RE: his application was rejected without review because he could not find a pharm manufacture to join the application.
Why do you need a pharm manufacturer to join the application? I’m not sure I understand the logic behind this.
FDA wants to review the manufacturing process too. This makes sense for a new drug that is being authorized. But it doesn't make sense for a repurposed drug.
In the posted article it mentions the applicants for Fluvoxamine EUA did have manufacturer lined up as part of the application.
It is not a sensible requirement for re-purposed drugs that are available at-scale and more or less off-the-shelf.
Well it does makes sense if the FDA is trying to protect a critical source of funding (Big Pharma). Also, important if you are an FDA executive/researcher that wants to graduate to private industry.
Note, the FDA is partially (46%) funded by user-fees. Pharma companies pay a lot of fees ($2.8 billion) to the FDA to process/review applications. Link: www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance