SCOTUS decision is very significant for FDA. Courts will continue to defer to FDA on product-review decisions, where Congress gave FDA discretion to make fact-based decisions based on careful process often outlined in guidance. But we'll see material changes in other areas 1/n When FDA's decision is purely a matter of how it interprets a statute that applies across a product area, courts will no longer give deference. Some immediately affected areas could be certain food safety rules, rule on intended use, and recent rule making related to LDTs 2/n

🧵The OIG just released their report detailing the factors that led to the Covid test failures in early 2020, providing new detail on internal design and quality control issues in CDC’s labs. 1/5

Report here:



Some notable findings 👇🏼oig.hhs.gov/oas/reports/re… Lack of Preparation: “Although CDC had agency guidance documents related to its response structure during a public health emergency…these documents do not address the development of a test kit” and it “did not have policies and procedures in place for developing a test kit” 2/5

🧵Lots of interesting nuggets in the new guidance CMS released to outline how it will set drug prices under the Inflation Reduction Act

This caught my eye. CMS says all negotiation materials from CMS have to be kept secret, and then documents must be destroyed within 30 days 1/7 It says off label use of a drug will be considered when establishing the "fair price," but only if the use is listed in a CMS recognized compendia -- this probably means that for purposes of setting a price, CMS will only consider the off label uses for cancer drugs. 2/7

My Op Ed. To reform CDC, we should focus it more squarely on its mission in communicable diseases; moving many other public health mandates to agencies that already oversee broad programs in same areas, getting analytical work closer to operational agents

washingtonpost.com/opinions/2023/… A thoughtful article documenting how CDC didn’t comply with law congress passed, and in 2010 update its information technology systems as Congress prescribed, by my @aei colleague Yuval Levin. Challenges CDC faces today were set in motion many years ago

aei.org/op-eds/bidens-…

🧵In the past, I've raised concerns with Twitter related to the safety of me and others, and threats being made on the platform. This included direct as well as specific threats. Sometimes it included statements that I believed were purposely false and inflammatory 👇 The selective disclosure of my private communications with Twitter stokes the threat environment. So does actions that empower people who’ve shown little restraint when it comes to purposeful vitriol. It instigates more menacing dialogue, with potentially serious consequences 👇

🧵If we lose chance to create modern framework for FDA regulation of diagnostics, FDA won't walk away from issue. If VALID doesn’t pass, FDA will move ahead under existing authorities; which aren't well suited to challenge of promoting safety, innovation

raps.org/news-and-artic… We should expect FDA to act on its own if VALID doesn't pass Congress. Easiest most efficient way? Would be to end agency's historical enforcement discretion. FDA could simply clarify that all LDTs are now subject to active regulation as medical devices fda.gov/medical-device…

🧵What happened in 3/22 when Omicron hit Hong Kong, illustrates challenge China faces

Hong Kong like China had low vaccination rates; especially among elderly

In face of much more contagious variant, low pre-existing immunity in HK was devastating 1/x

bloomberg.com/news/features/… When Omicron hit Hong Kong, only 72% of residents were fully vaccinated, 30% boosted

By comparison, in China, 88% were fully vaccinated, 40% boosted; a figure that hasn't changed much

Hong Kong, unlike China, deployed vaccines that have proven more effective against Omicron 2/x

#FoodSafety 🦃🥘🍽️

The @CDCgov estimates 48 million people get sick from food borne diseases every year in US, many outbreaks occur around #Thanksgiving. Here are a few cooking practices to keep your family safe and healthy this holiday season ⬇️ today.com/health/top-rea… 👉🏻 Always wash your food, hands, counters, and cooking tools.

👉🏻 Keep raw foods to themselves. Germs can spread from one food to another.

👉🏻 Foods need to get hot and stay hot. Heat kills germs.

👉🏻 Put perishable food in the fridge right away.

fda.gov/consumers/free…

Will be interesting to track development of this psychedelic by Lusaris and @rfsquared and how regulators approach compound. Sublingual, fast acting formulations of controlled substances have faced close scrutiny in past owing to risk of diversion, abuse thedalesreport.com/psychedelics/p… Recent controversies around at home Ketamine and history related to sublingual formulations of opioids could inform how @US_FDA considers issues related to drugs with characteristics like the new compound being developed by @LusarisTx @rfsquared
psychiatrictimes.com/view/virtually…

🧵Will discuss decisions made during Covid that impacted families; some of hardest were school closures. In WSJ I wrote in 2020 here wsj.com/articles/schoo… and here wsj.com/articles/want-… that states should open schools. Many like my state CT made it top priority, others didn't

https://twitter.com/margbrennan/status/1588704413774147584

My argument Summer 2020, after first wave, was: "Schools should open in the fall. It’s critical for meeting the educational and social needs of children. But local officials should have the discretion to take tailored actions to help keep children safe" wsj.com/articles/schoo…

We shouldn’t underestimate how much the predictable backlash to the failed 2021 mandate that businesses require employees to get vaccinated, using a contorted reading of OSHA provisions, is going to - regrettably - bleed into broader opposition to vaccines thelancet.com/journals/lance… My 2021 comments on that rule

https://twitter.com/scottgottliebmd/status/1457119597723795458?s=42&t=IDUGV6-4zci0lF5bZSLfoA

🧵Vaccines for Children (VFC) is federally funded program that "provides vaccines at no cost to children who might not otherwise be vaccinated because of inability to pay.” This program has long been used to help families in need get access to vaccines
cdc.gov/vaccines/progr… Under VFC, CDC buys vaccines at discount to distribute to registered providers. For CDC to add a vaccine to VFC, it must be 'recommended' by ACIP, then CDC. This allows costs to be covered by same program used to broaden access to other childhood vaccines cdc.gov/vaccines/progr…

🧵 My article with Mark McClellan in Journal of the American Medical Association on the VALID Act - a major provision before Congress that modernizes FDA oversight of diagnostic tests, promoting safety and innovation

Here’s why passage is critical:

jamanetwork.com/journals/jama-… 1/x Background: When I was FDA commissioner, the agency delivered to Congress comprehensive technical assistance on which VALID is based; as I discussed at Friends of Cancer Research in 2017:

insidehealthpolicy.com/daily-news/got…

I wrote this as well when VALID was introduced in March 2020. 2/x

https://twitter.com/scottgottliebmd/status/1235692686750797825

My article w/Mark McClellan in @JAMAHealthForum on three major provisions needed to modernize @US_FDA's oversight of dietary supplements, cosmetics, and diagnostic tests. We must advance these efforts to improve opportunities for patients. Here’s how…1/x
jamanetwork.com/journals/jama-… 80% of US consumers report using dietary supplements; most mistakenly believe FDA reviews or tests products before they reach market. No such requirements exist and manufacturers often don't disclose ingredients of new products to regulators, consumers 2/x pewtrusts.org/en/research-an…

CDC's proposed reforms and the self-analysis fueling these changes are the right diagnosis and prescription. They represent bold, comprehensive commitments that will go a long way to address many of the system challenges that plagued CDC for many years 1/x washingtonpost.com/health/2022/08… Among notable features: A self awareness that CDC's culture is academic in orientation when CDC must be much more operationally focused, emphasizing execution over publications. This bleeds into how CDC puts out information, issues guidance. It must be more consumer facing 2/x

There’s a lot of precedent for intradermal delivery of vaccines to extend supply in public health emergencies. It was done for yellow fever and Ebola. This is a reasonable move based on solid data. Challenges will be local delivery issues. Good planning can help mitigate them 1/x The study supporting intradermal inoculation found similar safety and immunogenicity using 20% of full dose 28 days apart to standard formulation of MVA, concluding that intradermal vaccination could be used to increase number of available doses 5-fold 2/x sciencedirect.com/science/articl…

WHO’s hesitation in making declaration earlier, when scope of crisis was already obvious, was an openly political gesture. The reality is the practical impact of declaration is muted, because WHO has marginalized itself. Nonetheless, a good move by Tedros to act with conviction.

https://twitter.com/bbcbreaking/status/1550846981764964353

Washington Post writing on the prior WHO decision not to make the declaration: “Monkeypox cases surge as WHO stops short of declaring a global emergency”
washingtonpost.com/health/2022/06…

Ukraine has been experiencing an outbreak of type-2 circulating vaccine-derived poliovirus since Oct 2021. A national catch-up vaccination campaign targeting ~140,000 children under 6 yrs old who missed routine polio doses began Feb to arrest the outbreak bit.ly/3RT3wv8 Two children with acute flaccid paralysis (AFP) have tested positive for cVDPV2 and the virus has been detected in 19 asymptomatic contacts. Millions have been displaced since the war began, including the 2 positive cases whose whereabouts cannot be traced bit.ly/3PtJcix

🧵Since 2002, health agencies have been tasked with ensuring that there’s enough smallpox vaccine in strategic national stockpile to meet U.S. health security needs

Yet only 100 million doses of the smallpox vaccine ACAM2000 are currently available, not enough for every American 100 million doses of ACAM2000 doesn’t meet the CDC’s claim that “The Strategic National Stockpile (SNS) has stockpiled enough smallpox vaccine to vaccinate every person in the United States,” a pledge that President Bush made in 2002 amidst concerns about the risk of bioterrorism

🧵It’s time to modernize regulation of clinical tests

VALID Act is bipartisan framework, reflecting broad stakeholder input. It's a historic opportunity to advance innovation, benefit patients

Link to HELP Committee
help.senate.gov/chair/newsroom…

or Burr PR
burr.senate.gov/2022/5/senator… US was tragically behind in testing early in pandemic. VALID is critical step toward making us better prepared to stand up testing in future public health emergencies, and FDA is key to making sure tests for emerging pathogens are accurate and reliable

cnbc.com/2020/01/26/op-…

New: House E&C Committee releases package to reauthorize FDA user fee agreements

Lots of good ideas in here

Link to legislative text below, summary attached

I’ll post my views on specific sections here as I go through bill.

Some initial thoughts: 1/n

republicans-energycommerce.house.gov/wp-content/upl… On closely watched provisions on accelerated approval

Congress preserves but tightens, by streamlining FDA ability to withdraw AA drugs that don’t achieve + confirmatory studies

But maintains ability of companies to have that decision go to FDA adcom and have public docket