June 13, 2017

Public Health & Healthcare Preparedness
FDA Could Act to Pull More Opioid Pain Pills from the US Market.
On Thursday, the FDA asked Endo International Plc to stop sales of its powerful opioid painkiller Opana ER, the first time the agency has taken such a step. The request was made after the drug was tied to outbreaks of viral infections including HIV, as addicts would inject the drug and spread disease by sharing needles.  (Bloomberg, 6/9/17)
Rotary and CDC - Partners in Polio and Beyond.
In 1988, the establishment of the Global Polio Eradication Initiative (GPEI) accelerated polio eradication efforts by uniting the strengths of Rotary International, the World Health Organization (WHO), UNICEF, and CDC into a global partnership to end polio.  (CDC, 6/9/17)
CDC Analysis of Data from US Territories Finds Serious Birth Defects in About 1 in 12 Fetuses or Infants of Pregnant Women with Zika Infection in the First Trimester.
Among the women with confirmed Zika infection during the first trimester, 8 percent or nearly 1 in 12 had a baby or fetus with Zika virus-associated birth defects.  (CDC, 6/8/17)
Democrats Home in on Opioid Crisis in Bashing Proposed Medicaid Cuts.
"What kind of voodoo math are you using to justify your statements claiming to help Americans?" Rep. Linda Sanchez of California, a Democrat, asked Price at a hearing before the House Committee on Ways and Means, "when you're taking over a trillion dollars out of the system to pay for tax cuts for the rich?"  (STAT News, 6/8/17)

Failure to Warn: An Early Warning System for Drug Risks Falls Flat.
In 2007, after a number of dangerous medicines were pulled off the market, Congress ordered the Food and Drug Administration to set up an early warning system to detect other harmful drugs before more people died. The FDA responded by creating a system called the Sentinel Initiative, which mines insurance data and medical records to identify possible risks. But a system that was touted as a revolutionary way to glean valuable information from electronic health records and protect patients has had little measurable impact.  (STAT News, 6/6/17)
CDC Urges Health Care Facilities to Address Legionnaire's in Their Water Systems.
The CDC's data found that 25 percent of the people who contracted their Legionnaires' disease in a health care facility died of it because they had risk factors that made them more susceptible to the disease - they smoked, were older or their immune system was compromised.  (Pittsburgh Post-Gazette, 6/6/17)
Why Access to Health Care is a National Security Issue.
Early last month, US House Republicans rammed through the American Health Care Act, a remarkably regressive piece of legislation that, among other flaws, would be disastrous for pandemic planning and preparedness.  (Bulletin of the Atomic Scientists, 6/5/17)

NIAID-Sponsored Trial of Experimental Chikungunya Vaccine Begins.
The Phase 1/2 trial, which is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is being conducted at several NIAID-funded Vaccine and Treatment Evaluation Units.  (NIAID, 6/5/17)
Guidance for Surveyors, Providers and Suppliers Regarding the New Emergency Preparedness (EP) Rule.
On September 8, 2016 the Federal Register posted the final rule Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers. The regulation went into effect on November 16, 2016. Health care providers and suppliers affected by this rule must comply and implement all regulations one year after the effective date, on November 16, 2017.  (Centers for Medicare & Medicaid Services, 6/2/17)

Letter to Secretary Tom Price.
Senator Bill Nelson (D-FL) expresses concern that the Administration's budget proposal would damage the United States' ability to adequately respond to the Zika virus. (Senator Bill Nelson, 5/31/17)


Letter to Senators Roy Blunt and Patty Murray (US Senate Committee on Appropriations).
Senators Mazie K. Hirono (D-HI), Bill Nelson (D-FL), Cory A. Booker (D-NJ), and Edward J. Markey (D-MA) urge the Subcommittee on Labor, Health and Human Services, Education, and Related Agencies to continue funding the Public Health Emergency Preparedness Program and the Hospital Preparedness Program, underscoring the need to continue strong investments in the overall level of preparedness in our nation's hospitals and public health systems. (US Senate, 5/25/17)


Federal Health Centers: An Overview.
This report provides an overview of the federal Health Center Program, including its statutory authority, program requirements, and appropriation levels.  (Congressional Research Service, 5/19/17)

Homeland Security & Disaster Preparedness
US Cyberweapons, Used Against Iran and North Korea, Are a Disappointment Against ISIS.
It has been more than a year since the Pentagon announced that it was opening a new line of combat against the Islamic State, directing Cyber Command, then six years old, to mount computer-network attacks. The mission was clear: Disrupt the ability of the Islamic State to spread its message, attract new adherents, pay fighters and circulate orders from commanders.  (New York Times, 6/12/17)
Wildland Fire Risk Reduction: Multiple Factors Affect Federal-Nonfederal Collaboration, but Action Could Be Taken to Better Measure Progress.
 GAO recommends
that federal agencies work with the Wildland Fire Leadership Council-which provides oversight and leadership for the strategy-to develop measures to assess progress toward achieving the strategy's goals.  (GAO, 6/9/17)
Lawmakers to Pentagon: Tell Us When You Use Cyber Weapons.
A proposed law would require congressional notification when DOD conducts external cyber operations - offensive or defensive.  (Defense One, 6/8/17)
House Homeland Security Committee Opposes Trump's Budget Cuts to Local First Responders at Hearing.
Members of the House Homeland Security Committee from both parties expressed opposition to the Trump administration's proposed budget that would cut funding for training and deployment for local security programs by as much as 30 percent next year, even while the overall funding for the Department of Homeland Security (DHS) increases almost 7 percent - one of the few federal agencies targeted for a budget increase.  (Homeland Preparedness News, 6/7/17)
Stafford Act Assistance and Acts of Terrorism.
This report provides an overview of emergency and major disaster declarations and explains how they might be used in the aftermath of a terrorist incident that does not involve a fire or an explosion, such as high casualty mass shootings or chemical gas attacks. This report also provides an overview of Stafford Act assistance provided for past terrorist incidents.  (Congressional Research Service, 6/2/17)
Private Flood Insurance and the National Flood Insurance Program.
Congress has found that many factors have made it uneconomic for the private insurance industry alone to make flood insurance available to those in need of such protection on reasonable terms and conditions.  (Congressional Research Service, 6/2/17)
Bill to Establish Cyber Bounty Program at DHS Introduced in Senate.
The Hack Department of Homeland Security Act will model its bounty program in a similar fashion to that of other bounty programs currently in place at the U.S. Department of Defense and major tech companies like Google and Apple.  (Homeland Preparedness News, 6/1/17)

Science & Technology Policy
Supreme Court Rules to Allow Lower-Cost Biosimilars to Market Faster in Sandoz-Amgen Case.
he US Supreme Court has reduced the time that companies will have to wait before selling lower-cost versions of expensive biologic medicines, a move that is expected to save the health care system piles of money.  (STAT News, 6/12/17)
Bacteriophage Therapy: Scientific and Regulatory Issues; Public Workshop.
The purpose of the public workshop, hosted by FDA, NIH, and NIAID, is to exchange information with the medical and scientific community about the regulatory and scientific issues associated with bacteriophage therapy. The public workshop will be held in Rockville, MD on July 10, 2017, from 8:30 AM to 5 PM and July 11, 2017, from 8:30 AM to 3 PM.  (Federal Register, 6/8/17)
NIH Drops Controversial Plan to Cap Funding for Individual Labs.
fficials at the federal agency that funds medical research Thursday scrapped a controversial plan to free up money for young researchers by capping the amount of grant money it gives to individual labs.  (STAT News, 6/8/17)
FBI Gets Synthetic Biology Crash Course at CSU.
For one week in May, 11 agents and analysts from the US Federal Bureau of Investigation were on campus for an intensive training program spearheaded by one of the university's preeminent biotechnologists. The goal: giving the law enforcement personnel foundational knowledge and insight into the rapidly evolving field of synthetic biology.  (Colorado State, 6/7/17)
Pull Incentives for Antibacterial Drug Development: An Analysis by the Trans-Atlantic Task Force on Antimicrobial Resistance.
In a previous publication, the Transatlantic Task Force on Antimicrobial Resistance (TATFAR) summarized the key areas of consensus for economic incentives for antibacterial drug development. In this second paper authored by representatives of TATFAR, we examine the advantages and disadvantages of different pull incentives for antibacterial drug development.  (Clinical Infectious Diseases, 6/7/17)
Humanitarian Use Devices; 21st Century Cures Act; Technical Amendment.
The Food and Drug Administration (FDA) is amending regulations to reflect changes recently enacted into law by the 21st Century Cures Act. Specifically, certain requirements related to humanitarian device exemptions (HDEs) and institutional review boards (IRBs) for devices have changed.  (Federal Register, 6/7/17)
Trump Says Francis Collins Will Stay On at the NIH.
Collins, who has led the agency since August 2009, is a holdover from the administration of president Barack Obama - and is now the first NIH director since the 1970s to be chosen by two presidents.   (Nature, 6/6/17)
Science in Extreme Environments: Building Extraterrestrial and Earth-Based Research Capabilities.
NASA astronaut and microbiologist Kate Rubins discusses her experiences conducting biological research in outer space.  (American Society for Microbiology, 6/4/17)
Science and Technology Issues in the 115th Congress.
This report briefly outlines an array of science and technology policy issues that may come before the 115th Congress. Given the rapid pace of S&T advancement and its importance in many diverse public policy issues, S&T-related issues not discussed in this report may come before the 115th Congress.  (Congressional Research Service, 5/23/17)
This Week's Hearings
State-Sponsored Cyberspace Threats: Recent Incidents and US Policy Response. US Senate Committee on Foreign Relations, Subcommittee on East Asia, the Pacific, and International Cybersecurity. 6/15/17, 10 AM, Rayburn 2318. More

States' Perspectives on Energy Security Planning, Emergency Preparedness, and State Energy Programs. US House Committee on Energy & Commerce, Subcommittee on Energy. 6/14/17, 10 AM, Rayburn 2123. More

Bolstering the Government's Cybersecurity: Lessons Learned from WannaCry. US House Committee on Science, Space, and Technology, Subcommittees on Oversight & Research and Technology. 6/15/17, 10 AM, Rayburn 2318. More

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