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Latest Top (4) News


Secretary Azar Praises Service of Acting Inspector General Joanne Chiedi

Secretary Alex Azar issued the following statement on the retirement of Joanne Chiedi, the Department's Acting Inspector General (effective December 31):

"Joanne Chiedi has been a respected and valued member of the HHS team since 2010, and I appreciate her selfless contributions to HHS and the American people during her 37 years of federal service. Joanne has provided insightful and effective leadership expertise during her time at OIG, first as the Deputy Inspector General for Management and Policy, then as Principal Deputy Inspector General in 2013. In June, she assumed the role of Acting IG and continued to make responsible, conscientious decisions in support of millions of HHS program beneficiaries and taxpayers. I have seen first-hand the significant impact the organization has made under Joanne's leadership. From work to revise the Anti-Kickback Statute's regulations to promote value-based arrangements and care coordination, to the creation of the first Chief Data Office in the IG community, the agency has made significant strides on many fronts under her watch. Joanne and the entire OIG workforce should be proud of their achievements."



Mon, 09 Dec 2019 17:00:00 -0500


Deputy Secretary Hargan to Lead U.S. Delegation to WHO Commission on Non-Communicable Diseases

In the coming days, Health and Human Services Deputy Secretary Eric Hargan will lead the U.S. delegation to the Sultanate of Oman to attend the World Health Organization’s (WHO) Independent High-level Commission on non-communicable diseases (NCD) on behalf of the Trump Administration.

To further this work, Deputy Secretary Hargan will be accompanied by staff from the Center of Global Health Protection at the Centers for Disease Control and Prevention (CDC), HHS Office of Global Affairs (OGA), National Cancer Institute (NCI), U.S. Department of Agriculture, and the U.S. Embassy in Muscat, Oman.

During his visit, Deputy Secretary Hargan will participate in various session panels on global health, NCDs, and mental health. He will also conduct bilateral meetings with health ministers and leaders, and participate in a tour of the Omani Royal Hospital Cardiovascular and Oncology Centers.

Additional information and details regarding the delegation’s meetings and site visits will be forthcoming in social media posts on Deputy Secretary Hargan’s Twitter account.



Mon, 09 Dec 2019 15:45:00 -0500


HHS Invests in Modernizing U.S. Manufacturing Capacity for Pandemic Influenza Vaccine

The U.S. Department of Health and Human Services (HHS) issued a six-year, $226 million contract today to increase capacity to produce recombinant influenza vaccine in the United States. The contract is in accordance with the Sept. 19 presidential executive order to enhance national security and the public health by modernizing influenza vaccines and technologies.

The work will take place through a public-private partnership between the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), and Sanofi Pasteur, a global pharmaceutical company with U.S. headquarters in Bridgewater, New Jersey.

“Influenza viruses can spread rapidly around the globe, infecting hundreds of millions of people in just weeks, making technologies that quickly and safely produce effective influenza vaccines fundamental in responding to an influenza outbreak,” said BARDA Director Rick Bright, Ph.D. “Keeping vaccine manufacturing in the United States is essential to protect Americans from pandemic influenza and to save lives. Better, faster vaccine technologies, produced in the U.S. will improve access, protect more people and, ultimately, strengthen our nation’s health security.”

Recombinant vaccine technology can produce new vaccines faster than traditional egg-based technology. Currently, Sanofi Pasteur is the only company with a seasonal recombinant influenza vaccine licensed in the United States and with the resources to leverage this technology for pandemic influenza preparedness.

To expand and retain domestic recombinant influenza vaccine capacity, Sanofi Pasteur will retrofit vaccine manufacturing facilities in Swiftwater, Pennsylvania. When the project is completed, it will double Sanofi’s recombinant protein-based influenza vaccine manufacturing capacity in the United States. The agreement with Sanofi Pasteur includes options for an additional facility at this site to be retrofitted to produce adjuvant; development and licensure of an adjuvanted, recombinant pandemic influenza vaccine; and HHS access to the vaccine production capacity for up to 25 years after the manufacturing facilities are completed. As a result of this agreement, Sanofi Pasteur could provide nearly 100 million doses of recombinant influenza vaccine for use during a pandemic.

An adjuvant is an ingredient used in some vaccines to help create a stronger immune response in people receiving the vaccine, meaning that adjuvant helps vaccines work better. Vaccines containing adjuvants are tested for safety and effectiveness in clinical trials before they are licensed for use in the United States, and when approved, they are continuously monitored by the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention.

About HHS, ASPR, and BARDA

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, devices, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. Since 2007, 52 BARDA-supported products have achieved regulatory approval, licensure or clearance. For more about ASPR and BARDA, visit www.phe.gov/aspr, and to learn more about partnering with BARDA, visit www.medicalcountermeasures.gov.



Mon, 09 Dec 2019 08:45:00 -0500


IHS and AAP Release Clinical Recommendations to Improve Care of American Indian, Alaska Native Women and Infants Impacted By Prenatal Opioid Exposure

Today, the Indian Health Service and the American Academy of Pediatrics Committee on Native American Child Health released clinical recommendations on neonatal opioid withdrawal syndrome, or NOWS, for IHS, tribal, and urban Indian organization health care facilities. These recommendations provide standards of care surrounding screening, diagnosing, and treatment of pregnant mothers and infants affected by prenatal opioid exposure.

"Infants born withdrawing from opioids represent one of the most heartbreaking aspects of our country's addiction crisis, which has hit American Indian and Alaska Native communities especially hard," said HHS Secretary Alex Azar. "The new clinical recommendations will help elevate the quality of care offered to mothers and infants affected by the opioid crisis, and this cooperative project reflects the priority that the Trump Administration has put on addressing substance abuse and increasing the quality of care provided through the Indian Health Service."

"At IHS, we recognize that preserving the infant-mother relationship is of the utmost importance," said IHS Chief Medical Officer Rear Adm. Michael Toedt, M.D. "These recommendations further establish the need for ongoing monitoring and clinical management of opioid-exposed infants to improve health outcomes as part of our comprehensive strategy to address the opioid epidemic."

The recommendations will serve as a resource to improve identification, care, and outcomes of infants at risk for NOWS. The recommendations were developed based on critical feedback the IHS received on the importance of prenatal opioid exposure in opioid listening sessions and tribal consultations throughout the past year.

"American Indian and Alaska Native women face significant barriers in obtaining appropriate care for substance use disorders while pregnant, which may delay early intervention efforts that are best for the newborn's health," said Shaquita Bell, M.D., FAAP, chair of the AAP Committee on Native American Child Health. "AAP is proud to partner with IHS to support efforts to prevent neonatal opioid withdrawal syndrome, to provide the most appropriate and effective treatments for infants and keep them connected with their families and communities."

The recommendations are also a companion guide to clinical recommendations to improve care of American Indian and Alaska Native pregnant women and women of childbearing age with opioid use disorder, which were announced by IHS and the American College of Obstetricians and Gynecologists in March 2019.

Maintaining relationships and forging new partnerships with tribes and tribal health organizations in rural and urban Indian communities are essential to addressing the opioid epidemic and caring for American Indian and Alaska Native mothers, infants, and families affected by NOWS. The IHS engages with communities and partners with tribes to promote evidence-based programs and policies to support recovery, as well as prevention efforts. The IHS is committed to developing strategies to implement these new recommendations that include sharing best practices in comprehensive care approaches, collaborating with community service providers, and sharing training and patient education resources.

NOWS occurs in 55-94 percent of infants prenatally exposed to opioids and varies in severity from mild to, in rare cases, life-threatening. Management of NOWS begins with identifying women at risk for opioid withdrawal to improve outcomes for both mothers and newborns and help to keep the family unit together.

Health and Human Services Secretary Alex Azar has identified ending the crisis of opioid addiction and overdose in America as one of the department's top priorities and an area of focus as an impactable health challenge. In 2017, the Department declared a public health emergency and announced a 5-Point Strategy to Combat the Opioid Crisis.

The IHS National Committee on Heroin, Opioids and Pain Efforts, or HOPE Committee, was established to promote appropriate and effective pain management, reduce overdose deaths from heroin and prescription opioid misuse, and improve access to culturally appropriate treatment.

The IHS, an agency in the U.S. Department of Health and Human Services, provides a comprehensive health service delivery system for approximately 2.6 million American Indians and Alaska Natives. Our mission is to raise the physical, mental, social, and spiritual health of American Indians and Alaska Natives to the highest level. Follow the agency via social media on Facebook and Twitter.

The American Academy of Pediatrics

For more than 50 years, pediatricians from the American Academy of Pediatrics have been meeting to advocate for the health needs of American Indian and Alaska Native children. The AAP Committee on Native American Child Health, offers its expertise to individuals and groups concerned about the issues facing Native American children. The committee meets twice a year to address the major problems that affect Native American children and youth and how committee members and pediatricians can deal with these problems.

The recommendations are available https://www.ihs.gov/opioids/childhealth/.



Thu, 05 Dec 2019 14:30:00 -0500