Another Makary-Prasad article lists the changes they are making at FDA: but again, it comes with flaws

Again, I doubt they are writing this, and it seems the writer(s) are unfamiliar with FDA procedures

Here is the JAMA article:

https://jamanetwork.com/journals/jama/fullarticle/2835314

I will be short:

During the COVID-19 pandemic, review processes that took a year were performed in weeks. We believe this is clear demonstration that rapid or instant reviews are possible.

Possible, yes but advisable—certainly not! Most people would have thought those reviews were a charade, and proved that warp speed reviews are a disaster for the public—Nass

At the FDA, we aim to pilot programs to deliver sponsors a decision in weeks. Our pilot will leverage expertise across FDA divisions and departments. For efficiency, the pathway will ask sponsors to submit much of the arduous paperwork to the FDA in advance of their final application, enabling regulators to examine the manufacturing plans, draft labels, and packaging before a clinical trial is complete.

This is called a rolling review, and FDA already uses this process. Described here last year, for example.

Isn’t it true that having the legal approval document (the label) and other materials drafted before a pivotal clinical trial is complete a sure way to bias the licensing decision toward approval? —Nass

The time from when pivotal trial results are known to when decisions are made must be shortened. This has implications for public welfare and will improve the risk-reward calculation of drug development.

Yes, more risk for the public, more reward for Pharma, unless you can show us how it will be done safely and prudently.—Nass