As drug CEOs begin their testimony they're getting sworn in to tell the whole truth ¬hing but the truth
CEOs had to do that at last year's drug pricing hearing too, but some statements were misleading
Here's a reminder of what happened last time: news.bloomberglaw.com/health-law-and…
Most of the CEOs testifying today and tomorrow are not from the same companies as last year. I bring up last year's hearing as a reminder to fact check what you hear during hearings like this where there's so much $ on the line
Sep 9, 2020 • 5 tweets • 2 min read
Senate HELP hearing on #COVID__19 and flu vaccines starting now
Francis Collins from NIH and Surgeon General Jerome Adams testifying
Trump and CDC says a vaccine could be ready by Nov. Fauci says that's unlikely.
Today will be about fostering public trust in the FDA/potential vaccine
Public messaging blunders (like w convalescent plasma) has shook some confidence but scientists assure safeguards will prevent a rushed process
Some thoughts on this well researched @washingtonpost piece on student health centers
Idk if it's just bc of the sample pop that responded to Qs from reporters, but a lot of the examples in this story are from women. Many instances where a symptom--physical pain-- is minimized
Women (especially women from minority groups) are more likely to have their pain minimized or misunderstood & be misdiagnosed bc of it. The Atlantic has some great stories on this
Thread: What's frustrating about Gilead's announcement re: remdesivir's '62% reduction in the risk of mortality' is that it will create even more confusion for people about what we know about treating #COVID__19
bc Gilead itself says it needs to actually confirm that 62% (1)
As others point out, we had a double-blind, randomized, placebo-controlled trial of remdesivir use in adults from May👇
-'Mortality was numerically lower in the remdesivir group than in the placebo group, but the difference was not significant' (2)
Senate hearing on FDA inspections of foreign drug plants starting now. Quality concerns have existed for years
Remember: FDA paused most foreign drug plant inspections in March due to #COVID19 March
In mid-May FDA said still postponing routine domestic and foreign inspections
From last week, per @annaedney: 'U.S. regulators are contacting pharmaceutical companies that make a popular diabetes medication after some of the pills were found to contain high levels of a chemical that can cause cancer.'
Mar 26, 2020 • 7 tweets • 3 min read
THREAD: Here's what this means in English, why it matters, and how it's another example of FDA weighing heavily on the pharmacy community during #COVID2019 (1/7)
But RTT has less robust reporting & cuts FDA completely out of the administration process (2/6)
Mar 11, 2020 • 7 tweets • 3 min read
Who would have thought it would only take a national crisis via #COVID2019 to make an FDA appropriations hearing so popular
FDA head Stephen Hahn about to start his testimony
-drug and medical device shortages due to #COVID2019 will definitely come up
This is the 1st time Hahn has appeared before the agency's appropriation's hearing
Feb 25, 2020 • 5 tweets • 4 min read
.@SecAzar telling lawmakers right now the govt has masks and ventilators stockpiled for possible #COVIDー19 outbreaks in the US but not enough
Murray: "I'm deeply concerned we're way behind the 8 ball on this"
CDC says 14 total confirmed cases in US as of yesterday
@SecAzar .@SenAlexander has concerns re:drug shortages bc coronavirus
Lots of focus on antibiotics lately
Antibiotics supply chain is in danger not just bc of #COVIDー19 but bc market is weak&businesses don't want to make them
Has been a problem for ~years~
Thx 4 coming 2 my TED talk
Jan 29, 2020 • 8 tweets • 3 min read
Orphan drugs loopholes 1 of the topics covered at this legislative hearing & @PeterWelch is especially frustrated w them
Here's how orphan drugs relate to this larger conversation about drug affordability, competition, and access (1/8)
-orphan drugs typically treat rare diseases. They get extra protection from competition, tax credits&$ breaks bc theoretically they're hard to make $ off of
But some drugs that get orphan status make a lot of money, raising Q about whether companies are abusing the system(2/8)
Dec 17, 2019 • 4 tweets • 1 min read
-Testing + for cocaine and fentanyl together spiked 1850% between 2013 and 2018,
-Nearly 1 in 5 cocaine users also testing positive for fentanyl in 2018
-Testing + for meth w fentanyl spiked nearly 800% during the same 5-year span
(from Senate Judiciary hearing on opioids)
DOJ official Amanda Liskamm pushing for permanent
scheduling for all "fentanyl like substances"
The DOJ has been asking for this for months. Their temporary order expires in 51 days
Confirmation hearing for Stephen Hahn to take over as FDA commissioner is about to begin. Vaping will no doubt come up
Related: regulatory agenda is out this morning and the supposed vape flavor ban is NOT included on the list (nor is it on long term actions list)
.@SenAlexander just entered 7 letters of support for Hahn
When we return Dec 3rd, hope we can report you out on bipartisan basis so we can confirm you before end of the year, Alexander says
Nov 4, 2019 • 5 tweets • 1 min read
Anna Abram speaking now at #GRxBiosims conference in place of Ned Sharpless (who was replaced on Friday as Acting Commissioner of FDA by Brett Giroir)
Abram touts need for more generics, biosimilars, but also interchangeable biologics (which would be a huge coup for biosimilar industry)
FDA put out new industry advice about interchangeability in May but so far no biosimilar has been approved in U.S. as interchangeable
Oct 30, 2019 • 15 tweets • 13 min read
E&C hearing on global drug supply safety starting now
@RepAnnaEshoo setting up the main issues pretty well in her opening statement 1) shortages 2) poor manufacturing 3) too many drug ingredients coming from foreign countries (esp. China)
@RepAnnaEshoo Witnesses include Janet Woodcock, from @US_FDA's
Center for Drug Evaluation and Research &
Michael Wessel, Commissioner of the U.S.-China Economic Security Review Commission
Sep 26, 2019 • 15 tweets • 21 min read
.@RepWilson kicking off 2nd hearing this week on Pelosi's drug bill
Naturally, she is wearing an incredible hat
"the central provision in this proposal have been endorsed by Pres. Trump himself" *plays video of clips of him talking drug prices*
When it comes to drug prices “every Republican will need a place to land.”
&“If McConnell wants to keep a Republican majority then this drug pricing bill is part of that plan.”
Sep 25, 2019 • 17 tweets • 15 min read
HAPPENING NOW: 2nd vaping/e-cigarette hearing w. Sharpless&other state officials
A lot has changed in the last 48 hours
--JUUL replaced its CEO & said it'll stop marketing
--Massachusetts has put a 4 mo ban on all vaping products
--spotlight placed on 4th gen. vaping devices
On the global e-cig stage here's what's happening:
-India last week banned all vaping products
-Israel banned flavored vapes yesterday, looking at how to ban all vaping products
-China last week halted online sales of JUUL
Sep 24, 2019 • 28 tweets • 33 min read
The 1st of 2 hearings this week on e-cigarettes&vaping about to begin
Looking over testimonies now &we're getting 2 from your 'average citizen'
1 is about a near death experience due to vaping, 1 is how e-cigs helped her quit smoking (expect both to be utilized in similar ways)
The long term health effects of vaping is unknown
FDA has received 127 reports of seizures related to e-cigs
When there aren't clinical trials for products this is what happens, Chairman Raja Krishnamoorthi says
Sep 23, 2019 • 13 tweets • 7 min read
HAPPENING NOW: Wendell Primus (Nancy Pelosi's health policy advisor) is speaking at this AHIP conference rn about Pelosi's bill
He wasn't supposed to speak so this is a surprise
"everything about this bill is geared toward the drugs where there is no effective competition:
"I would argue the Secretary doesn’t have information to negotiate effectively with drug companies."
That's why forcing companies to give info "on a confidential basis' is importanat
Sep 19, 2019 • 9 tweets • 2 min read
E&C hearing on drug patents and "gaming" patent regulations has started
Rep. Schakowsky says crafting legislation that would "encourage courts to view these gaming practices and anti-competitive"
preview of the hearing here: news.bloomberglaw.com/pharma-and-lif…
Drug patent "gaming" (like tweaking a product without improving it significantly for patients) is a tricky topic for Congress
In the Senate, Cornyn is trying to cap how many new patents can be filed for old products but there's been no movement on it since June
Sep 17, 2019 • 4 tweets • 3 min read
.@US_FDA holding its public hearing this morning on what should be considered when approving new opioids
As expected it's a mixed bag of speakers--some industry groups (BIO), advocacy groups like @Public_Citizen, and disability groups
@US_FDA@Public_Citizen Not the first meeting the FDA has held on this issue...not expecting a resolution at the end of this meeting either
Someone from National Council on Independent Living says FDA shouldn't change labeling, Congress should regulate opioid advertising
Sep 11, 2019 • 5 tweets • 3 min read
Amy Abernethy speaking at FDA's Science Forum now. @FDACommissioner Sharpless won't be speaking as planned however
@FDACommissioner .@NIHDirector Collins taking a moment to remember 9/11
"That's a motivation for all of us that are in the service of the nation to work as hard as we possibly can to make the world a better place through the work that’s done through our various agencies."
