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FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products

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SILVER SPRING, Md. (FNN NEWS) /FDA/ — The issue of opioid misuse and abuse remains one of my highest priorities and we believe it’s going to take carefully developed, sustained, and coordinated action by everyone involved to reduce the tide of opioid addiction and death afflicting our communities; while maintaining appropriate prescribing for patients in medical need. We recognize both the urgency and complexity of this crisis and are taking several steps today toward these goals.

Today, at a Part 15 hearing on this issue, we’re gathering a broad group of stakeholders, both private and public, to seek feedback on how the agency can strengthen our oversight of opioids. I’m encouraged that we have voices representing patients, industry, academia, and advocacy organizations, as well as provider groups and professional societies. I’m deeply committed to helping families, caregivers, and patients grapple with this crisis.

That’s why today we also took a fairly unprecedented and novel action regarding an over-the-counter (OTC) product that we’re concerned is contributing to the death toll associated with the opioid epidemic. Since establishing the Opioid Policy Steering Committee in May, senior FDA leaders across the agency have been hard at work to ensure that we’re leaving no stone unturned in our efforts to combat this immense public health emergency. With 11.5 million Americans misusing prescription opioids in the past year and more than 40 people dying every day from overdoses involving prescription opioids, it has become abundantly clear that more vigilant action is needed from the FDA and others to get ahead of this crisis.

At the FDA, we believe one of our key roles in addressing the opioid epidemic is to reduce new addiction. We’re exploring ways we can reduce exposure to opioids through our influence on prescribers, particularly through our Risk Evaluation and Mitigation Strategy (REMS) authorities. We’re also actively exploring how we can use changes in packaging as a way to give providers better options for tailoring how much they prescribe to the clinical need. This is especially true when it comes to immediate release formulations of opioid drugs like Vicodin and Percocet, which are typically meant for short-term use. If more immediate release opioid drugs, in particular, were packaged in three or six-day blister packs; then more doctors may opt for these shorter durations of use. Additionally, provided the FDA concluded that there was sufficient scientific support for these shorter durations of use, this could provide the basis for further regulatory action to drive more appropriate prescribing.

To illustrate the point: Suppose the dental community developed an expert guideline that said that no routine dental procedure should require more than a three or five-day initial fill of an immediate-release opioid, and the FDA reviewed and determined that blister packs in these quantities were necessary to ensure safe use. If the drugs were then packaged in blister packs that comported with these durations of use, it could help reduce overall dispensing. More doctors might more readily opt to prescribe these blister packs instead of other treatment options.

Today, toward these goals, we have taken a new action related to how one opioid product is packaged as a way to help address a growing problem of abuse and misuse of this product. The FDA is requesting that sponsors of OTC loperamide ‒ an FDA-approved product to help control short-term symptoms of diarrhea, including Travelers’ Diarrhea – change the way they label and package these drugs to stem abuse and misuse that leaves us deeply concerned.

Abuse of loperamide has been increasing in the United States. When used at extremely high and dangerous doses, it’s seen by those suffering from opioid addiction as a potential alternative to manage opioid withdrawal symptoms or to achieve euphoric effects of opioid use. The maximum approved daily dose for adults is 8 milligrams per day for OTC use and 16 milligrams per day for prescription use. It’s sold under the OTC brand name Imodium A-D, as store brands, and as generics.

Loperamide is safe at these approved doses. But when higher than recommended doses are taken we’ve received reports of serious heart problems and deaths with loperamide, particularly among people who are intentionally misusing or abusing high doses. The majority of reported serious heart problems occurred in individuals who were intentionally misusing and abusing high doses of loperamide.

The FDA added a warning to the product label in the spring of 2017 to warn of ingesting high doses of loperamide, including from abuse and misuse. Evidence suggests that package limitations and use of unit-dose packaging may reduce medication overdose and death.

Today we sent letters to the OTC manufacturers requesting that they implement changes consisting of packaging limitations and unit-of-dose packaging. We’re requesting that packages contain a limited amount of loperamide appropriate for use for short-term diarrhea according to the product label. One example is a single retail package containing eight 2-milligram capsules in blister packaging. We asked the manufacturers to take the necessary steps to implement these changes in a timely fashion to address these public health concerns.

I also plan to reach out to those who distribute loperamide online, through retail web sites, to ask them to take voluntary steps to help us address this abuse issue. The new packaging should help make limits on sales more easily achieved. The abuse of loperamide requires the purchase of extremely large quantities. Often this is done through the purchase of large bottles of loperamide, which is a common configuration in which the pill form of the medication is currently packaged. Today’s action is intended to change how the product is packaged, to eliminate these large volume containers. We know that many of the bulk purchases of these large volumes are being made online through major online web retailers.

I believe anyone who is distributing health care products has an obligation to be a partner in helping address the most pressing public health challenges like opioid abuse. If you’re selling a drug with the potential for abuse and misuse through an online website, you’re no longer in the business of selling widgets, or books. You have a social contract to take voluntary steps to help address public health challenges.

But this isn’t our only action today. I’m also pleased to announce that we posted the revised and updated Blueprint, “Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain,” which contains core educational messages for health care providers involved in the treatment and monitoring of patients with pain. It also includes more information on pain management, including the principles of acute and chronic pain management; non-pharmacologic treatments for pain; and pharmacologic treatments for pain (both non-opioid analgesic and opioid analgesic).

All of these steps are meant to help ensure appropriate use of opioids as they’re intended. But there is much more to do and we are mindful that any intervention the FDA considers should minimize the burden on appropriate patient access and, to the extent practicable, on the delivery system – which brings me back to today’s hearing and why stakeholder feedback is so important.

Engaging with stakeholders is critical to our success. That’s why, following the hearing and discussion today, we welcome and strongly encourage the public to submit electronic or written comments to the docket until March 16, 2018. Many already submitted comments to our previous Federal Register notice, and we’re currently carefully reviewing the more than 900 comments received. We look forward to reviewing the submitted comments from this meeting. Our discussion will also continue on Feb.15 in collaboration with the Duke Margolis Center for Health Policy, through a public workshop exploring strategies for promoting the safe use and appropriate prescribing of prescription opioids. This feedback, and continued engagement, will inform what more the FDA could be doing to stem the opioid crisis while helping to maintain safe, effective, and appropriate prescribing for patients who need it. Appropriate prescribing practices, better packaging, and education are important steps within our statutory authority to help address the human and financial toll of opioid addiction. They can reduce harm while still providing effective pain management protocols. Today’s Part 15 hearing, and the new actions I mentioned, are indicative of the kinds of steps we need to take as we confront this epidemic.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE | FDA

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Florida

U.S. Embassy Reopens in Caracas, Offering New Opportunities for Venezuelans in Central Florida

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WASHINGTON (FNN NEWS) — The United States has formally resumed operations at the U.S. Embassy in Caracas, Venezuela, marking the first permanent diplomatic presence in the country since 2019 and signaling a new phase in U.S.-Venezuela relations.

The reopening could have significant implications for Florida’s growing Venezuelan community, particularly in Central Florida, where thousands of Venezuelan families now call the Orlando region home.

The U.S. Department of State announced that diplomatic operations officially resumed March 30, following years in which U.S. engagement with Venezuela was conducted through the Venezuela Affairs Unit at the U.S. Embassy in Bogotá, Colombia.

In January, Ambassador Laura F. Dogu arrived in Caracas as Chargé d’Affaires to lead U.S. government operations on the ground and oversee preparations for the eventual return of full embassy personnel and consular services.

Potential Impact on Venezuelan Families

For years, many Venezuelans seeking U.S. visa interviews or consular assistance were required to travel to Bogotá, often incurring significant travel expenses and logistical challenges.

While routine visa and passport services have not yet resumed in Caracas, U.S. officials said embassy personnel are working toward restoring full consular operations.

Once fully operational, the embassy could provide Venezuelan families with easier access to visa processing, family reunification services, emergency assistance and other consular support.

Economic and Business Opportunities

The reopening could also strengthen economic and commercial ties between Venezuela and Central Florida.

Florida has become a major destination for Venezuelan entrepreneurs, investors and professionals. Business leaders say a restored diplomatic presence may encourage additional trade, investment and business expansion opportunities between the two regions.

Industries including real estate, healthcare, construction, logistics and professional services could benefit from increased cross-border activity.

Strengthening Community Ties

Community leaders believe renewed diplomatic relations could further strengthen cultural, educational and civic connections between Venezuela and Central Florida.

Orlando-area organizations, universities and business groups may find new opportunities for collaboration, exchanges and partnerships as relations continue to normalize.

Florida State Representative Daisy Morales (left) House District in Orlando included 70 percent hispanic population. (2020-2022)

Former Florida Lawmaker Welcomes Diplomatic Reengagement

Former Florida State Representative Daisy Morales, who is also a candidate for Florida House District 43, applauded the reopening of the U.S. Embassy in Caracas and highlighted its potential impact on Central Florida’s large Venezuelan and Hispanic communities.

Morales, a retired federal official who served with both the U.S. Department of Homeland Security and the U.S. Department of State, said the reopening represents an important first step toward strengthening diplomatic and economic ties between the United States and Venezuela.

“I applaud the United States for taking this important first step in reopening the U.S. Embassy in Caracas and strengthening diplomatic relations with Venezuela,” Morales said. “This decision could have a positive impact on Central Florida, particularly for Venezuelan families, businesses and community organizations. As diplomatic relations continue to improve, it could also create opportunities to establish a Venezuelan consulate or honorary consulate in Orlando to better serve the growing Venezuelan population in our region.”

Morales noted that during her tenure in the Florida House, the district she represented was approximately 70 percent Hispanic, providing her with extensive experience working with diverse immigrant communities, foreign nationals and diplomatic representatives of Mexico, Colombia, Brazil, Haiti, Grenada and France.

“Throughout my public service, I have worked closely with foreign nationals and diplomats on issues affecting our communities,” Morales said. “As conditions continue to improve and return to normalcy, I would not rule out visiting Venezuela in the future to strengthen relationships and explore opportunities that benefit both our communities and Central Florida.”

Morales also said that while renewed diplomatic engagement presents opportunities, policymakers should remain mindful of past experiences involving U.S. diplomatic relations with other nations.

“When President Barack Obama announced the reopening of the U.S. Embassy in Cuba in 2015, many viewed it as the beginning of a new chapter in U.S.-Cuba relations,” Morales said. “However, diplomatic relationships can evolve over time and are often affected by changing political and security conditions. As the United States begins this new chapter with Venezuela, policymakers should proceed carefully and remain focused on protecting U.S. interests, promoting democratic values and ensuring the safety and well-being of Americans.”

Challenges Remain

Despite the reopening, challenges remain.

The U.S. Embassy in Caracas has not yet resumed routine consular services, and the State Department continues to maintain travel advisories for Venezuela because of ongoing security concerns.

In addition, immigration programs affecting Venezuelans residing in the United States, including asylum and Temporary Protected Status policies, remain separate from the embassy reopening and continue to be governed by federal immigration policy.

For many Venezuelans in Central Florida, however, the return of a U.S. diplomatic presence in Caracas represents an important milestone and a step toward reconnecting families, expanding economic opportunities and strengthening ties between both regions.

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Politics

FORMER PRESIDENTS, CIVIL RIGHTS LEADERS GATHER FOR OPENING OF OBAMA PRESIDENTIAL CENTER

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FORMER PRESIDENTS, CIVIL RIGHTS LEADERS GATHER FOR OPENING OF OBAMA PRESIDENTIAL CENTER
Photo Credit: Angie McMonigal

CHICAGO (FNN NEWS) — The long-awaited Barack Obama Presidential Center officially opened Thursday with a star-studded dedication ceremony on Chicago’s South Side, drawing former presidents, national leaders, celebrities, and thousands of invited guests.

The ceremony began at 11 a.m. CDT with Chicago native and Grammy Award-winning singer Jennifer Hudson performing the national anthem.

Obama Center Opens

Former President Barack Obama and former First Lady Michelle Obama delivered remarks celebrating the opening of the center, which is designed to serve as a cultural, educational, and civic engagement hub.

The opening marks the formal debut of one of the most anticipated presidential centers in modern history. The campus opens to the public on Juneteenth and is expected to attract visitors from across the United States and around the world.

Former Presidents in Attendance

Among the dignitaries attending the ceremony were:

  • Former President Joe Biden
  • Former President George W. Bush
  • Former President Bill Clinton
  • Former First Lady Jill Biden
  • Former First Lady Laura Bush
  • Former Secretary of State and former First Lady Hillary Clinton

National Leaders and Celebrities Attend

The event also attracted prominent political leaders, civil rights advocates, entertainers, and business leaders, including:

  • California Gov. Gavin Newsom
  • Pennsylvania Gov. Josh Shapiro
  • Civil rights leaders Andrew Young and Al Sharpton
  • Media icon Oprah Winfrey
  • Comedians David Letterman, Conan O’Brien, and Stephen Colbert
  • Actor Tom Hanks
  • Tennis legend Billie Jean King
  • Chicago Cubs Chairman Tom Ricketts

Several attendees, including Newsom and Shapiro, are widely viewed as potential contenders for the 2028 Democratic presidential nomination.

A Landmark for Chicago’s South Side

The opening of the Obama Presidential Center represents a significant milestone for Chicago’s South Side, bringing national attention, tourism, and economic development opportunities to the community.

Thousands of invited guests attended the ceremony, while residents and supporters gathered at a free public watch party to celebrate the historic occasion.

The center is expected to serve as a lasting tribute to the legacy of the nation’s 44th president while inspiring future generations of leaders through civic engagement, education, and public service.

About the Obama Presidential Center

The Obama Presidential Center is a world-class campus dedicated to preserving and advancing the legacy of President Barack Obama and First Lady Michelle Obama. The center includes museum exhibits, public gathering spaces, educational programming, and community resources aimed at fostering leadership and civic participation.

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Politics

CARICOM Launches Online Platform for 51st Heads of Government Meeting Gros Islet, Saint Lucia conference set for July 5-8, 2026

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GEORGETOWN, Guyana (FNN NEWS) — The Caribbean Community (CARICOM) Secretariat has launched a dedicated online platform for the upcoming 51st Regular Meeting of the Conference of Heads of Government of CARICOM, scheduled to take place in Gros Islet, Saint Lucia, from July 5-8, 2026.

Central Hub for Meeting Information

The online platform will serve as the primary source of information for media representatives, government officials, stakeholders, and the public leading up to and during the conference.

Available at CARICOM 51st Heads of Government Meeting Platform, the website features:

  • Information on the Opening Ceremony speakers
  • A detailed program of events
  • A profile of the incoming CARICOM Chair
  • Daily news updates
  • Photo and video galleries
  • Livestreams of the Opening Ceremony
  • Livestreams of the Closing Media Conference

The official Meeting Communiqué, summarizing decisions and outcomes from the conference, will also be published on the platform following the conclusion of the meeting.

Media Encouraged to Bookmark Platform

CARICOM officials are encouraging members of the media and other stakeholders to bookmark the website and visit regularly for updates throughout the conference.

The Secretariat also invited users to follow and engage with CARICOM’s social media channels using the hashtag #51HGC for real-time updates and coverage.

About CARICOM

Caribbean Community (CARICOM) was established on July 4, 1973, with the signing of the Treaty of Chaguaramas. The treaty was revised in 2001 to facilitate the creation of the CARICOM Single Market and Economy (CSME).

CARICOM comprises 15 Member States and six Associate Members, representing approximately 16 million citizens across the Caribbean region. Nearly 60 percent of the Community’s population is under the age of 30.

The organization’s work is centered on four primary pillars:

  • Economic integration
  • Foreign policy coordination
  • Human and social development
  • Security cooperation

CARICOM’s vision is to build an integrated, inclusive, and resilient Caribbean Community driven by knowledge, innovation, excellence, and productivity while promoting human rights, social justice, and sustainable economic prosperity.

Headquartered in Georgetown

The principal administrative organ of the Community, the CARICOM Secretariat, is headquartered in Georgetown and coordinates the implementation of regional policies and initiatives among Member States.

CARICOM remains one of the most successful examples of regional integration in the developing world.

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