Rare Disease Progress, Tech Charity, & the Elizabeth Holmes Doc 10/19/26

Scott Gottlieb · New Enterprise Associates

FDA's rare-disease white paper is a meaningful step toward durable rules through formal rulemaking.

Gottlieb argues the FDA's Rare Disease Framework request for information is the start of a formal rulemaking process, which is more durable than policy made through press releases, TV statements or journal articles. He cites the agency's food-ingredient rule as evidence the current leadership uses careful regulation rather than jawboning. He says a rule is hard to retract, so drug developers get rules of the road that will last, which matters most for rare disease where smaller developers lack capital for long timelines. He expects a series of guidance documents over a multi-year process, with some ultra-rare disease guidance possibly coming sooner.

“I think this is a very good development. I think what it shows is a very careful policy making process that's been re implemented at FDA”at 30:18

Scott Gottlieb · New Enterprise Associates

Unapproved compounded peptides lack safety and efficacy evidence and consistent formulation; the market is unregulated.

Gottlieb says most unapproved peptides sold by compounders have no evidence that would meet FDA's standard for safe and effective. The advisory committee reviewed evidence from small series of 20 to 30 patients, nothing approaching approval. Formulations are inconsistent, so products may not contain what they claim. He says people probably get no benefit from most of them, and while the market is not necessarily unsafe, it is unregulated, and some animal data raises tumor-growth concerns about one popular peptide.

“there's no evidence around most of these that would rise to the level of being safe and effective from the standpoint of FDA”at 35:15

Scott Gottlieb · New Enterprise Associates

Peptide evidence is scant; opening the market to unapproved compounded peptides would undermine FDA authority.

Gottlieb argues the FDA is being pushed to let unapproved peptides onto the market, such as the so-called Wolverine peptide, with thin evidence. The only human data he cites is in ulcerative colitis and Crohn's disease, where it showed no benefit. He says the data the advisory committee reviewed was scant, and that many compounded peptides are synthesized rather than naturally sourced. He notes career FDA staff are deeply concerned, with some threats of resignation, and that the policy would weaken FDA's authority over compounded drugs more broadly. He says the secretary has been trying to force it through, with guidance reportedly at OMB.

“Actually, the only data that's been studied in is in ulcerative colitis and Crohn's disease where it didn't show a benefit.”at 37:13

Volodymyr Zelenskyy · Government of Ukraine

US policy decisions on Ukraine are mistakes that will hurt both Ukraine and the United States.

Zelenskyy says Ukraine still trusts the US and bipartisan support, and wants to trust President Trump, but hopes he will change his decisions because they are mistakes. He argues these decisions will not help Ukraine and will not help the United States. He is referring to the US pausing new Russia sanctions and related actions that he sees as hurting Ukraine's defense.

“We want to trust him, and I hope that he will change his decisions because I think that it's all mistakes, and it will not help us.”at 4:59

Scott Bessent · U.S. Department of the Treasury

Zelenskyy's claim that the US throttled Starlink in Ukraine is reckless and untrue.

Bessent responds to Zelenskyy's allegation that the US throttled Starlink service in Ukraine. He says President Trump and Secretary Rubio have categorically said no one in the administration did it, so Zelenskyy's charge is reckless and he should be careful about statements that are not true. The argument rests mainly on the administration's denial rather than independent evidence.

“President Trump and secretary Rubio have categorically said that no one on the Trump administration did that, and I think it is very reckless”at 5:44

Kevin Hassett · White House National Economic Council

Underlying inflation is decelerating; the latest CPI uptick looks like a possible blip, not a trend.

Hassett concedes the top-line 12-month CPI rose from 3.5% to 3.6% and core from 2.5% to 2.6%, but calls the core move a snoozer. He argues the trend is still benign: egg prices fell for a fourth straight month, the policy work is showing in the data, and the first-half deceleration came from a positive supply shock. He says the one-tenth uptick is hardly enough to overpower the good news, though he admits a month of data is needed to confirm whether the softening is a break or a blip.

“the stuff that we've been working so hard on, you're really starting to see in the data.”at 16:49

Kevin Hassett · White House National Economic Council

Real wages are rising about $2,000 a year, with wage gains accelerating while price increases slow.

Using month-to-month census data from a private estimate, Hassett says real wages are growing at about a $2,000 annual clip, with the average real wage at $88,000, up $2,000 since Trump took office after adjusting for inflation. He argues price increases are decelerating while wage increases are accelerating because of capital spending, and that the economy is raising wages. He acknowledges wages briefly fell below inflation in one recent month and calls it a blip.

“The price increases are decelerating, and the wage increases are accelerating because of all the capital spending”at 19:02

Kevin Hassett · White House National Economic Council

US economy is very strong and near 4% GDP growth; he is very bullish on the outlook.

Hassett argues the economy is in a boom. He cites GDP growth almost at 4%, discretionary travel and spending on hotels, flights and cars as evidence people feel good and have money to spend, rising real wages, and wage gains accelerating because of capital spending. He concludes 'on net, it's a very, very strong economy' and that he is still very bullish on the outlook despite the inflation readings.

“I think we're very bullish still on the outlook for the economy.”at 19:10

Kevin Hassett · White House National Economic Council

Higher mortgage rates are offset by rising incomes, and housing numbers improved over the summer.

Hassett acknowledges mortgage rates are up with the 10-year near 5.08%, but argues incomes are rising too and that housing numbers looked much better over the summer than in the fall. He presents this as one of the mixed-but-positive pieces of an overall strong economy, so the rate rise is not a major concern to him.

“mortgage rates are up, incomes are up too and the housing numbers started to look a lot better over the summer than they did in the fall.”at 21:30

Kevin Hassett · White House National Economic Council

Consumers are spending freely, so partisan sentiment surveys overstate the gloom; actual behavior shows a boom.

Hassett says sentiment surveys are highly partisan, with Democrats in surveys like Michigan's saying the economy is in a great depression while Republicans say things are fine, so the surveys have lost value. He argues the real measure is behavior: if people were as negative as polls suggest they would not be taking trips to nice hotels, flying, or buying cars. Spending on travel and autos shows people are acting like the economy is booming.

“sentiment, like true sentiment, is best measured by what you see that people are doing. And what people are doing is they're acting like we're in a boom.”at 24:24

Scott Gottlieb · New Enterprise Associates

US measles outbreak is very large and may approach 1991's ~10,000 cases this year; true counts are underreported.

Gottlieb says the outbreak is very big: in 1991 the US had roughly 9,600 to 10,000 cases and this year may reach that, with cases still picking up early in the year. He argues Pennsylvania's reported count of about 1,260 probably understates the real number by about threefold, perhaps 5,000 to 6,000, because people with mild symptoms don't present to doctors, which also makes hospitalization rates look higher than they are. Hospitalization is about 10% overall and 15% under five. He says the outbreak is driven by declining vaccination and, unlike past outbreaks, people are not getting vaccinated in response, so ring vaccination is harder.

“This is a very big outbreak. Think in 1991 we had I think nine thousand six hundred cases, almost ten thousand cases. We may hit that this year.”at 26:16