Politics
FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products
Published
8 years agoon
By
Willie DavidSILVER 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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Politics
Speaker Johnson Warns of ‘Communist Agenda’ in Democratic Party Ahead of Midterm Elections
Published
1 day agoon
July 20, 2026WASHINGTON (FNN NEWS) — House Speaker Mike Johnson on Tuesday warned that the United States faces what he described as a growing influence of socialist and communist ideology within the Democratic Party, arguing that the 2026 midterm elections will determine the future of the nation’s constitutional republic.
Speaking during a House Republican leadership press conference alongside House Majority Leader Steve Scalise, House Republican Conference Chair Lisa McClain, and U.S. Rep. Carlos Giménez, Johnson urged Americans to closely examine the policy positions of democratic socialist candidates and organizations.
Johnson Says Election Is About the Future of Constitutional Government
Johnson said voters will decide whether the United States remains “a constitutional republic” or moves toward what he characterized as a system based on communist ideology.
“We’re fighting right now in Congress over whether we’re going to maintain our status as a constitutional republic or we’re going to trade that in, dismantle the foundations and go down this dark road of death to communism,” Johnson said.
He described the upcoming election as a defining moment for the country and encouraged Americans to review the platform of the Democratic Socialists of America (DSA).
Johnson Criticizes Democratic Socialist Platform
According to Johnson, the DSA platform includes proposals to expand the Supreme Court, eliminate the U.S. Senate in favor of a unicameral legislature, abolish national borders, provide broad immigration amnesty, eliminate prisons, and reduce traditional law enforcement.
Johnson argued that candidates he described as “mini-Mamdani’s” are promoting similar ideas in congressional races around the country.
“This is not a game. Everybody needs to understand these crazy little mini-Mamdani’s who are popping up all around the country; they are a danger to you and your family,” Johnson said.
Johnson Contrasts Constitutional Government and Communism
Johnson said America’s founding principles recognize rights as originating from God rather than government, contrasting that belief with what he described as communist ideology.
“Our rights come from our Creator, God; they do not come from the government. The communist believes the opposite,” Johnson said.
He also cited the historical record of communist governments, stating that communist ideology “has led to the murder of tens of millions of innocent people in the 20th century alone.”
Cold War Comparison
Johnson compared today’s political climate with the Reagan era, when he said Republicans and Democrats were united in opposing communism overseas.
“Thirty-five years ago Republicans and Democrats in Congress… were fighting communism on a distant shore. Now it’s here,” Johnson said.
He argued that ideological differences between the two major political parties have expanded beyond disagreements over taxes and regulation into broader debates about the nation’s governing philosophy.
‘The Barbarians Are Inside the Gate’
Concluding his remarks, Johnson described the 2026 midterm elections as one of the most consequential in modern American history.
“The American people have to decide in November… whether we’re going to maintain our freedom in a constitutional republic,” Johnson said.
Johnson ended the press conference by warning:
“The barbarians are inside the gate.”
The remarks reflect House Republican leadership’s broader campaign message heading into the 2026 midterm elections, emphasizing constitutional government, border security, and opposition to socialism and communism. Democratic leaders have rejected Republican characterizations that equate Democratic policies or democratic socialism with authoritarian communism.
Florida
Democrats Jorge Figueroa and Anthony Nieves Compete for Florida House District 47 Nomination
Published
3 days agoon
July 18, 2026KISSIMMEE, Fla. (FNN NEWS) — Florida House District 47 voters will choose between two Puerto Rican Democrats in the Aug. 18 primary, setting the stage for one of Central Florida’s most closely watched legislative races.
Democratic candidates Jorge Figueroa and Anthony Nieves are presenting voters with two distinct campaigns centered on affordability, economic opportunity and improving the quality of life for residents across Osceola County.
The Democratic nominee will advance to the November general election, where the race could become even more competitive amid ongoing litigation involving Republican incumbent Rep. Paula Stark’s ballot qualification. While the court challenge has drawn statewide attention, Democratic candidates have focused their campaigns on earning the support of primary voters.
A growing Puerto Rican electorate
House District 47 serves communities in Osceola County, and parts of Orange County, one of Florida’s fastest-growing regions and home to one of the largest Puerto Rican populations in the continental United States.
The district has become increasingly influential in Florida politics as Puerto Rican voters continue shaping elections at the local, state and federal levels. Both Democratic candidates say they understand the unique needs of families who relocated from Puerto Rico and those who have called Central Florida home for generations.
Jorge Figueroa emphasizes economic opportunity
Jorge Figueroa is campaigning on expanding economic opportunity while improving government accountability and public services.
His campaign has highlighted priorities including:
- Supporting small businesses and entrepreneurs.
- Expanding workforce development.
- Promoting economic growth.
- Improving public safety.
- Increasing transparency in state government.
- Investing in neighborhood infrastructure.
Figueroa says state government should focus on creating opportunities that allow working families to succeed while ensuring taxpayers receive effective public services.
Anthony Nieves focuses on working families
Anthony Nieves brings previous campaign experience to the race after earlier bids for the Florida House.
His platform emphasizes policies affecting everyday families, including:
- Affordable housing.
- Public education.
- Access to healthcare.
- Economic mobility.
- Community investment.
- Increased constituent services.
Nieves has said the Legislature should prioritize lowering costs for families while strengthening public schools and expanding opportunities throughout Central Florida.
Shared priorities
Although each candidate brings a different background and campaign style, both have identified several common priorities:
- Addressing Florida’s housing affordability crisis.
- Strengthening public education.
- Supporting working families.
- Improving economic opportunity.
- Increasing access to healthcare.
- Delivering responsive constituent services.
The candidates also have emphasized the importance of listening to residents throughout the district and maintaining an active presence in the community if elected.
Puerto Rican representation
Regardless of the primary outcome, the Democratic nominee will reflect the growing political influence of Puerto Rican voters in Central Florida.
Puerto Rican residents have become an increasingly important voting bloc in Osceola and Orange Counties over the past decade, with many families citing education, affordable housing, healthcare, hurricane preparedness and economic opportunity among their top concerns.
Political observers say candidates who effectively connect with these issues often perform well in the district.
Why District 47 matters
House District 47 is considered an important legislative district because of its changing demographics, competitive elections and growing influence within Central Florida.
The representative elected from the district will vote on issues including:
- Florida’s annual state budget.
- Public education funding.
- Property insurance reforms.
- Housing affordability.
- Transportation infrastructure.
- Economic development.
- Healthcare policy.
- Disaster preparedness and recovery.
Looking Ahead
Democratic voters will choose their nominee in the Aug. 18 primary. Because Florida House District 47 is highly competitive. However, if a court rules that incumbent Republican Paula Stark is eligible to appear on the ballot, the general election is expected to remain one of Florida’s most closely watched legislative contests.
Meanwhile, litigation over Republican incumbent Paula Stark’s ballot qualification continues. While the courts determine the outcome, the Democratic candidates remain focused on presenting their vision for House District 47 and earning voters’ support in the Aug. 18 primary.
Florida
Vilchez Santiago Wins Union Backing; Daisy Morales Says Voters — Not Political Endorsements — Decide Elections
Published
2 weeks agoon
July 10, 2026ORLANDO, Fla. (FNN NEWS) — The Democratic primary for Florida House District 43 intensified this week after candidate Samuel Vilchez Santiago announced endorsements from a coalition of labor organizations, prompting former State Rep. Daisy Morales to respond that while endorsements are important, elections are ultimately decided by voters.
Vilchez Santiago announced support from 12 labor organizations, including the Florida AFL-CIO, Central Florida AFL-CIO, SEIU Florida, the Florida Education Association, the Orange County Fire Fighters Association, United Food and Commercial Workers Local 1625, the Orange County Classroom Teachers Association, the United Auto Workers, the International Brotherhood of Electrical Workers Local 606, the Laborers’ International Union of North America Local 517, SMART Transportation Division PAC, and the Amalgamated Transit Union Local 1596.
“I am incredibly honored to earn the support of these outstanding labor organizations,” Vilchez Santiago said.
He said the endorsements were especially meaningful because he grew up in a union household.
“These endorsements are deeply personal to me. As someone who grew up in a union household, I understand firsthand that unions create pathways into the middle class and give working families the opportunity to build a better future.”
Vilchez Santiago said he would continue advocating for workers’ rights and policies that strengthen Florida’s middle class if elected.
Morales Congratulates Opponent, Recognizes Union Members
In response, Morales congratulated Vilchez Santiago on receiving the endorsements while recognizing the contributions of organized labor across Florida.
“I congratulate Mr. Vilchez Santiago on earning the support of these organizations and appreciate every group that participates in our democratic process,” Morales said.
Morales praised union members working as teachers, firefighters, law enforcement officers, healthcare professionals, skilled trades workers, transportation employees and others who contribute to Florida’s economy.
“Every worker deserves respect, opportunity, safe workplaces, fair wages, and the opportunity to achieve the American Dream.”
Morales Points to 2020 Democratic Primary
Morales said endorsements are valued but do not determine election outcomes.
She cited the 2020 Democratic Primary for Florida House District 48, when Vilchez Santiago received endorsements from elected officials, political organizations and advocacy groups before Morales defeated him and three other Democratic candidates to win the Democratic nomination.
Following that election, Florida Politics wrote that endorsements “didn’t matter” after Morales emerged victorious.
“That election demonstrated a principle that remains true today,” Morales said. “Political endorsements are valued expressions of support, but they never replace the judgment of the voters. The people—not political insiders or special interests—have the final say on Election Day.”
Morales later won the general election and represented House District 48 from 2020 to 2022.
Contrasting Campaign Messages
The exchange highlights the different messages each campaign is emphasizing as the Aug. 18 Democratic primary approaches.
Vilchez Santiago has focused on labor support, workers’ rights, affordability, housing, healthcare and reducing the influence of special interests.
Morales has centered her campaign on her legislative experience, bipartisan record and accomplishments during her term in the Florida House.
Morales said her official legislative record includes sponsoring and co-sponsoring more than 110 bills during the 2021 and 2022 legislative sessions and helping secure more than $12.5 million in state appropriations supporting higher education, healthcare, workforce development, nonprofit organizations, infrastructure improvements and community projects.
Among the legislative priorities Morales highlighted were educational opportunities for disabled veterans, property tax relief, consumer protection, public safety, workforce development, healthcare initiatives, infrastructure investments and services benefiting veterans, seniors and individuals with disabilities.
“Working families deserve representatives who deliver results—not just campaign promises,” Morales said.
Leadership and Experience
Morales said voters should evaluate candidates based on their accomplishments in public office.
“There is a clear difference in this race. My opponent is asking voters to consider who has endorsed his campaign. I am asking voters to examine my record of public service, legislative accomplishments, and proven results. Experience matters because results matter.”
She encouraged voters to review her official legislative record on the Florida House of Representatives website, which includes sponsored and co-sponsored legislation, committee assignments, voting history and appropriations.
Primary Election Approaches
The Democratic primary for Florida House District 43 will be held on Tuesday, Aug. 18, 2026, with early voting scheduled for Aug. 3–16. The winner will advance to the Nov. 3 general election.
House District 43 includes portions of east Orange County, including Azalea Park, Union Park, Alafaya, Orlando, Rio Pinar and surrounding communities.
Both campaigns are expected to continue emphasizing their respective strengths as voters begin casting ballots in one of Central Florida’s most closely watched Democratic legislative primaries.