NY Times

Reuters

“…..Pluristem said it will start preparations to keep an emergency stock of PLX-R18 on hand for use in such events.

Full approval of the drug will depend on the results of a Phase III clinical trial…..”

FDA

MCMs to treat patients with radiation-induced myelosuppression following a radiological/nuclear incident (H-ARS)

Myelosuppression occurs when radiation damages the bone marrow. Suppression of the bone marrow blocks the production of blood cells. There are FDA-approved products that can help patients with H-ARS by facilitating recovery of bone marrow cells that develop into white blood cells, including neutrophils, which help fight off infections.

FDA-approved products that may be used to treat adult and pediatric patients acutely exposed to myelosuppressive doses of radiation, a condition known as Hematopoietic Syndrome of Acute Radiation Syndrome, or H-ARS:

• Neupogen (filgrastim) – approved March 2015 [more info; product label (PDF, 1.2 MB)]
• Neulasta (pegfilgrastim) – approved November 2015 [product label (PDF, 1.7 MB)]
• Leukine (sargramostim) – approved March 29, 2018 [more info (PDF, 299 KB); product label (PDF, 786 KB)]

FDA

Campus Safety

Shelter?

• Concrete and brick buildings.  A home basement OK too.
• Avoid structures made of wood and plaster:  No protection
• Go deep. Underground areas or the center of a tall building;

Then what?

• Stay inside for at least 24 hours. Radiation levels are extremely dangerous after a detonation, but levels decrease rapidly.
• Tune in to the news

NY Times

“…..The Federal Communications Commission said on Sunday that its initial investigation of the mistaken alert had concluded that Hawaii did not have “reasonable safeguards or process controls in place” in its emergency notification process. The alert was sent to cellphones across Hawaii on Saturday morning when a state employee pushed the wrong button in the midst of a shift-change safety drill. It then took 38 minutes for the agency to withdraw the alert.

The prospect of a battery of investigations by state and federal lawmakers, with public testimony about the timeline of events, suggested that the alert would probably be a dominant subject in Hawaii life for months to come…..

As officials tried to reconstruct exactly what happened on Saturday, a spokesman for the Pacific Command in Hawaii said the military had moved quickly to push back against the Hawaii state alert as soon as it was known to be incorrect.

“Upon confirming yesterday’s message was a false alarm, Uspacom Public Affairs worked quickly to inform the public through traditional and social media channels,” Cmdr. David Benham, a military spokesman, said in an email Sunday, using an acronym for the Pacific Command. “We will use this as an opportunity to improve our internal processes as well as coordination with State authorities. “

The Pacific Command first told Hawaii media that there was no approaching ballistic missile at 8:23 a.m. — about 13 minutes after Hawaii sent out the alert………”

NY Times

PHEMCE High-Priority Threats

The PHEMCE will continue to address MCM needs to protect against high-priority threats for which the Secretary of Homeland Security made a determination pose a material threat sufficient to affect national security or PHEMCE leadership determines to have the potential to threaten national health security.

This year, the PHEMCE added three chemical agents (chlorine, phosgene, and vesicants); otherwise, the high-priority threats are unchanged from those listed in the 2016 PHEMCE SIP. The PHEMCE high-priority threats are (in alphabetical order by threat area):

Biological Threats

• Bacillus anthracis (anthrax)* and
• Multi-drug resistant B. anthracis (MDR anthrax)*
• Burkholderia mallei (glanders)* and
• Burkholderia pseudomallei (melioidosis)*
• Clostridium botulinum toxin (botulism)*
• Ebola virus (Ebola hemorrhagic fever)*
• Emerging infectious diseases4
• Francisella tularensis (tularemia)*
• Marburg virus (Marburg hemorrhagic fever)*
• Pandemic influenza
• Rickettsia prowazekii (typhus)*
• Variola virus (smallpox)*
• Yersinia pestis (plague)*
• Chemical Threats
• Acetylcholinesterase inhibitor nerve agents*
• Chlorine5
• Cyanide salts (potassium and sodium cyanide)*
• Hydrogen cyanide*
• Phosgene5
• Vesicants*
• Radiological* and Nuclear* Threats(*) indicates threats identified under the following authorities related to MCMs: (1) emergency use authorities that rely on section 564(b)(1)(D) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); (2) priority review vouchers PRVs) under section 565A of the FD&C Act;6 and, (3) procurements of security countermeasures under section 319F-2 of the PHS Act.

4 EIDs continue to remain a high-priority threat for the PHEMCE. The PHEMCE developed a risk assessment framework to assess whether specific emerging pathogens should be included explicitly as a high-priority threat. These pathogens may be included if PHEMCE leadership determines they have the potential to affect national health security.

5 The PHEMCE added additional chemical threat agents to the high-priority threat list after considering multiple factors, including recent reported intentional use of agents as weapons, accidental releases, availability of agents in industry, and health impacts of exposure.

6 It is possible that a drug product meeting the requirements of section 565A (material threat MCM priority review vouchers (PRVs)) also may meet the requirements of section 524 of the FD&C Act (which enables sponsors of certain tropical disease applications to receive PRVs). However, under section 565A(e), the same application is not permitted to receive more than one voucher. U.S. Food & Drug Administration (2017). Tropical Disease Priority Review Voucher Program. https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm534162.htm and U.S. Food & Drug Administration (2017). 21st Century Cures Act: MCM-Related Cures Provisions. https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryand PolicyFramework/ucm566498.htm#prv.

The PHEMCE is an interagency coordinating body led by the HHS Assistant Secretary for Preparedness and Response, comprising the Centers for Disease Control and Prevention, the National Institutes of Health, the Food and Drug Administration, and interagency partners at the Departments of Defense, Veterans Affairs, Homeland Security, and Agriculture. It coordinates the development, acquisition, stockpiling, and recommendations for use of medical products that we need to effectively respond to a variety of high consequence public health emergencies, whether naturally occurring or intentional.

EXECUTIVE SUMMARY

The 2017-2018 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan (SIP) describes the priorities that the U.S. Department of Health and Human Services (HHS), in collaboration with its interagency partners, will implement over the next five years. This strategy updates the 2016 PHEMCE SIP and fulfills the annual requirement established by Section 2811(d) of the Public Health Service (PHS) Act, as amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA). The annual PHEMCE SIP provides the blueprint the Enterprise will use to enhance national health security through the procurement and effective use of medical countermeasures (MCM). Starting with this iteration of the SIP, the PHEMCE is retitling its SIP to reflect a more forward-focused strategic document by referring to the year the PHEMCE developed it as well as the following year. For example, the PHEMCE developed this SIP in 2017; therefore, it is the 2017-2018 PHEMCE SIP. The PHEMCE examines the SIP goals and objectives annually by taking into consideration the progress achieved and the remaining strategic gaps in MCM preparedness. During the development of the 20172018 PHEMCE SIP, the PHEMCE examined the goals and objectives articulated in the 2016 PHEMCE SIP and determined that no changes were necessary at this time.

The streamlined 2017-2018 PHEMCE SIP provides:

1) a summary of the major recent accomplishments;

2) new activities;

3) updates to the activities from the 2016 PHEMCE SIP; and

4) specific information required annually under PAHPRA reporting mandates.

The 2016 PHEMCE SIP identified priority activities in the near-term (fiscal year (FY) 20172018), mid-term (FY 2019-2020), and long-term (FY 2021 and beyond) timeframes. The PHEMCE maintained these timeframes in the 2017-2018 PHEMCE SIP. The PHEMCE is still pursuing activities detailed in the 2016 PHEMCE SIP unless otherwise noted in this document. All activities described are contingent on available appropriations.

PHEMC

Public Health Emergency Medical Countermeasures Enterprise

The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) coordinates Federal efforts to enhance chemical, biological, radiological and nuclear threats (CBRN) and emerging infectious diseases (EID) preparedness from a medical countermeasure (MCM) perspective. The PHEMCE is led by the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) and includes three primary HHS internal agency partners: the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), as well as several interagency partners: the Department of Defense (DoD), the U.S. Department of Veterans Affairs (VA), the Department of Homeland Security (DHS) and the U.S. Department of Agriculture (USDA).

	PHEMCE Strategy and Implementation Plans The HHS PHEMCE Strategy articulates the strategic direction and will guide policies and decisions for the end-to-end mission of the PHEMCE.  The HHS PHEMCE Implementation Plan identifies priorities across the PHEMCE mission areas.   Learn More >>
	​PHEMCE Multiyear Budget The multiyear budget highlights spending plans for the various HHS agencies within the PHEMCE and provides Congress and our external stakeholders with information on funds that have been invested in specific threat areas and future plans for investments in specific threat areas, based on availability of funds.​​ Learn More >>
	2010 PHEMCE Review The vision to combat emerging infectious diseases, pandemics, and bioterrorism is simple: our nation must have the nimble, flexible capability to produce MCMs rapidly in the face of any attack or threat, whether known or unknown, novel or reemerging, natural or intentional.    Learn More >>
	PHEMCE Mission Components The PHEMCE coordinates medical countermeasure-related efforts within HHS and in cooperation with PHEMCE interagency partners.  This is a complex mission space and many Federal agencies have responsibilities that are critical to its success.  Learn More >>
	PHEMCE Governance The PHEMCE evolved to address a wider array of challenges, including CBRN threats, pandemic influenza, and emerging infectious diseases.  Under this new paradigm, the PHEMCE is better positioned to address the range of cross-cutting activities that comprise the MCM development process. Learn More >>