SUNDAY TWEETORIAL: For those who follow me, you’ll know that the topic of this week’s #FDA Sunday Tweetorial is among the most critical: food safety. FDA takes our responsibility for assuring safety of the food supply seriously, and food safety is one of my highest priorities
The US has one of the safest food supplies in the world. #FDA continues to make sure the abundant, diverse, and complex global food supply is safe, and that food imported into the US is held to the same standards as food produced at home
FDA uses several tools to better identify foodborne illnesses and outbreaks. These advances in technology protect consumers, so let’s look deeper at some of these groundbreaking tools and their public health benefit
Let’s start with whole genome sequencing (WGS), a powerful technique that determines the genetic fingerprint of disease-causing microbes with unprecedented precision. #FDA is building a WGS food laboratory network to protect consumers globally bit.ly/2xRAfsa
WGS links human illnesses to identify if an outbreak is caused by a specific food. WGS compares the genetic fingerprint of disease-causing microbes in food to those isolated from ill consumers. Linking illnesses to specific food allows FDA to act quickly to protect public health
FDA collaborates closely with CDC on WGS, as CDC has sequencing capacity across the US to perform WGS on pathogens from ill people, while #FDA conducts sequencing on pathogens identified in foods and settings like food manufacturing plants bit.ly/2M1RIUO
FDA’s GenomeTrakr is 1st distributed network of food labs to use WGS. It consists of >60 federal, state, university, hospital & int’l labs. GenomeTrakr has sequenced >183k isolates and is regularly sequencing >5k isolates per month. NIH assists by storing & assessing the data
By sequencing the DNA of pathogens, WGS reveals markers like genetic fingerprint and antimicrobial resistance, and offers clues about geographic source. This helps scientists respond more effectively to food contamination, allowing faster recalls and preventing illnesses
Robust research has confirmed that WGS provides investigators with a new tool to determine whether or not consumers got sick from the same pathogen or a closely related cousin. This speeds up investigations by eliminating unrelated cases bit.ly/2tbncRl
#FDA also is developing a new microbiological surveillance sampling program designed to identify patterns that may help predict and prevent future contamination by disease-causing bacteria bit.ly/2tgmW3Fbit.ly/2M9pJCA
To help inform consumers, retailers and restaurants during outbreaks, #FDA provides info about specific pathogens, the foods linked to them, and what consumers can do to protect themselves and their families. Our newest page talks about Cyclospora: bit.ly/2KbwuX7
It may seem there are more foodborne illnesses lately, but we’re able to spot previously undetected outbreaks as we apply tools like WGS. By investigating outbreaks, we can determine underlying causes and take steps to prevent problems from reoccurring bit.ly/2tjX1YM
It’s not enough to slow or stop an outbreak. Our goal, through regulation and use of technology, is to shift our food system from one that just reacts to problems to one that prevents them from happening in first place. Food safety is priority #1 from the farm to table
#FSMA implementation is critical to our efforts but more resources are needed to fully implement the #FSMA rules at home and abroad; to provide technical support to industry and growers to get it right; and to conduct inspections to assure compliance bit.ly/2CjBNwE
Recent outbreaks highlight the all-too-real consequences of foodborne illness. They also provide a roadmap of where we must head to ultimately prevent them from happening. I believe we’re heading in the right direction and over time we'll see the benefits of our efforts
Meet the key #FDA leaders dedicated to keeping foods safe and responding to hazards from contamination of all kinds, including toxins in the environment, bacteria from unsafe production practices, and intentional adulteration bit.ly/2MdoCBY
#FDA’s food safety mission covers animals too. The Center for Veterinary Medicine works to keep animal feed and pet food free of the contaminants that not only make animals sick, but can have an impact on human health too bit.ly/2IiWrPr
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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.
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
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.
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.
THREAD ON NEW ENFORCEMENT ACTION: We’re taking action against manufacturers marketing “vaginal rejuvenation” devices to women by deceptively claiming the procedures treat conditions and symptoms related to menopause, urinary incontinence, & sexual function fda.gov/NewsEvents/New…
These products have serious risks and don’t have adequate evidence to support their use for these purposes. We’re deeply concerned women are being harmed by these procedures
In some cases, the devices are marketed to women who’ve completed treatment for breast cancer and experience symptoms caused by early menopause. Deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious.
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.