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View Diary: On Raising My Children To Be Free -- Free To Leave The U.S.A. (275 comments)

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  •  You would not believe the regulation in pharma. (0+ / 0-)

    Title 21 of the Code of Federal Regulations stems from the FD&C Act.  I only worked within one portion of this, mainly Parts 211 and 820.  However, that said, quality assurance ends up being a direct cost to the company.  And something where bean counters seek to cut corners.  Easily done during the presidency of son of bushlips.  

    Luckily Obama has increased the severity with which quality systems are inspected, even with an agency that lacks adequate funding.  That has led to many warning letters to big pharma and quite a few consent decrees.  And, in pharma, if a company signs the consent decree, which they must in order to stay in business, there is a penalty called "disgorgement of profit."  It means exactly that, the profits from a product line that is found to be adulterated must be returned to the FDA as a penalty.

    How many corporations work in that manner?

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