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FDA Moves Forward with Mail-back Envelopes for Opioid Analgesics Dispensed in Outpatient Settings

Agency Continues to Take Steps to Reduce New Cases of Opioid Use Disorder

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Agency Continues to Take Steps to Reduce New Cases of Opioid Use Disorder

Today, the U.S. Food and Drug Administration announced it is requiring manufacturers of opioid analgesics dispensed in outpatient settings to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients.

“Expanding impactful opioid disposal options, such as mail-back envelopes and in-home disposal, for patients to safely and securely dispose of their unused opioid medications is part of the agency’s comprehensive approach to addressing the overdose crisis,” said FDA Commissioner Robert M. Califf, M.D. “We believe these efforts will not only increase convenient disposal options for many Americans, but also reduce unfortunate opportunities for nonmedical use, accidental exposure, overdose and potential new cases of opioid use disorder. We’re pleased to take this first critical step to increase mail-back envelope options in partnership with the U.S. Postal Service.” 

The FDA issued notice today to all manufacturers of opioid analgesics used in outpatient settings that they are required to submit the proposed modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) within 180 days of the date of the notification letter. The agency anticipates approval of the modified REMS in 2024. When implemented, outpatient pharmacies and other dispensers will have the option to order prepaid mail-back envelopes from opioid analgesic manufacturers, which they may then provide to patients prescribed opioid analgesics. The REMS modification also requires manufacturers to develop educational materials for patients on safe disposal of opioid analgesics, which outpatient pharmacies and other dispensers may also provide to patients. 

This action follows a Federal Register notice issued in April 2022 that sought public comment on a potential modification of the OA REMS to require that mail-back envelopes be dispensed and education on safe disposal be provided with opioid analgesics dispensed in an outpatient setting. 

Patients commonly report having unused opioid analgesics following surgical procedures and many Americans gain access to opioids through friends or relatives who have unused opioids. Data show educating patients about disposal options may increase the disposal rate of unused opioids and that providing a disposal option along with education could further increase that rate. 

Currently, there are multiple mail-back envelope programs operating in the U.S. and mail-back envelopes are commercially available from multiple entities. There are long-standing regulations and policies, under the Drug Enforcement Administration and United States Postal Service, in place to ensure that mail-back envelopes are nondescript, fit for purpose, and can safely and securely transport unused medicines from the patient’s home to the location where they will be destroyed.

“The U.S. Postal Service is proud to partner with the FDA to expand the use of mail-back envelopes as a safe and secure disposal option for prescription opioid analgesics,” said Postal Service Chief Customer and Marketing Officer and Executive Vice President Steven Monteith. “Serving nearly 165 million addresses each day, with more than 31,000 retail locations across the country, the Postal Service makes it convenient for Americans to dispose of unused prescription drugs to help prevent accidental exposure and overdose.” 

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The FDA continues to consider additional ways to increase safe disposal of unused opioid analgesics. Specifically, the agency is exploring whether manufacturers of opioid analgesic should also be required to make in-home disposal products available to patients who are prescribed opioid analgesics. In an effort to further evaluate this potential option, the agency will participate in the workshop, Defining and Evaluating In-Home Drug Disposal Systems for Opioid AnalgesicsExternal Link Disclaimer, to examine current in-home disposal options hosted by the National Academies of Sciences, Engineering and Medicine’s (NASEM’s) Forum on Drug Discovery, Development, and Translation in June 2023. The FDA has also issued a Federal Register Notice to seek information and comments from the public to aid the agency’s assessment of in-home disposal methods.

These collective efforts are part of the agency’s implementation of the FDA Overdose Prevention Framework that aims to prevent drug overdoses and reduce deaths through impactful and creative actions. The FDA remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose and death in the U.S. through the four priorities of the framework, including; supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted or counterfeit drugs presenting overdose risks.

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Source: FDA

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Supreme Court Reverses Lower Court Decision Shielding Officers Who Arrested Texas Citizen Journalist

The U.S. Supreme Court has overturned protections for Texas officers in citizen journalist Priscilla Villarreal’s case, emphasizing the need for accountability in press freedom.

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In a pivotal move for press freedom, the U.S. Supreme Court has overturned a lower court’s ruling that previously granted legal protections to Texas law enforcement officers involved in the arrest of citizen journalist Priscilla Villarreal, widely known as “Lagordiloca.” This decision underscores the ongoing tension between the First Amendment’s guarantee of a free press and the doctrine of qualified immunity that often shields government officials from accountability.

Citizen Journalist

Villarreal, a prominent figure in Laredo, Texas, has gained significant attention for her reporting on local issues, including crime and public affairs, through her Facebook page, “Lagordiloca News.” Her interactions with police sources, however, led to her arrest, sparking a legal battle that raised important questions about the rights of journalists—especially those operating outside traditional media structures.

The Supreme Court’s brief order not only nullified the lower court’s protective ruling for the officers but also mandated further proceedings, indicating the need for a deeper examination of the case. Villarreal expressed her gratitude for the ruling, noting that it represents a significant stride towards addressing the injustices she has faced.

JT Morris, an attorney representing Villarreal through The Foundation for Individual Rights and Expression, praised the decision as a crucial win for free speech and press freedom. He emphasized the importance of holding officials accountable when they infringe upon First Amendment rights, reinforcing the idea that the ability to seek information from public officials is a fundamental aspect of journalistic practice.

Villarreal’s status as one of the most influential journalists in Laredo is notable, especially considering her ability to engage the community and report on issues that often go unaddressed. However, her work has not come without challenges, as her reporting has occasionally drawn the ire of local officials, including the Laredo Police Department. This case serves as a reminder of the critical role that citizen journalists play in our media landscape, particularly in local communities where traditional news outlets may fall short.

The Supreme Court’s decision is likely to resonate beyond Texas, setting a precedent that could impact similar cases across the country. As the legal proceedings continue, the outcome will undoubtedly shape the conversation around press freedom, accountability, and the rights of citizen journalists in the digital age. For Villarreal and her supporters, this ruling not only serves as a validation of her work but also as a beacon of hope for journalists striving to uphold the First Amendment in the face of adversity.

Related Link: https://www.cbsnews.com/news/supreme-court-qualified-immunity-texas-citizen-journalist/

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Will the exploding pager attack be the spark that ignites an Israel-Hezbollah war?

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Civil Defense first-responders carry a man who was wounded after his handheld pager exploded, in the southern port city of Sidon, Lebanon, Tuesday, Sept. 17, 2024.(AP Photo)

Amin Saikal, Australian National University

Exploding Pager

The alleged Israeli attack on members of Hezbollah via their pagers is another ominous development propelling the Middle East towards a full-scale regional war. It leaves Hezbollah with little option but to retaliate with the full support of the Iran-led “axis of resistance”.

The sophistication and impact of targeting the pagers is unprecedented. The attack resulted in at least 11 deaths, including some of Hezbollah’s fighters, and up to 3,000 people wounded.

The main aim of the attack, which US officials have reportedly said was carried out by Israel, was intended to disrupt Hezbollah’s means of communication and its command and control system in Lebanon.

Since Hezbollah has reduced the use of mobile phones by its forces because Israel can easily detect and target them, pagers have increasingly become the preferred messaging device within the group.

The attack may have also been designed to cause panic within the group and among the Lebanese public, many of whom do not support Hezbollah, given the political divisions in the country.

Since Hamas’ October 7 attacks on southern Israel, the Israeli leadership under Prime Minister Benjamin Netanyahu has repeatedly said it is determined to remove the threat of Hezbollah, which has operated in solidarity with Hamas.

Hours before the pager attack, Netanyahu’s government clarified that Israel’s war goals would expand to include a return of the tens of thousands of residents to their homes in northern Israel, which they have fled due to constant rocket fire from Hezbollah. Israel’s defence minister, Yoav Gallant, said the only way to do this was through military action.

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The simultaneous pager explosions on Tuesday, then, may be a prelude to an all-out Israeli offensive against Hezbollah.

The consequences of war with Hezbollah

Hezbollah has already declared it will retaliate. What form this will take remains to be seen. The group has a massive military capability to not only to pound northern Israel with drones and missiles, but also attack other parts of the Jewish state, including heavily populated cities such as Tel Aviv.

Hezbollah showed this capability in its 2006 war with Israel. The war lasted 34 days, during which 165 Israelis were killed (121 IDF soldiers and 44 civilians) and Israel’s economy and tourist industry were markedly damaged. Hezbollah and Lebanese losses were far greater, with at least 1,100 deaths. However, the Israel Defence Forces (IDF) failed to destroy or incapacitate the group.

Any successful retaliatory attack on Israel’s cities could result in serious civilian casualties, giving Israel a further pretext to pursue its long-held aim of destroying Hezbollah and punishing its main backer, the Islamic Republic of Iran.

In a wider conflict, the United States is committed to defending Israel, while Iran would support Hezbollah in whatever way necessary. If Israeli and US leaders think Iran will continue to refrain from any action that could propel it into war with Israel and the US, they are mistaken.

Hezbollah is a central piece in the regime’s national and regional security paradigm. Tehran has invested heavily in the group, along with other regional affiliates – Iraqi militias, the Yemeni Houthis and the Syrian regime of Bashar al-Assad, in particular. The aim of this “axis of resistance” has been to build a strong deterrent against Israel and the US.

Ever since its foundation 45 years ago, the Iranian regime has viewed Israel and its main backer, the US, as an existential threat, just as Israel has regarded Iran in the same way. For this, the regime has reoriented its foreign relations towards America’s major adversaries, especially Russia and China. Russo-Iranian military cooperation has grown so strong, in fact, that Moscow will have little hesitation in backing Iran and its affiliates in any war.

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Tehran is fully cognisant of Israel’s nuclear prowess. To guard against it, Iran has developed its own nuclear program to the threshold level of developing a weapon. Iranian leaders may have also gained Russia’s assurances it would help defend Iran should Israel resort to the use of its nuclear weapons.

Meanwhile, it is important to remember that after nearly a year of demolishing Gaza and devastating its inhabitants, Israel has not been able to wipe out Hamas.

Its own actions speak to this. It has constantly forced Gazans to relocate so IDF soldiers can operate in areas they had previously declared to be cleared of fighters.

The task of defeating Hezbollah and its backers would be a far greater objective to achieve. It carries the serious risk of a war that all parties have been saying that they do not want, yet all are preparing for.

The pager attack is just the latest in a string of operations that keeps imperilling any chances of a permanent Gaza ceasefire that could stabilise the region and contribute to the causes of peace rather than war.

Amin Saikal, Emeritus professor of Middle Eastern and Central Asian Studies, Australian National University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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NASA Decides to Bring Starliner Spacecraft Back to Earth Without Crew 

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NASA Administrator Bill Nelson and leadership participate in a live news conference on Saturday, Aug. 24, 2024, at the agency’s Johnson Space Center in Houston where they provided an update about NASA’s Boeing Crew Flight Test. Credit: NASA

Bringing Starliner Home

NASA will return Boeing’s Starliner to Earth without astronauts Butch Wilmore and Suni Williams aboard the spacecraft, the agency announced Saturday. The uncrewed return allows NASA and Boeing to continue gathering testing data on Starliner during its upcoming flight home, while also not accepting more risk than necessary for its crew.

Wilmore and Williams, who flew to the International Space Station in June aboard NASA’s Boeing Crew Flight Test, have been busy supporting station research, maintenance, and Starliner system testing and data analysis, among other activities.

“Spaceflight is risky, even at its safest and most routine. A test flight, by nature, is neither safe, nor routine. The decision to keep Butch and Suni aboard the International Space Station and bring Boeing’s Starliner home uncrewed is the result of our commitment to safety: our core value and our North Star,” said NASA Administrator Bill Nelson. “I’m grateful to both the NASA and Boeing teams for all their incredible and detailed work.”

Wilmore and Williams will continue their work formally as part of the Expedition 71/72 crew through February 2025. They will fly home aboard a Dragon spacecraft with two other crew members assigned to the agency’s SpaceX Crew-9 mission. Starliner is expected to depart from the space station and make a safe, controlled autonomous re-entry and landing in early September.

NASA and Boeing identified helium leaks and experienced issues with the spacecraft reaction control thrusters on June 6 as Starliner approached the space station. Since then, engineering teams have completed a significant amount of work, including reviewing a collection of data, conducting flight and ground testing, hosting independent reviews with agency propulsion experts, and developing various return contingency plans. The uncertainty and lack of expert concurrence does not meet the agency’s safety and performance requirements for human spaceflight, thus prompting NASA leadership to move the astronauts to the Crew-9 mission.

“Decisions like this are never easy, but I want to commend our NASA and Boeing teams for their thorough analysis, transparent discussions, and focus on safety during the Crew Flight Test,” said Ken Bowersox, associate administrator for NASA’s Space Operations Mission Directorate. “We’ve learned a lot about the spacecraft during its journey to the station and its docked operations. We also will continue to gather more data about Starliner during the uncrewed return and improve the system for future flights to the space station.”

Boeing Starliner
NASA’s Boeing Crew Flight Test astronauts (from top) Butch Wilmore and Suni Williams pose on June 13, 2024 for a portrait inside the vestibule between the forward port on the International Space Station’s Harmony module and Boeing’s Starliner spacecraft. Credit: NASA

Starliner is designed to operate autonomously and previously completed two uncrewed flights. NASA and Boeing will work together to adjust end-of-mission planning and Starliner’s systems to set up for the uncrewed return in the coming weeks. Starliner must return to Earth before the Crew-9 mission launches to ensure a docking port is available on station.

“Starliner is a very capable spacecraft and, ultimately, this comes down to needing a higher level of certainty to perform a crewed return,” said Steve Stich, manager of NASA’s Commercial Crew Program. “The NASA and Boeing teams have completed a tremendous amount of testing and analysis, and this flight test is providing critical information on Starliner’s performance in space. Our efforts will help prepare for the uncrewed return and will greatly benefit future corrective actions for the spacecraft.”

NASA’s Commercial Crew Program requires spacecraft fly a crewed test flight to prove the system is ready for regular flights to and from the space station. Following Starliner’s return, the agency will review all mission-related data to inform what additional actions are required to meet NASA’s certification requirements.

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The agency’s SpaceX Crew-9 mission, originally slated with four crew members, will launch no earlier than Tuesday, Sept. 24. The agency will share more information about the Crew-9 complement when details are finalized. 

NASA and SpaceX currently are working several items before launch, including reconfiguring seats on the Crew-9 Dragon, and adjusting the manifest to carry additional cargo, personal effects, and Dragon-specific spacesuits for Wilmore and Williams. In addition, NASA and SpaceX now will use new facilities at Space Launch Complex-40 at Cape Canaveral Space Force Station in Florida to launch Crew-9, which provides increased operational flexibility around NASA’s planned Europa Clipper launch.

The Crew-9 mission will be the ninth rotational mission to the space station under NASA’s Commercial Crew Program, which works with the American aerospace industry to meet the goal of safe, reliable, and cost-effective transportation to and from the orbital outpost on American-made rockets and spacecraft launching from American soil.

For more than two decades, people have lived and worked continuously aboard the International Space Station, advancing scientific knowledge and demonstrating new technologies, making research breakthroughs not possible on Earth. The station is a critical testbed for NASA to understand and overcome the challenges of long-duration spaceflight and to expand commercial opportunities in low Earth orbit. As commercial companies focus on providing human space transportation services and destinations as part of a robust low Earth orbit economy, NASA’s Artemis campaign is underway at the Moon where the agency is preparing for future human exploration of Mars.

Find more information on NASA’s Commercial Crew Program at:

https://www.nasa.gov/commercialcrew

Source: NASA

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