperation against the AMR threat: Recognizing that confronting antimicrobial resistance (AMR) requires cooperation from across nations and sectors, HHS launched the AMR Challenge at the 2018 United Nations General Assembly in September, as an opportunity for governments, corporations, and non-governmental organizations to make pledges to further the progress against AMR.

A new FDA strategy for AMR: In September, Commissioner Scott Gottlieb announced FDA’s strategic approach to antimicrobial resistance, launching a new website highlighting the work happening across FDA’s programs and issuing a Request for Information to solicit input from the public and private sectors on developing an annual list of regulatory science initiatives specific for antimicrobial products.

Improving stewardship of antibiotics in veterinary settings: A 2018 report from FDA’s Center for Veterinary Medicine found that U.S. sales and distribution of antimicrobials approved for use in food-producing animals dropped by 33 percent from 2016 to 2017, suggesting progress in efforts to reduce unnecessary use and improve stewardship. The Center for Veterinary Medicine also published an action plan “Supporting Antimicrobial Stewardship in Veterinary Settings,” which details its goals in this area for Fiscal Years 2019-2023.

Expanding scientific knowledge of AMR: NIH’s National Institute for Allergy and Infectious Diseases (NIAID) began supporting U.S. clinical sites participating in two ongoing international Phase 2 clinical trials evaluating investigational antibody-based therapies aimed at preventing potentially antibiotic-resistant infections.

Responding to Natural Disasters

Responding to hurricanes, wildfires, and more: In 2018, the Assistant Secretary for Preparedness and Response (ASPR) led the federal government’s public health and medical response to 22 disaster responses, drills, and national special security events including a hurricane season with two of the largest storms ever recorded in U.S. history, as well as the worst wildfire season on record in California. More than 700 HHS personnel deployed for the hurricanes and wildfires and provided care to more than 7,800 patients in impacted areas where hospitals had been destroyed or overwhelmed or evacuated residents needed medical care in shelters. The Assistant Secretary for Health, who leads the U.S. Public Health Service Commissioned Corps, deployed more than 1,050 Commissioned Corps officers to respond to nearly 30 disaster responses, planned events, and community health and services mission.

Over the past year, HHS staff, led by ASPR, dedicated more than 119,000 hours to assist in the recovery of health and social services in communities impacted by the unprecedented 2017 hurricane season. Commissioned Corps officers responded to Hurricanes Florence and Michael, the Hawaii volcano eruption, the California wildfires, Typhoon Yutu, and the NIAID Ebola vaccine trial in Liberia. Through the end of 2018, HHS personnel continued work with recovery efforts from the effects of the 2017 hurricane season in Puerto Rico.

Historic recognition of HHS role in disaster response: For the first time ever, in 2018, Commissioned Corps officers received the Humanitarian Services Medal in recognition of a large-scale deployment, alongside personnel from the Department of Defense, for their work on response and recovery efforts in the wake of the devastation caused in 2017 by Hurricanes Harvey, Irma, and Maria.

Improving systemic preparedness: Building on the success of coalitions among state and local healthcare providers through the Hospital Preparedness Program, ASPR began implementing a vision for a Regional Disaster Health Response System, which draws public and private health care facilities and services together to provide comprehensive care during disasters. Demonstration projects in Massachusetts and Nebraska began in the fall of 2018, taking the idea from concept to design to demonstration in less than a year. In 2018, existing coalitions successfully responded to hurricanes, train derailments, and more. ASPR also led the largest patient movement exercise in the department’s history, working with 50 partners from state and local agencies and the private sector to test the nation’s readiness for Ebola and other highly infectious disease outbreaks.

More than 230 U.S. Public Health Commissioned Corps officers deployed in North Carolina to help residents in the aftermath of Hurricane Florence, including providing care to patients at a shelter in Clayton, NC.

Defending against Chemical, Biological, and Radiological Threats

HHS leads the first-ever biodefense strategy: President Trump unveiled the first National Biodefense Strategy and tapped HHS to lead implementation of that strategy to make America safer from all biological threats to national security. The naming of HHS as the lead agency for the National Biodefense Strategy is a culmination of the department’s long emergence as a key player on national security, stretching from Secretary Donna Shalala’s declaring HHS a national security agency for the first time in the 1990s through the integral role HHS played in responding to the post-9/11 anthrax attacks, new pandemic influenza threats in the 2000s, and the Ebola outbreak of 2014.

A new home for the Strategic National Stockpile: HHS completed the transfer of the Strategic National Stockpile from CDC to ASPR, a reorganization of over $600 million in federal resources, including personnel, records, and assets that provide life-saving pharmaceuticals and medical supplies during a disaster or other public health emergency. The program transfer is expected to increase efficiencies within the HHS medical countermeasure enterprise, appropriately integrating the stockpile into HHS’s disaster-response arm.

Work continues toward a universal influenza vaccine: Influenza vaccines need regular updates and vary in effectiveness against seasonal viruses. NIH supports a comprehensive research portfolio to develop more effective vaccines and adjuvants, including “universal” influenza vaccines capable of generating protection against multiple seasonal and pandemic influenza strains. In 2018, the National Institute of Allergy and Infectious Diseases (NIAID) published a Strategic Plan for a Universal Influenza Vaccine was developed focusing on natural history and pathogenesis of influenza infections; influenza immunity and correlates of protection; and the rational design of universal influenza vaccines.

New countermeasures approved: ASPR’s Biomedical Advanced Research and Development Authority (BARDA) continued to partner with private industry to develop medicines, vaccines, and diagnostics, nine of which received FDA approval in the past year, bringing the total number of FDA approvals for BARDA-sponsored medical countermeasures to 42. Approvals in 2018 included:

• The world’s first approved treatment for smallpox
• A new radiation injury treatment
• Blood screening tests for Zika virus
• Novel spray skin cells for severe burn injuries
• Three new drugs to fight antibiotic-resistant infections

U.S. Public Health Commissioned Corps officers present the colors at the 2017 Hurricane Response: Joint Services Awards Ceremony last November.

Providing Epidemiological Assistance Here and Abroad

Battling seasonal flu: CDC provided critical response to the 2017-2018 severe flu season, including working with industry to facilitate smoother antiviral distribution, providing timely interim estimates of influenza vaccine effectiveness, and using sequence-first surveillance to improve detection of emerging viruses and candidate vaccine virus selection for the 2018-19 season.

Responding to outbreaks at home: Epidemic Intelligence Service officers and other CDC subject matter experts conducted 50 Epi-Aids to assist state, local, territorial health departments and other public authorities to rapidly respond to infectious or non-communicable disease outbreaks, unexplained illnesses, or natural or man-made disasters. Outbreaks investigated this year included Colorado tick fever, Legionnaires’ disease, group A Streptococcus infection, opioid related infections, and youth suicide. CDC also supported responses to multistate outbreaks of hepatitis A with staff deployments, technical assistance, and vaccine procurements, with the resulting evidence base leading the Advisory Committee on Immunization Practices to recommend hepatitis A vaccine for homeless populations.

Responding to outbreaks abroad: CDC provided epidemiology and laboratory support to Uganda during an outbreak of deadly Marburg virus, a viral hemorrhagic fever similar to Ebola, helping limit the number of infected people to only five cases. CDC and partners also decreased the number of polio cases worldwide to 24 in FY 2018, a dramatic reduction from 30 years ago, when there were 350,000 cases recorded worldwide.

Responding to Ebola in Central Africa: Two separate Ebola outbreaks in the Democratic Republic of the Congo required global assistance in 2018, and CDC and NIH experts deployed for both responses to support the Congolese government and international partners. Tens of thousands of people have received an investigational Ebola vaccine under compassionate use and millions of border screenings were completed as part of response activities. In November 2018, FDA issued an emergency use authorization for the first Ebola fingerstick test with a battery-operated portable reader, allowing use by healthcare providers in the field. Also in November, an international consortium led by the World Health Organization, the Congolese National Institute of Biomedical Research and NIAID launched a randomized clinical trial of investigational Ebola therapeutics.

Combating Nicotine Addiction

FDA’s comprehensive plan for tobacco and nicotine regulation: The agency successfully advanced a comprehensive plan for tobacco and nicotine regulation by publishing three Advance Notices of Proposed Rulemaking on nicotine, flavors, and premium cigars. FDA also launched its new “Every Try Counts” smoking cessation campaign in 25 markets.

Law enforcement actions on e-cigarette sales: FDA took numerous actions as part of its Youth Tobacco Prevention Plan to help stop youth use of, and access to, e-cigarettes. For example, in the largest coordinated enforcement effort in the FDA’s history, the agency announced in September it had issued more than 1,300 warning letters and fines to retailers who illegally sold e-cigarette products to minors during a nationwide, undercover blitz of brick-and-mortar and online stores. The agency issued warning letters to companies misleading kids with e-liquids that resemble children’s food products, as well as a warning letter to HelloCig Electronic Technology Co. Ltd. for various violations of the Federal Food, Drug, and Cosmetic Act, including selling two e-liquids that contained prescription drugs leading FDA to determine that the products were unapproved new drugs.

Secretary Alex Azar delivers remarks alongside Surgeon General Jerome Adams and FDA Commissioner Scott Gottlieb during a press event for the Surgeon General’s advisory on e-cigarette use among youth.

Promoting Health through Physical Activity

A new mission for the President’s Council: President Trump renamed the President’s Council on Fitness, Sports and Nutrition to the President’s Council on Sports, Fitness and Nutrition, and charged the HHS Secretary, through the President’s Council, to develop a national strategy to expand participation in youth sports, encourage regular physical activity—including active play—and promote good nutrition for all Americans

Establishing the Council: On May 4, President Trump announced his intent to nominate new members to the Council, including co-chairs Olympic volleyball champion Misty May-Treanor, Super Bowl champion Herschel Walker, and World Series champion Mariano Rivera. On September 21, Secretary Azar kicked off the inaugural annual meeting, where the new members of the President’s Council convened to discuss their recommendations for the youth sports strategy and how to address barriers and opportunities to get more kids in the game, particularly those in economically distressed areas, girls, and children with a disability.

New guidelines for physical activity: OASH’s Office of Disease Prevention and Health Promotion published the second-ever edition of Physical Activity Guidelines for Americans, in collaboration with CDC, NIH, and the President’s Council. The “Move Your Way” campaign launched to promote new Guidelines helped generate 2.5 billion media impressions, with favorable reception to key changes in this edition such as the message that “all activity counts” and the recommendation that Americans should “move more and sit less” throughout the day.

Surgeon General Jerome Adams poses with the “Youth of the Month” during the White House Sports and Fitness Day – a day to encourage kids to participate in sports and live an active lifestyle.

Modernizing Food Safety and Nutrition

Supporting food innovation: As companies prepare to introduce foods derived from cultured animal cells into the U.S. market, providing additional choices for consumers and opportunities for industry, FDA took significant steps toward a regulatory framework for these foods.  A deliberative process between FDA and the Department of Agriculture resulted in a combined statement to publicly announce that both agencies intend to jointly oversee the production of cell-cultured food products derived from livestock and poultry.

Empowering Americans with more useful nutritional information: Recognizing that more accessible information about healthy foods could have a significant impact on Americans’ health, FDA launched its Nutrition Innovation Strategy and took several meaningful steps to empower consumers with nutrition information, completing draft and final guidance documents to help industry implement the new requirements for updating the Nutrition Facts label and new menu-labeling requirements.

Continuing successful implementation of the FDA Food Safety Modernization Act (FSMA): FDA published more than 20 draft and final guidances related to the FSMA rules, used new tools to help ensure that foods imported into the United States are produced in accordance with the same safety standards required of food produced domestically, and issued new draft guidance regarding the serious situations where the FDA intends to make public the retail locations that may have sold or distributed a recalled human or animal food.

Enhancing outbreak response: CDC’s PulseNet program has begun using whole-genome sequencing for the most common bacterial foodborne pathogens, which in 2018 resulted in more than 43,000 bacterial strains sequenced and solved at least 18 major foodborne disease investigations, such as the Spring romaine lettuce, packaged vegetable trays, and breakfast cereal outbreaks.

Advancing Drug Safety

Addressing drug shortages: FDA launched the Drug Shortage Task Force, including members from the FDA, CMS, ASPR, the Department of Defense, the Department of Veterans Affairs and the Federal Trade Commission, and began to solicit feedback on the root causes of and enduring solutions to drug shortages.

Supporting safe access to compounded drugs: In an effort to balance safety with the need some patients have for accessing compounded drugs rather than the FDA-approved version of some drugs, FDA issued warning letters and took enforcement actions regarding manufacturers who were not meeting standards for compounding drugs. At the same time, FDA issued new draft guidance regarding the quality of compounded drugs made in outsourcing facilities and traditional pharmacies, to help support safe compounding practices.

Improving Mental Health Treatment

Historic guidance around the IMD exclusion: CMS released guidance on a new demonstration opportunity for states to improve access to mental health services for adults with serious mental illness (SMI) and children with serious emotional disturbance. These services can include community-based services and crisis stabilization services, as well as short-term stays in psychiatric hospitals and residential treatment settings that are ordinarily excluded from Medicaid reimbursement due to the decades-old IMD exclusion. CMS’s guidance encouraged states to use these waivers as part of a continuum of care that includes increased integration of mental health services with other health care services, earlier identification of individuals with mental illness, and improved transitions between levels of care.

Expanding the options available for treating SMI: In 2018, FDA approved a batch of first generics for treatment of depressive episodes associated with bipolar depression and for the treatment of schizophrenia, and reclassified certain uses of electroconvulsive therapy devices, for treating catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder, from a class III to a class II medical device, involving slightly less strict controls for this narrow but effective therapeutic application of such devices.

Building on progress of the ISMICC: After the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC) was established in 2017, under the 21st Century Cures Act, SAMHSA met the congressional requirement to develop, in conjunction with other federal departments, a comprehensive report to Congress including recommendations to address SMI. Acting on these recommendations, SAMHSA has formed five specific workgroups around: 1) strengthening federal coordination, 2) establishing evidence-based treatments, 3) addressing populations involved in the justice system, 4) closing the gap between what works and what is offered, and 5) developing financing strategies to increase affordability and accessibility

Supporting research on treatments for SMI: Findings from the large-scale Recovery After an Initial Schizophrenia Episode (RAISE) project demonstrated that a team-based interdisciplinary treatment program outperformed usual treatment for first episode psychosis.

Understanding SMI interventions: ASPE-led projects analyzed the effectiveness of coordinated specialty care for psychosis, mental health parity, Community Behavioral Health Clinics, and assisted outpatient treatment, all policy interventions under consideration by the ISMICC.

Studying suicide prevention: Suicide prevention also continues to be a priority area for NIH. In 2018, an NIH-supported clinical trial demonstrated that dialectical behavior therapy, effective in reducing suicide-related behavior in adults, can also reduce adolescent suicide attempts and suicidal behavior. NIH intramural researchers developed and made available a free resource—the Ask Suicide-Screening Questions toolkit—in multiple languages to help clinicians identify youth at risk for suicide. NIH also collaborated with the Mental Health Innovation Network and other federal partners on the Reducing the Incidence of Suicide in Indigenous Groups–Strengths United through Networks (RISING SUN) toolkit to help clinicians, communities, policymakers, and researchers measure the impact and effectiveness of suicide prevention efforts in rural and tribal communities.

Secretary Alex Azar is joined by Secretary of Education Betsy DeVos, Assistant Secretary for Mental Health and Substance Use, Dr. McCance-Katz, and Wisconsin First Lady Tonette Walker on a field visit in Wisconsin.

Advancing school safety and mental health treatment: Secretary Azar represented HHS alongside the Secretaries of Education, Homeland Security, and Justice on the Federal Commission on School Safety, which was established in March 2018 by President Trump and sent its final report to the President in December 2018. HHS’s investigation included participation by Secretary Azar and Assistant Secretary McCance-Katz in listening sessions and site visits nationwide. HHS’s contributions to the report covered the integration of behavioral health services into schools, the use of psychotropic medications for children, and ways that federal privacy laws such as HIPAA and FERPA apply to mental health issues and treatment in schools. In part as a result of HHS work on the commission, in July, SAMHSA established technical assistance and training to support school-based mental health services at each of its twelve Mental Health Technology Transfer Centers (one is located in each HHS region, one serves American Indian and Alaska Native communities, and one serves Hispanic American communities).