FDA CDC News

FDA Advances Additional Activities to Prevent Drug Overdoses and Reduce Death

Published

2 years ago

February 16, 2023

Addressing the drug overdose crisis and substance use disorder (SUD) is an issue of great concern for our nation and remains a top public health priority for the U.S. Food and Drug Administration. Upon returning to the FDA as Commissioner, I expressed my commitment to respond to all aspects of this ongoing crisis. As an agency focused on protecting public health, combatting this evolving emergency is an issue of particular urgency for us. Of note, a public health emergency, as a consequence of the opioid crisis, was declared by the U.S. Department of Health and Human Services in October 2017 and renewed on December 22, 2022.

In August 2022, I announced the FDA’s Overdose Prevention Framework – our expanded vision to undertake creative actions with an impact not only on preventing drug overdoses and reducing deaths from opioids and other substances, but also ameliorating the tremendous toll of addiction on American individuals and families. As part of that announcement, I shared that the agency would commission an independent external opioid-related activities review. That review was conducted by a team of subject matter experts affiliated with The Ohio State University who are familiar with the 2017 National Academies for Sciences, Engineering, and Medicine’s (NASEM) recommendations, a project initiated on my watch, and also related opioid prescribing issues. The review analyzed the FDA’s implementation of the NASEM recommendations along with key regulatory policies and decisions, including labeling.

Today, we are sharing that report, which provides lessons learned, recognizes the work already being done by the FDA, and makes the following three overarching recommendations outlined for the agency to take action:

Continue efforts to comprehensively implement the recommendations in the 2017 NASEM Report, including evaluating scientifically-sound, inclusive study designs to inform a systems approach for regulatory decision-making that incorporates public health considerations.
Consider seeking from Congress certain additional authorities regarding opioid analgesic approvals and review of the advertising and promotion for such products, as well as additional resources to implement such authorities to strengthen oversight of prescription opioid analgesics.
Be as transparent as possible regarding decision-making for opioid analgesics, as increased transparency can encourage appropriate uses of prescription opioid analgesics, promote innovation in pain management and prevention of opioid use disorder, and enhance public trust.

We have reviewed these recommendations and while we are thoughtfully considering our actions to implement them, I am encouraged that the agency is already moving forward on multiple workstreams, while also adapting to the changing epidemiology of the ongoing public health emergency. New challenges confronting us include much more multidrug use and troubling distribution of powerful chemically-synthesized drugs.

While our response is centered on opioid regulation by the Center for Drug Evaluation and Research (CDER), all elements of the agency are involved as we work with digital applications of substance use disorder treatment, the inappropriate intermixing of prescription drugs—like certain veterinary medicines—in the illicit market, enforcement activities in the domain of the Office of Regulatory Affairs and the intersection of nicotine addiction with use of other addictive substances as the Center for Tobacco Products oversees tobacco products.

The activities outlined below are a sample of the broad and energetic effort across the agency to combat this emergency:

First, we’re taking steps to strengthen evidence generation within the agency and with multiple partner organizations in order to better inform our response to the opioid crisis. The FDA has invested significant resources to develop a data-driven, national-level simulation model of the opioids system, named SOURCE. We will continue to enhance systems modeling approaches, including SOURCE, to enable identification of evolving trends and gaps in our interventions.

Of particular interest is deepening our understanding of the long-term efficacy of opioid analgesics. To clarify the current state of this research and knowledge gap, we will hold an advisory committee meeting in April 2023. It will focus on clinical trial paradigms, including an enriched enrollment randomized withdrawal trial design to evaluate long term efficacy and the risk of opioid-induced hyperalgesia. This is part of a postmarketing requirement we issued to application holders of new drug applications for extended release and long-acting opioid analgesics. We appreciate the revised 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain that once again pointed out the paucity of evidence on the potential benefits of long-term opioid use, raising questions for our consideration about the labeling of these drugs.

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I had the opportunity to contribute to the planning in 2015-16 that eventually led to the NIH’s HEAL Initiative, which has multiple ongoing studies evaluating the clinical epidemiology, health services and interventions in clinical practice. As this extensive network conducts its work, we anticipate a steady stream of information that will inform our policies.

This information, along with other scientific evidence and insight, will aid our science-based evaluations of the benefit-risk assessment of opioid products, and help ensure that the benefit-risk assessment considers not only the outcomes of prescription opioids when used as prescribed but also the public health effects of inappropriate use.

Next, the report suggests the agency should consider seeking additional authorities through Congress. We know that having fit for purpose regulatory authority is key to addressing opioid use, misuse and abuse. As referenced in the agency’s Overdose Prevention Framework, we are exploring the need for potential new authorities for opioid approval standards, including whether drug developers seeking approval for the marketing of new opioid analgesics should be required to demonstrate that their products offer material safety advantages over existing approved opioid analgesics.

For many years, the FDA has based decisions on whether to approve drugs, including opioids, on a framework for the assessment of the benefits and risks of a drug. That approach is the authority Congress mandated for us. When it comes to opioids, we also take into account public health factors such as the impact on family and others when reaching a decision on whether to approve a drug. Currently, the FDA lacks the statutory authority to require that drug developers seeking approval for the marketing of new opioid products demonstrate that their products offer material safety advantages (such as a reduction in abuse potential or a reduction in respiratory depression) over existing approved opioids. By enabling the FDA to refuse to approve new opioid analgesics that do not offer material safety advantages over already-approved opioids there is potential to, over time, improve the safety of opioid analgesics available to treat severe acute and chronic pain or drive research towards non-opioid alternatives to relieve pain. We stand ready to work with Congress on an improved regulatory tool for the agency.

As we examine the need for new authorities, we will continue to explore ways to use our current authorities, not only to regulate opioids more effectively, but also to improve the pipeline of non-addictive treatments for pain. While this has been a goal for many years now, the industry has been disappointingly unable to develop these much-needed alternatives.

Lastly, continuously working to earn and retain the public’s trust is not only important to our work, but also critical to our mission to protect public health. The report correctly highlights the importance of transparency in our decisions regarding opioid analgesics.

An area where we believe we can increase transparency is through further improvements of our advisory committee meetings. Our commitment to explore more effective use of our advisory committees to increase transparency regarding opioid analgesics will be a part of a broader internal effort to evaluate how to make the best use of all of our advisory committees and ensure agency decisions are informed by input from knowledgeable external advisors and the public and the decisions are shared publicly. Advisory committees play a crucial role in regulatory decision-making and publicly clarify the FDA’s expectations and the views of experts in the field while giving the public a chance for direct input. Although the airing of opinions at advisory committees, like democracy, can be messy, by improving transparency, better public understanding of the FDA’s decision-making process will lead to more confidence in it.

Within each of the overarching recommendations outlined are additional, more specific recommendations that we will continue to address and prioritize through our existing authorities and current activities within CDER and beyond.

I look forward to continuing to work across the agency to advance solutions that encourage appropriate prescribing, promote innovation in pain management, prioritize overdose prevention, reduce opioid and other substance use disorders, and champion effective treatment and support for those with SUD. We recognize that in the face of this ongoing emergency, we must continuously assess and improve our efforts and I appreciate the commitment of the FDA’s center directors and staff in this continuing effort while also dealing with other challenges that impact public health.

Related Information

Source: FDA

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Alert: Kroger Issues Food Recalls Affecting Multiple States

Published

2 weeks ago

February 7, 2025

Hal Machina

Senior woman with tablet computer in the store.

As of early February 2025, Kroger has announced a series of food recalls affecting customers across at least 15 states, as well as several subsidiary stores nationwide. The recalls, initiated due to safety concerns, include a variety of products that consumers should be aware of.

Twelve Hummus Tubs from King Harvest

Kroger subsidiary stores Fred Meyer and QFC, located in Alaska, Idaho, Oregon, and Washington, have recalled the following King Harvest hummus tubs, each weighing 10 oz:

King Harvest Lemon Hummus
King Harvest Classic Hummus
King Harvest Roasted Garlic Hummus
King Harvest Toasted Onion Hummus
King Harvest Chipotle Hummus
King Harvest Spinach Hummus
King Harvest Black Olive Hummus
King Harvest Sesame Hummus
King Harvest Jalapeño Hummus
King Harvest Balsamic Hummus
King Harvest Sun Dried Tomato Hummus
King Harvest Roasted Pepper Hummus

These products were recalled on February 5, 2025, due to a defect in their plastic tubs that may lead to the presence of plastic foreign objects within the containers. Kroger has advised customers, “Customers who purchased any of the item(s) below should not eat the product.” It remains unclear whether this recall is connected to a previous incident from September 2024 involving similar concerns.

DJs Boudain Products in Texas and Louisiana

Kroger stores in Texas and Louisiana have also issued a recall for the following DJs Boudain products:

DJs Boudain Hot Jalapeño Boudain, 12 oz
DJs Boudain Boudain Sausage, 24 oz
DJs Boudain Boudain Sausage, 16 oz

These items were recalled on February 1, 2025, due to potential contamination with pieces of a pen. This recall is part of a broader action directed by the U.S. Department of Agriculture (USDA), which called for around 17,720 pounds of boudain sausage link products to be removed from stores across Louisiana, Mississippi, and Texas.

Gerber Products for Teething Children

In addition, two Gerber products intended for teething children were recalled from Kroger stores across multiple states, including Ohio, Virginia, Michigan, Indiana, Illinois, Missouri, Kentucky, Tennessee, Alabama, North Carolina, West Virginia, Texas, and Louisiana. The affected products are:

Gerber Soothe N Chew Teething Sticks Banana, 3.2 oz
Gerber Soothe N Chew Teething Sticks Strawberry Apple, 3.2 oz

These products were removed from shelves due to potential choking hazards. Kroger has assured customers that those who purchased these items can return them for a full refund. This recall is part of a nationwide action announced by the Food and Drug Administration (FDA). Gerber has expressed regret over the situation, stating, “The recall was initiated after receiving consumer complaints of choking incidents. To date, one emergency room visit has been reported to the firm…We sincerely apologize for any concern or inconvenience this action represents to parents, caregivers, and retail customers.”

Conclusion

Customers who have purchased any of the recalled products are urged to refrain from consuming them and to return the items for a refund. It is always advisable to stay informed about food recalls to ensure the safety of you and your family. For more updates on recalls and food safety, keep an eye on announcements from Kroger and the relevant health authorities. Stay safe!

STM Daily News is a vibrant news blog dedicated to sharing the brighter side of human experiences. Emphasizing positive, uplifting stories, the site focuses on delivering inspiring, informative, and well-researched content. With a commitment to accurate, fair, and responsible journalism, STM Daily News aims to foster a community of readers passionate about positive change and engaged in meaningful conversations. Join the movement and explore stories that celebrate the positive impacts shaping our world.

Read the article in Newsweek: https://www.newsweek.com/kroger-food-recalls-issued-15-states-full-list-products-impacted-2027160

https://stmdailynews.com/

Author

Hal Machina

Hal Machina is a passionate writer, blogger, and self-proclaimed journalist who explores the intersection of science, tech, and futurism. Join him on a journey into innovative ideas and groundbreaking discoveries! View all posts journalist

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A Bold Move Towards a Healthier Future: FDA’s Proposed Nicotine Regulation

On January 15, 2025, the FDA proposed regulating nicotine levels in cigarettes to minimize addiction, aiming to prevent millions from smoking. This significant public health initiative promotes fewer smoking-related diseases and economic benefits.

Published

4 weeks ago

January 27, 2025

Charles Elliot

close up photo of cigarette ashes. nicotine — Photo by Basil MK on Pexels.com

On January 15, 2025, the U.S. Food and Drug Administration (FDA) made headlines with a groundbreaking proposal that could revolutionize the landscape of tobacco products. The agency announced a plan to limit the nicotine content in cigarettes and certain combusted tobacco products to levels that will make them minimally or nonaddictive. This significant step is geared towards preventing future generations from falling victim to the perils of tobacco addiction and smoking-related diseases.

A Bold Move Towards a Healthier Future: FDA’s Proposed Nicotine Regulation

A Step Long in the Making

The journey to this proposal began in 2018 when the FDA first expressed intentions to regulate nicotine levels in tobacco products. Now, as we stand on the brink of potentially transformative change, it’s clear that the FDA’s vision is not only ambitious but also rooted in a wealth of scientific evidence. The proposed nicotine cap, set at a mere 0.7 milligrams per gram of tobacco, is poised to dismantle the addictive potential of cigarettes, thus reducing the likelihood of new smokers picking up the habit.

Saving Lives and Reducing Costs

The impact of this regulation could be enormous. According to the FDA’s research, by the year 2100, this new nicotine standard has the potential to prevent around 48 million young people from starting to smoke. Additionally, it could encourage over 12.9 million current smokers to quit within the first year of the regulation’s enactment—numbers that elevate to an astonishing 19.5 million after five years. Ultimately, the FDA estimates that over the coming decades, we could see 1.8 million lives saved, climbing even higher to 4.3 million by the end of the century.

The financial implications are just as compelling. With an estimated annual benefit of over $1.1 trillion—not to mention the reduction in healthcare costs, lost productivity, and the avoidance of tobacco-related diseases—the proposal is not only a public health victory but also an economic one.

A Public Health Perspective

Cigarettes remain the deadliest consumer product in history, accounting for nearly half a million preventable deaths each year in the U.S. alone. The FDA Commissioner Robert M. Califf, M.D., expressed a clear commitment to making significant progress in combating this public health crisis. “Today’s proposal envisions a future where it would be less likely for young people to use cigarettes and more individuals who currently smoke could quit or switch to less harmful products,” he stated.

The focus on addiction prevention and smoking cessation aligns with a broader goal: to create a healthier society where smoking-related diseases are no longer a pervasive threat. The proposed rule does not impose a ban on tobacco products but instead aims to create a safer environment by altering the products themselves. This is a crucial distinction as it allows for a path that encourages adult smokers to transition to less harmful alternatives without criminalizing their existing choices.

Why Public Engagement Matters

With the proposal open for public comment from January 16 to September 15, 2025, the FDA is keen on gathering input from diverse stakeholders, ensuring that a myriad of perspectives is considered. This effort to foster public dialogue is essential as it demonstrates a collaborative approach to policymaking, inviting the voices of health advocates, smokers wishing to quit, and the general public into the conversation.

The FDA is also reaching out to its Tobacco Products Scientific Advisory Committee to explore further implications of this proposal, underlining the importance of scientific scrutiny in shaping effective tobacco regulations.

Looking Ahead

As we await the final decision on this transformative proposal, the message is clear: reducing nicotine levels in combusted tobacco products could redefine smoking norms in America. The FDA’s intent to prioritize public health and encourage cessation underscores a commitment to safeguarding future generations.

While no tobacco product is completely safe and the best choice for individual health is to avoid all forms of tobacco, the proposed regulations represent a critical stride towards mitigating the risks associated with smoking. With collective efforts and robust community engagement, a healthier future is not only possible, but within reach.

Join the Conversation

Are you interested in contributing to this historic movement? The FDA encourages public input, and your voice matters! Take part in this important conversation in shaping the future of tobacco regulation. Together, we can help create a society where smoking-related deaths are significantly reduced, and a healthier lifestyle becomes the norm.

Stay engaged, stay informed, and let’s pave the way for a smoke-free future!

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FDA Issues Class I Recall for Costco’s Kirkland Signature Smoked Salmon

Published

4 weeks ago

January 25, 2025

Rod Washington

In a significant health alert, the U.S. Food and Drug Administration (FDA) has upgraded the recall of Costco’s Kirkland Signature Smoked Salmon to a Class I designation, indicating a serious health risk. This recall follows the discovery of Listeria monocytogenes during routine laboratory testing.

Originally announced in late October, the recall involved 111 cases of smoked salmon packaged in twin 12-ounce units, with a UPC number of 0 96619 25697 6 and a lot number of 8512801270. The affected products have a best-by date of November 13, 2024, and were distributed between October 9 and October 13, 2024, specifically to Costco locations in Florida.

Listeria monocytogenes is known to cause listeriosis, a severe infection that can result in serious health complications or even death, especially among vulnerable populations such as pregnant individuals, the elderly, and those with weakened immune systems. Although no illnesses have been reported in connection with this product, consumers are advised to check their freezers for these recalled items.

FDA Issues Class I Recall for Costco’s Kirkland Signature Smoked Salmon

Costco is urging customers who purchased this product to return it for a full refund.

For your safety, the FDA reminds consumers that Listeria can be found in a variety of foods, particularly raw or smoked seafood, unpasteurized dairy products, and deli meats. If you suspect you may have consumed contaminated food, please consult with a healthcare professional.

Stay safe and informed by regularly checking for updates on food recalls from reliable sources.

Related links:

The FDA Issued a Class I Recall on Costco’s Kirkland Signature Smoked Salmon https://www.foodandwine.com/costco-kirkland-signature-smoked-salmon-class-i-recall-listeria-monocytogenes-8780336

https://www.fda.gov/food/foodborne-pathogens/listeria-listeriosis

https://stmdailynews.com/