MAHA-FDA: "we are creating a safe space for pharma companies".

Read this article for more exciting news on future drugs and vaccines without safety or efficacy testing!

Today is June 23, 2025, and I welcome you all to the official opening of WWIII, brought to you by the most peace-loving Trump Administration that may or may not be controlled by a stash of Epstein files and/or by some bizarre ideological cargo cult of which Trump’s spiritual advisor, Paula White, is definitely a member. You can watch this lady being spiritual here. If anyone can put this to some heavy metal sound track, we will all appreciate it. Edit: Dustin Roberts obliged, this is now a much better viewing experience:

Let’s get to the main topic of my post.

Safe spaces for pharma

Recently FDA Commissioner Makary and CBER head Prasad (who also recently bestowed titles of Chief Scientific Officer and Chief Medical Officer upon himself) embarked on a journey, aka a “listening tour”. In case you thought that the listening tour was to listen to vaccine victims - don’t hold your breath. In a weekly recap video, Makary said the goal of the pharma listening sessions has been to create a “safe space” for executives to air grievances and proposals, free from shareholders or employees. This clarifies the MAHA-FDA priorities, doesn’t it?

Makary also spoke at the Drug Information Association’s annual meeting in Washington DC. In his speech he proclaimed there will be a universal flu vaccine within the next five years, “including potential bird flu variants”. Clinical trials for universal influenza vaccines are expected to begin next year, with FDA approval targeted for 2029, according to HHS.

Makary also advertised a new regulatory pathway, a “National Priority” voucher program which will be based on “plausible mechanism” to more quickly approve cell and gene therapies for rare diseases. This new pathway would not require any safety or efficacy testing prior to “approval”, only a manufacturing file review, and the approvals can happen in as short as 1 month vs 10-12 months for a normal regulatory review and approval. A “plausible mechanism” is a hypothesis in science. Therefore, this bold proposal amounts to illegal human experimentation which Commissioner Makary would like to permanently legalize.

The new FDA voucher program aims to cut drug review times to support “national priorities.” Who decides on these priorities? Another question, why is the FDA applying regulations so unequally? Some manufacturers [those, perhaps, that don’t have friends/investors from HHS and/or Congress trading their stocks?] are supposed to comply with everything, while “national-priorities” will warp-speed to the market without any real regulations.

This [allegedly] one-year pilot will make vouchers available to certain companies aligned with addressing “a health crisis in the U.S.,” delivering “innovative therapies,” addressing an “unmet public health” need, or “significantly increasing” national security.

I think it is clear what this is about - military countermeasures by another name. Deployed without any regulations, wrapped in lies, based on “maybe effective”, ahem, “national priority” determined by the gold standard science, no doubt. Emphasis on gold… The FDA will not look at safety or efficacy before pushing this junk onto unsuspecting consumers, accompanied by the usual - heavy lies, propaganda, fear mongering, financially incentivized manipulation, etc. Thus the rebranding of the regulation-free and liability-free EUA Countermeasures into “national-priority” vouchers, because faking a pandemic every time pharma needs a safe space is costly, cumbersome and too many people are now wise to this scam.

My readers know the drill by now very well. However, if you are new to this stack, here is the briefing about EUA Countermeasures:

Memo Re EUA Countermeasures to send to your doctor, pharmacist, employer, school, sheriff, county commissioner and state lawmakers

There is a little snag to this grand visionary strategy - the pesky Congress.

Current and former FDA officials debated at the DIA annual conference whether the pilot program will need congressional approval. This innovative “pilot” is similar to a new approval pathway, historically in Congress’ domain, and all of the previous priority review voucher (PRV) programs — those for rare tropical diseases, medical countermeasures and rare pediatric diseases — have also come from Congress.

And those vouchers are gold (did I say emphasis on gold?) The PRVs ostensibly seek to incentivize rare disease research, however, it turns out that the majority of recent ones have been sold for about $100-$300 million each. Yes, the pharma companies are allowed to sell these babies to each other. A GAO report from 2020 raised questions about whether the previously authorized PRV programs had incentivized new R&D — or if companies were advancing older drugs just to win the $100 million voucher. An organization called NORD (a thinktank?) published a report that found 53 PRVs have been awarded for 39 pediatric rare diseases since 2012. Before this PRV program, three of those same 39 rare diseases had an FDA-approved drug.

The Q&A posted on the FDA website states that the new “national-priority” voucher program is separate from the previous priority voucher programs:

These are separate programs and not mutually exclusive. The existing priority review programs and PRV programs will continue as is. The CNPV program will begin in 2025 and contains some of the elements and themes of the priority review programs and PRV programs with a different timeline for the review, product designated and product undesignated subtypes, and prohibition on the sale of the voucher.

There we go, more ways to print cash for our dear pharma friends, Makary’s indulgencies… ahem… I mean “national priorities” are each worth at least $100M, and you can have several different types of them!

For avoidance of any doubt about true priorities at HHS, Secretary Kennedy tweeted this:

Oh well…MAHA is now officially MABA.

Gene therapy Sarepta kills yet another patient

Next, let’s talk about Sarepta. I wrote about this miracle of gene editing therapy some time ago:

mRNA/Gene Therapy Technology: Futile, Deadly, but Hugely Profitable - Part 2

Recall that Peter Marks “approved” this product with an eye watering $4M/dose (!!!) by overriding ALL the FDA review teams who recommended against the approval. “Peter-approved” revolutionary gold standard science killed 2 people so far. That’s a high % of the patients because the drug was administered to a total of ~900 subjects, including those in the clinical trial. And these 2 deaths are the ones that the company couldn’t blame on other causes, which is quite an easy thing when the patients are terminally ill to begin with. Sarepta Therapeutics reported a second patient death due to liver failure related to its Duchenne muscular dystrophy gene therapy Elevidys, and said it’s suspending shipments of the treatment for the subset of patients who can no longer walk.

The patient who died was non-ambulatory — meaning they were unable to walk independently, which typically happens with older Duchenne patients whose disease is more advanced.

Sarepta said it would stop distribution of Elevidys to non-walking patients who were getting it via commercial channels. That suspension will be in place while it develops and implements an “enhanced immunosuppressive regimen” for those patients.

Right. It’s their immune system’s fault that they died from the miraculous gene editing science!!

The news of a second patient death follows Sarepta’s report in March that a teenager died of liver failure after receiving Elevidys. That patient was also non-walking.

Gene therapy safety has been closely scrutinized as of late. Another gene editing miracle, Rocket Therapeutics also reported in May that a patient died in its trial for a rare heart disease gene therapy after receiving an experimental immunosuppressive regimen. This time it was 1 out of 12 patients whose immune system was incorrect, did not trust the experts and did not appreciate the gold standard science. The FDA put a clinical hold on this trial and the company stock collapsed. For now at least.

Here is an idea for Rocket - maybe they can apply for the “national-priority” voucher from Dr. Makary?

Art for today: I spent a week in Mendocino. Watercolor, 5x7 in.