Showing posts with label Food and Drug Administration. Show all posts
Showing posts with label Food and Drug Administration. Show all posts

Monday, April 22, 2019

Statement from Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, on FDA’s continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine

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by: U.S. Food and Drug Administration

Washington, D.C. - April 22, 2019 - (The Ponder News) -- The FDA is a public health agency that always strives to use the best available scientific evidence to promote and protect the well being of individuals. It deeply concerns us when we see preventable diseases such as measles or mumps reemerging in the United States and threatening our communities. The World Health Organization recently named vaccine hesitancy one of the top 10 threats to global health. In this time of multiple measles outbreaks, and as we approach National Infant Immunization Week, we want to underscore our continued confidence in the safety and effectiveness of the vaccines that are highly successful at preventing – in some cases, nearly eradicating – preventable diseases.

The MMR vaccine has been approved in the United States for nearly 50 years to prevent measles, mumps and rubella (also known as German Measles). As a result of its use, measles and rubella were completely eradicated in the United States, and mumps cases decreased by 99%. Large well-designed studies have confirmed the safety and effectiveness of the MMR vaccine and have demonstrated that administration of the vaccine is not associated with the development of autism. However we’re seeing an increasing number of outbreaks of measles in communities across the country, including those in New York, New Jersey, Washington, California, and Michigan.

Considered eradicated within the U.S. since 2000, measles has persisted in other areas of the world where the vaccine is not as readily available, including countries in Europe, Asia, the Pacific Islands, and Africa. Unvaccinated U.S. residents may be exposed to measles while they are abroad and bring the disease back into the U.S. and spread it to others. Worldwide, about 20 million people get measles each year. According to the Centers for Disease Control and Prevention (CDC), there have also been outbreaks of mumps reported. It’s an urgent public health priority to monitor these diseases and raise awareness of the importance of timely immunizations, especially as outbreaks are taking hold among unvaccinated populations in this country.

These diseases start with symptoms that may mirror the common cold, but they can cause serious illness and in some cases, even death. Measles – a respiratory disease that causes a skin rash, fever, cough and runny nose – can be dangerous, especially for babies and young children. It is one of the most contagious diseases and can cause severe complications, including pneumonia, swelling of the brain and death. In fact, one to two children out of every 1,000 who contract measles dies from complications of the disease and one in four people who get measles need to be hospitalized. Mumps causes fever, headache, loss of appetite and the well-known sign of swollen cheeks and jaw from the swelling of the salivary glands. Complications, though rare, can include deafness and meningitis (an infection of the lining that surrounds the brain and spinal cord). Rubella, once a common disease that occurred primarily among young children, causes fever, rash, and -- mainly in women -- arthritis. Rubella infection during pregnancy can also lead to birth defects.

We cannot state strongly enough – the overwhelming scientific evidence shows that vaccines are among the most effective and safest interventions to both prevent individual illness and protect public health.

Vaccinating against measles, mumps and rubella not only protects us and our children, it protects people who can’t be vaccinated, including children with compromised immune systems due to illness and its treatment, such as cancer.

We do not take lightly our responsibility to ensure the safety and effectiveness of vaccines, and work diligently to assess safety and effectiveness of all licensed vaccines for their intended uses. The MMR vaccine is very effective at protecting people against measles, mumps, and rubella. It also prevents complications caused by these diseases. And we have nearly 50 years of experience and evidence supporting that fact. In fact, according to the CDC, two doses of the MMR vaccine beginning at 12 months of age (the recommended dosing schedule) are 97% effective against measles, 88% effective against mumps, and 97% effective for rubella.

Like many medical products, the MMR vaccine has known potential side effects that are generally mild and short-lived, such as rash and fever. If parents have concerns about these side effects, we recommend that they speak with their health care providers about the benefits and risks of vaccines, along with the potential consequences of not vaccinating against diseases.

The FDA will continue to closely monitor these outbreaks of vaccine-preventable diseases alongside our federal partners at CDC and the Department of Health and Human Services, and will provide any new information about vaccine safety or effectiveness to the public. But just to be clear, the FDA has determined that the MMR vaccine is both safe and effective in preventing these diseases. We join our colleagues at HHS, CDC, National Institutes of Health and state and local health departments across the country in the continued effort to encourage vaccinations against these preventable diseases.

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.

FDA permits marketing of first medical device for treatment of ADHD

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by: U.S. Food and Drug Administration

Washington, D.C. - April 22, 2019 - (The Ponder News) -- The U.S. Food and Drug Administration has permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD). The prescription-only device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, is indicated for patients ages 7 to12 years old who are not currently taking prescription ADHD medication and is the first non-drug treatment for ADHD granted marketing authorization by the FDA.

“This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind,” said Carlos Peña, Ph.D., director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “Today’s action reflects our deep commitment to working with device manufacturers to advance the development of pediatric medical devices so that children have access to innovative, safe and effective medical devices that meet their unique needs.”

ADHD is a common disorder that begins in childhood. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior and very high levels of activity. The diagnosis of ADHD requires a comprehensive evaluation by a health care professional. For a person to receive a diagnosis of ADHD, the symptoms of inattention and/or hyperactivity-impulsivity must be chronic or long-lasting, impair the person’s functioning and cause the person to fall behind normal development for his or her age.

The Monarch eTNS System is intended to be used in the home under the supervision of a caregiver. The cell-phone sized device generates a low-level electrical pulse and connects via a wire to a small patch that adheres to a patient's forehead, just above the eyebrows, and should feel like a tingling sensation on the skin. The system delivers the low-level electrical stimulation to the branches of the trigeminal nerve, which sends therapeutic signals to the parts of the brain thought to be involved in ADHD. While the exact mechanism of eTNS is not yet known, neuroimaging studies have shown that eTNS increases activity in the brain regions that are known to be important in regulating attention, emotion and behavior.

The stimulation should feel like a tingling sensation on the skin, and the device should be used in the home under the supervision of a caregiver during periods of sleep. Clinical trials suggest that a response to eTNS may take up to 4 weeks to become evident. Patients should consult with their health care professional after four weeks of use to assess treatment effects.

The Monarch eTNS System’s efficacy in treating ADHD was shown in a clinical trial that compared eTNS as the sole treatment, or monotherapy, to a placebo device. A total of 62 children with moderate to severe ADHD were enrolled in the trial and used either the eTNS therapy each night or a placebo device at home for four weeks. The trial's primary endpoint was improvement on a clinician-administered ADHD Rating Scale, ADHD-RS. ADHD-RS scales are used to monitor severity and frequency of ADHD symptoms. A higher score is indicative of worsening symptoms. The ADHD-RS uses questions about the patient’s behavior, such as whether they have difficulty paying attention or regularly interrupt others. The trial showed that subjects using the eTNS device had statistically significant improvement in their ADHD symptoms compared with the placebo group. At the end of week four, the average ADHD-RS score in the active group decreased from 34.1 points at baseline to 23.4 points, versus a decrease from 33.7 to 27.5 points in the placebo group.

The most common side effects observed with eTNS use are: drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue. No serious adverse events were associated with use of the device.

The Monarch eTNS System should not be used in children under seven years of age. It should not be used in patients with an active implantable pacemaker or with active implantable neurostimulators. Patients with body-worn devices such as insulin pumps should not use this device. The eTNS System should not be used in the presence of radio frequency energy such as magnetic resonance imaging (MRI), because it has not been tested in an MRI machine, or cell phones, because the phone’s low levels of electromagnetic energy may interrupt the therapy.

The FDA reviewed the Monarch eTNS System through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

The FDA granted marketing authorization of the Monarch eTNS System to NeuroSigma.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, 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.

Thursday, March 28, 2019

Congressman Blumenauer Leads a Letter to FDA in Support of Plant-Based Food Products

by: Earl Blumenauer (D-OR, 3rd)

Portland, OR - March 28, 2019 - (The Ponder News) -- Congressman Earl Blumenauer (D-OR), along with several members of Congress, wrote a letter to the Food and Drug Administration (FDA) in support of plant-based alternative food products like almond milk and coconut butter. The lawmakers wrote to urge FDA Commissioner Scott Gottlieb and the agency to preserve use of terms like “milk, cheese, yogurt, and butter” in product labels of plant-based alternatives.

“American consumers seek these [plant-based] alternatives for many reasons, including allergies or intolerance to dairy, nutritional needs, religious and ethical beliefs, sustainability, and, quite often, taste preference,” the lawmakers wrote in the letter. “To prevent these food products from including the names of dairy foods in their labels would only lead to confusion in the marketplace.”

“We applaud Congressman Blumenauer and his colleagues in the House for advocating for food innovation by asking the FDA to not make unnecessary and harmful labeling changes,” said Michele Simon, Executive Director of the Plant Based Food Association. “The FDA’s proposed labeling changes would undermine our members’ ability to communicate to consumers who are seeking out healthier and more sustainable plant-based options.”

In 2018, FDA Commissioner Scott Gottlieb announced FDA’s Nutrition Innovation Strategy (NIS) in a speech to the National Food Policy Conference. As part of its strategy, the FDA is considering approaches to modernize “standards of identity,” which are regulations that set forward requirements for the content and sometimes the methods used to produce certain foods.

Click here to read the letter.

Wednesday, December 13, 2017

Federal Food, Drug, and Cosmetic Act Amendment Signed Into Law

By Greg Walden (R-OR, 2nd)



Washington, D.C. - December 13, 2017 - (The Ponder News) -- President Trump signed into law legislation introduced by Rep. Greg Walden (R-Hood River) to ensure the military has access to lifesaving medical treatments. Walden’s legislation (H.R. 4374) passed the House and Senate unanimously, and will amend the Federal Food, Drug, and Cosmetic Act to authorize additional emergency uses for medical products to reduce deaths and severity of injuries caused by agents of war.

“This is an important day for our brave men and women in uniform, ensuring they get the timely care they need while protecting our country,” said Walden. “Today we are well on our way to delivering the newest treatments and devices to our war fighters without forgoing important safety mechanisms.”

Specifically, Walden’s legislation corrects language within the National Defense Authorization Act – which was also signed into law today – that could have usurped FDA’s critical authority of ensuring the safety and efficacy of cutting edge medicines for our soldiers on the front lines.

Walden’s bill will streamline the processes at the Food and Drug Administration (FDA) and Department of Defense (DoD) to ensure America’s warfighters have access to new, lifesaving medications in a timely manner.

''Our men and women in uniform put their lives on the line for this country, and they deserve to have the earliest possible access to medical products that could save their lives on the battlefield,” said Walden in a speech on the House floor when the legislation passed the House in November. “In short, H.R. 4374 addresses the critical issue of military access to the newest available products by expanding the circumstances under which emergency use authorizations can be issued, and by establishing an expedited pathway to full approval of products that the Secretary of Defense requests.”

For Representative Walden’s legislation, please click here.


Wednesday, April 12, 2017

Food and Drug Administration



Free KY Amish Farmer Samuel Girod
Kentucky Free Press
March 30, 2017

Samuel Girod and his family have been making and selling three all-natural herbal products for nearly 20 years.

No one has ever been harmed by the products, the Girods have pages of testimonials and scores of repeat customers.

Similar products are currently made and sold online worldwide (including on Amazon) by other people using the same or similar basic ingredients. The recipes are online as well, you can make them in your kitchen.

In 2001, an FDA agent informed Sam that his product labels were making medical claims regarding healing certain conditions. Sam had to change his label or do very expensive testing proving the claims.

Sam changed the label, removing any medical claims.

Sam did not receive any further communication from the FDA until 2012 when someone called the FDA and reported that a store in MO was selling Sam’s products and that medical claims were being made.

The “medical claims” were in fact customer testimonials contained in a brochure about Sam’s products!

Then the FDA claimed to have found a customer who had been harmed by Sam’s bloodroot salve. This customer has never been identified or produced, yet a federal judge put an injunction on Sam’s products with three stipulations: none could be sold until all medical claims were removed (referring to the brochures), the bloodroot salve could never be sold again ever (1), and Sam had to allow inspection of his property where the products were made.

Read more...