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2019 Annual Report banner

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

Protecting Americans’ health is a vital piece of HHS’s work, ranging from combating health emergencies and promoting proven prevention efforts like vaccination to tackling longstanding public health problems, such as the HIV epidemic. HHS leadership has identified in particular a number of specific health challenges where a focused approach can and has begun to make a real impact, such as America’s crisis of opioid addiction and overdose.

Around the world in 2019, HHS played a key role in keeping Americans safe and healthy by responding to health emergencies, especially the refugee crisis in South America and the Ebola outbreak in the Democratic Republic of the Congo.

On this page:

Combating the Opioid and Drug Overdose Crisis

In 2017, HHS formulated a five-point strategy for combating the opioid crisis, and President Trump made it one of his administration’s top priorities. By 2019, key data points showed that the dedication of HHS and communities across America is bearing fruit:

  • In 2018, drug overdose deaths declined by 4 percent, the first decline in more than two decades.
  • According to HHS estimates, the number of Americans now receiving medication assisted treatment (MAT) has increased by 39 percent since 2016, with more than 1.28 million individuals receiving MAT for opioid use disorder in 2018.
  • From January 2017 through October 2019, the estimated total amount of opioids prescribed declined by 32 percent.
  • The number of Americans misusing prescription pain relievers has declined significantly, from 12.5 million in 2015 to 9.9 million in 2018.
  • The number of young adults with a heroin-use disorder significantly decreased from 165,000 in 2017 to 101,000 in 2018.

Following are some of the many actions taken across HHS to combat the opioid crisis, divided into the five points of the HHS strategy, during 2019.

Assistant Secretary Brett Giroir speaks at a press conference at HHS, standing on a stage with others
Assistant Secretary Brett Giroir speaks at a press conference at HHS

Better Access to Treatment, prevention, and recovery services

Continuing the State Opioid Response program: SAMHSA implemented the State Opioid Response (SOR) grant program, providing $1.4 billion in grants to states, continuing the program launched in 2018 with a special focus on boosting access to MAT. As of 2019 mid-year reporting, thanks to states’ use of SOR funds, 46,681 clients were served, 271,550 naloxone kits were distributed, and 14,433 overdoses were reversed.

SAMHSA block grants going to support MAT: From 2016 to 2018, utilization of MAT supported by SAMHSA’s Substance Abuse Prevention and Treatment Block Grant increased by approximately 100 percent, from 58,000 to 110,000 service recipients.

Historic numbers of Medicaid Substance Use Disorder treatment demonstrations: By the end of 2019, CMS had approved 27 state Medicaid demonstrations to improve access to substance use disorder (SUD) treatment, which includes opioid use disorder treatment, with new flexibility to cover inpatient and residential treatment.

New payment models: CMS announced cooperative agreements and funding awards with states for the implementation of the Integrated Care for Kids (InCK) and the Maternal Opioids Misuse (MoM) payment models, which focus on coordinating and increasing access to treatment for children and pregnant women, including for the treatment and prevention of substance abuse and other mental health challenges.

Supporting state Medicaid programs in fighting the crisis: CMS made $47.5 million in planning grants to 15 states through $47.5 million to help increase the capacity of Medicaid providers to deliver substance use disorder treatment and recovery services.

Covering MAT in Medicare: CMS finalized an expansion of Medicare coverage to include opioid treatment programs that deliver MAT, effective January 1, 2020.

Expanding access to treatment in health centers: HRSA awarded $200 million to 1,208 Health Center Program grantees to establish and expand access to SUD and mental health services. Compared with the prior year, health centers saw a 33 percent increase in SUD patients, a 46 percent increase in patients receiving MAT, and a 65 percent increase in the number of providers eligible to prescribe MAT when compared to last year.

Improving early interventions for neonatal abstinence syndrome: In 2019, ACL launched a three-year, $1.3 million cooperative agreement with the University of Wyoming to improve availability and quality of treatment and support services for children and families affected by neonatal abstinence syndrome. It is estimated that a baby experiencing opioid withdrawal is born every 15 minutes, and research suggests they are at risk for poorer developmental outcomes.

Laying the foundation for a stronger behavioral health workforce: The National Health Service Corps established the Substance Use Disorder Workforce Loan Repayment Program, which added new provider types and made approximately 1,100 awards. In addition, HRSA delivered two new Opioid Workforce Expansion Programs, which are slated to train and add 2,700 behavioral health professionals and 4,300 new paraprofessionals to the workforce.

Combating the opioid crisis in rural America: HRSA awarded $135 million to 216 rural organizations across 47 states to establish partnerships to develop and implement plans for addressing the treatment and recovery needs in their communities and support MAT in rural hospitals, health clinics, or tribal organizations. HRSA also awarded grants to establish three Centers of Excellence on Substance Use Disorders to identify, translate, and disseminate evidence-based practices, at the University of Kentucky, the University of Rochester, and the University of Vermont.

Office on Women’s Health support for screening and treating women and girls: The Office on Women’s Health supported the work of 20 grantees in training more than 500 primary care and OB-GYN health providers to use the evidence-based screening, brief intervention, and referral to treatment services (SBIRT) approach to support patient care.

Addressing the opioid crisis among racial/ethnic minority and disadvantaged populations: The Office of Minority Health supported the work of 12 grantees to prevent opioid abuse, increase access to opioid treatment and recovery services, and reduce the health consequences of opioid abuse in racial/ethnic minority and disadvantaged communities disproportionately affected by the opioid crisis.

Establishing a national Opioid Response Network: Through the Opioid Response Network, SAMHSA made teams of local experts are available in every state across the country to support responses to the opioid crisis. These teams have responded to over 1,000 requests and provided training to individuals who collectively serve more than 1 million Americans.

New waivers for MAT prescribing: SAMHSA approved 23,049 waivers to prescribe opioid-addiction medication in FY 2019, allowing new practitioners to undertake office-based opioid treatment, bringing the total number of waivered providers to more than 73,000.

A new easy-to-use treatment finder: SAMHSA launched FindTreatment.gov, a newly designed website that helps connect Americans looking for substance abuse treatment with approximately 13,000 locations across the United States.

Launching Opioid Rapid Response Teams: CDC and the U.S. Public Health Service Commissioned Corps launched the first Opioid Rapid Response Teams, which are available on short notice worked to support state and local governments when there is a spike in opioid-related overdoses or closure of a clinic where patients are prescribed opioid therapy.

Helping primary care providers implement MAT in their practices: AHRQ developed and posted the MAT Playbook, an online interactive guide to support primary care practices through the process of offering MAT to their patients. The Playbook is accompanied by a searchable database of over 400 tools and resources.

Addressing the rise in opioid related harms in older adults:AHRQ launched an integrated set of projects, including an evidence review, a quality improvement pilot, and a funding opportunity announcement to address the rise in opioid related hospitalizations and emergency department visits in older adults by improving management of pain, opioid use, and OUD in this population.

Partnering with faith-based organizations: The Center for Faith and Opportunity Initiatives (the Partnership Center) worked to convene and educate faith-based organizations and other partners regarding the opioid crisis, including:

  • Co-hosting, with the National League of Cities, more than 60 faith and community-based organizations, entrepreneurs, social service, and public health agencies for a national meeting, “Partners in Hope: Strengthening Recovery with Community-based Workforce Development Efforts.”
  • Producing the “Faith & Community Roadmap to Recovery Support: Getting Back to Work,” a roadmap to help congregations and communities support people in recovery seeking to find employment
  • Hosting national webinars for faith and community leaders related to opioid addiction and related issues, on topics including the CDC’s “Evidence-based Strategies for Preventing Opioid Overdose,” addictions and trauma-informed care for veterans, and bereavement services to cope with traumatic loss.
National Institute on Drug Abuse Director Nora Volkow speaks at a press conference at HHS
National Institute on Drug Abuse Director Nora Volkow speaks at a press conference at HHS

Better data on the epidemic

Supporting state and local health department prevention efforts and reporting: In September, CDC made more than $300 million in awards to launch three-year cooperative agreements under the Overdose Data to Action Initiative, which will support state, territorial, county, and city health departments in obtaining high quality, more comprehensive, and more timely data on overdose morbidity and mortality and using those data to inform prevention and response efforts.

Google Maps featuring drug disposal sites: Based on technology developed during the HHS Opioid Code-A-Thon in 2018, the HHS Office of the Chief Technology Officer (CTO) worked with Google to launch a drug disposal site locator on Google Maps, which draws on over 70 datasets from HHS and other federal agencies, and covers over 7,000 safe disposal sites across 17 participating states.

Launching a new national awareness network: SAMHSA successfully launched the Drug Abuse Warning Network (DAWN) program, using data from more than 35 hospitals in rural, suburban and urban communities. SAMHSA will be able to quickly identify trends in substance use and identify emerging issues across the country.

Updating the National Survey on Drug Use and Health: SAMHSA successfully updated the National Survey on Drug Use and Health by adding questions related to the use of MAT for opioid use disorder as well as the use of kratom.

Tracking Neonatal Abstinence Syndrome (NAS) trends: Using Hospital Cost and Utilization Project (HCUP) data, AHRQ developed a series of quarterly reports and an online interactive map to help policy makers track the rate of NAS-related newborn hospitalizations over time by state, patient characteristics such as sex, expected payer, and measures such as cost and length of stay.

Better targeting of overdose reversing drugs

Developing a new overdose-reversing drug: To help save lives in the current opioid epidemic or following a deliberate attack using fentanyl, ASPR issued a contract between BARDA and a pharmaceutical company to help develop a product that, if approved by FDA, would be a fast-acting, long-lasting intranasal, potentially improved form of an opioid overdose drug. The life-saving drug naloxone, while effective, often must be given multiple times to completely reverse the effects of an opioid in someone exposed to high doses, and longer lasting drugs can reduce the need for repeat dosing.

Equipping first responders with overdose-reversing tools: SAMHSA awarded an additional 28 First Responder – Comprehensive Addiction Recovery Act grants, which over the life of the program has led to the distribution of 69,677 naloxone kits, 18,909 naloxone administrations, and 7,056 overdose reversals reported.

Better pain management

Protecting Part D beneficiaries from opioid misuse: CMS introduced new Medicare Part D opioid safety policies to reduce prescription opioid misuse while preserving medically necessary access to these medications. The new opioid policies include improved safety alerts at the pharmacy for Part D beneficiaries who are filling their initial opioid prescription or who are receiving high doses of prescription opioids.

New guide for safe reduction in opioid prescribing: In October, the Assistant Secretary for Health published a new Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics, which provides advice to clinicians who are contemplating or initiating a change in opioid dosage, helping clinicians to conduct a thorough, deliberative case review and discussion with the patient and avoid any harm to the patient through a reduced dosage.

A final report on pain management best practices: In May, the Pain Management Best Practices Inter-Agency Task Force issued its final report, which lays out the need for an individualized, multimodal, multidisciplinary approach to pain management, and provides recommendations for clinicians centers on five major treatment approaches.

A new digital tool for pain management: Surveys have found that almost 20 million Americans suffer from pain that interferes with their daily lives. In response, AHRQ released an interoperable digital tool that helps clinicians find pain-related information about specific patients and consolidates that information into a single dashboard. The dashboard helps clinicians quickly access vital information, such as patients’ pertinent medical history, pain assessments, previous treatments, and potential risks, all to identify options and assist in shared decision making between clinicians and patients.

Using data to take down pill mills: OIG used advanced data analytics to assess broad usage patterns and target pill mills with increasing sophistication. One OIG take-down in a single state netted 50 individuals, including medical providers, diverting prescription opioids through pill mill clinics. Losses to public and private payers in this single operation came to $66 million and involved 6.2 million diverted pills.

Combating unsafe corporate marketing: OIG investigations resulted in a pharmaceutical company paying $700 million to settle allegations that it illegally marketed and promoted the opioid treatment drug suboxone. Allegations included the knowing promotion to physicians prescribing in an unsafe manner, and making false and misleading claims to the Food and Drug Administration, state Medicaid agencies, and physicians.

Record-breaking prescription takeback operations: HHS leadership promoted and educated the public about safe removal of unused opioid medications from homes. This included promotion of two National Take Back Days, in April and October, covering more than 6,000 collection sites and working with nearly 5,000 law enforcement partners, which resulted in the collection of more than 1.8 million pounds worth of prescription drugs.

Better research on pain and addiction

Historic new levels of support for research on pain and addiction: NIH used $945 million in total FY 2019 funding to award over 375 projects, involving both researchers and private biotech firms, across 41 states through the NIH HEAL Initiative, a trans-agency effort aimed at accelerating scientific solutions to stem the national opioid public health crisis and offer new hope for individuals, families, and communities affected by the devastating crisis. Research supported through HEAL is working to discover safer treatment options for pain management and expedite the development of therapies to treat OUD and reverse overdose.

Launching the HEALing Communities Study: As part of the HEAL Initiative, NIDA and SAMHSA have launched the HEALing Communities Study in Ohio, Kentucky, New York and Massachusetts, with more than $350 million in NIH funding, which aims to reduce opioid fatalities by at least 40 percent in participating communities over three years with a whole-of-society approach to combating the crisis.

Ending the HIV Epidemic

In the State of the Union Address on February 5, President Trump announced the historic goal of ending the HIV epidemic in the United States by 2030. The Ending the HIV Epidemic: A Plan for America initiative will leverage the powerful data and tools currently available to reduce new HIV infections in the United States by 75 percent in five years and by 90 percent by 2030. HHS immediately began work on the President’s initiative.

Planning grants to key jurisdictions: The initiative identified 48 counties which account for more than 50 percent of the new HIV diagnosis and seven states with a disproportionate rural occurrence of HIV. CDC awarded all of these jurisdictions funds to conduct state and local planning as part of the new initiative.

Jumpstart grants to four jurisdictions: HHS kicked off the implementation phase of the initiative by announcing awards of $1.5 million each to three jurisdictions—DeKalb County, Ga.; Baltimore City, Md.; and East Baton Rouge, La.—to jumpstart activities on reducing the number of new HIV transmissions. In addition, the Indian Health Service awarded $1.5 million to the Cherokee Nation to begin implementation work.

Unprecedented expansion of access to preventive medication: HHS secured from Gilead Sciences, Inc., a historic donation of medication for pre-exposure prophylaxis (PrEP), taken daily to prevent HIV, for up to 200,000 uninsured, at-risk Americans for up to ten years, at no cost to the individuals. In December, OASH launched Ready, Set, PrEP, a national program that will make these medications available in pharmacies, including with donated dispensing and promotion services from a number of corporations.

Securing Year One funding: The President’s FY 2020 Budget requested $291 million to fund the first year of Ending the HIV Epidemic, a request that was fully funded in the appropriations bill passed in December 2019.

Conducting deep community outreach: CDC leadership, in coordination with Secretary Azar, OASH, HRSA, and the Indian Health Service, visited 38 of the prioritized jurisdictions identified by the initiative. HHS leadership met with community leaders on the ground, including state, tribal, local, and territorial leaders, governors, members of Congress and staff, community-based organizations, and people living with HIV, with a goal of learning from the perspective of communities hardest hit by HIV, including black and Hispanic Americans, American Indians and Alaska Natives, and gay men.

USPSTF recommendation on PrEP: AHRQ commissioned a review of the existing evidence on the benefits and harms of pre-exposure prophylaxis (PrEP) in high-risk populations, which has been shown to reduce the risk of acquiring HIV by up to 97 percent. AHRQ’s review led to a new clinical practice recommendation from the U.S. Preventive Services Task Force encouraging clinicians to offer PrEP to people at high risk of acquiring HIV.

Using Title X as an avenue for PrEP: The Office of Population Affairs published resources for Title X family planning sites to help guide them through ways to add PrEP services for their clients, including how to prepare clinicians and staff for PrEP implementation, how to approach clients about PrEP, and other lessons learned.

Advancing epidemiology in Indian Country: IHS provided $2.4 million to enable Tribal Epidemiology Centers to strengthen public health capacity of tribal, urban Indian organizations, and intertribal consortia in developing or accelerating Native-specific community plans to end the HIV epidemic in Indian Country.

The first-ever HHS Global-Domestic HIV Meeting: In June, the Office of Global Affairs and the Office of Infectious Disease and HIV/AIDS Policy, hosted the first-ever HHS-wide meeting on combining the lessons of domestic and global HIV efforts, including data use, prevention, treatment, finding and testing, and adherence to treatment, bringing together HHS employees working on HIV-related programs globally and domestically, from CDC, HRSA, SAMHSA, NIH, FDA, IHS, OASH, and the Office of the Secretary.

Record results for the Ryan White HIV/AIDS Program: In December, HRSA announced that clients of the Ryan White HIV/AIDS Program had reached a new record high for viral suppression, at 87 percent of clients, compared with 63 percent of the general population diagnosed with HIV. Viral suppression among people with HIV ensures longer, healthier lives, and also prevents further transmission of the virus, playing an essential role in helping to end the HIV epidemic.

New tool to help identify the right HIV treatments: FDA authorized marketing of the first next-generation sequencing test for detecting HIV-1 drug resistant mutations, which offers healthcare professionals a new tool in helping to select treatment options for their patients, as the right combination of antivirals can lower viral loads and help keep patients with HIV healthy for many years.

Approved new HIV Prevention and Treatment Drugs: In 2019, the FDA approved two new important products for the prevention and treatment of HIV: a new pre-exposure prophylaxis drug to prevent HIV infection, and a new two-drug regimen for HIV-infected patients who have never received antiretroviral treatment. The new two-pill regimen replaces a predecessor three-pill regimen, representing a new benefit to patients who may have issues taking multiple medications over a long period of time.

CDC Director Robert Redfield speaks to community members on an Ending the HIV Epidemic initiative visit
CDC Director Robert Redfield speaks to community members on an Ending the HIV Epidemic initiative visit

Advancing American Kidney Health

In July, President Trump signed an executive order to launch Advancing American Kidney Health, a bold new initiative to improve the lives of Americans suffering from kidney disease, expand options for American patients, and reduce healthcare costs.

A vision for better kidney health: The Office of the Assistant Secretary for Planning and Evaluation, in partnership with experts from across HHS, published a paper laying out the initiative’s vision, including specific solutions to deliver on three specific goals: fewer patients developing kidney failure, fewer Americans receiving dialysis in dialysis centers, and more kidneys available for transplant.

Value-Based Payment Models for Kidney Care: In July, the Center for Medicare and Medicaid Innovation (the Innovation Center) announced the Kidney Care Choices Model, which adds financial incentives for providers to manage care for Medicare beneficiaries to delay the onset of kidney disease, increases the array of options for dialysis, and incentivizes kidney transplantation. Also in July, the Innovation Center proposed the End-Stage Renal Disease (ESRD) Treatment Choices Model, which would create financial incentives for clinicians and ESRD facilities to increase rates of home dialysis and kidney transplants. In October, the Innovation Center began accepting applications for Kidney Care Choices, which is expected to include more than 200,000 Medicare beneficiaries.

Preparing an Educational Campaign: More than 30 million Americans have some stage of kidney disease, and most are not aware of it. As called for in the President’s executive order, in October, HHS signed a memorandum of understanding with the American Society of Nephrology and the National Kidney Foundation to partner on an educational campaign to increase awareness of the signs and risks of kidney disease.

Proposing new accountability to increase the organ supply: Each year, more than 8,000 Americans die waiting for an organ transplant. Life-saving organs such as kidneys are obtained from deceased donors by organ procurement organizations (OPOs), private entities that are regulated by CMS. Longstanding concerns have existed about OPOs’ varying performance, particularly because they are allowed to essentially self-report on their own work—allowing them to exclude difficult-to-procure or -transplant organs and potentially leading thousands of viable organs to be unused. In December, CMS issued a proposed rule to reform the way OPOs are held accountable, a proposal that attracted broad bipartisan support and support from former Obama Administration officials. Administration estimates suggest that the proposed rule could result in 5,000 more organs procured per year.

A proposal to expand support for generous living donors: HRSA issued a proposed rule to remove financial barriers to organ donation by expanding the scope of reimbursable expenses incurred by living organ donors to include lost wages and child-care and elder-care expenses incurred by a primary care giver.

New prizes from KidneyX: The novel public-private partnership, run out of the CTO’s office, continues to advance innovation in the prevention, diagnosis, and treatment of kidney disease. Through 2019, KidneyX has awarded $1,000,000 in prizes to over 15 teams to advance testing of artificial kidneys, launched prize competitions to unlock ideas from those living with kidney disease, prototype redesigned dialysis, and issued a Request for Information to help shape a moonshot Artificial Kidney Prize.

Ms. Tunisia Bullock speaks at a press conference at which President Trump signed an Executive Order on Advancing American Kidney Health
Ms. Tunisia Bullock speaks at a press conference at which President Trump signed an Executive Order on Advancing American Kidney Health

Improving Maternal and Women’s Health

Nearly 1 million home visits: HRSA announced $351 million in funding to 56 states, territories, and nonprofit organizations through its Maternal, Infant, and Early Childhood Home Visiting Program. Awardees showed improvement in 18 of 19 performance measures, providing voluntary, evidence-based home visiting for at-risk pregnant women and parents with children up to kindergarten, with 930,000 visits provided in 2019.

Testing new models to improve rural maternal health and obstetric care: In September, HRSA awarded nearly $9 million to launch the Rural Maternity and Obstetrics Management Strategies (RMOMS) program with partners in Missouri, New Mexico and Texas, to pilot, test, and develop models that improve access to and continuity of maternal obstetrics care in rural communities.

Supporting better data on maternal health: To better identify and characterize maternal deaths and identify prevention opportunities, CDC supported 25 states for the Enhancing Reviews and Surveillance to Eliminate Maternal Mortality (ERASE MM) program. This program coordinates and manages Maternal Mortality Review Committees that support CDC Perinatal Quality Collaboratives, which are networks to improve quality of care for mothers and babies.

A landmark year for promoting women’s health at FDA: In the year that FDA’s Office of Women’s Health (OWH) marked its 20th anniversary, the FDA took significant steps to improve the health of American women:

  • OWH funded research projects on pulmonary embolism, which is the blockage of blood flow to the lungs by blood clots, and a leading cause of maternal death, and the development of an artificially intelligent virtual pregnant woman modeling suite to support regulatory decisions.
  • Funding was allocated to evaluate the labeling compliance of dietary supplements targeted specifically to women, as well as evaluation of potential contamination of products that contain live microbes, with special emphasis on pregnant women and lactating women, and infants.
  • FDA approved a variety of new therapies to help advance women’s health, including:
    • a new targeted therapy for patients with a certain type of metastatic breast cancer;
    • a new biologic drug to treat osteoporosis in certain postmenopausal women at high risk of breaking a bone;
    • a new drug to treat premenopausal women with acquired, generalized hypoactive sexual desire disorder (low sexual desire); and
    • the first FDA-approved drug specifically for the treatment of women with postpartum depression (based on research from the National Institute of Mental Health)
  • In September, FDA’s Center for Devices and Radiological Health unveiled a new Health of Women Program Strategic Plan, seeking input from stakeholders to help shape its implementation and aiming to work towards a better understanding of how medical devices perform in women and exploring unique issues in the regulation of medical devices related to the health of women.

Rural Health

Covering virtual check-ins: Starting in 2019, Medicare began to pay for “virtual check-ins,” allowing a patient to check in with their clinician by phone or other telecommunication system and send videos or images their clinician and helping the clinician decide whether the patient needs to make a trip to be seen in-person.

Addressing wage index disparities for rural areas: CMS made changes to the hospital wage index in inpatient and outpatient settings that help address Medicare wage index disparities between high wage index and low wage index hospitals, which have been seen as disproportionately burdening rural hospitals.

New flexibilities for rural hospitals: CMS made it easier for hospitals to provide outpatient services under general supervision, which does not require a physician to be present for actual procedure, as opposed to the prior rule of direct supervision, relaxing a burden that can be a particular impediment for Critical Access Hospitals and hospitals in rural areas with limited access to providers.

Expanding access to telehealth in health centers: HRSA added standard language encouraging telehealth to its funding opportunities, resulting in a 30 percent increase in awards that incorporate telehealth. Grantees in HRSA’s Telehealth Network Programs reported saving 3.1 million miles annually for patients not driving to distant providers.

Commissioned Corps officers providing no-cost medical care to the vulnerable: The U.S. Public Health Commissioned Corps continued its partnership with Remote Area Medical, to provide no-cost medical, vision, and dental services to individuals in underserved and underinsured rural communities, with almost 600 Commissioned Corps officers deploying to nine mobile clinics across the country.

Protecting the Health of American Youth

A historic Surgeon General’s advisory on marijuana: In August, the Surgeon General released an Advisory on Marijuana Use and the Developing Brain, which emphasizes the importance of protecting young Americans and pregnant women from the risks that marijuana poses to healthy brain development in adolescence and during pregnancy. Thanks to President Trump’s donation of his paycheck from the second quarter of 2019, the Office of the Surgeon General released a digital ad campaign across Facebook, Instagram, Twitter, and Google Search targeted towards pregnant women and parents of adolescents. The campaign, which ran seven weeks, resulted in 6,831,681 impressions, 344,030 clicks and 17,081 social engagements, with 158,350 visits to the advisory itself.

The first-ever blueprint for increasing youth sports participation: The Office of the Assistant Secretary for Health released the National Youth Sports Strategy, the first federal roadmap that outlines steps that communities, state and local governments, businesses, and other stakeholders can take to ensure that all youth have the opportunity, motivation, and access to play sports—regardless of their race, ethnicity, sex, ability or ZIP code. The strategy was announced by Secretary Azar, Surgeon General Adams, and Advisor to the President Ivanka Trump at an event at the Washington Nationals Youth Baseball Academy and Fort Dupont Ice Arena.

Supporting community collaboration for youth sports: As part of the Youth Engagement in Sports Initiative, the Office of Minority Health and Office on Women’s Health co-funded 18 grantees with the aim of identifying characteristics of effective collaborations that improve physical activity and nutrition via increased sports participation, especially for disadvantaged youth or those in communities with no or few sports programs.

Members of the President’s Council on Sports, Fitness, and Nutrition join Ivanka Trump, Advisor to the President, and HHS Secretary Alex Azar at an event launching the first National Youth Sports Strategy
Members of the President’s Council on Sports, Fitness, and Nutrition join Ivanka Trump, Advisor to the President, and HHS Secretary Alex Azar at an event launching the first National Youth Sports Strategy

Promoting Global Health and Global Health Security

Fulfilling the National Biodefense Strategy: In the first year following the release of the National Biodefense Strategy, HHS stood up and led the interagency Biodefense Coordination Team, issuing a data call on biodefense programs across the federal government, soliciting input from non-governmental stakeholders, and working to develop a comprehensive assessment of the U.S. biodefense enterprise. The process will culminate in a public report describing actions taken to reduce the risk of biological threat to the American people, to be released in 2020.

New health policy dialogues with key regional partners: Through the Office of Global Affairs, HHS convened two first-ever policy dialogues in 2019, one with Brazil and the other with Canada, to strengthen bilateral cooperation on a range of shared priorities, such as strengthening immunization rates, tackling the challenge of influenza preparedness, reducing rates of vaping in youth, combating the opioid epidemic, collaborating more closely on preventing anti-microbial resistance, and cooperation in multilateral fora. These meetings were the first of what are expected to become annual events to strengthen global health security in the Americas.

Protecting life and sovereignty around the world: Across the United Nations system and beyond—such as the United Nations General Assembly, the World Health Organization, and the Pan American Health Organization—HHS worked actively to support the sovereign right of nations to make their own laws on abortion, in the face of intense intimidation from U.N. agencies and other nations. As President Trump said at the 2019 U.N. General Assembly: “We are aware that many United Nations projects have attempted to assert a global right to taxpayer funded abortion on demand, right up until the moment of delivery. Global bureaucrats have absolutely no business attacking the sovereignty of nations that wish to protect innocent life.” As part of an effort dubbed “Protecting Life on Global Health Policy,” the United States government worked with countries to produce and present joint statements, with 8 countries at the World Health Assembly in May, 20 countries at UNGA in September, and with 10 countries at the Nairobi ICPD+25 in November, underscoring a joint commitment to protecting national sovereignty in matters that pertain to life and the family. To secure these commitments, in July, Secretary Azar sent a letter with Secretary of State Mike Pompeo to urge countries to partner with the U.S., and HHS officials visited Hungary, Poland, Canada, St. Lucia, and Brazil to educate leaders on the initiative. In total, countries joining the initiative represented more than 1 billion people.

Boosting global health through FDA approvals: FDA approved the first live, non-replicating vaccine to prevent smallpox and monkeypox, authorized marketing of the first diagnostic for detecting Zika virus, and approved the first vaccine for the prevention of dengue disease.

Advancing Sickle Cell Disease treatment and cures globally: At the World Health Assembly in May, HHS held a side event on sickle cell in Sub-Saharan Africa, convening seven African delegations, Ministers of Health, the WHO, and professional societies, enabling the identification of major gaps in treatment and care. In August, HHS co-sponsored a side event on the same topic at the WHO Africa Regional Committee Meeting, alongside the First Lady of the Republic of Congo, Antoinette Sassou Nguesso. These meetings, combined with ongoing contacts with key bilateral and multilateral stakeholders in the region, are building efforts toward the development of an Africa-based Sickle-Cell-Disease nitiative.

The Ebola Outbreak

In 2019, the outbreak of Ebola that began in August 2018 in the eastern Democratic Republic of the Congo (DRC) continued, but significant efforts by the United States have helped contain its spread and save lives.

Seeing the situation on the ground: In September, Secretary Azar, CDC Director Robert Redfield, and NIAID Director Tony Fauci, Admiral Tim Ziemer of the U.S. Agency for International Development, alongside officials from the National Security Council, led a delegation to the DRC, Uganda, and Rwanda to see the situation on the ground and communicate the Trump Administration’s commitment to bringing the outbreak to an end. Dr. Redfield had previously visited the region during the outbreak.

Running a historic clinical trial in a war zone: NIH advanced several promising agents for treating Ebola, including supporting the Pamoja Tulinde Maisha (PALM) clinical trial of four investigational agents for the treatment of patients with Ebola. Preliminary results indicated that individuals with Ebola receiving two of the treatments had a greater chance of survival, leading patients to now be randomized among the two more successful treatments.

A first-ever FDA-approved vaccine: The FDA approved a BARDA-supported vaccine for the prevention of Ebola virus disease, which, as part of an expanded access protocol, has been administrated to more than 255,000 people, including first responders, healthcare workers, burial providers, and contacts of Ebola cases. The research approach used to study the effectiveness and safety of this vaccine was precedent-setting during a public health emergency. The FDA granted the vaccine’s application Priority Review, a Tropical Disease Priority Review Voucher, and a Breakthrough Therapy designation. Because of the public health importance of the vaccine, the FDA worked closely with the company to demonstrate safety and effectiveness of the vaccine in less than six months.

CDC continues large-scale deployments and technical assistance: As of December 13, 2019, CDC staff have conducted 573 deployments to the DRC, neighboring countries, and WHO headquarters to respond to the Ebola outbreak, complementing CDC permanent staff in the three high-risk countries bordering the outbreak—South Sudan, Rwanda, and Uganda—as well as the DRC. CDC’s border health technical assistance has been used to improve the public health screening of more than 75 million travelers at 80 checkpoints in the DRC since the outbreak began. Swift efforts by CDC and international partners in Goma and Uganda extinguished transmission when cases emerged.

Fostering relationships to combat the outbreak: In April, Secretary Azar hosted a meeting with then recently elected DRC President Tshisekedi to discuss response efforts, as well as other key health issues in the country, and in September, Secretary Azar co-hosted a meeting with regional leaders, including President Tshisekedi, at the U.N. General Assembly on the same topic.

Members of the U.S. delegation to the Democratic Republic of the Congo speak with a boy who had just been told he no longer had Ebola in Butembo, Democratic Republic of the Congo
Members of the U.S. delegation to the Democratic Republic of the Congo speak with a boy who had just been told he no longer had Ebola in Butembo, Democratic Republic of the Congo

The South American Refugee Crisis

Addressing regional health crises and security: In response to the humanitarian and refugee crisis created by the failure of the illegitimate Maduro regime in Venezuela—the largest humanitarian crisis the Americas have ever seen—Secretary Azar continued a series of Americas Health Ministerial meetings to focus attention on and discuss needs and solutions to the regional health crisis, with Ministerial meetings occurring in Peru and Colombia in 2019.

Delivering tangible victories to protect the health of refugees: HHS helped deliver a number of tangible accomplishments to promote refugee health, including the development of a Unified Vaccination Card for the region, a mental health training for healthcare workers to better assist traumatized refugees, and a continuing coordination mechanism that allows technical experts from the region to share information and make decisions.

Supporting the deployment of the USNS Comfort: The Commissioned Corps helped respond to the crisis by contributing staff to the USNS Comfort, a U.S. Navy hospital ship, as it sailed through Latin America, to provide medical assistance, with a total of 893 days deployed, as part of the inter-service humanitarian mission.

Secretary Alex Azar speaks with U.S. Public Health Service Commissioned Corps officers at an event launching the USNS Comfort mission to Latin America
Secretary Alex Azar speaks with U.S. Public Health Service Commissioned Corps officers at an event launching the USNS Comfort mission to Latin America

Fighting the Flu

New presidential leadership on the influenza: Each year, seasonal influenza sickens millions of Americans, hospitalizes hundreds of thousands, and kills tens of thousands, while an influenza pandemic is widely acknowledged to be the single greatest potential health threat. In 2019, President Trump signed an executive order to modernize flu manufacturing and protect Americans from the flu, and HHS took a number of steps as part of this work.

Increasing advanced flu vaccine manufacturing capacity: ASPR issued a six-year, $226 million contract to retain and increase capacity to produce recombinant flu vaccine, a more modern and efficient form of flu vaccine manufacturing. When the project is completed, it will double the awardee’s recombinant protein-based flu vaccine manufacturing capacity in the United States.

Novel antivirals for flu infection: ASPR currently is supporting two novel antivirals for the treatment of hospitalized flu-infected patients, increasing America’s capacity to treat people who become infected and prepare for a future flu pandemic.

Supporting better flu diagnostics: Through BARDA, ASPR continued pursuing better diagnostics for the flu that are closer to the patient supporting the development of two in home diagnostic tests and six wearable biometric sensors to inform and empower individuals to take action early.

A new ventilator for vulnerable populations: ASPR supported the development of a portable ventilator capable of providing mechanical respiratory support for critical care of newborn babies, adults and elderly patients. The Philips ventilator was cleared by FDA earlier this year for use in institutional, home, and field settings by minimally trained operators and is now stockpiled in the Strategic National Stockpile for immediate distribution when needed.

NIH continues work toward a universal flu vaccine: NIH-supported research for “universal” influenza vaccines capable of generating protection against multiple seasonal and pandemic influenza strains continued in 2019, with the NIH establishing the Collaborative Influenza Vaccine Innovation Centers (CIVICs), a multidisciplinary program to support research and development of promising new influenza vaccine candidates. NIH also announced multi-year studies to examine how initial and repeated exposures to influenza viruses in childhood shape immune response to future influenza exposures and vaccines. In addition, the NIH Clinical Center launched a clinical phase I trial of an NIH-developed universal influenza vaccine candidate.

CDC support for flu testing and vaccine manufacturing: CDC developed and characterized more than 50 candidate vaccine viruses for vaccine manufacturers and characterized more than 10,000 influenza viruses with next-generation genetic testing, providing valuable information for vaccine improvement and drug development to increase uptake and reduce vaccine hesitancy.

Boosting Vaccine Confidence

A new push to promote infant immunization: To mark National Infant Immunization Week in 2019, leaders from across HHS—including Secretary Azar, Assistant Secretary for Health Brett Giroir, CDC Director Robert Redfield, NIH’s Tony Fauci, and other officials from CMS and elsewhere—undertook a major media push, participated in TV and radio interviews, social media conversations, and other activities, generating tens of millions of impressions.

Global efforts to promote vaccine confidence: Together with Canada, the European Union, Romania, Ukraine, and Brazil, the U.S. hosted one of the largest side events of the World Health Assembly, entitled Promoting Vaccine Confidence: Enhancing Global Immunization Efforts to Protect the Health of All Generations, which galvanized support for increased global action on vaccine confidence. Following the side event, the United States began work on an immunization resolution for the 2020 World Health Assembly.

A new charge for the National Vaccine Advisory Committee (NVAC): Assistant Secretary for Health Brett P. Giroir charged the NVAC with developing a report that summarizes the evidence and research in vaccine confidence and provides recommendations on strategies to improve vaccine confidence across the lifespan. This report will be submitted for vote during the September 2020 NVAC meeting.

Responding to Health Threats at Home

Real-Time Data on Disease Threats: CDC expanded the ability to investigate disease threats and share information through its National Syndromic Surveillance Program BioSense Platform. Data from 58 sites, representing 4,478 facilities, like emergency departments, can now be used as a real-time data source for healthcare providers to use in making quicker data-driven decisions to satisfy individual patient needs.

Investigating lung injury associated with use of e-cigarette, or vaping, products: CDC and FDA actively investigated the outbreak of e-cigarette, or vaping, product use-associated lung injury (EVALI), together with state and local health departments and clinicians. In a breakthrough, CDC laboratories detected vitamin E acetate in the lungs of lung injury patients, consistent with findings from FDA testing of products used by patients. These data, together with epidemiologic data showing most cases reported using THC-containing e-cigarette, or vaping, products from informal sources, provide direct evidence that vitamin E acetate is strongly linked to EVALI. At the time of publishing of this report, evidence is insufficient to rule out the contribution of other chemicals of concern in some of the reported EVALI cases.

Public health response to largest measles outbreak in decades: CDC led a major public health response to the largest measles outbreak since 1992, which threatened the nation’s elimination status. More than 1,200 measles cases occurred in close-knit communities and were linked to travelers from other countries with large measles outbreaks like Israel, Ukraine, and Philippines. CDC assets were deployed alongside state and local health workers to stop the spread of the outbreak, successfully preserving the nation’s measles elimination status.

Combating hepatitis A: CDC led an investigation into nearly 24,000 hepatitis A cases that were part of the widespread outbreaks affecting more than 29 states. Sixty percent of cases have resulted in hospitalization, and 236 people have died. CDC has helped every affected state in its outbreak response efforts.

Combating Nicotine Addiction and Tobacco Use

Tackling the surge in youth e-cigarette use: The 2019 National Youth Tobacco Survey, fielded by CDC and FDA, showed a continued increase in youth use of e-cigarettes, while the 2019 Monitoring the Future Survey, fielded by NIDA, showed that youth who primarily used a commonly sold cartridge-based brand of e-cigarettes, overwhelmingly used fruit, mango, mint, and other flavors. In response to these data, the FDA and leaders from across HHS developed a targeted approach to protecting youth from nicotine addiction, leading to the January 2020 announcement that FDA would prioritize enforcement against illegally marketed cartridge-based Electronic Nicotine Delivery Systems (ENDS) of all flavors, excluding tobacco and menthol, while also prioritizing enforcement against any ENDS product that is targeted to minors or whose marketing is likely to promote use of ENDS by minors, and against all other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access.

Continuing CDC commitment to tobacco control: CDC provided funding and technical support to health departments through its National Tobacco Control Program, the only nationwide investment that supports all 50 states, the District of Columbia, eight U.S. Territories, and multiple American Indians/Alaska Natives tribes for comprehensive tobacco control efforts. In 2019, these entities prepared health advisories; collected state-level data on youth use of tobacco products, including e-cigarettes; and created and disseminated evidence-based educational materials about youth use of tobacco products, including e-cigarettes, to the public through social media and other mechanisms.

Educating youth about the dangers of e-cigarette use: FDA launched “The Real Cost” Youth E-Cigarette Prevention Campaign, a comprehensive effort targeting nearly 10.7 million youth, aged 12-17, who have used e-cigarettes or are open to trying them. The campaign features hard-hitting advertising on TV, digital and social media sites popular among teens, as well as posters with e-cigarette prevention messages in high schools across the nation.

Providing educational resources for teachers and administrators: FDA joined forces with Scholastic to develop educational resources about the use of e-cigarettes for high school teachers and administrators, distributed to more than 700,000 high school educators.

Surgeons general statement on tobacco product use in the uniformed services: Vice Admiral Jerome Adams, Surgeon General of the U.S. Public Health Service Commissioned Corps, joined with the Surgeons General of the Air Force, Army, and Navy to pen the first-ever joint letter on the impact of tobacco product use on force readiness in July 2019 and summarized resources available for service members to help them quit. In 2019, the Commissioned Corps remained the only tobacco-free uniformed service.

Secretary Alex Azar receives a briefing from Assistant Secretary for Preparedness and Response Robert Kadlec in the Secretary’s Operations Center at HHS
Secretary Alex Azar receives a briefing from Assistant Secretary for Preparedness and Response Robert Kadlec in the Secretary’s Operations Center at HHS

Responding to Natural Disasters

Protecting health and saving lives in disasters: In 2019, ASPR led the federal government’s public health and medical response to seven hurricanes, two earthquakes, California wildfires, and five National Special Security Events. More than 2,120 federal disaster responders were deployed to help lead the response, along with 214 tons of medical equipment and supplies. ASPR also deployed 1,804 recovery specialists who dedicated more than 220,900 hours to rebuilding the capacity for health and social services in Puerto Rico, Florida, U.S. Virgin Islands, and California.

Training for first responders: Through HHS’s Counter-Narcotics and Terrorism Operational Medical Support program, ASPR provided tactical medical training to 716 EMTs, paramedics, physicians, first responders and law enforcement officers in 2019. This nationally recognized training furthers the medical and public health response to terrorism and other incidents of national significance, including active shooter situations.

New steps for regional preparedness: ASPR continued to expand and demonstrate the effectiveness and viability of its Regional Disaster Health Response System pilot projects, which aim to improve the local, state, and regional situational awareness, integration, and coordination of medical response activities to a large-scale incident. The system builds on the success of ASPR’s Hospital Preparedness Program, which in 2019 grew to include 32,000 health care coalition partners, including pharmacies, blood blanks, long-term care organizations, clinical labs, outpatient care centers, and medical supply chain organizations.

Preparing for medical countermeasure distribution: Through the Last Mile Pilot Program, ASPR collaborated with seven major U.S. cities to identify gaps and possible solutions for distributing and dispensing medical countermeasures during a public health emergency.

An unprecedented pandemic exercise: ASPR also led Crimson Contagion, the largest-ever exercise involving twelve federal departments/agencies, twelve states, 96 local jurisdictions, 24 native American Tribes, 87 hospitals, and more than 100 private sector partners.

A new opportunity for disaster-related healthcare innovations: ASPR released a new broad agency announcement—the equivalent of a request for proposals, with more flexibility to support innovators—called “ASPR Next,” inviting proposals for next generation solutions such as cutting-edge technologies that transform drinking water to water for sterile injection/infusion or ensure hemodialysis in disaster settings.

Ongoing responses from a ready Commissioned Corps: In part using deployment teams that are ready to deploy within eight hours—as part of a force that stands at over 95 percent readiness—Commissioned Corps officers responded to 32 disaster responses, planned events, and community health and services mission, representing 12,372 days deployed.

At the United Nations General Assembly, Secretary Alex Azar at a podium standing with five other men and one woman
At the United Nations General Assembly, Secretary Alex Azar joins representatives from other countries issuing a joint statement coalescing on the principle that there is no international right to abortion

Combating Anti-Microbial Resistance (AMR)

A new clarion call from the CDC: CDC published the second Antibiotic Resistance (AR) Threats Report, showing that antibiotic-resistant infections cause more than 35,000 deaths each year in the United States. This report, a follow-up to CDC’s first AR Threats Report in 2013, which sounded the alarm about AMR and drove initial action by highlighting the 18 most dangerous bacteria and fungi that cause resistant infections in the United States. There was good news in the new report —an overall 18 percent reduction in deaths from antibiotic-resistant infections since the 2013 report, and a nearly 30 percent reduction in hospital deaths—but the new report found emerging threats and the need for new levels of cooperation and action.

Collecting an unprecedented set of government and private-sector commitments: In September, CDC marked the close of the AMR Challenge, a year-long global call to accelerate progress in the fight against AMR. In response to the challenge, governments from around the globe, NGOs, pharmaceutical and biotech companies, and other private-sector businesses made nearly 350 commitments to fight AMR, such as commitments to reduce antibiotic use in animals.

Addressing the economic challenges for antibiotic development? CMS finalized an alternative, expanded pathway for a New Technology Add-On Payment for drugs designated by the FDA as Qualified Infectious Disease Products—for which new antimicrobials can qualify—and increased the potential add-on payment from 50 percent to 75 percent. CMS also finalized a change to inpatient payments that recognizes the added clinical complexity and cost of treating patients with drug resistance, to ensure that hospitals are not financially disadvantaged by using the most appropriate antimicrobial drug.

CDC testing to support healthcare providers: CDC tested more than 46,000 isolates for containment through the AR Laboratory Network, which aims to detect new and emerging drug resistance. CDC supported more than 360 responses to contain the spread of resistant pathogens.

Generating new knowledge for combating AMR: In 2019, AHRQ provided $10.6 million of funding for new and continuing investigator-initiated research grants to develop improved methods for combating antibiotic-resistant infections and improving antibiotic use.

Leading nations to fight AMR globally: During the World Health Assembly, the United States sponsored and led a resolution, calling for WHO to take action on combating AMR, asking WHO to strengthen the One-Health Tripartite partnership—including WHO, the Food and Agriculture Organization, and the World Organization for Animal Health (OIE)—and providing for continued member state input on the implementation of WHO programs and activities. The resolution was adopted by all member states, with more than 40 co-sponsors across all WHO regions.

Working with India to combat AMR: HHS’s Office of Global Affairs worked with counterparts from India to combat AMR by strengthen surveillance systems for AMR and Hospital Acquired Infections, facilitating a new Memorandum of Understanding between the HHS-funded CARB-X initiative and the Indian Department of Biotechnology to develop new antimicrobials, and engaging with Indian stakeholders on regulatory pathways for new antimicrobials.

Tackling Mental Health, Serious Mental Illness, and Suicide

Supporting inpatient treatment for serious mental illness: CMS approved the two first-ever demonstration approvals—for Vermont and Washington, D.C.—to support comprehensive mental health treatment by providing flexibility around Medicaid’s bar on payment for treatment in institutes for medical diseases.

New resources from HRSA to help respond to mental health crises: In July 2019, HRSA launched a new Critical Crossroads: Pediatric Mental Health Care in the Emergency Department Toolkit to provide hospital emergency departments with resources to better manage and coordinate care for children and adolescents in mental health crisis.

Providing support for mental health services and schools: Through the Mental Health Technology Transfer Centers, SAMHSA under took new efforts to provide school-based mental health training and education, providing training to more than 10,500 school personnel, state officials, local officials and mental health practitioners.

Working with state governments: SAMHSA launched the SAMHSA/VA Governor’s Challenge to Prevent Suicide among Service Members, Veterans and their Families, with the first cohort of seven states, focused on working to identify and support at-risk veterans and their families not in VA care. So far, examples of progress include training of military cultural competency for hundreds of providers in Virginia, expansion of screening for veteran status and suicide risk within healthcare systems in New Hampshire, and implementation of lethal means education and programming with gun shops in Colorado.

Working toward an improved suicide hotline: SAMHSA submitted the National Suicide Hotline Improvement Act Report to the Federal Communication Commission (FCC), leading to the FCC recommendation that 988 be assigned as the nation’s national suicide prevention hotline number. SAMHSA continued to support its suicide helpline, which fielded 2.1 million calls in FY 2019.

Training faith-based partners about mental illness: The Partnership Center worked to establish a two-way street of collaboration between faith communities and mental health professionals to help combat serious mental illness, including:

  • Conducting six “Mental Illness 101” webinars, educating close to 9,000 registrants on different mental health disorders and ways in which faith and community leaders can better support individuals and their families experiencing these disorders.
  • Convening more than 50 faith leaders for a national meeting ― Small Acts of Great Love: Building a Framework for Faith Communities to Respond to Mental Illness — where leaders advised the Partnership Center on how to better engage faith leaders.
  • Continued technical assistance to a learning collaborative of organizations and leaders working at the intersection of mental illness and faith communities, to discuss strategies for peer engagement, models for faith engagement in addressing mental illness, and best practices for applying for funding from SAMHSA.
  • Hosting an expert panel meeting, in partnership with SAMHSA, to encourage mental health professionals to be more competent about religion and spirituality, and develop more understanding of how it can improve outcomes for clients.
Assistant Secretary Elinore McCance-Katz speaks at the SAMHSA Prevention Day event
Assistant Secretary Elinore McCance-Katz speaks at the SAMHSA Prevention Day event

Modernizing Food Safety and Oversight

Starting up routine inspections under the Produce Safety Rule: As part of implementing the Food Safety Modernization Act (FSMA), FDA initiated routine inspections of large farms for produce safety (other than sprouts operations), working under cooperative agreements with state regulatory partners to conduct 1,000 large farm inspections.

Tracking FSMA progress: In September, the FDA launched a Food Safety Dashboard designed to track the impact of the FSMA rules, measure their progress, and help the FDA continue to refine its implementation.

Using new technology to improve food safety: The FDA announced its intent to develop a new approach to food safety to leverage technology in creating a more digital, traceable, and safer food system, including the use of blockchain, sensor technology, the Internet of Things, and artificial intelligence. In October, the FDA held a public meeting and opened a Federal Register docket to hear from a broad cross-section of stakeholders on what concepts should be incorporated in the new initiative in order to strengthen the safety of the food supply.

Launching a historic modernization of dietary supplement regulation: The FDA announced a new plan for implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years, which will include: the Dietary Supplement Ingredient Advisory List, a rapid-response tool to communicate more quickly when there are concerns about unlawful ingredients; a flexible regulatory framework; and new partnerships to protect public health. As one example, partnerships would include the creation of the Botanical Safety Consortium, a public-private enterprise that allows scientists from industry, academia, and government to explore and promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements.


Content created by Assistant Secretary for Public Affairs (ASPA)
Content last reviewed on February 2, 2020