HHS, FDA and RFK are being rolled over the coals for issuing a *fast track designation* for a self-amplifying mRNA COVID vaccine
This is an example of social media journalists writing before educating themselves on the subject
Congress passed 2 laws in the 1990s that I disagree with (FDA Modernization Act (FDAMA) and Prescription Drug User Fee Act (PDUFA)) but they are the law and they require FDA to issue fast track designations and to charge pharmacy companies hefty fees for them. The fees are called “user fees” and can only be spent to review a proposed product for licensure.
Patent exclusivity is what pharmacy companies live and die by. They must get a patent before FDA reviews their drug, vaccine, biological, or device. While FDA performs the licensure review, the clock is ticking and they are losing patent exclusivity time.
So companies pay FDA several million dollars to speed up the review. That buys them a guarantee that the review will be completed with 6 months (or sometimes 10 months) and then they get more time before the patent runs out, which more than compensates them for the user fee.
FDA now gets almost half its budget from these user fees:
The amount of the FDA’s budget that comes from user fees fluctuates annually, but it consistently represents a significant portion of the agency’s overall funding. Here’s a breakdown based on recent data:
Fiscal Year 2025 (Estimates):
- The FDA’s total program funding level is projected to be $7.2 billion.
- Of this, $3.5 billion is estimated to come from user fees.
- This suggests that user fees may constitute slightly less than half of the FDA’s budget for FY 2025.
Fiscal Year 2024 (Estimates):
- The FDA’s total program funding level was approximately $7.2 billion.
- User fees contributed around $3.3 billion to this total.
- Therefore, user fees made up roughly 45.8% of the FDA’s budget in FY 2024.
While only special cases were supposed to be eligible for fast track designations, the money was so good, that the requirements expanded for them and now the majority of drugs and vaccines reviewed by FDA have received a fast track designation.
Are you getting it now?
The designation does not mean the drug or vaccine will be approved. It means the company will get an answer in a short time. FDA is supposed to spend the fees it gets providing more reviewers to get the job done fast.
If the horrible self-amplifying mRNA vaccine is licensed for human use in the US, I will eat my hat. It isn’t going to happen. Relax. Remember that the agencies are not yet under Trumpian/Kennedy control, but they will be by the time the 6 month review is completed.
PS: Important response of mine to Sasha’s comment (near the top) below:
Disagree–I spent many hours investigating the legal status of the PREP declaration for bird flu and advised RFK on this before the election.
Here is how the declarations work. There must be 3 made sequentially in order to push forward an EUA—the use of an unlicensed drug, vaccine or medical device. One only was made and it was from a Biden official.
1. A Secretary (DOD, HS or HHS) must declare there is an emergency or potential for an emergency with a specific agent, bird flu in this case. Sec. Xavier Becerra did this.
2. Second, the HHS Secretary must declare there is a specific medical product that may alleviate the emergency. This has NOT been declared.
3. The FDA Commissioner must declare that he is issuing an EUA for that product. This has not been done.
I guarantee you neither Bobby nor Marty will make these declarations under the current circumstances.
3 bird flu vaccines have already been approved (see my slide show on bird flu): in 2007, 2013 (and for kids n 2015) and in 2020.
They will not be used. They are dangerous. But they could be used as prototypes for newer, unlicensed vaccines using the “mock-up” approach. This is why RFK is critical. He will NEVER approve this. Other flunkies like Becerra might.