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FDA Seeks $7.2 Billion to Protect and Advance Public Health by Enhancing Food Safety and Advancing Medical Product Availability

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Today, the U.S. Food and Drug Administration announced it is requesting $7.2 billion as part of the president’s fiscal year (FY) 2024 budget. This funding will allow the agency to continue to leverage new and emerging technologies, recruit and support a highly skilled workforce and adapt oversight to new production and business models. This is work that will have an immediate impact on food, tobacco and medical product safety in this country while also preparing the agency to address rapid innovation across the food and medical products fields. The request includes an increase of $372 million in budget authority — or 10% above the FY 2023 Enacted Level — and a $150 million increase in user fees. 

“This year’s funding request builds on our accomplishments and lessons learned over the past year and adds new funding to continue modernizing the FDA and its capabilities for the future. We continue to deliver on a wide range of priorities and have strategically focused our request to ensure our program areas have the funding they need to operate with the highest success for the good of public health,” said FDA Commissioner Robert M. Califf, M.D. “Our investments to strengthen medical product safety and availability, along with funding for vital oversight of tobacco products continue to be a central focus. The budget also provides a historic investment to strengthen the FDA’s food safety and nutrition capacity—especially for infants and young children, demonstrating the Administration’s ongoing commitment to these responsibilities. As always, our foremost focus is on the well-being of patients and consumers, and we look forward to continuing our work with Congress to help meet the critical public health challenges ahead.”

The FY 2024 request, which covers the period from Oct. 1, 2023, through Sept. 30, 2024, includes new efforts for high priority program areas. Highlights of the agency’s request include:

Enhancing Food Safety, Nutrition and Cosmetics

  • $128.2 million in investments in food safety and nutrition modernization, including food labeling and animal food safety oversight. While the agency is in the process of defining its future vision for the Human Foods Program, there is significant need for additional resources to strengthen its foundational food safety and nutrition capacity. The budget seeks to strengthen consumer protection and implement lasting solutions for more efficient operations through continued investments in the New Era of Smarter Food Safety. Building on lessons learned from the infant formula supply chain response, the budget includes funding to modernize infant formula oversight and strengthen efforts to respond to shortages of critical foods, empower consumers to make healthier food choices and reduce exposure to toxic chemicals in the food supply. The budget will also help position the FDA to keep pace with innovative and novel technologies being used to develop animal food ingredients while addressing foundational gaps in the oversight of the animal food industry as these ingredients are combined, packaged, and sold as animal food. 
  • $5 million toward modernizing oversight of cosmetics. The budget includes new funding for the development of regulations, compliance policies, product registration and listing platforms, adverse event reporting and other activities to start to implement new authorities recently signed into law related to the safety and proper labeling of cosmetic products. 

Advancing Access to Safe and Effective Medical Products

  • $23 million in additional funds to advance the goal of ending the opioid crisis. Funding will support broader development of opioid overdose reversal treatments and treatments for substance use disorders and enhance regulatory oversight, expand compliance, enforcement and laboratory support. Additionally, the budget request assists in advancing the development, evaluation and market authorizations of related digital health medical devices. 
  • $11.6 million increase toward improving the medical device supply chain and shortage programs. The agency will continue to build its capabilities to ensure patients have access to medical devices at all times. The budget will allow the FDA to expand efforts to work proactively with medical device companies, health care providers, device distributors, and patients to enhance resiliency in the supply chain of critical medical devices and prevent shortages of critical devices that most often impact vulnerable populations. 
  • $2.5 million to implement ACT for ALS to foster development of treatments for ALS and other rare neurodegenerative diseases. To help the FDA implement the ACT for ALS Act, additional funding will strengthen the FDA’s ability to issue new grants and contracts, hire dedicated expert staff and allow the FDA to facilitate access to investigational therapies and medical devices for neurodegenerative diseases such as amyotrophic lateral sclerosis (i.e., ALS, also known as Lou Gehrig’s disease, a progressive and fatal disease).

Reigniting Cancer Moonshot

  • $50 million to advance the president’s Cancer Moonshot goals. This funding will advance the President’s Cancer Moonshot, including by expanding resources and collaborations for innovative and new diagnostic and therapeutic products to treat rare cancers, and other efforts to address cancer morbidity and mortality. This budget will enhance efforts to improve evidence generation for underrepresented subgroups in oncology clinical trials, and to support pragmatic and decentralized trials and our sources of evidence through patient-generated data, learnings, and real-world evidence. Additionally, these resources will also assist the FDA’s expansion of its efforts to facilitate the approvals of innovative and new cancer treatments by international regulatory authorities at the time of the FDA’s approval and will foster collaboration of cancer treatments in other countries with standards comparable to the U.S. standard of care.  

Strengthening Public Health and Mission Support Capacity

  • $10 million in further investments in enterprise data and IT modernization. The budget will expand data exchange capabilities and underlying technology platforms to better meet the challenges of the FDA’s programs and mission-critical responsibilities. Specific focuses include emerging threats, supporting needs for real-time evaluation, and more continuously accessing, analyzing and aggregating multiple sources of information, such as for recalls, adverse events, outbreaks and pandemics.  
  • $16 million for regulatory and mission support functions within the Office of the Commissioner. These resources will enable the FDA to provide the appropriate crosscutting strategic direction, policy coordination, and business services to ensure that the FDA’s programs operate effectively, efficiently, and are well coordinated. The budget includes funding for the new enterprise transformation effort to improve business process, data and technology management that will allow us to work more efficiently and optimize the use of the vast amount of data that is the foundation of our work. 
  • $9.4 million for FDA buildings, facilities and infrastructure improvements. The budget includes additional funding to help ensure that the FDA’s offices and laboratories across the country are secure, modern, reliable and cost-effective spaces that empowers the FDA’s workforce to protect and promote the safety and health of American families.

To complement the funding requests, the agency’s budget proposal also includes a package of legislative proposals designed to bolster the FDA’s authorities to further its mission to protect and promote public health. Notable proposals include efforts to: 

  • Require animal drug sponsors to make post-approval safety-related labeling changes based on new data; develop programs for safe use of certain products; and require post-approval studies based on new safety information that becomes available after approval.  
  • Provide the FDA the ability to exclude certain products or classes of products that the FDA and the Environmental Protection Agency (EPA) agree are more appropriately regulated by the EPA as pesticides; and facilitate an orderly transfer of regulatory responsibility from the EPA to the FDA of specified products that are currently registered as pesticides that the two agencies agree are more appropriately regulated by the FDA as animal drugs. The proposed changes would remove regulatory uncertainty and provide clarity to sponsors about which agency intends to regulate a given product or type of products. 
  • Expand the drug shortage notification requirements to include situations when a drug manufacturer is unlikely to be able to meet an increased demand. Currently, the FDA generally does not receive notice or adequate information from drug manufacturers regarding increases in demand that would position the agency to assist in preventing or mitigating drug shortages. 
  • Broaden the FDA’s authority to request records or other information in advance of or in lieu of inspections to include all FDA-regulated product areas, explicitly to include food, tobacco products and cosmetic establishments. Currently remote regulatory inspections are limited to drug, device and biomedical research, with only drug assessments requiring mandatory participation. This proposal will promote regulatory compliance and help facilitate certain oversight activities prior to arriving for or instead of an inspection. 
  • Remove limitations that require manufacturers to notify the FDA about interruptions or discontinuances in the manufacture of certain medical devices only during or in advance of a Public Health Emergency (PHE). Medical device shortages occur in many situations that fall outside of or are unrelated to PHEs, including natural or human-made disasters, recalls, geopolitical conflicts, production shutdowns and cybersecurity incidents. These events can lead to device shortages that significantly impact patient care and jeopardize healthcare worker safety. Therefore, the FDA is seeking the requirement for manufacture notifications at all times, as well as the authority to require and review risk management plans to help ensure that manufacturers are prepared for situations where their ability to manufacture product may be disrupted or may be insufficient to meet demand. 
  • Expand the FDA’s mandatory recall authority to cover all human and animal drugs. The agency currently has authority to order the recall of controlled substances, biological products, medical devices, tobacco products, cosmetics and foods. The agency lacks mandatory recall authority for other human and animal drugs.  
  • Enhance tools to help reduce exposure to toxic elements in the food supply, including food consumed by infants and young children. The FDA is seeking new authority to establish binding contamination limits in food and efficiently update such limits as new scientific information becomes available. 
  • Require industry to test final food products marketed for consumption by infants and children for toxic elements and allow FDA access to those records. This new authority would help the FDA better understand levels of toxic elements in these products, allow the FDA to monitor industry progress in reducing levels of these toxic elements over time and identify where the FDA should devote more time and resources. 
  • Assess user fees on and collect fees from manufacturers and importers of all tobacco products. The budget also requests an additional $100 million in funding to support regulatory activities including for oversight of e-cigarettes, which currently have high rates of youth use. The additional funding will support hiring more staff and help the FDA strengthen its tobacco product work—including application reviews, compliance and enforcement, policy development and research programs.

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Understanding RSV: Symptoms, Treatment, and Prevention

RSV: a viral respiratory infection affecting children and adults. Learn about symptoms, treatment, and prevention for a healthier future.

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man in gray sweater sitting beside woman
Photo by Vlada Karpovich on Pexels.com

RSV, short for Respiratory Syncytial Virus, is a common viral infection that primarily affects the respiratory system, particularly young children. While RSV infections are usually mild, they can pose a greater risk to infants, older adults, and individuals with weakened immune systems. If you or a loved one are facing RSV, it can be overwhelming to know what to do next. That’s why it’s important to know the symptoms, treatment options, and preventative measures available to you. By being informed and taking action, you can give yourself and those around you hope and guidance during this difficult time. So let’s explore what you can do to fight RSV and emerge victorious.

Symptoms and Diagnosis:
RSV presents symptoms resembling a cold, including cough, runny nose, fever, and occasionally, difficulty breathing. Infants may exhibit irritability, decreased appetite, and lethargy. Diagnosing RSV usually involves a medical professional evaluating symptoms, conducting a physical examination, and, if necessary, performing laboratory tests to confirm the presence of the virus.

Treatment and Management:
In most cases, RSV infections can be managed at home with supportive care. This includes ensuring proper hydration, maintaining a comfortable environment, and using over-the-counter medications to alleviate symptoms under a doctor’s guidance. However, for high-risk individuals or severe cases, hospitalization may be required for closer monitoring and specialized treatment, such as oxygen therapy or intravenous fluids.

Prevention is Key:
Preventing the spread of RSV is crucial, especially for vulnerable populations. Practicing good hygiene, such as frequent handwashing, covering coughs and sneezes, and avoiding close contact with infected individuals, can significantly reduce the risk of transmission. Additionally, promoting a clean and sanitized environment, particularly in daycare centers and schools, can help curb the spread of the virus.

Hopeful Outlook:
While RSV can be concerning, it’s important to remember that most cases resolve on their own with time and supportive care. In fact, the majority of children infected with RSV recover fully without complications. By following preventive measures, seeking medical attention when needed, and staying informed about the latest developments in RSV research and treatment, we can approach this viral infection with hope and confidence.

Respiratory Syncytial Virus (RSV) is a common viral infection that primarily affects young children, causing cold-like symptoms and occasionally resulting in more severe respiratory distress. However, with proper care and attention, RSV can be managed effectively. By understanding the symptoms, seeking medical help when necessary, and adopting preventive measures, we can protect ourselves and our loved ones from the impact of RSV and look forward to brighter days ahead.

You can find more information about RSV, including its treatment and prevention, by visiting the CDC website. https://www.cdc.gov/rsv/index.html

https://q5i.09c.myftpupload.com/eating-beans-improves-gut-health-regulates-immune-and-inflammatory-processes-in-colorectal-cancer-survivors/

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FDA CDC News

FDA Approves First Therapy for Rare Type of Non-Cancerous Tumors

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Today, the U.S. Food and Drug Administration approved Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Ogsiveo is the first drug to be approved for the treatment of patients with desmoid tumors, a rare subtype of soft tissue sarcomas.

Desmoid tumors are non-cancerous but can be locally aggressive. The tumors may invade into surrounding structures and organs, resulting in pain, issues with being able to move, and decreased quality of life. Although surgical removal has historically been the treatment of choice, there is a high risk that the tumor will return or that other health challenges will occur after removal; therefore, systemic therapies (cancer treatment targeting the entire body) are being increasingly evaluated in clinical trials. 

“The FDA continues to address unmet medical need and advance the development of safe and effective therapies for the millions of Americans whose lives are affected by rare tumors,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “Desmoid tumors are rare tumors that can lead to severe pain and disability. Today’s approval will offer the first approved treatment option for patients beyond surgery and radiation.”

The effectiveness of Ogsiveo was evaluated in an international, multicenter, randomized, double-blind, placebo-controlled trial in 142 adult patients with progressing desmoid tumors not amenable to surgery. Patients were randomized to receive 150 milligrams (mg) of Ogsiveo or placebo orally, twice daily, until disease progression or unacceptable toxicity. The main efficacy outcome measure was progression-free survival (the length of time after the start of treatment for which a person is alive and their cancer does not grow or spread). Objective response rate (a measure of tumor shrinkage) was an additional efficacy outcome measure. 

The pivotal clinical trial demonstrated that Ogsiveo provided clinically meaningful and statistically significant improvement in progression-free survival compared to placebo. Additionally, the objective response rate was also statistically different between the two arms with a response rate of 41% in the Ogsiveo arm and 8% in the placebo arm. The progression-free survival results were also supported by an assessment of patient-reported pain favoring the Ogsiveo arm. 

The most common side effects seen in at least 15% of the patients in the trial were diarrhea, ovarian toxicity, rash, nausea, fatigue, stomatitis, headache, abdominal pain, cough, alopecia, upper respiratory tract infection and dyspnea. 

Ogsiveo was granted Priority Review under which the FDA’s goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition compared to available therapies. Ogsiveo also received FDA Fast Track and Breakthrough Therapy designations for the indication noted above, as well as Orphan-Drug designation for treatment of desmoid tumor (aggressive fibromatosis). Orphan-drug designation provides incentives to assist and encourage drug development for rare diseases.

The FDA granted the approval of Ogsiveo to SpringWorks Therapeutics Inc.

Source: FDA

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Salmonella Outbreak: Cantaloupe Recall Investigation

Salmonella outbreak: Cantaloupes recalled. Ongoing investigation. Stay informed for updates on the recall.

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In recent weeks, an outbreak of Salmonella linked to cantaloupes has raised concerns across the United States and parts of Canada. The outbreak, which began in early November 2023, has resulted in numerous cases of illness reported from various states. Health authorities, including the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), are diligently investigating this outbreak to identify the source of contamination and prevent further illnesses. This blog post aims to provide an overview of the outbreak investigation, affected products and stores, symptoms of Salmonella infection, and recommendations for consumers and businesses.

The Outbreak:
On November 22, 2023, Crown Jewels Produce, Sofia Produce, and CF Dallas initiated a recall of fresh cantaloupes and related products due to potential Salmonella contamination. As of November 24, CDC reported a total of 99 cases from 32 states, with the latest onset date being November 10, 2023. The investigation is still ongoing, as authorities are working to determine if additional products are linked to the illnesses. The FDA will provide updates on this situation as more information becomes available.

Affected Products and Stores:
The following brands of whole fresh cantaloupes have been recalled:

  • Cantaloupes labeled “Malichita” or “Rudy,” with the numbers “4050” and “Product of Mexico/produit du Mexique.”
  • These cantaloupes were sold in retail stores located in Arizona, California, Maryland, New Jersey, Tennessee, Illinois, Indiana, Kentucky, Michigan, Ohio, Oklahoma, Wisconsin, Texas, Florida, and Canada. It is important to note that this list may not include all states, as the cantaloupes could have reached consumers through further retail distribution.

Recalled cut cantaloupe and products made from the recalled whole cantaloupes include:

  • ALDI’s cantaloupe, cut cantaloupe, and pineapple spears in clamshell packaging with Best-by dates between October 27 and October 31.
  • Vinyard’s cantaloupe chunks and cubes, fruit mixes, melon medleys, and fruit cups containing cantaloupe. Most of these products have a “Vinyard” label, and some have a red label with “Fresh” sold between October 30 and November 10 in Oklahoma stores.
  • Freshness Guaranteed seasonal blend, melon trio, melon mix, fruit blend, fruit bowl, seasonal fruit tray, fruit mix, and cantaloupe chunks. RaceTrac fruit medley sold in clear square or round plastic containers at select retail stores in Indiana, Michigan, Ohio, Kentucky, North Carolina, Tennessee, Virginia, Illinois, Texas, and Louisiana.

Symptoms of Salmonella Infection:
Salmonella infection typically manifests within 12 to 72 hours after consuming contaminated food and typically lasts for four to seven days. Common symptoms include diarrhea, fever, and abdominal cramps. It is important to note that severe infections are more likely to occur in children younger than five, the elderly, and individuals with weakened immune systems.

Status and Recommendations:
The investigation into the cantaloupe-related Salmonella outbreak is still ongoing. Authorities will continue to provide updates as new information becomes available. In the meantime, the following recommendations are crucial:

  • Consumers, restaurants, retailers, and wholesalers should refrain from consuming, selling, or serving recalled cantaloupes or products containing cantaloupe.
  • Those who have frozen cantaloupes for later use should check their freezers and discard any recalled fresh or cut cantaloupes.
  • If you are unsure whether your cantaloupe is part of the recall, it is best to err on the side of caution and dispose of it.
  • Retailers and wholesalers who received recalled whole melons should identify the boxes labeled “Malachita/Z Farms” or “Malichita” or “Rudy” from Crown Jewels Produce and Sofia Produce (TruFresh) and remove them from their inventory.
  • It is crucial to follow FDA’s safe handling and cleaning advice, ensuring that any surfaces and containers that may have come in contact with the recalled products are thoroughly cleaned and sanitized to prevent cross-contamination.
  • If you suspect you may be experiencing symptoms of a Salmonella infection after consuming recalled cantaloupes, it is essential to seek medical attention promptly.

The outbreak investigation of Salmonella linked to cantaloupes is a matter of concern, and authorities are actively working to protect public health. By staying informed, following the recommendations, and taking necessary precautions, we can collectively mitigate the risks associated with this outbreak. Stay tuned for updates and adhere to the guidance provided by health authorities to ensure the safety of yourself and your loved ones.

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-cantaloupes-november-2023

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