FDA pushes back on Trump administration attempt to rebrand ‘emergency authorization’

While Congress mandated earlier this year that Medicare cover the cost of administering a licensed vaccine, the requirement did not include drugs authorized under emergency-use designations. That’s raised the prospect that millions of people could be forced to pay out of pocket unless Congress were to adopt a quick fix.

HHS officials over the past month thought they found a solution, with Charrow arguing that the FDA should make clear that emergency authorization of a Covid-19 vaccine is equal to a “pre-licensure,” and should be covered by Medicare as a result, the officials said.

But Hahn firmly opposed the idea, amid concerns that failing to stick to the FDA’s technical language would erode the agency’s credibility and open it up to accusations that it’s allowing politics to influence its role in the Trump administration’s vaccine hunt.

“Hahn is hell bent against any modification of definitions, because it would be viewed as a politicization of science,” one senior administration official said, adding that while Hahn has so far rebuffed the proposal, some believe the White House could still get involved and demand changes.

Of particular concern, the official said, is that referring to a Covid-19 vaccine as having won a “pre-licensure” would be conflated with the shot being fully licensed by the FDA – a level of regulatory approval that signals the vaccine has met significantly higher standards for safety and effectiveness, and one the agency does not expect to grant to any vaccine candidates any time soon.

President Donald Trump has already spent months contradicting his own health officials involved in the complicated vaccine development process, claiming repeatedly that a viable vaccine is just around the corner and could be delivered faster than the end-of-year target agreed upon by the officials.

Suddenly changing how the FDA labels an eventual coronavirus vaccine could further muddle the situation, FDA officials worried, sparking confusion and deepening distrust of its work toward authorizing a vaccine.

In a statement, an FDA spokesperson pointed to “important substantive differences” between an emergency use authorization and the more stringent process required to seek full licensure of a vaccine.

“There is no such thing as ‘pre-licensure’ or ‘pre-approval’ under the laws FDA administers,” the spokesperson said.

An HHS spokesperson said that its Centers for Medicare and Medicaid Services is still exploring coverage options for vaccines authorized under an emergency use designation. And two administration officials downplayed the “pre-licensure” concept as an “academic discussion” about safety and effectiveness that never rose to the level of HHS Secretary Alex Azar.

But in talks with Hahn over the past several weeks, HHS officials presented the “pre-licensure” relabeling as the simplest and quickest way to close the Medicare coverage loophole, officials familiar with the conversations said.

The move would also prevent the Trump administration from having to rely on Congress to pass a legislative fix – a path that could get bogged down in gridlock on Capitol Hill.

“They’re trying to get creative – Congress is in disarray and they want a solution

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Coronavirus declared global health emergency by WHO

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Media captionDr Tedros Adhanom Ghebreyesus: “We must all act together now to limit further spread”

The new coronavirus has been declared a global emergency by the World Health Organization, as the outbreak continues to spread outside China.

“The main reason for this declaration is not what is happening in China but what is happening in other countries,” said WHO chief Tedros Adhanom Ghebreyesus.

The concern is that it could spread to countries with weaker health systems.

Meanwhile, the US has told its citizens not to travel to China.

The state department issued a level four warning – having previously urged Americans to “reconsider” travel to China – and said any citizens in China “should consider departing using commercial means”.

China has said it will send charter plans to bring back Hubei province residents who are overseas “as soon as possible”.

A foreign ministry spokesman said this was because of the “practical difficulties” Chinese citizens have faced abroad. Hubei is where the virus emerged.

At least 213 people in the China have died from the virus, mostly in Hubei, with almost 10,000 cases nationally.

  • US advises against all travel to China over virus
  • Cement mixers become celebrities in China lockdown

The WHO said there had been 98 cases in 18 other countries, but no deaths.

Most international cases are in people who had been to Wuhan in Hubei.

However in eight cases – in Germany, Japan, Vietnam and the United States – patients were infected by people who had travelled to China.

People wearing masks

Getty

Coronavirus outbreak outside ChinaSource: WHO and local authorities

Speaking at a news conference in Geneva, Dr Tedros described the virus as an “unprecedented outbreak” that has been met with an “unprecedented response”.

He praised the “extraordinary measures” Chinese authorities had taken, and said there was no reason to limit trade or travel to China.

  • Trump official: Coronavirus may boost US jobs
  • Britons on evacuation flight home from Wuhan

“Let me be clear, this declaration is not a vote of no confidence in China,” he said.

But various countries have taken steps to close borders or cancel flights, and companies like Google, Ikea, Starbucks and Tesla have closed their shops or stopped operations.

The US Commerce Secretary, Wilbur Ross, has said the outbreak could “accelerate the return of jobs to North America”.

Preparing other countries

What happens if this virus finds its way into a country that cannot cope?

Many low- and middle-income countries simply lack the tools to spot or contain it. The fear is it could spread uncontrollably and that it may go unnoticed for some time.

Remember this is a disease which emerged only last month – and yet there are already almost 10,000 confirmed cases in China.

The 2014 Ebola outbreak in West Africa – the largest in human history – showed how easily poorer countries can be overwhelmed by such outbreaks.

And if novel coronavirus gets a significant foothold in such places, then it would

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Dentist Delray Beach | General and Emergency Dentistry

Welcome To Dentist Delray Beach

Dentist Delray Beach was founded in 2012 and is the leading dentist in Delray Beach in all aspects of dentistry such as: teeth cleaning, dental exams, crowns, bridges, dental implants, sedation dentistry, sealants, extractions, general dentistry, holistic dentistry, Invisalign®, orthodontics, dentures, periodontal work, Lumineers®, root canals, dental implants, teeth whitening, TMJ treatment, veneers and laminates, and tooth colored fillings. We have an emphasis on patient comfort as well as keeping up-to-date with the latest advancements in dentistry. This enables us to provide our patients with the best quality of care in the field. We also have a wide range of experience in different areas of dentistry, from cosmetic and restorative dentistry to surgical treatments and root canal treatments.

“I am proud to provide my patients with the best in dental technology, treatment options and patient comfort. It is my pleasure to address all your questions and concerns.”

Our team consists of dedicated individuals who are kind, friendly, and caring. The staff is here to ensure a pleasant experience during your visit to our office. The world-class  team at Dentistry Delray Beach includes experienced and energetic people whose goal is to communicate well with our patients and provide the best care possible.

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American Academy of Emergency Medicine

President’s Message

As, I write my last president’s message, I have been reflecting on the last 27 months. Thank you for the amazing opportunity you gave me to earn your trust and support. My last president’s message will be a call to action. Our specialty is under attack from every possible angle… insurance companies, the threat of advanced practice provider (APP) independent practices, CMGs controlling our practice, congress “fixing” the balanced billing issue, etc. 

As a specialty, we need for all emergency physicians to get involved. I often hear: “Why should I join an AAEM committee?” “Why should I write and visit my congressional representative?” “Why should I encourage others to join AAEM and get involved?” “Why should I donate to the AAEM PAC?” “I am content, I am happy where I am!” This is the “laissez-faire” attitude that got us where we are at today! Laissez-faire is a French noun meaning “attitude of letting things take their own course, without interfering” We allowed others to make decisions for us, we allowed others to be at the table making decision for us—not just emergency physicians, but all physicians.

 

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How to Handle a Dental Emergency: Dentists’ Tips

You may consider your teeth to be a low priority compared to the rest of your body. Aside from brushing and the occasional flossing, you probably neglect them until you experience dental problems like pain, swelling, or bleeding. Sometimes this can manifest into a dental emergency. But should you go to the hospital or your dentist?

The American Dental Association (ADA) says that emergency room (ER) visits for dental problems have consistently been on the rise since 2000, jumping from 1.1 million to roughly 2.1 million a year. Of those visits, 1.65 million could have been referred to a dental practice instead, saving the healthcare system $1.7 billion, not to mention savings for the consumer, too. “Most ERs do not have dentists available,” says Mary Hayes, DDS, an ADA spokesperson based in Chicago. “Physicians have limited training when it comes to mouth issues, so your dentist is usually the best authority.” Check out the 13 signs you need to see your dentist ASAP.

To successfully navigate common dental problems, we spoke with dentists on how to handle dental emergencies at home with a few key items. Plus, they share when you should wait for a dentist or go to the hospital for urgent care.

young woman brushing her teeth close up

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Monitor your diet for cavity care

It’s important to schedule your dental checkup (which is on average every three to six months) to make sure you’re practicing good oral hygiene. In the meantime, if you haven’t been following the best preventative care—brushing twice a day and flossing often—tooth decay can build up, leading to cavities. And while a cavity can be painful on its own, leaving one untreated for too long can cause more serious issues.

“When cavities progress they can lead to nerve damage, and this results in the patient needing a root canal,” says Bruce Lein, DDS, a dentist based in Jupiter, Florida. Even if your cavity doesn’t warrant a root canal other problems may arise like gum disease, adds Mark Burhenne, DDS, a dentist based in Sunnyvale, California.

You can’t reverse a cavity, but there are a few things you can do on top of good oral hygiene to slow and prevent further decay. “Stay away from carbs, processed foods, and packaged goods,” says Dr. Burhenne. “Bread is one of the most common causes of decay and gum disease.” (There are actually 8 foods that will help prevent tooth decay.) Another factor is if you suffer from dry mouth. “This is where mouth tape can come in handy,” says Dr. Burhenne. “If you tend to sleep with your mouth open, tape will keep it shut and prevent pH changes in your mouth, helping the oral microbiome stay balanced.” Not sure if you have a cavity?

Use temporary filling material for a broken molar

Next to cavities, Dr. Burhenne says molar issues are a common problem he sees in his practice. Molars can break from biting something too hard, or as a result of a fall. Unfortunately, you won’t be able to

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Emergency Medicine Foundation to Fund Research to Improve Nation’s Response to COVID-19

WASHINGTON, April 14, 2020 /PRNewswire/ — The Emergency Medicine Foundation, a 501(c)(3) nonprofit organization founded by the American College of Emergency Physicians (ACEP) to advance research and education in emergency medicine, has recently announced that it will award up to $100,000 in new research grants to further the medical community’s understanding of and response to the novel coronavirus, COVID-19. 

“Emergency Medicine Foundation sponsored research has been defining and refining the practice of emergency medicine for almost 50 years, and it is imperative that we act immediately as new threats, like COVID-19, arise,” said David Wilcox, MD, FACEP, Chair of the EMF Board of Trustees.

Through these funds, the Emergency Medicine Foundation and ACEP seek to effect quick and meaningful change by advancing emergency patient care, improving how our health care system responds and ensuring that our health care workers are protected during this and future pandemics.

Proposals are due June 5, 2020 and eligible applicants must be a United States-based emergency physician as principal or co-principal investigator with a project active and in place by July 1, 2020. Proposal topics may include, but are not limited to, the following:

  • Personal Protective Equipment (PPE), including Design, Cleaning, Re-use
  • Ventilator Scarcity
  • Telemedicine
  • Laboratory Testing
  • Rapid Screening, Triage and Testing
  • Clinical Diagnosis
  • Epidemiology of Disease
  • Therapeutics
  • Diagnostic Radiology, including Point of Care Ultrasound
  • Emergency Medicine Workforce, including Safety
  • Emergency Physician Wellness
  • Special Populations (High Risk, Homeless, Non-English Speaking, Transplantation Patients)

Click here to read the request for proposals.

The American College of Emergency Physicians (ACEP) is the national medical society representing emergency medicine. Through continuing education, research, public education and advocacy, ACEP advances emergency care on behalf of its 39,000 emergency physician members, and the more than 150 million Americans they treat on an annual basis. For more information, visit www.acep.org and www.emergencyphysicians.org. 

The Emergency Medicine Foundation (EMF) is a 501(c)(3) nonprofit organization founded in 1972 by visionary leaders of the American College of Emergency Physicians (ACEP). EMF supports scientifically rigorous research and education that improves the care of the acutely ill and injured. To date, EMF has awarded more than $17 million in research grants to advance emergency medicine science and health policy. For more information visit www.emfoundation.org. Companies or individuals interested in contributing to support emergency medicine research can contact Peggy Brock, EMF Executive Director, at [email protected].

SOURCE Emergency Medicine Foundation

Related Links

https://www.emfoundation.org

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Promenade is an Emergency Dentist and Temecula Dentist Near To Me

Finding an affordable Temecula dentist is difficult! Dr. Bao is the most affordable dentist in Temecula. He is friendly and professional. It is even more challenging to find an office where you can see the same dentist on every visit. Dr. Bao will be your dentist on every visit so that you can get personalized service. Our friendly and knowledgeable staff understands your dental needs. We are always available if you need an emergency dentist.

$850 Same-Day Crowns*

We provide cutting-edge dentistry that gives our patients more choices. Our technology includes Digital X-rays, digital record keeping, and intraoral photos. We also use CEREC® CAD/CAM restorations same-day crown restorations and more. We will keep your teeth looking their best and be more efficient and accurate with your dental care. Best of all, our affordable prices are the best in Temecula.

$19 Exam and Xrays

We offer comprehensive dental services from cleanings to exams to crowns and braces. Promenade Temecula Dental serves all your dental needs. Our military, trained dentist, has the training to minimize your discomfort. We even provide emergency dentist services. You can see a doctor immediately when you have a dental emergency.

$95 Advanced Teeth Cleaning

Everyone must get their teeth cleaned twice a year to maintain a healthy mouth and gums. Most dentists use old metal tools to scrape your teeth. Not only do they remove plaque but, they remove the enamel. With high-tech ultra-sonic teeth cleaning, we can clean your teeth pain free without removing any enamel. We charge only $95 rather than $199 like most dentists. We are also a high tech teeth whitening dentist. We offer teeth whitening for only $199.

Pain-Free Dentist Near Me

We understand that everyone has a different threshold for pain. If you have had a toothache that’s lasted several days you should find an emergency dentist. The pain could be the result of tooth decay. Even worse would be a dental abscess. Our staff at the Promenade Temecula Dentist can put an end to the pain. It will also help prevent your condition from getting worse.

* The $850 price for Same Day Crowns is a cash only price. It excludes any additional works such as root canal or build ups.

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Cosmetic, Family, Sedation, Emergency, Kids Dental

Your Dentists Providing The Best Dental Care Throughout New Mexico

TruCare Dental provides dentistry for families throughout Albuquerque, Rio Rancho and surrounding areas. Our dentists focus on providing the highest quality of dental services in a safe, clean, stress free and comfortable environment. Whether in need of emergency treatment, looking for another dentist or just coming in for a routine cleaning we are dentists you can trust. Our dentists are trained, skilled and qualified to offer you the expertise you are looking for. We provide conservative treatment options while always keeping your best interests in mind.

Let us be your dental home!

Our dentists and staff pride themselves in providing exceptional dentistry and are committed to creating a friendly, patient focused experience that you will enjoy. We strive to build a long-lasting relationship of trust by treating you as a special individual. When you set foot in our office, you will find that every staff member truly listens and wants to help address your specific needs.

Cosmetic Dentistry

cosmetic and natural dentistry albuquerque

If you are looking to spruce up your smile, our dentists have a number of cosmetic dentistry treatments that can take your smile from dull to dazzling. We offer: teeth whitening, tooth colored fillings, dental crowns, dental bridges and dental veneers. 

Sedation Dentistry

safe dental iv sedation

Is dental anxiety stopping you from getting the dental treatment you need? Sedation dentistry might help you come see the dentist without fear. We are confident that our sedation options can give you the relaxation you need during your visit with us.

Dental Implants

affordable dental implants in albuquerque

If you are missing one or more teeth, there are many dental treatments available. The one that is the most durable, permanent, attractive and sturdy is dental implants. Call our office to learn more about dental implants and how they can give you a new smile.

Family Dentistry

best family dentist near me

Our well-trained team want to give you and your loved ones the best family dentistry care possible. Our family dentistry treatments include tooth cleaning, fillings, crowns, root canals, bonding, wisdom teeth removal and emergency dental care. Family dentistry isn’t just about procedures. It’s about caring about our patients.

Your Smile Is Our Reward!

Don’t wait another day. You deserve to feel great about your smile and to feel confident. When you visit our office, your smile and oral health are out top priority. Call Us At (505) 369-0074!

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Emergency Dentist Vancouver | Coal Harbour Dentist

Emergency Dentist Vancouver | Coal Harbour Dentist | Vancouver Dental Clinic

We’re closed due to COVID-19 crisis and in support of public health emergency. For more detail Click Here

Dr. Nasrin Mansuripur is expert dentist in treatments like Lumineers, Laser dentistry, advanced Endodontics with rotary system, implants, and advanced cosmetic dentistry in our Vancouver dental clinic.

Dr.Nasrin Mansuripur

A key figure at Vancouver Harbour Dental, Dr. Nasrin plays a pivotal
role in organization and administration of the facility. She graduated in
the year 2006 from UBC and has working experience as a dentist in other
countries for about ten years. She recently gave her career a push, along
with pursuing further studies and research in courses like Invisalign,
Lumineers, Laser dentistry, advanced Endodontics with rotary system,
implants, and advanced cosmetic dentistry while also participating
in various study clubs.

Dr. Nasrin states her ultimate goal as a dental professional is to
ensure your treatment is carried out in a comfortable, stress free and safe manner.

Dr. Tonny Gill, dentist in Vancouver harbour dental clinic expertise in orthodontics, restorative & cosmetic dentistry and implantology.

Dr. Tony Gill

Dr. Gill has been doing difficult cosmetic and surgical cases since 1996, combining his expertise in orthodontics,
restorative & cosmetic dentistry and implantology, to create natural smiles which most people are unable to detect.

Dr. Gill worked with 11 different lower mainland dental offices last year, in performing all of their difficult
extractions as well as placing implants, bone grafting and assisting those dentists in learning about and restoring them.

He has been working with implants since 1993 and has taken many lectures and hands-on courses on implants,
surgery and bone grafting, including travel to the USA and Germany for courses and even studying with Dr. Paul Weigl
at the University of Frankfurt, School of Dentistry.

Dr. Nematollahi, expert dentist in Vancouver harbour dental clinic in orthodontics, restorative & cosmetic dentistry and implantology.

Dr. Nematollahi

Dr. Nematollahi is a board certified periodontist and a Fellow of the Royal College of Dentist of Canada. She practices full spectrum of periodontics with special interests in field of implant aesthetics and implant supported full mouth rehabilitations. Dr. Nematollahi portrays her passion for periodontics and her patients, by providing timely care and ensuring high quality and continuity of care and support to her patients.

Dr. Nematollahi is a published author in effects of implant surface on tissue behaviour and has been awarded J Tonzetich scholarship for her excellence in research in two consecutive years. She was awarded a fellowship in dental implants at UCLA where she trained under the direct supervision of internationally renowned oral surgeon, Professor Peter Moy.

She is a Clinical Assistant Professor at University of British Columbia and pursues her passion of teaching by devoting her time by supervising graduate students in the periodontal clinic.

She has had several international invitations as a speaker and has lectured at International Association of Dental Research (IADR) and Dental Training Institute in Beijing.

Dr. Nematollahi believes that the key to successful patient care is close collaboration and open communication with the dental team; her referring colleagues, hygienists and lab technicians.

Dr. Forogh Enjavitaraz has almost 27 years of experience working as a dentist.

Dr. Forogh Enjavitaraz

Dr. Forogh Enjavitaraz has almost 27 years of experience working as a dentist. She
graduated in 1991, started working overseas in the same year in her own dental office
and also at other dental clinics. She continued her

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Temecula Dentist Teeth Whitening Dentist -Emergency Dentist Near To Me.

Finding an affordable Temecula dentist is difficult! Dr. Bao is the most affordable dentist in Temecula. He is friendly and professional. It is even more challenging to find an office where you can see the same dentist on every visit. Dr. Bao will be your dentist on every visit so that you can get personalized service. Our friendly and knowledgeable staff understands your dental needs. We are always available if you need an emergency dentist.

$850 Same-Day Crowns*

We provide cutting-edge dentistry that gives our patients more choices. Our technology includes Digital X-rays, digital record keeping, and intraoral photos. We also use CEREC® CAD/CAM restorations same-day crown restorations and more. We will keep your teeth looking their best and be more efficient and accurate with your dental care. Best of all, our affordable prices are the best in Temecula.

$19 Exam and Xrays

We offer comprehensive dental services from cleanings to exams to crowns and braces. Promenade Temecula Dental serves all your dental needs. Our military, trained dentist, has the training to minimize your discomfort. We even provide emergency dentist services. You can see a doctor immediately when you have a dental emergency.

$95 Advanced Teeth Cleaning

Everyone must get their teeth cleaned twice a year to maintain a healthy mouth and gums. Most dentists use old metal tools to scrape your teeth. Not only do they remove plaque but, they remove the enamel. With high-tech ultra-sonic teeth cleaning, we can clean your teeth pain free without removing any enamel. We charge only $95 rather than $199 like most dentists. We are also a high tech teeth whitening dentist. We offer teeth whitening for only $199.

Pain-Free Dentist Near Me

We understand that everyone has a different threshold for pain. If you have had a toothache that’s lasted several days you should find an emergency dentist. The pain could be the result of tooth decay. Even worse would be a dental abscess. Our staff at the Promenade Temecula Dentist can put an end to the pain. It will also help prevent your condition from getting worse.

Emergency Dentist

Our dentist near to me at Promenade Dental Care has many years as a military emergency dentist. As such, he has more experience and training than most dentists. He uses the latest techniques to reattach knocked out teeth, and broken teeth. He can help ease your pain with toothaches or abscessed teeth. We can also assist you with a loose or broken crown. He can usually see you within an hour for emergency dental care.

The sooner you get help for a knocked-out tooth or a broken tooth the more likely Promenade will be able to save it. To improve your chances, preserve your knocked-out tooth in a glass of milk and bring it to our office. For lost dental crowns or dental fillings, use a piece of sugarless gum to fill the gap. Then immediately seek emergency dental care as soon as possible.

Call us for Promenade Temecula Dentist or

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