ole vern,
Unfortunately you make way too many assumptions in your question.
The company I work for is not a drug company. The FDA is involved with many other things than drugs.
On another note, reproducibility is not the same thing as reliability. Not even close. A calculator, for instance that provides an answer of 5 every time you punch in 2 plus 2, has a very high reproducibilty but zero reliability.
The FDA is interested in reliability.
regards,
frog