I mean yeah. To get anything through the FDA you have to hire these “FDA consultants”—former FDA employees—who mostly chill out on your payroll. The FDA sends random questions about whatever you’re doing every once in a while and you have to come up with some answers. A few years of this and your drug’s approved. Anything resembling a standardized pathway where you simply test the drug threatens this grift.
>>The FDA doesn’t regularly test either ingredients or the finished products. During inspections, it primarily checks to see how well companies follow manufacturing procedures rather than conduct its own sampling. When the regulator does find problems, it typically relies on the company to voluntarily take action to address the root cause.<<
FDA commissioner Califf returned from India, …Asked about the idea of health systems doing independent tests, he responded: “I might say there are better ways to spend your money.”