Profile picture
Alex Clark
@Hello_Alex
, 6 tweets, 3 min read Read on Twitter
Re: #FDA Compliance Policy Mod for Certain #Tobacco products.

The real timeline here starts with 2010 when @FDATobacco was denied authority to regulate #vaping as a drug/device. That's we knew for certain that these products would be regulated. . .
. . . under the TCA. But now, after YEARS of failing to provide meaningful guidance to industry regarding PMTA and/or streamlining the process for low-risk tobacco and #nicotine products, @FDATobacco is claiming . . .
. . .that a sudden spike in youth trying #vaping in 2017-2018 is responsible for derailing their efforts to ensure access to safer tobacco/nicotine products.

Moreover. . .
FDA has had every opportunity SINCE 2014 (when the proposed #FDAdeeming rule was published for comment) to recommend/implement ROBUST AGE VERIFICATION REQUIREMENTS for ALL TOBACCO and NICOTINE products.

>> But Did Nothing<<

So now, . . .
. . . in response to a "crisis" they helped to create, FDA is returning to heavy-handed regulation that will discourage EVERYONE from switching to safer, #smokeFree alternatives to combustible tobacco.

¯\_(ツ)_/¯
Missing some Tweet in this thread?
You can try to force a refresh.

Like this thread? Get email updates or save it to PDF!

Subscribe to Alex Clark
Profile picture

Get real-time email alerts when new unrolls are available from this author!

This content may be removed anytime!

Twitter may remove this content at anytime, convert it as a PDF, save and print for later use!

Try unrolling a thread yourself!

how to unroll video

1) Follow Thread Reader App on Twitter so you can easily mention us!

2) Go to a Twitter thread (series of Tweets by the same owner) and mention us with a keyword "unroll" @threadreaderapp unroll

You can practice here first or read more on our help page!

Related hashtags

#FDA #Tobacco #vaping #nicotine #FDAdeeming #smokeFree

Related threads

Profile picture
Scott Gottlieb, M.D.
@SGottliebFDA
THREAD: #FDA will continue to advance certain policy, consistent with what's permissible under law. Carryover user-fees support important actions, including developing guidance and advancing policies that further FDA’s regulatory oversight of medical products and animal drugs.
#FDA will also use carryover funding to support development of medical products. This includes participating in pre-approval discussions with sponsors seeking guidance on how to go forward with clinical research and other ongoing discussions to help advance development programs.
However, this doesn't mean it's business as usual at #FDA; the lapse in funding will limit many medical product related activities, including the development of certain guidances. We also cannot accept new applications for medical products that require the payment of a user fee.
Read 16 tweets
Profile picture
Scott Gottlieb, M.D.
@SGottliebFDA
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
Profile picture
Scott Gottlieb, M.D.
@SGottliebFDA
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
Profile picture
Clara Jeffery
@ClaraJeffery
1/ Amid Twitter maybe getting rid of the "like" to promote "better dialog" and certainly giving safe haven to nazis and other extremists, a rant:
2/ You probably noticed how, people came forward to say that they'd reported the bomber for violent threats, and Twitter (as always) did nothing and (as always) now apologizes but (as always) won't say how they'll better handle. They won't, and I'll tell you one big reason why.
3/ to address complaints about threats and "improve the dialog" Twitter introduced the "quality filter." You see fewer threats and hate speech. BUT THAT DOESN'T MEAN THERE'S LESS OF IT.
Read 16 tweets
Profile picture
Scott Gottlieb, M.D.
@SGottliebFDA
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
Profile picture
Clive Bates
@Clive_Bates
Unacceptable on what ethical basis? @fdatobacco surely recognises the reality-based world of youth doing risky things, whatever FDA wants? When kids who would otherwise have smoked take to #vaping instead, there is a clear public health benefit. Preventing that causes harm. 1/7
There is something disturbing about this argument, beyond the obvious indifference to the health and wellbeing of young people from more disadvantaged backgrounds. It’s an attempt to simplify the world by declaring a moral posture rather than deal with the world as it is. 2/7
And why do this? Because @FDATobacco’s favoured #vaping policies - e.g. banning e-liquid flavors and bullying @JUULvapor - are impossible to justify if #ecigs are reducing youth smoking. So that potential benefit can’t be recognised. 3/7
Read 7 tweets

Trending hashtags

#SundayTweetorial #delusion #Strauss #DontNameThem #Qproofs #permit #premium #SuperBowl #ChequersPlan #German #MFN #here #REGULATE #licence #chicken #FDA #Regulation #reclaimedfur #quote #PR #ProjectProsperity #poultry #ContractManagement #métis #companies
Follow Us on Twitter!

Did Thread Reader help you today?

Support us! We are indie developers!

This site is made by just three indie developers on a laptop doing marketing, support and development! Read more about the story.

Become a Premium Member ($3.00/month or $30.00/year) and get exclusive features!

Become Premium

Too expensive? Make a small donation by buying us coffee ($5) or help with server cost ($10)

Donate via Paypal Become our Patreon

Thank you for your support!