FDA CDC News

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

Published

1 year ago

March 10, 2023

Daily News Staff

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.

Related Information

Food and Beverage

Nationwide Health Alert for E. coli Contaminated Ground Beef: What You Need to Know

“Nationwide health alert issued for E. coli-contaminated ground beef. Check FSIS website for affected products and disposal instructions.”

Published

2 weeks ago

April 24, 2024

Charles Elliot and Daily News Staff

A recent national health alert has been issued by the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) regarding Greater Omaha ground beef products potentially contaminated with E. coli O157:H7. This particular strain of E. coli can cause severe gastrointestinal infections in humans. In this article, we will provide you with all the information you need to know about this alert and how to stay safe.

Product Details:
The affected ground beef products were produced and packaged on March 28, 2024, with a “Use/Freeze by” date of April 22, 2024. The packaging will also have “EST.960A” inside the USDA mark of inspection. While the ground beef was distributed to various restaurants and retail locations nationwide, it is important to note that the impacted products are no longer available for sale.

Affected Products:

10-lb. ground beef chub: GROUND BEEF 85 FINE GRIND 10#/6 (Lot codes: 25, 28, 29, 30, 31, 32, and 33; Case code: 263085)
5-lb. ground beef chub: GROUND BEEF GOHERF GB RIB BRISKET CHUCK CRAFT BURGER 5LB (Lot code: 26; Case code: 66500)
5-lb. ground beef chub: Greater Omaha 100% ALL NATURAL 5 LBS. GOURMET BLEND RIB BRISKET CHUCK
5-lb. ground beef chub: GROUND BEEF GOHERF GB 81 FINE GRIND 5#/12 EXACT WEIGHT (Lot code: 26; Case code: 663581)
4-pack 8-oz ground beef patties: GROUND BEEF GOANG GB Patty 8OZ Homestyle Rib/Brisket/CH (Lot code: 34; Case code: 716800)
4-pack 8-oz ground beef patties: LOT 34 Ground Beef GB GOANG 75 PATTY PUCK 8 OZ (Lot code: 34; Case code: 728075)
4-pack 7-oz ground beef patties: LOT 34 GROUND BEEF GOANG Rib/Brisket/Chuck 7OZ HOMESTYLE (Lot code: 34; Case code: 716700)
6-oz ground beef patties: LOT 34 GROUND BEEF GOANG GB PATTY 6 OZ HOMESTYLE RIB/BRISKET/CHUCK (Lot code: 34; Case code: 716600)
5-lb. ground beef chub: GROUND BEEF GOHERF GB 81 FINE GRIND 5LB EXACT WEIGHT (Lot code: 26; Case code: 63581)
6-pack 5.33-oz ground beef patties: Ground Beef GOHERF RIB BRISKET CHUCK 5.33oz HOMESTYLE (Lot code: 27; Case code: 616500)
4-pack 8-oz ground beef patties: LOT 27 Ground Beef GOHERF Homestyle GB PATTY RIB/BRISKET/CHUCK 8 OZ (Lot code: 27; Case code: 616800)
10-lb. ground beef chub: GROUND BEEF 73 FINE GRIND 10#/6 (Lot code: 37; Case code: 263073)
4-pack 8-oz ground beef patties: LOT 51 Ground Beef GB GOANG 75 PATTY PUCK 8OZ (Lot code: 51; Case code: 728075)

Recommendations:
If you have any of the above-mentioned ground beef products stored in your freezer, the FSIS advises against consuming them. Instead, it is important to either throw them away or return them to the place of purchase. Doing so will help prevent potential health risks.

Moreover, it is essential to note that no confirmed illness cases have been reported thus far in connection with this specific health alert. However, if you have consumed the ground beef and are experiencing any symptoms of illness, it is recommended to reach out to a healthcare provider immediately.

Ensuring the safety and well-being of consumers is a priority, and that is precisely why this nationwide health alert has been issued concerning E. coli contamination in specific Greater Omaha ground beef products. By taking the necessary precautions and following the FSIS recommendations, we can collectively prevent any potential health risks associated with this incident.

Remember, staying informed and proactive during such situations is crucial for ensuring the health and safety of yourself and your loved ones. Keep up to date with any further developments by visiting the FSIS website or seeking information from reliable sources. Stay safe and healthy!

Check out the article on The Hill regarding the E. Coli warning. https://thehill.com/changing-america/well-being/prevention-cures/4610002-nationwide-health-alert-issued-for-ground-beef-over-potential-e-coli-risk/

What is E. Coli?

-Escherichia coli is a gram-negative, facultative anaerobic, rod-shaped coliform bacterium. – It is commonly found in the lower intestine of warm-blooded organisms. – Most E. coli strains are harmless, but some can cause food poisoning and contamination incidents. – Some strains of E. coli are beneficial to humans by producing vitamin or preventing the colonization of pathogenic bacteria. – E. coli is expelled through fecal matter and grows rapidly for three days before declining.

E. coli and other bacteria make up only a small part of the gut microbiota, but can cause disease through fecal-oral transmission. They can be used as indicators to test for fecal contamination in the environment, and some strains can survive for days outside a host.

E. coli is a bacterium that has been extensively studied for over 60 years and can be easily and inexpensively grown in a lab. It is a chemoheterotroph and requires carbon and energy. E. coli is the most widely studied prokaryotic model organism and is significant in biotechnology and microbiology. It reproduces quickly, taking as little as 20 minutes under favorable conditions. (Wikipedia)

https://stmdailynews.com/category/food-and-beverage/

FDA CDC News

FDA Approval of Nonsteroidal Treatment for Duchenne Muscular Dystrophy

Breaking news! FDA approves Duvyzat for Duchenne Muscular Dystrophy, a nonsteroidal treatment providing hope for patients and families. #DMD #FDAApproval

Published

2 months ago

March 21, 2024

Charles Elliot

Breaking news in the medical world! The U.S. Food and Drug Administration has just approved Duvyzat (givinostat), an oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is making history as the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. This is a significant milestone in the treatment of this devastating disease.

DMD, being the most common childhood form of muscular dystrophy, primarily affects males. It is a neurological disorder that leads to progressive muscle weakness due to a lack of dystrophin, a muscle protein. Over time, the muscles deteriorate, causing difficulties with walking, muscle strength, and eventually leading to breathing problems and early death. However, with advancements in treatment, the life expectancy for individuals with DMD has been steadily increasing, with some patients surviving beyond 30 years.

Duvyzat is a histone deacetylase (HDAC) inhibitor that targets pathogenic processes to reduce inflammation and loss of muscle in patients with DMD. Its efficacy for the treatment of DMD was evaluated in an 18-month phase 3 study involving a randomized, double-blind, placebo-controlled trial. The primary endpoint of the study was the change in muscle function, measured by the time it took patients to climb four stairs. Patients treated with Duvyzat showed a statistically significant reduction in the decline of muscle function compared to placebo.

Another measure of efficacy was the change in physical function assessed by the North Star Ambulatory Assessment (NSAA), a scale commonly used to rate motor function in boys with DMD who can still walk. Patients treated with Duvyzat experienced less worsening in their NSAA scores after 18 months, compared to those on placebo.

Like any medication, Duvyzat does come with some potential side effects. The most common ones reported were diarrhea, abdominal pain, a decrease in platelets, nausea/vomiting, an increase in triglycerides, and fever. It’s important for healthcare providers to evaluate a patient’s platelet counts and triglyceride levels before prescribing Duvyzat. Patients with low platelet counts should not take the drug. Monitoring of platelet counts and triglycerides throughout treatment will help determine if any dosage adjustments are needed.

Healthcare professionals should also be aware that Duvyzat may cause QTc prolongation, which can increase the risk of irregular heartbeats. It’s crucial for patients taking other medications known to cause QTc prolongation or with certain types of heart disease to avoid taking Duvyzat.

The recommended dosage of Duvyzat is determined by the patient’s body weight, and it should be taken orally twice daily with food.

The approval of Duvyzat was granted to Italfarmaco S.p.A., and it received priority review, fast-track designation, as well as orphan drug and rare pediatric disease designations from the FDA. This demonstrates the agency’s commitment to advancing the development of new therapies for DMD and its recognition of the urgent need for effective treatments.

This milestone approval represents hope and progress for individuals and families affected by DMD. It provides another treatment option to help reduce the burden of this progressive and debilitating disease, regardless of the specific genetic mutation. With continued advancements in medical research and the dedication of organizations like the FDA, we are moving closer to a future where individuals with DMD can lead healthier lives.

As always, it’s important to consult with healthcare professionals for more information and guidance regarding Duvyzat and its suitability for individual cases. Let’s celebrate this achievement in medical science and look forward to more groundbreaking developments in the treatment of Duchenne Muscular Dystrophy.

Source: FDA

Related Information

Duchenne muscular dystrophy – About the Disease – Genetic and Rare Diseases Information Center
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.

https://stmdailynews.com/category/lifestyle/

Daily News

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.

Published

5 months ago

December 23, 2023

Daily News Staff

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