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The FDA said on Tuesday it has developed guidelines to take plasma from coronavirus survivors to treat patients who are critically ill from the virus. The FDA said on Tuesday that It is possible that convalescent plasma contains antibodies to the coronavirus and might be effective against the infection. The FDA said that although the announcement is promising, convalescent plasma has not been shown to be effective in every disease studied. The FDA is not approving using plasma as a treatment, instead using it as a clinical trial and for the treatment of those who are critically ill. "Given the public health emergency that the expanding COVID-19 outbreak presents, while clinical trials are being conducted, FDA is facilitating access to COVID-19 convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections," the FDA said. The plasma will be collected from recovered individuals only if they are eligible to donate blood. The FDA said on Sunday that it was altering its guidelines on Risk Evaluation and Mitigation Strategy (REMS)-required testing, which allows healthcare providers to weigh the benefits of an experimental drug over its risks.“The FDA recognizes that during the COVID-19 public health emergency, the completion of some REMS-required laboratory testing or imaging studies may be difficult because patients suspected of having COVID-19 may be self-isolating and/or subject to quarantine,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “Under these circumstances, undergoing testing or imaging studies in order to obtain a drug that is subject to a REMS can put patients and others at risk for transmission of the coronavirus. We will continue to work with sponsors to ensure that patients have appropriate access to the medications they need.” 1843
The federal agency that oversees the financial condition of U.S. banks says it will offer voluntary early retirement to about 20% of its 5,800 employees.Agency officials say the early retirements could create a more highly skilled workforce with the goal of attracting employees with a new set of skills.The Federal Deposit Insurance Corp. announced the move Thursday, saying it isn’t designed to reduce its budget or the total size of the workforce. About 42% of the current workforce is eligible for retirement within five years, the FDIC says. A wave of potential retirements could sap the agency’s institutional knowledge, especially during a crisis, the FDIC’s inspector general said in a recent report.In addition, the FDIC plans to close a handful of field offices, and to relocate and consolidate others. No staff involved in examining banks will be affected, the agency says.“This program will enhance our agility, preparedness and technological transformation,” FDIC Chair Jelena McWilliams said in a statement. It’s part of the agency’s strategy to “further reduce layers of management and acquire new skill sets,” she said.Sen. Sherrod Brown of Ohio, the senior Democrat on the Senate Banking Committee, questioned the approach of phasing out veteran employees and said it could hurt the FDIC’s ability to deal with another financial crisis. “If the FDIC chair were interested in increasing the agency’s capability to respond to a crisis, she would be focused on hiring and training a new generation of workers, not encouraging experienced and senior staff to rush to the exit,” Brown said. “Let’s be clear –- no matter how Chair McWilliams tries to spin it, reducing FDIC’s workforce will make us less prepared for a financial downturn.”During the 2008-09 financial crisis and the following years, the FDIC closed hundreds of failed U.S. banks and transferred their loans and deposits to other, healthy banks. Bank failures reached a peak of 157 in 2010. With the new plan, the FDIC is looking build up its staff engaged in inspecting banks, and in specialized information technology, computer science and data management. Officials declined to estimate what portion of the employees being offered early retirement is expected to take it. They include executive managers as well as administrative staff at FDIC headquarters in Washington and in the field. The union representing FDIC employees said it’s concerned about employees having enough time to adequately assess their options and make informed decisions. Employees who accept the offer must leave by June 6. Under terms of the offer, most of the employees who choose to leave or retire will receive six months of salary.The union, the National Treasury Employees Union, said it will negotiate with the agency on the office closures and consolidations to prevent involuntary relocations of employees to another FDIC office and allow them to continue to inspect banks in their areas.“We also intend to closely examine the FDIC’s justification for these decisions, and our union will raise concerns if we feel the moves are unwarranted or harmful to FDIC’s ability to accomplish its mission,” NTEU President Tony Reardon said in a statement.In addition to monitoring the banks’ condition, the FDIC was established during the Great Depression to insure deposits of banks that fail. It guarantees deposits up to 0,000 per account. 3411

The House of Representatives will vote Wednesday on significant gun control legislation for the first time in more than two decades, a move that Democrats hope will increase a pressure campaign for a vote in the Senate.The universal background check bill, H.R. 8, will come to the floor for a vote and is expected to pass with the Democratic majority. The legislation would require background checks on all firearm sales in the country. Currently, only licensed gun dealers have to perform background checks for anyone seeking to purchase a firearm. Most unlicensed sellers do not; H.R. 8 would make that illegal. There are exemptions to the law like "gifts to family members and transfers for hunting, target shooting, and self-defense," according to the House Judiciary Committee website.The bill, sponsored by a bipartisan duo of Reps. Mike Thompson, a California Democrat, and Peter King, a New York Republican, remains an outlier right now in the House since it has bipartisan support. Most of the legislation related to gun control has been sponsored by Democrats.Four other Republicans co-sponsored the bill: Brian Mast of Florida, Brian Fitzpatrick of Pennsylvania, Chris Smith of New Jersey and Fred Upton of Michigan. King told CNN on Tuesday that he may get a few more Republican colleagues to vote for the measure, but "no more than a handful."At a 25-year anniversary party for the gun control group the Brady Campaign on Tuesday evening, House Speaker Nancy Pelosi expressed confidence that the universal background checks bill would pass the House of Representatives. At the event, Pelosi also recalled her her efforts with Senate Minority Leader Chuck Schumer in the 1990s on gun control as "hard," but a "triumph that saved millions of lives.""Tomorrow we're going to send him the background check legislation," Pelosi said to her Senate colleague with a wide smile.Schumer predicted that the country is on the "precipice of great change" on the issue of gun safety."We have a Democratic House that will not flinch. We have a Senate Democratic minority that will not flinch. Most of all, we have a public who is aroused and strong."Democrats, including Pelosi, have made this a top policy priority in the new Congress, staging public hearings on the topic which had not been held for years in Congress. The legislation also has the backing of a multitude of outside groups, including the former congresswoman and gun control advocate Gabby Giffords, the Brady Campaign, Everytown for Gun Safety and Moms Demand Action.Once it passes the House, the bill will move to the Senate, where it is unlikely to pass in the Republican-majority chamber when legislation often needs 60 or more votes to advance.On Tuesday, King urged his Senate colleagues to consider the bill."I would think that they should let it come to a vote," he said, adding that the average American supports the universal background checks bill."This is not going to affect more than probably less than 1% of the American people and the ones it will affect either suffer from mental illness or are criminals. So to me, it's a phony issue being raised by some of the gun groups," he said.King understands that public opinion is on his side on this issue. 3247
The list of places intended for sporting events, entertainment, and other everyday activities, that are instead being used as temporary hospitals just got longer. On Tuesday, work began to convert the indoor tennis center at the Billie Jean King U.S. Open facility into a 350-bed temporary hospital. It joins a group of nine locations in or near New York City being converted into temporary hospitals. All but one of the temporary facilities are intended to handle non-coronavirus patients. However, doctors are fast learning that there may be no such thing."That was one of the initial most surprising things for us," said Dr. Eric Wei, NYC Health + Hospitals' chief quality officer. "People who got hit by cars or were beat up," Dr. Wei continued, "had pneumonia that's consistent for COVID-19."It's why the city is now instructing its medical personnel to assume that all patients have coronavirus. The temporary facilities are part of a constellation of hospitals in the city and its suburbs where patients can be moved and treated, depending on their condition. More than 170 hospitals and temporary hospitals are part of the network, and on Monday, Gov. Andrew Cuomo promised that a central command center would be operational by Tuesday to coordinate them all. "It is up and running," said Deanne Criswell, the city's emergency management commissioner at a news conference on Tuesday afternoon. "It's located at the Javits Center."Criswell added that, for now, the command center is only coordinating between two locations, the U.S.N.S. Comfort hospital ship, and the temporary hospital at the Jacob Javits Center.The full center is not expected to be fully operational until next week. 1705
The Environmental Protection Agency announced a commitment to fully eliminate animal testing by 2035."This is a longstanding personal belief on my behalf," EPA Administrator Andrew Wheeler said Tuesday, recalling an op-ed he wrote for his college newspaper, The Observer, at Case Western Reserve University, in 1987, which the agency handed out to reporters.The EPA has relied on animal testing to evaluate the risks of chemicals and pesticides to human health but has taken steps in recent years to move toward new alternatives and technologies. The Toxic Substances Control Act that was amended in 2016 to reduce reliance on animal testing as well.Animal rights groups, including the Humane Society and PETA, praised the move."PETA is celebrating the EPA's decision to protect animals certainly, but also humans and the environment, by switching from cruel and scientifically flawed animal tests in favor of modern, non-animal testing methods," said Dr. Amy Clippinger, director of PETA's regulatory testing department.Wheeler said the agency will provide .25 million in grant funding to five universities, Johns Hopkins University, Vanderbilt University, Vanderbilt University Medical Center, Oregon State University and University of California Riverside, to research alternative test methods, like computer modeling and invitro testing.However environmental groups slammed the EPA's directive, raising concerns about the adequacy of the alternative test methods for all chemicals, and arguing the move largely benefits chemical companies more than the public."EPA is eliminating tools that lay the groundwork for protecting the public from dangers like chlorpyrifos, formaldehyde and PFAS. Phasing out foundational scientific testing methods can make it much harder to identify toxic chemicals -- and protect human health," Jennifer Sass, senior scientist for the Healthy People and Thriving Communities program at the Natural Resources Defense Council, said in a statement. 1993
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