June 12, 2018

NEWS
House Panel Questions FDA's Track Record Combating Illegal Opioids. US lawmakers fear the Food and Drug Administration is not doing enough to stop the flow of illegal drugs into the United States as the country works to combat the opioid epidemic. (Reuters, 6/11/18)

REPORT
Update: Influenza Activity in the United States During the 2017-18 Season and Composition of the 2018-19 Influenza Vaccine. The United States 2017-18 influenza season (October 1, 2017-May 19, 2018) was a high severity season with high levels of outpatient clinic and emergency department visits for influenza-like illness (ILI), high influenza-related hospitalization rates, and elevated and geographically widespread influenza activity across the country for an extended period.  (CDC, 6/8/18)

REPORT
Update: ACIP Recommendations for the Use of Quadrivalent Live Attenuated Influenza Vaccine (LAIV4) - United States, 2018-19 Influenza Season. On February 21, 2018, ACIP recommended that LAIV4 be an option for influenza vaccination of persons for whom it is appropriate for the 2018-19 season (3). This document provides an overview of the information discussed in the decision-making process leading to this recommendation. (CDC, 6/8/18)

FUNDING OPPORTUNITY
The USAID Global Health Broad Agency Announcement for Research & Development. The global community has made great strides in reducing mortality around the world over the last 50 years, but progress in developing countries lags far behind that seen in developed countries. Outbreaks of emerging infectious diseases like Ebola and Zika only serve to further compound these health challenges, taxing already stressed health systems and elevating the risk of disease epidemics of global proportions. USAID and partners will work to rapidly implement solutions and create an environment for sustainability, scalability, and ultimately health impact. (Grants.gov, 6/7/18)

NEWS
House Health Subcommittee Members Prepare PAHPA Reauthorization. Members of the US House Energy and Commerce Subcommittee on Health on Wednesday considered proposed updates to the nation's law on preparing for and responding to national and global public health emergencies resulting from any chemical, biological, radiological, or nuclear (CBRN) agent, toxin, disaster, threat or attack - be it naturally occurring, unintentional or deliberate. (Homeland Preparedness News, 6/7/18)

See also: FDA Deputy Commissioner for Policy, Planning, Legislation, and Analysis Anna Abram - Remarks Prepared for Testimony Before a Subcommittee of the US House Committee on Energy and Commerce on the Pandemic and All-Hazards Preparedness Act (FDA, 6/6/18)

HEALTH ALERT
Update - CDC Recommendations for Managing and Reporting Shigella Infections with Possible Reduced Susceptibility to Ciprofloxacin. The Centers for Disease Control and Prevention (CDC) continues to identify an increasing number of Shigella isolates that test within the susceptible range for the fluoroquinolone antibiotic ciprofloxacin (minimum inhibitory concentration [MIC] values of 0.12-1 μg/mL), but harbor one or more resistance mechanisms. CDC remains concerned about potential clinical failures with fluoroquinolone treatment. (CDC, 6/7/18)

NEWS
Trump Walks Back a Disastrous Ebola Funding Cut and Experts Sigh in Relief. The Trump administration has walked back its proposal to reclaim $252 million in unspent Ebola funds on Tuesday, which experts lauded as a welcome shift in the administration's approach to global health leadership -- especially amid the new Ebola outbreak. (Huffington Post, 6/6/18)

See also: Supplementary Report - Report Pursuant to Section 1014(c) of the Congressional Budget and Impoundment Control Act of 1974 (2 U.S.C. 685(c)) (The White House, 6/5/18)

REPORT
MCMi Fiscal Year 2017 Program Update. Together with US government partners through the Department of Health and Human Services Public Health Emergency Medical Countermeasures Enterprise, FDA helps define and prioritize requirements for MCMs in public health emergencies. This includes coordinating research, setting deployment and use strategies, and facilitating access to MCMs. (FDA, 6/6/18)

PRESS RELEASE
FDA Seeks Permanent Injunction Against Company Selling Unapproved Hand Sanitizers that Claim to Prevent Infections from Numerous Pathogens. The US Food and Drug Administration today filed a complaint against Innovative BioDefense, Inc. of Lake Forest, California, and Colette Cozean, the company's president and chief executive officer, to prohibit them from selling Zylast topical antiseptics with claims that they are effective against infection by pathogens such as norovirus, rotavirus, flu virus, MRSA, and Ebola. (FDA, 6/6/18)

NEWS
US Diplomats Evacuated in China as Medical Mystery Grows. A crisis over a mysterious ailment sickening American diplomats and their families - which began in Cuba and recently appeared in China - has widened as the State Department evacuated at least two more Americans from China on Wednesday. (New York Times, 6/6/18)

NEWS
HHS Launches New Initiative to Address Health Concerns as National Security Threats. DRIVe, or Division of Research, Innovation and Ventures, was unveiled on Tuesday as a new component of the department's Office of the Assistant Secretary for Preparedness and Response. It will be spearheaded by the Biomedical Advanced Research and Development Authority.   (Fierce Healthcare, 6/5/18)

See also:

• Seattle-Bellevue Company Selected to Accelerate Innovation for US Health Security, Daily Medical Care (ASPR, 6/5/18)
• Raleigh-Durham Company Selected to Accelerate Innovation for US Health Security, Daily Medical Care (ASPR, 6/5/18)
• Greater Boston Company Selected to Accelerate Innovation for US Health Security, Daily Medical Care (ASPR, 6/5/18)
• Los Angeles Company Selected to Accelerate Innovation for US Health Security, Daily Medical Care (ASPR, 6/5/18)
• New Orleans Company Selected to Accelerate Innovation for US Health Security, Daily Medical Care (ASPR, 6/5/18) 

EDITORIAL
Impact of Vector Biology Research on Old and Emerging Neglected Tropical Diseases. NIAID scientists note that vector-borne diseases (VBDs) represent a great proportion of the neglected tropical diseases in tropical regions of the world, where they disproportionately affect the poorest and most disadvantaged populations. That said, in recent years, the expansion of vectors from the tropics has placed many more people living in the temperate regions of the world at risk of contracting VBDs. (PLOS Neglected Tropical Diseases, 5/31/18)

FACT SHEET
USAID Response to the Ebola Outbreak. The US Agency for International Development (USAID) has contributed $8 million dollars to support the joint Government of the Democratic Republic of the Congo (DRC) and World Health Organization (WHO) Strategic Response Plan to the outbreak (currently budgeted at $56.7 million). In addition to this funding, USAID has provided personal protective equipment, laboratory supplies, the mobilization of two existing mobile labs, and a robust presence on the ground. (USAID, 6/1/18)

REPORT
Federal Grants and Loans for State and Local Emergency Communications Projects: Frequently Asked Questions. This report provides congressional staff with information on current federal grants and loans that fund emergency communications, information on the application process, eligible communications activities, and other resources they can provide to constituents seeking federal grant and loan funding to support emergency communications projects. (Congressional Research Service, 6/1/18)

BLOG
Building a Resilient Nation. FEMA Resilience includes our programs focused on preparing for disasters and making our nation more resilient.  By formalizing how we have been informally working together as a unified organization, we believe we can drive risk reduction and enhance the nation's resilience to disasters by leveraging several FEMA missions including mitigation, insurance, preparedness, grants, and continuity. (FEMA, 6/4/18)

See also: 2018-2022 Strategic Plan (FEMA, 5/18)

NEWS
America is Not Ready for Disability Disaster Response in the Coming Hurricane Season. The 2018 hurricane season starts on June 1st. According to the nation's leading experts on disability and disaster response, we're not ready. In fact, thanks to changes at the Federal Emergency Management Agency and clashes between disability groups and the American Red Cross, we might be even less prepared than we were a year ago. Meanwhile, for many disabled people in Puerto Rico and the southeastern United States, last year's hurricane season never really ended. (Pacific Standard, 6/1/18)

BLOG
FDA's New Efforts to Advance Biotechnology Innovation. Scientific advances in biotechnology, such as genome editing and synthetic biology, hold enormous potential to improve human and animal health, animal welfare, and food security. And researchers and companies based in the United States helped pioneer these technologies. (FDA, 6/6/18)

This Week's Hearings

The Chemical Facilities Anti-Terrorism Standards Program (CFATS) - A Progress Report. US House Committee on Energy & Commerce, Subcommittee on Environment. 6/14/2018, 10 AM. Rayburn 2123. More