Discover and read the best of Twitter Threads about #SundayTweetorial

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Today’s #FDA #SundayTweetorial is personal. I look back at what we've accomplished at FDA to advance innovations to benefit patients, promote policies to protect consumers, and address public health challenges during the two years I've shared these experiences with my colleagues.
I was truly fortunate to arrive at #FDA at an inflection point in medicine, health, and science – during a time when new discoveries, made right down to the molecular level, offer the potential to transform health, protect consumers, and cure disease in fundamentally novel ways.
Each novel medical technology challenged #FDA to be nimble and creative in its approach to product evaluation so that innovation would not only advance efficiently to benefit patients but do so while strengthening the agency’s gold standard for safety and effectiveness.
Read 46 tweets
The U.S. is facing a new epidemic sparked by the surging popularity of e-cig use by kids. Halting this public health crisis requires forceful steps from FDA. In today’s #FDA #SundayTweetorial I’ll detail what we advanced last week – and why. And what additional steps we may take.
To explain, let’s go back a bit in time to see how this issue has evolved. In 2017, early after I became commissioner, #FDA was poised to put us on a path to overcome one of the most pernicious public health challenges of our times – death and disease caused by cigarette smoking.
I saw the chance to advance new technologies like electronic cigarettes as part of that plan. We saw these products as potentially less harmful alternatives to cigarettes for some adult smokers seeking access to nicotine, without all the deadly effects of combustion.
Read 28 tweets
One of the most troubling public health issues today is the escalating popularity of e-cigarettes among our nation’s youth. In today’s #FDA #SundayTweetorial I’m laying out our case for why vaping endangers the health of youth.
Anecdotally, I’ve heard from parents of kids who are addicted – telling me how easy it is for teens to buy and use e-cigarettes, how e-cig images are all over social media, and how their kids tell them that so many of their friends in high school are using these products.
You’ve probably heard those reports, too. But my comments today aren’t based on anecdotes. They’re informed by a growing body of evidence showing e-cigarette use by youth is truly a health epidemic—and one with the potential for serious consequences.
Read 19 tweets
Our #FDA #SUNDAYTWEETORIAL is BACK! Are you throwing a party this #SuperBowl Sunday? Don’t forget to tackle food safety. In today’s Tweetorial, I’ll be serving up a defensive game plan for how you can best protect your family and friends from foodborne illness during the telecast
We know that three common foodborne bacteria like to crash parties. They are Staphylococcus aureus, Clostridium perfringens and Listeria monocytogenes. And unlike microbes that cause food to spoil, you can’t detect these bacteria by smelling or tasting them.
So, what to do? Consider following this four-step game plan. It involves Cleaning (hands, utensils surfaces); Separating (Don’t cross-contaminate); Cooking (use a food thermometer): and Chilling (food promptly), + a few added tips for entertaining go.usa.gov/xE9AJ.
Read 16 tweets
As a science-based agency we rely on evidence generated from data to inform regulatory decisions. #FDA's #SundayTweetorial discusses how we use data from real-world settings to enhance what we know about medical products. This week we'll announce policies to advance these efforts
What I’m talking about is the use of “real-world data” (RWD) to generate “real-world evidence” (RWE), concepts promoted by Congress in 21st Century Cures Act of 2016 and of great interest to #FDA bit.ly/2MUOEL0. To better understand our efforts, let’s define some terms.
RWD are data relating to patient health status and/or delivery of health care routinely collected from a variety of sources, including health insurance claims, electronic health records (EHRs), product and disease registries, lab results, patient-generated data and mobile devices
Read 23 tweets
Assuring the safety of medical products is central to FDA’s consumer protection mission. In today’s #FDA #SUNDAYTWEETORIAL I’m going to talk about FDA’s ambitious new safety goal for medical devices and our 510K reforms that, once implemented, will advance safety and innovation.
We've set a new goal that WE WILL achieve: Ensuring #FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices. This is a top priority. Many have asked me what does that mean? And how will #FDA do that?
First, a little background: #FDA regulates more than 190,000 different medical devices that are manufactured by more than 18,000 companies in more than 21,000 facilities worldwide. We approve, clear or grant marketing authorization to about 12 new or modified devices every day.
Read 26 tweets
It’s the start of flu season – time to protect yourself and your family by getting vaccinated! In today’s #FDA #SUNDAYTWEETORIAL I’m going to talk about #FDA’s role in ensuring the safety, effectiveness, and availability of the 2019 influenza vaccines. #VaccinesWork #FightFlu
I know there are questions about the effectiveness and benefits of the flu vaccine given the severity of last year’s flu season, so I want to update you on what we’ve learned, the effectiveness of this year’s vaccine and why vaccination is important go.usa.gov/xPWhS.
We've made important modifications to this year's #Flu vaccine to improve its effectiveness; changing two of the strains (for the H3N2 and Influenza B components) to better reflect the influenza strains that we believe are most likely to circulate this winter. More on this later.
Read 22 tweets
Compounded drugs serve an important medical need for patients who can’t use an FDA-approved medication. In today’s #FDA #SUNDAYTWEETORIAL, I’m going to talk about what FDA is doing to preserve access to appropriately compounded drugs while protecting patients from serious risks.
In drug compounding, ingredients are combined, mixed or altered to create a sterile or non-sterile medication tailored to a patient - such as those with an allergy who need a drug without a certain dye or a child who can’t swallow a tablet and needs medicine in a liquid form.
But compounded drugs, which aren’t FDA-approved, may pose serious risks if not produced properly, potentially resulting in contamination or medications that do not possess the strength, quality or purity they are supposed to have bit.ly/2G7IpjB
Read 23 tweets
As kids are heading back to school, for this #FDA #SUNDAYTWEETORIAL I’m going to talk about MEASLES and the vital importance of vaccination. You may’ve seen recent news stories reporting cases of measles in parts of the US and EU. Most cases have occurred in unvaccinated people
In 2018 there have been 124 individual cases of measles in 22 states and D.C. Measles can spread when it reaches a community where there are groups of unvaccinated people. And travelers with measles continue to bring the disease into the United States go.usa.gov/xUzwa
Measles is caused by the rubeola virus and is highly contagious. It is normally passed through direct contact or through the air. The virus infects the respiratory tract, then spreads throughout the body, causing a skin rash, fever, cough and runny nose.
Read 19 tweets
Consumers want and expect safe, wholesome and affordable food. They deserve nothing less. In today’s #FDA #SUNDAYTWEETORIAL I’m talking about what steps the FDA, the states and produce farmers are taking - in collaboration - to ensure the safety of fresh fruits and vegetables.
We hear too often about food safety concerns involving fresh fruit and vegetables -most recently the outbreak of E. coli O157:H7 infections associated with romaine lettuce from the Yuma growing region, the largest such outbreak in the U.S. in more than 10 years.
From 1998-2008 there were 455 produce-associated food outbreaks, with more than 16,000 people becoming ill, more than twice the number of produce-associated illnesses from 1973-1997. This is a significant public health burden that should be largely preventable.
Read 25 tweets
For this weekend's #FDA #SUNDAYTWEETORIAL I’m going to talk about what FDA is doing to modernize clinical trials to reduce the cost of drug development, potentially lower drug costs and bring more safe, effective therapies to patients.
FDA’s mission is to both promote and protect public health. For medical products, this means ensuring that they are safe and effective for their intended use. Clinical trials are the primary vehicle for generating the evidence FDA needs to ensure that.
The traditional drug development paradigm calls for 3 clinical trial phases: A small phase 1 tests safety and dosing, phase 2 tests short-term side effects and effectiveness over a range of doses; and the large phase 3 assesses whether the product’s benefits outweigh its risks.
Read 22 tweets
The topic of this week’s #FDA #SUNDAYTWEETORIAL is #drugshortages. FDA does everything possible within our authority to help address shortages. While we’ve made progress to mitigate shortages; we must do even more to understand and address the root causes of persistent shortages
Manufacturing & quality issues are some of the proximate causes of drug shortages. Availability of raw materials; unexpected increases in demand, i.e. due to illness outbreaks or changes in clinical practice; or unavailability of other drugs in a class also can lead to a shortage
We’ve seen # of new drug shortages steadily decline due to work by FDA, industry and others. In 2017, we worked w/ manufacturers to prevent 145 shortages. There were still 35 new shortages last year, but this compared to peak of 251 new shortages in ‘11 bit.ly/2JiNGpf
Read 17 tweets
For this week’s #FDA #SUNDAYTWEETORIAL, I want to talk about #biosimilars. It's a critical moment in the development of the market for these products. We'll advance major policy changes in this area soon. Enhancing biosimilar competition is a key to reducing overall drug spending
Congress charged #FDA with maintaining balance between encouraging and rewarding innovation and facilitating robust and timely competition. We must ensure that this balance exists across the spectrum of pharma products; from small molecules to more complex products to biologics
Biologics play a key role in treating many serious illnesses like cancer or genetic disorders. While they offer many therapeutic benefits, biologics often come at high expense. While <2% of US patients use biologics, they represent ~40% of total Rx spend bit.ly/2EsWDOr
Read 19 tweets

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