Product quality and safety assurance is the primary remit of an FDA inspector. As a part of the Public Health Service which has been in existence since 1798, I think we can agree that assuring the quality of production placed into interstate commerce which is impactful to public health, particularly consumables, is something that has had precedent since the Nation's earliest times.
As a fellow New Englander you'll likely recall significant contamination problems which engulfed places like Copley Pharmaceuticals, Canton, MA (metered dose inhalers bacterial contamination) ~1998, Genzyme, Arlington, MA (contaminated biologics) ~2009, Lonza Biologics (sterile fill and finish microbial contamination) ~ 2011 and New England Compounding Pharmacy, Framingham, MA (64 patients killed, >800 sickened) ~2014.
My consulting firm does regulatory compliance assessments for pharmaceutical, biologics, device, food/nutraceutical and cosmetic manufacturers world-wide. We prepare clients for FDA inspections and often accompany clients during FDA inspections. We remediate the findings of FDA inspections.
Sometimes (rarely) FDA will get something wrong in an inspection. Example: Chinese manufacturers of heparin made for Baxter Healthcare (2009) took FDA to the wrong plants for inspection and FDA missed what were the offending plants. Heparin imported from offending plants was contaminated and killed 150 in the US and injured 350. Fraud investigations against ensued against the manufacturers. Offending exporters were subsequently banned. Significant fines assessed.
FDA takes product contamination and product adulteration seriously. It is why the US has the purest best manufactured drug supply in the world, and avoids contamination events impactful to the public in most cases.
Continued regulation in this space is not something that the public will welcome nor is it something Trump wishes to curtail. I think he wants to lower the hurdles for new drug approvals and do so more in line with meaningful risk based approval processes to streamline things (I was once a Review Chemist who served at FDA and was responsible for review and approval of manufacturing submissions for drug products.)
FReegards!
