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patphil

(9,144 posts)
10. promoting the "health interests of Ameriica"?
Wed Jun 18, 2025, 11:26 AM
Jun 2025

Translation: promoting the financial interests of Pharmaceutical Corporations.

Except in extreme emergencies, where time costs lives, there isn't any real health benefit in shortening the review process. There is, however, a real benefit in insuring a thorough review process.
Unfortunately, with all the cuts in staff at the FDA, there aren't enough people to do the kind of thorough review that new drugs need to insure safety and efficacy.
I worked in the QC/QA section of a large Pharmaceutical Company for 36 years. I often participated in FDA inspection and review of documents related to drug testing. The whole process of new drug application (NDA), review, and approval is quite extensive and complex. It's better to take the time to do it right than to rush the approval through and risk harm to patients.
Corporations are too focused on the bottom line. Return On Investment (ROI) is the name of the game for them. Each month "delay" can cost millions in profits.
The real bottom line is that drastically shortening the final approval process is a bad idea.

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