Why is it so hard to do the right thing? Why do companies insist on falsifying data on drug development and manufacture. I realise all too well that the almighty buck is at stake. Companies that are hired to do testing are implicitly under the gun to achieve the right result. The entire ANDA development may be compromised by a failed BE study. An ANDA sponsor may miss a potentially valuable first-to-file date (e.g., an NCE-1 date). The testing company, therefore, is urged to re-run tests, re-test samples, etc. to get that right result.
When it comes to manufacturers, the pressure is even greater. Expensive API is purchased, released, and formulated. If QA/QC finds a problem, then the batches are compromised and could be wasted. To what result then? New API has to be made, new money spent on new batches, inventory write-off of the adulterated batch, potential supply chain disruption, potential "failure to supply" penalties in contracts, a bad reputation in the marketplace, and a lack of consumer confidence. But it seems that the offenders actually don't care of about the bad reputation and the lack of consumer confidence. A bad reputation and lack of consumer confidence do not impact the bottom line ... yet. Bad feelings do not cost a company money.
So it is no wonder that the activity around the out of spec (OOS) batches is all geared around saving the batch. The batch is all about the money.
I would not be surprised if the FDA gets so angry at the repeat offenders that the strong message of criminal indictment of the top executives is what is needed. I am reminded of times when foreign executives would travel to the U.S. only to be arrested at the U.S. airport and indicted. Foreign executives need to be reminded about the U.S. "Park" doctrine that can hold the corporate responsible official liable, criminally, for FDA violations.
Data integrity/data falsification is a top-down activity. If the company culture encourages non-compliance then it is no wonder that the lower level employees follow that culture of non-compliance.
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