Latest news with #JacquelineCorrigan-Curay
Yahoo
13-03-2025
- Business
- Yahoo
FDA warns of scramble for work and parking space in Monday return to office
(Reuters) - The U.S. Food and Drug Administration told staff this week it cannot guarantee work space or parking spots among the hurdles they will face on Monday when they return to their offices en mass as required, raising concerns of further disruption at the agency. The warnings were issued in at least three separate division meetings, according to transcripts of the meetings seen by Reuters, as most of the FDA's roughly 18,000 employees prepare to start full-time office work. In Thursday's meeting, Jacqueline Corrigan-Curay - director of the FDA's Center for Drug Evaluation and Research - said plans for coming layoffs were being made by the Department of Health and Human Services with input from acting FDA commissioner Sara Brenner. See for yourself — The Yodel is the go-to source for daily news, entertainment and feel-good stories. By signing up, you agree to our Terms and Privacy Policy. She said Brenner is an advocate for the FDA who understands user fees and the unique skill set of the agency's employees. "But I do not have any insight into" the plans. U.S. federal agencies including the HHS, which oversees the FDA and Centers for Disease Control and Prevention, are due to submit layoff plans to the Trump administration on Thursday. Neither HHS nor FDA immediately responded to requests for comment. President Donald Trump and billionaire ally Elon Musk, who oversees the so-called Department of Government Efficiency, have been gutting agencies as part of an effort to shrink the federal bureaucracy. They fired around 1,000 probationary FDA employees last month before bringing some back. Reuters could not confirm the final number of staff fired. Trump issued a mandate earlier this year that federal agencies terminate remote or hybrid work arrangements, which required all FDA staff who live within 50 miles (80.5 km) of a facility to work from them after March 17. Staff who live further away were given until April 28. The FDA has long allowed some employees to work from home, but like many organizations expanded remote work and gave away office space, including a main building for the Center for Tobacco Products, following the COVID-19 pandemic. Some staff for the FDA's centers for medical devices and tobacco products who live near the agency's headquarters in Silver Spring, Maryland, close to Washington, will work in the same building as of Monday, executives at the divisions said in two separate meetings. EXPECT LONG WAITS The Trump administration last week also said it was considering selling some government buildings, posting a directory of those up for possible sale that included some FDA facilities, which has since been taken down. Jaime Horman, deputy office director for the FDA's center that regulates medical devices, said in a meeting on Wednesday that staff based in offices due to be sold would be allowed to keep working remotely until the agency finds them a new location. Some FDA field workers have yet to be assigned an office this week or have been told to report to locations far from their homes, according to sources. One source said a colleague in Hawaii had been assigned to a facility more than 2,000 miles (3,219 km) away in San Francisco with less than a week's notice. FDA executives said headquarters staff might need to park on the street due to limited spaces, and encouraged them to use carpools and public transportation as much as possible. Horman said the FDA expected to have stacked parking in the future. Returning staff should expect crowds and long waits to clear enhanced security when they arrive at the Silver Spring campus, and should only bring essentials such as laptops and docking stations, the executives said. Officials for the FDA's tobacco and medical devices centers said with not enough workspace seating for all field staff, some may be forced to work at conference room tables with other employees. Workspaces at headquarters and other locations might not be fitted with docking stations or computer monitors, cautioned the medical devices official. A representative from the National Treasury Employees Union, which represents HHS workers, in one meeting encouraged staff to document working conditions including the time it took to find parking and get through security.
Reuters
13-03-2025
- Business
- Reuters
FDA warns of scramble for work and parking space in Monday return to office
March 13 (Reuters) - The U.S. Food and Drug Administration told staff this week it cannot guarantee work space or parking spots among the hurdles they will face on Monday when they return to their offices en mass as required, raising concerns of further disruption at the agency. The warnings were issued in at least three separate division meetings, according to transcripts of the meetings seen by Reuters, as most of the FDA's roughly 18,000 employees prepare to start full-time office work. here. In Thursday's meeting, Jacqueline Corrigan-Curay - director of the FDA's Center for Drug Evaluation and Research - said plans for coming layoffs were being made by the Department of Health and Human Services with input from acting FDA commissioner Sara Brenner. She said Brenner is an advocate for the FDA who understands user fees and the unique skill set of the agency's employees. "But I do not have any insight into" the plans. U.S. federal agencies including the HHS, which oversees the FDA and Centers for Disease Control and Prevention, are due to submit layoff plans to the Trump administration on Thursday. Neither HHS nor FDA immediately responded to requests for comment. President Donald Trump and billionaire ally Elon Musk, who oversees the so-called Department of Government Efficiency, have been gutting agencies as part of an effort to shrink the federal bureaucracy. They fired around 1,000 probationary FDA employees last month before bringing some back. Reuters could not confirm the final number of staff fired. Trump issued a mandate earlier this year that federal agencies terminate remote or hybrid work arrangements, which required all FDA staff who live within 50 miles (80.5 km) of a facility to work from them after March 17. Staff who live further away were given until April 28. The FDA has long allowed some employees to work from home, but like many organizations expanded remote work and gave away office space, including a main building for the Center for Tobacco Products, following the COVID-19 pandemic. Some staff for the FDA's centers for medical devices and tobacco products who live near the agency's headquarters in Silver Spring, Maryland, close to Washington, will work in the same building as of Monday, executives at the divisions said in two separate meetings. EXPECT LONG WAITS The Trump administration last week also said it was considering selling some government buildings, posting a directory of those up for possible sale that included some FDA facilities, which has since been taken down. Jaime Horman, deputy office director for the FDA's center that regulates medical devices, said in a meeting on Wednesday that staff based in offices due to be sold would be allowed to keep working remotely until the agency finds them a new location. Some FDA field workers have yet to be assigned an office this week or have been told to report to locations far from their homes, according to sources. One source said a colleague in Hawaii had been assigned to a facility more than 2,000 miles (3,219 km) away in San Francisco with less than a week's notice. FDA executives said headquarters staff might need to park on the street due to limited spaces, and encouraged them to use carpools and public transportation as much as possible. Horman said the FDA expected to have stacked parking in the future. Returning staff should expect crowds and long waits to clear enhanced security when they arrive at the Silver Spring campus, and should only bring essentials such as laptops and docking stations, the executives said. Officials for the FDA's tobacco and medical devices centers said with not enough workspace seating for all field staff, some may be forced to work at conference room tables with other employees. Workspaces at headquarters and other locations might not be fitted with docking stations or computer monitors, cautioned the medical devices official. A representative from the National Treasury Employees Union, which represents HHS workers, in one meeting encouraged staff to document working conditions including the time it took to find parking and get through security.
Yahoo
31-01-2025
- Health
- Yahoo
FDA approves new pain medication as an alternative to opioids: What to know about Journavx
For the first time in two decades, the Food and Drug Administration (FDA) has approved a new class of medication that provides an alternative to addictive opioids for patients looking to manage certain kinds of pain. The drug, suzetrigine, received the FDA's official stamp of approval Thursday to be sold as a 50-milligram prescription pill taken every 12 hours, according to a press release. The medication will be sold under the brand name Journavx for $15.50 per pill, according to Vertex Pharmaceuticals, the company that developed the new drug. The FDA's sign-off on the medication comes as the agency says it is prioritizing supporting the development of non-opioid pain treatment. Suzetrigine is the first non-opioid analgesic – or medication to control pain – of its class to receive federal approval in more than 20 years. Vertex Pharmaceuticals claimed in a press release that the medication can be used for many types of moderate-to-severe acute pain and has shown no evidence that it is addictive, like opioids. 'Today's approval is an important public health milestone in acute pain management,' Jacqueline Corrigan-Curay, acting director of the FDA's Center for Drug Evaluation and Research, said in a statement. "This action and the agency's designations to expedite the drug's development and review underscore FDA's commitment to approving safe and effective alternatives to opioids for pain management.' FDA news: Trump administration pauses communication from CDC, other health agencies Journavx was evaluated in two random double-blind experiments with a total of 874 participants following surgical procedures in which information was withheld from participants that may have influenced their behavior or perceptions. One of the drug trials followed abdominoplasty surgeries – known colloquially as a "tummy tuck" – while the other followed bunionectomies, or an operation on toes. Both trials involved randomly administering placebos and the active drug, and all participants were able to use ibuprofen if the pain became too great. "Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to placebo," the FDA said in its press release. Acute pain is something more than 80 million Americans fill prescriptions to treat each year, according to Vertex. As opposed to chronic pain, which can last well after an injury or illness has been treated, acute pain is more sudden – often caused by surgery or injury – and is easier to treat in the short term. Journavx was found to help reduce pain by blocking pain signals in the peripheral nervous system before pain signals reach the brain. Reshma Kewalramani, CEO and president of Vertex, called the drug's approval "a historic milestone" in a statement. "We have the opportunity to change the paradigm of acute pain management and establish a new standard of care,' Kewalramani most common reactions study participants experienced after receiving Journavx were itching, muscle spasms and rashes, according to the FDA. Eric Lagatta covers breaking and trending news for USA TODAY. Reach him at elagatta@ This article originally appeared on USA TODAY: FDA approves new non-opioid pain medication Journavx: What to know
USA Today
31-01-2025
- Health
- USA Today
FDA approves new pain medication as an alternative to opioids: What to know about Journavx
For the first time in two decades, the Food and Drug Administration (FDA) has approved a new class of medication that provides an alternative to addictive opioids for patients looking to manage certain kinds of pain. The drug, suzetrigine, received the FDA's official stamp of approval Thursday to be sold as a 50-milligram prescription pill taken every 12 hours, according to a press release. The medication will be sold under the brand name Journavx for $15.50 per pill, according to Vertex Pharmaceuticals, the company that developed the new drug. The FDA's sign-off on the medication comes as the agency says it is prioritizing supporting the development of non-opioid pain treatment. Suzetrigine is the first non-opioid analgesic – or medication to control pain – of its class to receive federal approval in more than 20 years. Vertex Pharmaceuticals claimed in a press release that the medication can be used for many types of moderate-to-severe acute pain and has shown no evidence that it is addictive, like opioids. 'Today's approval is an important public health milestone in acute pain management,' Jacqueline Corrigan-Curay, acting director of the FDA's Center for Drug Evaluation and Research, said in a statement. "This action and the agency's designations to expedite the drug's development and review underscore FDA's commitment to approving safe and effective alternatives to opioids for pain management.' FDA news:Trump administration pauses communication from CDC, other health agencies FDA approval of Journavx comes after 2 drug trials Journavx was evaluated in two random double-blind experiments with a total of 874 participants following surgical procedures in which information was withheld from participants that may have influenced their behavior or perceptions. One of the drug trials followed abdominoplasty surgeries – known colloquially as a "tummy tuck" – while the other followed bunionectomies, or an operation on toes. Both trials involved randomly administering placebos and the active drug, and all participants were able to use ibuprofen if the pain became too great. "Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to placebo," the FDA said in its press release. How does Journavx work? Acute pain is something more than 80 million Americans fill prescriptions to treat each year, according to Vertex. As opposed to chronic pain, which can last well after an injury or illness has been treated, acute pain is more sudden – often caused by surgery or injury – and is easier to treat in the short term. Journavx was found to help reduce pain by blocking pain signals in the peripheral nervous system before pain signals reach the brain. Reshma Kewalramani, CEO and president of Vertex, called the drug's approval "a historic milestone" in a statement. "We have the opportunity to change the paradigm of acute pain management and establish a new standard of care,' Kewalramani said. Does Journavx have any known side effects? The most common reactions study participants experienced after receiving Journavx were itching, muscle spasms and rashes, according to the FDA. Eric Lagatta covers breaking and trending news for USA TODAY. Reach him at elagatta@
Yahoo
31-01-2025
- Health
- Yahoo
New type of non-opioid pain medication approved by FDA
(The Hill) – The U.S. Food and Drug Administration (FDA) approved Journavx (suzetrigine) oral tablets on Thursday as a first-in-class non-opioid analgesic to treat acute pain in adults. 'Today's approval is an important public health milestone in acute pain management,' Jacqueline Corrigan-Curay, acting director of the FDA's Center for Drug Evaluation and Research said in a statement. 'A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option,' she added. Corrigan-Curay said the approval underlines the agency's commitment to 'safe' and 'effective' alternatives to opioids for pain management. The new development is groundbreaking because it provides an alternative to opioids. Tens of millions of Americans are prescribed opioids like hydrocodone, oxycodone and fentanyl each year for pain. Nearly 108,000 people died from drug overdoses in 2022, with approximately 82,000, or 76 percent, of those deaths stemming from opioid usage, according to the Center for Disease Control. After the FDA's approval, suzetrigine became the first new painkiller approved in the US in 27 years. Journavx was evaluated in two randomized controlled trials of acute surgical pain. Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to placebo, according to the FDA. The 50-milligram prescription pill which contains the drug suzetrigine will be taken every 12 hours after a larger starter dose. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
