Kilmer, Washington National Guard and Port Angeles Leaders Applaud FAA’s Decision to Fully Fund Vital Port Angeles Runway
Press release issued 12/ 8/ 17http://kilmer.house.gov/news/press-releases/kilmer-washington-national-guard-and-port-angeles-leaders-applaud-faas-decision-to-fully-fund-vital-port-angeles-runway-
PORT ANGELES, Wash.— After listening to the concerns of Representative Derek Kilmer (D-WA), the state’s emergency managers, and the Port of Port Angeles’s Commissioners, the Federal Aviation Administration has issued a final decision to continue funding to maintain the current runway at the William R. Fairchild International Airport. The FAA had previously considered reducing this funding, which would have left the Port with two bad options: either reduce the airport’s 5,000-foot runway to 3,850 feet, or pay the bill to maintain the other 1,150 feet using only local funds, a potentially prohibitively-expensive cost.
“In rural regions like ours, peace of mind comes by knowing that the government has the infrastructure to get help to us quickly in the event of a disaster. I applaud the FAA for doing the right thing and funding the full runway in Port Angeles,” Rep. Derek Kilmer said. “Keeping the runway fully-funded will not only give emergency responders a vital lifeline to our region in an emergency, but also drive economic growth that will sustain skilled jobs in our region.”
Port Angeles officials and Rep. Kilmer worked with leaders of the state’s emergency response community to explain to the FAA the unique importance of Fairchild’s runway for both medical emergencies and emergency response. The FAA considered reducing the runway length it was willing to fund using the Airport Improvement Program. The AIP funds the planning and development of public-use airports. According to the Washington Emergency Plan and Federal Emergency Management Agency, Fairchild International Airport is a piece of critical infrastructure vital to the government’s response to wildfires and earthquakes.
Port Commission President Colleen McAleer said: “The Port of Port Angeles appreciates the FAA’s decision and the efforts of Congressman Kilmer, who listened to the community and conveyed its concerns. Our airport is vital to the safety and well-being of all county residents and visitors, and we look forward to working with the FAA and Representative Kilmer to protect this important regional asset into the future.”
Major General Bret Daugherty, the Adjutant General and Commander of the Washington National Guard said: "During a Cascadia Subduction Zone event, the Fairchild Airport in Port Angeles will be a crucial asset. A five-thousand foot runway at Fairchild will enable large aircraft to bring life-saving supplies and sustainment to the Olympic Peninsula and the communities along the Strait of Juan de Fuca."
Penelope Linterman, an Emergency Management Program Coordinator with the Clallam County Sheriff’s Office said: “the FAA decision to maintain our present runway’s length at five thousand feet continues to allow large aircraft to land and takeoff here and will supply emergency essentials and personnel during a catastrophic disaster. This will save lives by improving the local response time during the event. It will also enable large aircraft traveling from the East or Midwest to land directly in Port Angeles without diverting to Central Washington or to an airport in the I-5 corridor. That deconflicts the airspace, saves time and allows direct evacuation of a limited number of critically wounded out of the area to receive prompt care.”
In addition to raising the issue with the FAA, Rep. Derek Kilmer drafted legislation to reform the Airport Improvement Program to explicitly direct the FAA to consider how downsizing runways would affect the emergency response plan in the region where the airport is located. Kilmer is continuing to pursue a policy remedy that would prevent other rural communities from facing the same hard choices Port Angeles was given, but still gives the FAA the flexibility to determine the most effective use of the Airport Improvement Program’s funding.
In the past, FAA officials have told other communities that runways shorter than 5,000 feet are not worth the federal government’s support, meaning Port Angeles could have seen diminished federal support for the airport over time if it couldn’t afford the repairs.
THIS WEEK'S big story
WTAS: Support For President Trump's Decision To Recognize Jerusalem As Israel's Capital
Press release issued by the White House 12/ 7/ 17https://www.whitehouse.gov/the-press-office/2017/12/07/wtas-support-president-trumps-decision-recognize-jerusalem-israels
ISRAELI OFFICIALS
Prime Minister of Israel Benjamin Netanyahu: “We’re profoundly grateful for the President for his courageous and just decision to recognize Jerusalem as the capital of Israel and to prepare for the opening of the US embassy here. This decision reflects the President’s commitment to an ancient but enduring truth, to fulfilling his promises and to advancing peace. The President’s decision is an important step towards peace, for there is no peace that doesn’t include Jerusalem as the capital of the State of Israel.”
President of Israel Reuven Rivlin: “Thank you @POTUS @realDonaldTrump. There is no more fitting or beautiful gift, as we approach 70 years of the State of Israel’s independence. Jerusalem is not, and never will be, an obstacle to peace for those who want peace.”
Israel’s Permanent Representative to the United Nations Danny Danon: “We welcome this courageous decision by President Trump. In 1948, President Truman was the first world leader to recognize the State of Israel and today President Trump righted a historic wrong by recognizing Jerusalem as our capital.”
U.S. OFFICIALS
Secretary of State Rex Tillerson: “President Trump‘s decision to recognize Jerusalem as Israel’s capital aligns U.S. presence with the reality that Jerusalem is home to Israel’s legislature, Supreme Court, President’s office, and Prime Minister‘s office. We have consulted with many friends, partners, and allies in advance of the President making his decision. We firmly believe there is an opportunity for a lasting peace.”
Speaker Of The House Paul Ryan (R-WI): “This is a day that is long overdue. Jerusalem has been, and always will be, the eternal, undivided capital of the State of Israel. The city’s status as the religious epicenter of Judaism is an historical fact—not a matter of debate. Today’s announcement is a recognition of reality that in no way inhibits efforts to reach a lasting peace between Israelis and Palestinians. I commend President Trump for taking this important action, and for exploring next steps to move the U.S. embassy from Tel Aviv to Jerusalem.”
House Majority Leader Kevin McCarthy (R-CA): “Today the President recognized a reality: Jerusalem is the capital of Israel. The House and Senate have on three separate occasions supported recognizing Jerusalem as Israel’s capital, including by enacting the Jerusalem Embassy Act in 1995 to move the United States embassy in Israel to Jerusalem. If acknowledging truth inspires violence, it is those who commit the violence, not the truth, that are at fault.”
House Majority Whip Steve Scalise (R-LA): “By recognizing Jerusalem as the capital of Israel, @POTUS has shown we’re willing to back up our allies.”
House Minority Whip Steny Hoyer (D-MD): “Jerusalem is the capital of the State of Israel, something that the United States Congress has reaffirmed and a fact of history that cannot be denied. Our country must play a constructive role in supporting Israel as it seeks the peace and security its people deserve by continuing to promote a two-state solution through direct, bilateral negotiations that will end any question of Jerusalem’s status.”
Senate Foreign Relations Committee Chairman Bob Corker (R-TN): “Today’s announcement recognizes what has been true for almost 70 years, namely that Jerusalem is Israel’s seat of government. On a bipartisan basis, Congress has repeatedly voted overwhelmingly to recognize Jerusalem as Israel’s capital, and I applaud the president’s initiative in making this a reality.”
House Foreign Affairs Committee Chairman Ed Royce (R-CA): “I welcome the administration’s decision to recognize Israel’s self-identified capital. Sovereign nations have a right to determine their seat of government, and our close ally Israel should not be treated differently. Relocating the U.S. Embassy should be done carefully, and in a way that advances our national security interests in a dangerous and unstable region.”
House Foreign Affairs Committee Ranking Member Eliot Engel (D-NY): “I support the decision to recognize Jerusalem as the eternal capital of Israel and to move the U.S. embassy there. This decision is long overdue and helps correct a decades-long indignity. It recognizes where Israel’s government—the parliament and the prime minister—is based, as well as the ancient and unbreakable connection between the Jewish people and Jerusalem. I look forward to a plan to ensure the safety and security of our embassy personnel.”
Sen. Marco Rubio (R-FL): “I commend President Trump for following U.S. law and recognizing Jerusalem as the eternal capital of the Jewish state of Israel…. Today’s announcement is an important step in right direction. Unequivocal recognition of Jerusalem as Israel’s capital will be complete when the U.S. embassy is officially relocated there.”
(see link source for more reactions from Congressional leaders)
UN REACTION: United Nations Position on Jerusalem Unchanged, Special Coordinator Stresses, as Security Council Debates United States Recognition of City
Press release issued 12/ 8/ 17https://www.un.org/press/en/2017/sc13111.doc.htm
Permanent Representative Defends Decision, as Delegations Endorse Two-State Solution, Determination of Final Status Issues
The abiding position of the United Nations on Jerusalem was that the city remained a final status issue to be determined through a comprehensive, just and lasting solution to be negotiated between the two sides concerned on the basis of relevant United Nations resolutions and other agreements, the Special Coordinator for the Middle East Peace Process told the Security Council today.
Special Coordinator Nickolay Mladenov was briefing Council members during a special meeting called in the wake of President Donald Trump’s 6 December announcement that the United States would recognize Jerusalem as the capital of Israel and move its embassy to that city from Tel Aviv. He reported that although the announcement had been widely welcomed in Israel, it had caused much anger among Palestinians and anxiety across the Middle East.
He expressed particular concern about the potential for an escalation of violence, noting that widespread demonstrations and clashes between Palestinian protestors and Israeli security forces had occurred throughout the West Bank and Gaza Strip since the decision. There had also been protests in Arab areas within Israel, and in cities around the region and beyond, he noted.
Urging all political, religious and community leaders to refrain from provocative actions and rhetoric, and instead engage in dialogue, he declared: “It is now more important than ever that we preserve the prospects for peace.” He cautioned that it was ordinary Israelis and Palestinians who would suffer from further violence, reiterating that the legitimate national aspirations of both sides could only be achieved through a negotiated two‑State solution.
The Permanent Observer for the State of Palestine denounced the decision, saying the United States had essentially disqualified itself from its leadership role in the quest for Middle East peace. He underlined Jerusalem’s great significance for the Palestinian people, describing the city’s status as a priority and a “red line” for them. There could be no just and lasting solution to the question of Palestine without a just solution to the question of Jerusalem, he reiterated. Pointing out that no country had ever recognized Israel’s sovereignty over Jerusalem, he said the city’s status remained unresolved and was a final status issue in the Middle East peace process. Actions contravening Council resolutions lacked legal effect and could not change the applicability of international law to the situation, he said. One side could not continue to monopolize the peace process, especially one that acted in biased favour of the occupying Power at the expense of the law and the rights of the occupied people.
Israel’s representative, on the other hand, applauded the courage and sound moral judgment of the United States in righting historical wrongs and recognizing Jerusalem as Israel’s capital. From the moment of the country’s founding, the Government had vowed to create a State that would honour a democracy that respected and valued the traditions of all peoples, he said. Wednesday’s announcement had revealed a sad truth about people who threatened to ignite violence against Israel and Jews everywhere, he added, emphasizing that such people may claim to want peace, but their actions spoke louder than words. The Palestinians could choose violence, as they had always done, or they could join Israel at the negotiating table, with respect and an eye to the future, he said.
Egypt’s representative recalled the legal parameters in place concerning Jerusalem, emphasizing that following international law was the only way to address the issue. Invoking binding Security Council resolutions relating to Jerusalem’s status, he recalled that they requested that States differentiate Israel’s territory from territories occupied in 1967, including Jerusalem. In light of that city’s spiritual and historic significance for Muslims, Egypt was seriously concerned about the potential repercussions of the decision by the United States for regional stability, he said.
The United Kingdom’s representative said his delegation disagreed with the decision, and affirmed that Jerusalem’s status should not be determined before a final status agreement had been reached. He expressed deep concern about developments on the ground, including the expansion of settlements, and particularly in East Jerusalem, saying they constituted a barrier to a lasting solution, alongside terrorism and incitement.
Defending her country’s decision, the representative of the United States reminded Council members that the United States had not taken a position on boundaries or borders, saying questions would be decided by Israel and the Palestinians. Emphasizing Israel’s right to determine its own capital city, she said it was simple common sense to locate foreign embassies there, noting that United States embassies around the world were hosted in capital cities, and Israel should be no different. The United States would not be lectured by countries that had not treated both sides fairly, she stressed, affirming that her country enjoyed credibility with both Israel and the Palestinians. Israel should not be bullied into an agreement by the United States or any other country, she added.
The Russian Federation’s representative stressed, however, that as a member of the Quartet for Middle East Peace, his country supported the active involvement of regional players, particularly Egypt and Jordan. Moreover, the Russian Federation could hold a summit between the Palestinian and Israeli leaders, he said, adding that Moscow was still awaiting the long‑promised proposal from the United States in that regard. It was as important as ever to relaunch a sensible peace process based on a two‑State solution, he said, adding that the Quartet remained unique as a mediation mechanism.
Senegal’s representative urged strict respect for the status quo in Jerusalem, in accordance with internationally established parameters. For Senegal, the question of Jerusalem should depend on the determination of final status issues. He called for peace at sacred sites, describing the violence around them as an unfortunate result of the decision by the United States. Senegal called for a return to the spirit of sharing that had prevailed 70 years ago, amid prospects for the creation of two States, Israel and Palestine, he said.
WORD FROM OUR GOVERNOR Jay Inslee
Inslee awards $6 million to create apprenticeship and career connections for 29,000 youth in 11 communities--from the Governor's blog page, dated 12/ 8/ 17
https://medium.com/wagovernor/inslee-awards-6-4-129c4de96df3Job shadowing, internships and apprenticeships are just a few of the career connections that will become available to 29,000 students thanks to $6.4 million in new Career Connect Washington grant funding.
The awardees expect to create 29,000 new career connected learning experiences in 11 communities from now through September 2019. These include STEM (science, technology, engineering and math) learning experiences, job shadows at local employers, career planning, and over 4,800 new internships, pre-apprenticeships, and registered apprenticeships.
“A four-year degree isn’t the only path to a fulfilling career,” Gov. Jay Inslee said. “Business leaders have told us they are looking for talent in everything from information technology to health care. And that’s what this initiative is all about: connecting students to great employers and high-quality job training.”
The initiative expands registered apprenticeship programs and puts a new focus on youth registered apprenticeships. The awardees expect to move over 1,400 young people, plus more than 400 adults, into new apprenticeships and pre-apprenticeships in fields such as advanced manufacturing, health care, agricultural irrigation systems, building trades, IT and maritime manufacturing.
“This is the most critical commitment to apprenticeships for young people and adults the state has made in almost a decade, and we hope to see more in the future,” said Lynn Strickland, Executive Director of the Aerospace Joint Apprenticeship Committee (AJAC).
Local workforce development councils and STEM networks led local application teams, which brought businesses together with schools, apprenticeships, community and technical colleges, and local youth organizations to connect youth with local employers.
The grants support the Career Connect Washington initiative Inslee launched May 31 at the Governor’s Summit on Career Connected Learning, which attracted more than 1,200 participants from 27 sites around the state. The initiative’s goal is to connect 100,000 students during the next five years with employer internships, registered apprenticeships, and other career connected learning to prepare them for high-demand jobs.
“It’s all about jobs, and Career Connect Washington means thousands of young people getting good jobs, living rewarding lives, and not going through the difficulties of unemployment,” said Tim Probst, Director of Workforce Initiatives for the Washington State Employment Security Department.
Inslee’s Career Connect Washington Task Force includes representation from employers, labor, and the public sector. It is co-chaired by Brad Smith, president of Microsoft, and Perry England, chair of the Workforce Board and a vice president at MacDonald-Miller Facility Solutions. Several task force members were part of Inslee’s recent apprenticeship study mission to Switzerland.
“Washington is committed to expanding career connected learning and youth registered apprenticeships. These opportunities change lives for young people and make our economy grow,” England said. “The Career Connect Washington proposals showed a commitment to these goals and a level of local partnership that is unprecedented in this state.”
The $6.4 million is federal money made available through the Workforce Innovation and Opportunity Act. It is the second investment in Career Connect Washington, following a $1 million investment by JP Morgan Chase in May.
Representatives from business, labor, apprenticeship programs, the Office of the Governor, the Office of Superintendent of Public Instruction, the Employment Security Department, Washington STEM, the Department of Labor and Industries, the Washington State Board for Community and Technical Colleges, and the state Workforce Training & Education Coordinating Board developed the grant criteria and made recommendations on funding to the governor.
The Office of the Governor awarded the grants as follows:
$1.3 million to Career Connect Seattle-King County
Career Connect Seattle-King County focuses on providing relevant experiences across the continuum of career awareness, exploration, preparation and training for all youth, with an emphasis on underrepresented populations. The proposal partners with Highline and Seattle Public Schools, along with Open Doors sites, while engaging business and expanding apprenticeship pathways for youth and adults across the aerospace, culinary, allied health and construction sectors.
$957,255 to Career Connect Northwest (Island, San Juan, Skagit and Whatcom counties)
Career Connect Northwest will deliver sequenced career learning experiences and expanded apprenticeship opportunities to nearly 900 young adults, including mentorship opportunities, informational interviews, job shadows and structured work based activity. The project will expand existing career connected learning programs such as the Washington Apprenticeship Vocation Training Tour. The project will expand five existing apprenticeships while creating two new apprenticeship programs, resulting in 45 new apprenticeship opportunities annually.
$854,547 to Career Connect North Central (Adams, Chelan, Douglas, Grant and Okanogan counties)
Career Connect North Central addresses the challenges of a large rural region by creating career connect teams in the region’s three labor market subareas of health care, manufacturing and computer science. Using lessons learned from the Wenatchee Learns Connect initiative, which has garnered statewide acclaim, the Workforce Development Council, Apple STEM Network, business champions, local employers, partner agencies, school districts and post-secondary institutions will create high-quality career connected learning experiences for youth and new apprenticeship opportunities.
$852,910 to Career Connect Tacoma-Pierce County
Career Connect Tacoma-Pierce County will collaborate with WorkForce Central, Bates and Clover Park Technical Colleges, sheet metal and carpenters labor organizations, AJAC, Associated General Contractors Educational Foundation, the Construction Center of Excellence, ResCare Workforce Services, and the Tacoma STEAM Network (science, technology, engineering, art and math). The group will provide youth and young adults with a multitude of experiences that include career connected learning opportunities, sector training in growth occupations, and apprenticeships. The project focuses on creating new registered apprenticeship programs as well as expanding youth and young adult enrollment into existing apprenticeship and pre-apprenticeship programs.
$831,984 to Career Connect South Central (Kittitas, Klickitat, Skamania and Yakima counties)
Career Connect South Central partners with STEM champions from local business and industry, education, government, apprenticeship-sponsoring organizations, and community organizations to provide equitable access to high-quality career connected learning experiences to rural and underserved youth. Through internships, expanded and newly developed apprenticeship programs, job shadows, career exploration events, networking opportunities and the development of interest-driven career plans, participating youth will seamlessly enter high-demand STEM jobs in Washington.
$740,000 to Career Connect Southwest (Clark, Cowlitz and Wahkiakum counties)
This grant will activate the region’s rich expertise in career connected learning by continuing work done through YouthWorks to dramatically increase internships and work-based learning opportunities for youth. These strong partnerships will continue to build long-lasting registered apprenticeships in the high-growth and in-demand field of health care through partnerships with Peace Health, Rebound Orthopedics, Kaiser Permanente and Great Rivers Behavioral Health. Career Connect Southwest will expand the AJAC registered apprenticeship program in rural Cowlitz County through partnerships with Lower Columbia College and Millennium Bulk Terminals.
$263,303 to Career Connect Eastern Washington (Asotin, Columbia, Ferry, Franklin, Garfield, Lincoln, Pend Oreille, Stevens and Walla Walla counties)
Career Connect Eastern Washington will provide students in Ferry, Pend Oreille and Stevens counties with 90-hour internships in natural resources, including in forestry and water and soil conservation. Students matched with a mentor will develop and conduct FieldSTEM investigations, present their career plan and project to various community groups, and then lead additional youth FieldSTEM investigations. This regional will work with employers to convert forest products internships into registered apprenticeships — youth or adult — and will work with additional partners to convert existing apprenticeships into youth registered apprenticeships.
$150,000 each to Career Connect Olympic Peninsula (Clallam, Jefferson and Kitsap counties), Career Connect Pacific Mountain (Grays Harbor, Lewis, Mason, Pacific and Thurston counties), Career Connect Snohomish County, and Career Connect Spokane County
These regional teams will continue to refine their local design with a strong focus on identifying employers willing to expand or launch registered apprenticeships for youth and adults, internships and pre-application slots.
Editorial note: The Governor apparently had no comment about the US Embassy moving to Jerusalem either from what I seen from his webpage, and he's thinking about running for president?
(page 2)
OUR HEALTH & FITNESS DIGEST
FDA Commissioner Gottlieb provides testimony before the U.S. Senate HELP Committee on the agency’s implementation of the 21st Century Cures Act
Press release issued 12/ 7/ 17https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm588046.htm
Chairman Alexander, Ranking Member Murray, and members of the committee, thank you for the invitation to testify at this hearing to discuss the implementation of the 21st Century Cures Act.
“Cures” set FDA on a transformative path. It set out to optimize our investments in science by modernizing how FDA oversees breakthrough technologies. You asked us to advance innovations more efficiently, while maintaining our gold standard for protecting patients.
This focus on innovation couldn’t come at a better time. Across multiple fields of science, we stand at an inflection point in medicine – where new technology is creating foundational opportunities to treat and cure disease in ways that weren’t possible just a short time ago.
Take, for example, our recent experience with gene therapy.
We’ve seen two recent approvals of CAR-T therapies for cancer, where a patient’s own immune cells are re-engineered – using the tools of gene therapy – to target a patient’s individual cancer. This form of gene therapy represents a whole new paradigm in treating cancer. And the early results are changing the way we treat serious tumors.
This experience shows how a single, fundamental breakthrough in science can open up a whole new way of combatting disease.
In gene therapy, that breakthrough has been the development of vehicles that can deliver genes more efficiently to their target inside the body. These often are referred to as vectors. And they’ve taken the form of viruses that are specially engineered for this purpose.
In particular, the advent of a specific kind of largely inert adeno-associated virus – or “AAV” vector – was an inflection point in this field.
I liken the advent of AAV vectors to the development of processes for developing antibody drugs and making these medicines nearly identical to the fully human cells that they were mimicking.
Monoclonal antibodies represented a promising field of potentially breakthrough medicines in the 1990s. But for a long time, these therapeutic drugs fell short of their promise.
That was because these drugs were made with antibodies from mice, and the antibody drugs themselves were soon rejected by patients’ immune systems. Then came the science for humanizing these antibodies, so they’d more fully mimic their normal human counterparts. And pretty soon, we saw many breakthrough drugs result. A whole new field of medicine grew up very fast.
I believe we’re at a similar turning point when it comes to gene therapy. Over the next several years, we’ll see this approach become a mainstay of treating, and probably curing, a lot of our most devastating and intractable illness. At FDA, we’re focused right now on establishing the right policy framework to capitalize on this scientific opening.
Researchers at MIT recently estimated that about 40 gene therapies might win FDA approval by the end of 2022 from a current pipeline of 932 development candidates. They estimate that 45 percent of the total gene therapy drugs are expected to target cancer.
I can’t affirm their assessment. But I can confirm that we’re at the early stages of a transformation in medical treatment as a consequence of this new technology. And the benefits are likely to accelerate quickly.
The advance of this field is not risk-free. Yet it’s a good example of how FDA’s embrace of the Cures Act – and our efforts to build on what Congress set out to do in balancing safety with scientific promise – is expanding our ability to capitalize on breakthrough innovation.
In this case, Cures provided a pathway for certain regenerative medicine products to receive expedited review by FDA through the RMAT designation. We extended that opportunity.
FDA has considered CAR-T products to be a form of gene therapy, since the key therapeutic manipulation that’s made to the cells is through a gene product delivered by a vector.
In FDA’s new draft guidance on “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, FDA clarified that regenerative medicine therapies would include gene therapies that lead to a durable modification of cells or tissues – including genetically modified cells. This would include CAR-T products, when these gene therapy products lead to a durable modification of cells or tissues and therefore deliver a sustainable effect in the body.
For example, if a gene therapy alters tissue to allow the body to express a certain therapeutic protein, or if CAR-T cells have resiliency and maintain a presence that delivers a sustainable therapeutic effect, we would consider them to be regenerative medicine therapies.
By FDA taking these science-based decisions, it means that gene therapies – including CAR-T – may be eligible for the RMAT designation.
Next year, we’ll be building on these opportunities. We’ll begin issuing a suite of disease-specific guidance documents on the development of specific gene therapy products.
We intend to lay out modern and more efficient parameters – including new clinical measures – for the evaluation and approval review of gene therapy for different high-priority diseases where the platform is being targeted. We plan to focus the first guidance document on the use of gene therapy in hemophilia.
Other documents will address clinical areas where there’s a lot of interest in using these techniques, such as certain more common single gene disorders. We’ll provide innovators with advice on development pathways, including potential accelerated approval endpoints.
Gene therapy is just one opportunity transforming medicine. This year FDA may be on track to approve the highest or second highest number of novel medicines across our combined biologics and drug centers in FDA’s entire history. We’ll also approve the highest number of generic medicines ever. And we’re on pace to approve the highest number of novel medical devices in our modern history.
All this year. All at one moment in time.
This progress is a reflection of scientific opportunity.
It’s also a reflection of sound policy – advanced by Congress – that gave FDA key resources and authorities at the very moment that those new policies lined up with a turning point in science.
The result is measured in these product approvals, and in the impact of some highly novel medicines like the new gene therapies.
Ultimately, this progress will be measured in its human impact. We witnessed an inflection point in the survivability of cancers after the advent of a lot of new therapies in the late 1990s and early 2000s. The most significant were the antibody drugs. I predict we’ll see a similar turning point in how we cope with illness as we consolidate the latest wave of advances into new ways of combatting disease.
Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation
Press release issued 12/ 7/ 17https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587890.htm
Today we’re announcing three new, significant policy documents to advance the FDA’s approach to the development and proper oversight of innovative digital health tools. We know that consumers and health care providers are increasingly embracing digital health technologies to inform everyday decisions. From fitness trackers to mobile applications tracking insulin administration, these digital tools can provide consumers with a wealth of valuable health information. Further, clinical evidence demonstrates that consumers who are better informed about health make better and more efficient decisions, take steps to improve their lifestyles and their health choices, and often experience better outcomes.
Given these meaningful benefits from empowering consumers, we believe the FDA must, whenever possible, encourage the development of tools that can help people be more informed about their health. And we recognize that our regulations play a crucial role in the efficient development of such technologies. Therefore, our approach to regulating these novel, swiftly evolving products must foster, not inhibit, innovation. Moreover, we must always lean in the direction of enhancing access to more information – not restricting information flow – given the ability of reliable information to positively impact daily life.
Over the last five years, the FDA has made great strides in adapting our policies to better align our regulatory approach to the iterative nature of digital health products. We’re finding that in some parts of our regulatory portfolio, our traditional approach to overseeing certain health care products does not easily fit the types of innovations that are being developed. In these cases, we must adapt and evolve our policies to make sure we continue to provide a gold standard for oversight, while enabling advancement of beneficial innovations and greater consumer access to technologies that can improve their health.
To this aim, this past summer, we issued the Digital Health Innovation Action Plan, which outlines our efforts to reimagine the FDA’s approach to ensuring all Americans have timely access to high-quality, safe and effective digital health products. As part of this plan, we committed to several key goals, including increasing the number and expertise of digital health staff at the FDA, launching the digital health software precertification pilot program (“Pre-Cert”) and issuing guidance to modernize our policies.
As we come to the end of 2017, I’m proud of the significant progress the FDA’s digital health team has made on the Action Plan. We launched the Pre-Cert pilot and selected nine diverse companies to participate. We also have invested in hiring additional talent for our digital health team, including announcing the Entrepreneurs in Residence program. Yet, we recognize there’s more work to do.
Today, we’re announcing three new guidances – two draft and one final – that address, in part, important provisions of the 21st Century Cures Act (“Cures Act”), that offer additional clarity about where the FDA sees its role in digital health, and importantly, where we don’t see a need for FDA involvement. We’ve taken the instructions Congress gave us under the Cures Act and are building on these provisions to make sure that we’re adopting the full spirit of the goals we were entrusted with by Congress.
The first draft guidance, “Clinical and Patient Decision Support Software,” outlines our approach to clinical decision support software (CDS). CDS has many uses, including helping providers, and ultimately patients, identify the most appropriate treatment plan for their disease or condition. For example, such software can include programs that compare patient-specific signs, symptoms or results with available clinical guidelines to recommend diagnostic tests, investigations or therapy. This type of technology has the potential to enable providers and patients to fully leverage digital tools to improve decision making. We want to encourage developers to create, adapt and expand the functionalities of their software to aid providers in diagnosing and treating old and new medical maladies.
This draft guidance is intended to make clear what types of CDS would no longer be defined as a medical device, and thus would not be regulated by the agency. For example, generally, CDS that allows for the provider to independently review the basis for the recommendations are excluded from the FDA’s regulation. This type of CDS can include software that suggests a provider order liver function tests before starting statin medication, consistent with clinical guidelines and approved drug labeling.
However, the FDA will continue to enforce oversight of software programs that are intended to process or analyze medical images, signals from in vitro diagnostic devices or patterns acquired from a processor like an electrocardiogram that use analytical functionalities to make treatment recommendations, as these remain medical devices under the Cures Act. For example, we would continue to oversee software that analyzes data from a patient’s spinal fluid test to diagnose tuberculosis meningitis or viral meningitis. These are areas in which the information provided in the clinical decision software, if not accurate, has the potential for significant patient harm, and the FDA plays an important role in ensuring the safety and effectiveness of these products.
Similarly, the CDS draft guidance also proposes to not enforce regulatory requirements for lower-risk decision support software that’s intended to be used by patients or caregivers -- known as patient decision support software (PDS) -- when such software allows a patient or a caregiver to independently review the basis of the treatment recommendation. Although PDS was not part of the Cures Act, the FDA believes that PDS should follow a similar regulatory structure as CDS. An example of lower-risk PDS products could include software that reminds a patient how or when to take a prescribed drug, consistent with the drug’s labeling. PDS software that does not clearly allow independent review of the recommendation by the patient or a caregiver would continue to be subject to the FDA’s active oversight. This might include a warfarin monitoring device that makes recommendations for dosing based on the outcome of a home blood test.
We believe our proposals for regulating CDS and PDS not only fulfill the provisions of the Cures Act, but also strike the right balance between ensuring patient safety and promoting innovation.
The second draft guidance being issued today, “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act,” addresses other digital health provisions included in the Cures Act. Specifically, this second guidance outlines the FDA’s interpretation of the types of software that are no longer considered medical devices. We’re making clear that certain digital health technologies – such as mobile apps that are intended only for maintaining or encouraging a healthy lifestyle – generally fall outside the scope of the FDA’s regulation. Such technologies tend to pose a low risk to patients, but can provide great value to consumers and the healthcare system.
Through this draft guidance, we’re proposing changes to previously published agency guidance documents, including: General Wellness and Mobile Medical Applications, among others, to be consistent with the Cures Act and reflective of the agency’s new, more modern approach to digital health products. The proposed changes include updating the categories of products for which, prior to the Cures Act, the FDA already intended to exercise enforcement discretion owing to their very low risk and potential benefits to patients from greater innovation. Now, to create an even clearer distinction, consistent with the Cures Act, we’re saying that many of these products no longer qualify as medical devices that would be subject to the FDA’s oversight.
In addition to taking steps to clarify the FDA’s position on digital health, we’re also working with our global counterparts to harmonize and streamline the regulation of digital health products internationally.
Innovations in digital health remind us that we live in an interconnected world – one that reaches across borders and joins us in new and unique ways. That’s why in recent years, we’ve worked closely with regulatory authorities across the globe through the International Medical Device Regulators Forumdisclaimer icon (IMDRF) to evaluate requirements in individual countries, and harmonize our regulatory approaches to digital health medical devices, where possible. Many of our global counterparts are represented, including Australia, Brazil, Canada, China, the European Union, Japan, Russia and Singapore.
As part of our package of policies being announced today, the FDA also is issuing a final guidance, “Software as a Medical Device: Clinical Evaluation,” in fulfillment of these international harmonization efforts. This guidance was initially issued in draft in October 2016 and informed by global and domestic comments. Today’s final guidance expands on that draft. It establishes common principles for regulators to use in evaluating the safety, effectiveness and performance of Software as a Medical Device (SaMD). This final guidance provides globally recognized principles for analyzing and assessing SaMD, based on the overall risk of the product. The agency’s adoption of these principles provides us with an initial framework when further developing our own specific regulatory approaches and expectations for regulatory oversight, and is another important piece in our overarching policy framework for digital health.
In sum, these three important guidance documents being issued today will continue to expand our efforts to encourage innovation in the ever-changing field of digital health. Our aim is to provide more clarity on and innovative changes to our risk-based approach to digital health products so that innovators know where they stand relative to the FDA’s regulatory framework. Our interpretation of the Cures Act is creating a bright line to define those areas where we do not require premarket review. And we’re providing more detail on those technologies and applications that would no longer be classified as a medical device subject to FDA regulation. This will allow us to focus our efforts on the highest-risk products. Finally, we’re issuing new details on the common principles we and our international partners will use for evaluating the safety and effectiveness of SaMD. Through this comprehensive approach, we can deliver on our commitment of promoting beneficial innovation in this space while providing proper oversight where it’s merited.
We’ll be taking other steps to implement our Digital Health Innovation Action Plan. We’re hosting a Pre-Cert Pilot Program workshop on January 30-31, 2018 to update FDA staff, participants and stakeholders on the lessons learned from the pilot. Later in the year, we’ll share the pilot’s proof of concept and outline next steps for establishing a Pre-Certification Program. We look forward to working with patients, providers, technology developers and other customers in helping Americans access safe and innovative digital health products.
(Page 3)
Screening for Critical Congenital Heart Disease at Birth Saves Lives
CDC press release issued 12/ 5/ 17https://www.cdc.gov/media/releases/2017/p1205-screening-congenital-heart-disease.html
Infant deaths from critical congenital heart disease (CCHD) decreased more than 33 percent in eight states that mandated screening for CCHD using a test called pulse oximetry. In addition, deaths from other or unspecified cardiac causes decreased by 21 percent.
Pulse oximetry is a simple bedside test to determine the amount of oxygen in a baby’s blood and the baby’s pulse rate. Low levels of oxygen in the blood can be a sign of a CCHD.
CCHD screening nationwide could save at least 120 babies each year, according to a new study published in the Journal of the American Medical Association. This study is the first look at the impact of state policies to either require or recommend screening of infants for CCHD at birth.
The study, Association of U.S. State Implementation of Newborn Screening Policies for Critical Congenital Heart Disease With Infant Cardiac Deaths, shows that states that required their hospitals to screen newborns with pulse oximetry saw the most significant decrease in infant deaths compared with states without screening policies. Voluntary policies or mandated policies not yet implemented were not associated with reductions in infant death rates. The encouraging news is that 47 states and D.C. now have mandatory screening policies in place and one additional state, California, requires screening be offered. These results serve as a reminder to hospitals across the country to remain vigilant in their screening for CCHD.
“More families are able to celebrate special milestones in a child’s life thanks to the early identification and treatment of heart defects,” said CDC Director Brenda Fitzgerald, M.D. “Screening newborns for critical congenital heart disease in every state, tribe, and territory will save lives and help babies thrive.”
About 1 in every 4 babies born with a congenital heart defect has CCHD and will need surgery or other procedures in the first year of life. In the U.S., about 7,200 babies born each year have one of seven CCHDs. Without screening by a pulse oximetry reading, some babies born with a congenital heart defect can appear healthy at first and be sent home with their families before their heart defect is detected.
CDC works to identify causes of congenital heart defects, find opportunities to prevent them, and improve the health of people living with these conditions.
AT THE STATE LEVEL
DOH: Thurston Co. pharmacy tech suspended for diverting patient meds and making errors while compounding medications
Press release issued 12/ 5/ 17https://www.doh.wa.gov/Newsroom/2017NewsReleases/17168GregoryBriannePTechSuspensionNR
OLYMPIA -- The Pharmacy Commission immediately suspended the pharmacy technician credential of Brianne K. Gregory (VA.60174629) pending further legal action.
The charges state that in May 2017, Gregory diverted and consumed a morphine tablet from a patient’s medication supply, came to work after drinking alcohol and made several errors while compounding medications. Gregory also admitted to regularly drinking 3 to 4 shots of alcohol in the mornings before going to work in the evening.
Gregory has 20 days to request a hearing to contest the charges and the suspension. She cannot practice as a pharmacy technician in Washington until these charges are resolved.
The legal documents on this case can be seen online by clicking the link on Provider Credential Search on the Department of Health website; copies can be requested by calling 360-236-4700. Anyone who believes a health care provider acted unprofessionally is encouraged to call that number to report their complaint.
The Department of Health and Pharmacy Quality Assurance Commission protect and promote public health, safety, and welfare in Washington by regulating the competency and quality of health care providers. The agency establishes, monitors, and enforces qualifications for licensing, consistent standards of practice, continuing competency mechanisms, and discipline. Rules, policies, and procedures promote the delivery of quality health care to people in Washington.
( page 4) OUR SCHOOL'S REPORT CARD
Department Issues New Q&A on Free Appropriate Public Education following Supreme Court Decision
Press release issued 12/ 7/ 17https://www.ed.gov/news/press-releases/department-issues-new-qa-free-appropriate-public-education-following-supreme-court-decision
Washington — The U.S. Department of Education today released a question-and-answer document supporting the unanimous March 2017 U.S. Supreme Court opinion on the Individuals with Disabilities Education Act (IDEA)-related case Endrew F. v. Douglas County School District clarifying the scope of a free appropriate public education (FAPE).
"The Supreme Court sent a strong and unanimous message: all children must be given an opportunity to make real progress in their learning environment—they cannot simply be passed along from year to year without meaningful improvement," said U.S. Secretary of Education Betsy DeVos. "For too long, too many students offered IEPs were denied that chance. I firmly believe all children, especially those with disabilities, must be provided the support needed to empower them to grow and achieve ambitious goals."
The Department issued the Q&A document to provide parents, educators and other stakeholders information on the issues addressed in Endrew F. and the impact of the Court's decision.
The Q&A explains the case and provides a summary of the Court's final decision and prior case law addressing the FAPE standard. The document also explains how FAPE is currently defined, clarifies the standard for determining FAPE and addresses how this ruling can support children with disabilities.
US DEPT. of EDUCATION BLOG: Very Special Student Artists Display Vision, Imagination in VSA Exhibit at U.S. Department of Education
Posted on 12/ 5/ 17https://blog.ed.gov/2017/12/special-student-artists-display-vision-imagination-vsa-art-exhibit-u-s-department-education/
Seventeen-year-old Keevon Howard has mastered one cardinal rule laid down by his high school art teacher, one that resonates beyond the classroom. “Don’t erase,” his teacher counselled — accept the mistake and weave it into your composition. Coping is a vital life skill, she said, so whatever you put on the paper, that’s what you deal with.
Keevon was at the U.S. Department of Education (ED) headquarters in Washington, D.C., for the opening of the 13th annual VSA exhibit, a joint project of ED and the Department of VSA and Accessibility at the Kennedy Center. His collage is on display at ED through December, along with the works of other students with disabilities from five countries. The opening, and the panel discussion, “Changing Lives Through Arts Education,” drew artists and their families, ED staff, representatives from VSA and the Kennedy Center, and arts educators and advocates.
“You can express yourself better with art than with words,” the Rhode Island teen said. In his collage, light and dark scraps of newsletter are crowded around the heads of a nuzzling mother and child. “The dark surroundings symbolize all of the problems in the world,” he explained.
Amid the chaos, however, the mother and child, illuminated by yellow paint, remain connected. Keevon’s mother, Kinya Howard, said her son has behavioral issues and created his artwork during a time when the two often clashed. Struggles notwithstanding, Keevon’s bond with his mother has blossomed.
The exhibit is titled “Ubuntu: Yo Soy … Je Suis … I Am … Because You Are.” A South African concept, “Ubuntu” colloquially translates to “my humanity is connected to yours.” Like Keevon’s work of art, all of the pieces in the show explore this relationship among humans via a variety of visions and of mediums.
During the panel discussion, the hopes and goals of the student artists and people close to them came through forcefully: to develop a voice, to connect and to communicate.
“The world can be very hard and very harsh on those who are different from the mainstream,” said Jeannine Chartier, executive and artistic director of VSA Arts Rhode Island. Chartier has a personal link to her vocation; the limp with which she walks is the result of childhood polio.
Another panel member, 25-year-old Mara Clawson, a 2016–17 winner of a VSA Kennedy Center Emerging Artists with Disabilities award, has a neurogenetic disorder, as well as developmental delays. “Her first language was sign language, and we didn’t know if we’d get beyond ‘I want more,’” Mara’s mother, Michelle Marks, explained. When Mara was about 11, however, a teacher placed newsprint and pastels in front of her, “and the world came out in an amazing conversation of stories about eggs falling out of nests and bowling pins flying,” Marks added. “We had no idea that this was inside of her.”
The artistic capacities of special education students are often underestimated, according to panel member Carmen Jenkins-Frazier, a D.C. arts teacher at the School Without Walls at Francis-Stevens. “If you have patience and your children are able to trust and understand that you are there for them, and they feel secure in your space — then anything is possible in that classroom.”
The panel moderator was Mario Rossero, senior vice president of education at the Kennedy Center. From his experience in this role and as a former arts teacher, Rossero offered these thoughts: “When students create artwork it plays a critical role in their learning, growth, development, and ability to make connections; they are often able to communicate complex ideas that would be difficult to say through other means.”
Kimberly Richey, ED’s acting assistant secretary for special education and rehabilitation services, said, “Our partnership with VSA allows us to say to all of our employees and all of our visitors every day that arts education develops knowledge for all people, no matter their differences — cultural, geographic, abilities, age, gender — and that we each have a lot to learn from the artists, not least of which is about having the courage to be creative in our life’s work.”
Following the panel discussion and the ribbon-cutting ceremony by the students, attendees reflected on what they had learned at the opening.
“I liked the focus on artists with disabilities,” Kali Wasenko, an external engagement specialist at the D.C. Commission on Arts and Humanities, remarked. Beyond demonstrating the importance of art as therapy, she added, “the exhibit is very validating of their talents as artists.”
NEWS STORY COMMENTARY
Article from PJ MEDIA: President Trump Slams Clinton, Bush, Obama — and Explains Jerusalem Move — in One Tweet
https://pjmedia.com/video/president-trump-slams-clinton-bush-obama-and-explains-jerusalem-move-in-one-tweet/
Quote: " On Friday morning, President Donald Trump explained his Jerusalem announcement in one fiery tweet that mocked former presidents Bill Clinton, George W. Bush, and Barack Obama for not keeping their promises on the issue.
"I fulfilled my campaign promise — others didn't," the president tweeted, along with a video montage.
The video shows Clinton, Bush, and Obama — as candidates — promising to recognize Jerusalem as the formal capital city of Israel. Each of those presidents broke that promise, Trump's tweet suggested.
Israel took control of the entire city of Jerusalem in the 1967 Six Day War. The country had formally declared the city its capital in 1949, but no foreign nation has opened an embassy there."
Editorial Comment: Without a doubt the lead headline story this week was about President Trump making the decision to move the American Embassy to Jerusalem. It makes sense to make the move since Jerusalem has been the jewish state capital since its rebirth in 1949. Much of their governmental agencies are there. Trump was correct in saying each nation as the right to choose their capital, why not Israel? It's like saying some foreign government saying we can't call Washington D.C our nation's capital. Secondly, if America chooses to move it embassy there, that's our choice. Thirdly, other presidents had the opportunity to do the samething but, didn't have the backbone to do it, and if you read all the statements from the congressional delegations you'll note the majority of applaud the move was from Republicans! I thought the democrats were on the side of Israel! So much for that. Of course the Arab nations are going to go nuts about this, that's nothing new, they been at the throats of Israel since the days when they first became a nation some 4,000 years ago. I also noted as of yet, no reaction from any of our congressional delegation , about US embassy moving to Jerusalem. Their silence speaks volumes.
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WEEKLY BIBLE STUDY
Can You Be Saved Outside the Church?
Can a person be saved without being a member of the church? It depends on what you mean by "the church." Surely a person can be saved outside the many man-made denominations. In fact, people in the Bible were always saved outside denominations, simply because denominations did not exist in the Bible! All denominations are human in origin and exist by human authority (read Matthew 15:9).---GOSPEL WAY
https://www.gospelway.com/topics/church/saved_outside_church.art.php
Is Your Priesthood Acceptable to God?
Who should serve as priests today? The Jews in the Old Testament had a special class of men who offered animal sacrifices and performed other rites of worship on behalf of the people. These men served as mediators or representatives through whom the people worshiped God. What about today? Should we have a special class of priests who perform ceremonial rites that the people in general cannot perform?---Gospel Way
https://www.gospelway.com/topics/church/priesthood.php
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