Katherine Ellen Foley (she/they)

I have been thinking a lot about how I want to live in the era AI, and think the answer is to protect your joy at all costs:
scrapfacts.substack.com/p/ai-can-nev...

Was hoping the ACIP agenda would give us some insight on the populations these shots were considered for, but doesn't seem like we've got that. Will be curious to see if they recommend updated shots for everyone again.

Happy Monday morning, everyone! We finally got the ACIP agenda for tomorrow—usually we get it 2 biz days before, but nothing happened Friday). It doesn't tell us a lot. We still don't have authorizations for new shots from FDA, either. Expect those today cdc.gov/vaccines/aci...

The FDA's ad comms skedded thru September are all remote, even though we're well past peak Covid. In today's RxP, I report on what that could mean 4 the regulatory landscape https://www.politico.com/newsletters/prescription-pulse/2023/08/01/remote-advisory-meetings-persist-after-peak-covid-00109078

@davidlim.bsky.social breaks down what the upticks in Covid-19 hospitalizations actually mean: https://www.politico.com/news/2023/07/31/covid-19-cases-are-climbing-but-dont-be-alarmed-00109074

No one wants kids to get hooked on nicotine, but some smokers who can't quit may be getting left behind in this current regulatory environment: https://subscriber.politicopro.com/article/2023/07/the-biden-administration-could-blow-its-biggest-chance-to-get-smokers-to-quit-00106647

But as far as what will happen to people who need to quit now? Unclear to me. The Biden admin announced plans to make an inter-agency effort on smoking cessation as part of the Cancer Moonshot. Shoring up smoking cessation support was one of its goals - but still in development

And the pathway for smoking cessation isn't empty: Just last week, a company announced positive Phase III results for a new drug candidate, and said that they plan to ask for FDA approval in early 2024. Zeller is also now on the board of a company making a new NRT

To be fair, some experts still think that we don't need more e-cigs on the market to increase smoking cessation. They argue instead we need feds to support more robust smoking cessation efforts with existing tools, and that the risk to kids is too high.

There was a time when Scott Gottlieb was commissioner when he and former CTP director Mitch Zeller launched a tobacco regulatory plan that included harm reduction for adults: but that plan got quiet, especially after youth vaping skyrocketed in 2019

We also know that quitting smoking is REALLY HARD! In 2018, less than 10% of smokers who tried to quit succeeded. It can take dozens of quit attempts for it to really stick.

There's somewhat mixed science on whether a menthol ban will lead to smokers quitting -- in Poland, menthol smokers switched to traditional cigs. Estimates from Canada suggest 100s of 1000s of smokers will quit, but the Canadian population is a lot different from the US'

In 2021, 11.5 percent of the U.S. population, or 28.3 million adults, smoked. In 2022, 14.1 percent of high school students, or 2.14 million, reported vaping at least once a month, as did 3.3 percent or 380,000 middle school students. This is down from 2019, when > 5M kids vaped.

In its denial of more menthol vapes, FDA has said companies must show that the benefit to adult smokers is > than tobacco vapes, because there is known evidence that menthol vapes could appeal to youth. What surprised me is that adult smoker preference didn't make the cut.

The TPL stated that even though Logic showed that adult menthol smokers would prefer menthol vapes > tobacco vapes, the FDA didn't see preference as evidence of behavior change. FDA said that the risk of youth uptake was too high.

I FOIA'd the technical project lead for the denial of Logic's menthol vapes. Logic, owned by JTI had the first menthol vapes to get denied after being fully-vetted in 2022. (The company appealed the decision, oral arguments have been heard, and a ruling could be made any day)

ut there hasn't been a new smoking cessation tool approved in 17 years. And though FDA has stated that e-cigs are a less-harmful alternative for adult smokers, marketing denial orders for menthol vapes show that the agency has a standard that some see as impossibly high.

FDA is finalizing a rule that would ban menthol cigarettes, which make up 40% of the market. They're also disproportionately popular with Black smokers. The goal is to get menthol smokers to quit — and public health experts agree this is a key step toward improving health equity

POLITICO Pro: Experts say the Biden administration could blow its biggest chance to get smokers to q... Experts fear that without bolstered support for smokers trying to quit, the FDA’s menthol ban could be a bust.

As the Biden admin plans to launch one of the biggest smoking cessation pushes in history, some experts question whether it will work given its vape regulation:
https://subscriber.politicopro.com/article/2023/07/the-biden-administration-could-blow-its-biggest-chance-to-get-smokers-to-quit-00106647

These committees matter because they're a public window into how the FDA makes decisions around new drug products — including vaccines, or some of the gene editing therapies the agency is currently evaluating.

The FDA never has to follow its advisers' recommendations, but study authors found that around drug products, it did 88% of the time between 2010 to 2021. So it's still following a lot of recommendations.

Super interesting paper in JAMA Health Forums today — the FDA has called on its independent expert advisers a lot less in recent years. https://jamanetwork.com/journals/jama-health-forum/fullarticle/2807050

hi eepy.bsky.social can I be added to the list of gardeners? I feel this will be the most important thing I do on this website.

Now, all eyes are on CMS -- health care providers and advocates want to see just how labor-intensive this registry will be. There are fears that if it's too hard to do, patients still won't be able to access the drug

Breaking: FDA grants first new Alzheimer's drug traditional approval in 20 years. This moves triggers Medicare to cover the drug, Leqembi, for any patient enrolled in a registry. Out of pocket, it costs $26,500.

As a reminder, we're expecting FDA to make a final decision on Leqembi next week. If approved, it would be the first new drug* for AD in ~20 years.

*Agency approved a combination of 2 existing therapies in 2014

In today's Prescription Pulse, I preview some of the Alzheimer's therapies coming through the pipeline after Leqembi. https://www.politico.com/newsletters/prescription-pulse/2023/06/27/the-alzheimers-treatments-of-the-future-00103684

A Japanese Angel shark

I’m excited for tomorrow’s Angel shark awareness day, but I worry we’ve forgotten the truly spirit of the holiday. It used to be about taking a nap under sand until lunch swims close enough to your mouth that you can eat it without having to spend energy hunting. It’s all corporate now.

you telling me a baja blasted this mountain dew?

Also relevant is to remember that Brian King, head of
@fda.bsky.social tobacco, has often said that smokers who switch entirely to e-cigarettes are decreasing their risk. Interesting that CDC came to this conclusion today: