I have done this kind of analysis in the past for Foolishness...Or Is It?. I am doing it again because you were not paying attention last time.
Point of discussion for today: Our Laws Are So Confusing They Can’t Be Understood
Send in the Regulators (or as Frank Sinatra used to sing), “Send In The Clowns”. These Civil Servants tell us what the laws mean based on their understanding of what the words say...
Ø Or is it...What they think they say.
Ø Or is it...What they are told they say.
Ø Or is it...What they want them to say.
We will never know. We just comply as best we can and, if we get it wrong, we go to jail.
I contend that the excerpts you are about to read below are Silliness That Even the Creators of this Confusion Do Not Understand.
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I promise you that the 3 paragraphs below were taken completely at random from...
PUBLIC LAW 115–52—AUG. 18, 2017 entitled
“FDA Reauthorization Act of 2017”
My completely at random first paragraph:
(J) in subparagraph (A) of such paragraph (2), by
amending the first sentence to read as follows: ‘‘Except
as provided in subparagraphs (B) and (C), each person
who is named as the applicant in a human drug application,
and who, after September 1, 1992, had pending before
the Secretary a human drug application or supplement,
shall pay the annual prescription drug program fee established
for a fiscal year under subsection (c)(5) for each
prescription drug product that is identified in such a human
drug application approved as of October 1 of such fiscal
year.’’;
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Another completely at random paragraph from the same law:
(G) scientific or operational challenges associated with
performing an investigation described in section
505B(a)(1)(B) of the Federal Food, Drug, and Cosmetic
Act, including the effect on pediatric studies currently
underway in a pediatric patient population, treatment of
a pediatric patient population, and the ability to complete
adult clinical trials;
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The last completely at random paragraph from the same law:
‘‘(A) data, analysis, and discussion of the changes in
the number of full-time equivalents hired as agreed upon
in the letters described in section 301(b) of the Generic
Drug User Fee Amendments of 2017 and the number of
full time equivalents funded by budget authority at the
Food and Drug Administration by each division within
the Center for Drug Evaluation and Research, the Center
for Biologics Evaluation and Research, the Office of Regulatory
Affairs, and the Office of the Commissioner;
All Regulatory Interpretations usually come down to one or all of the following...
Ø Trust us.
Ø We are smart and you’re not.
Ø You owe more taxes.
Would I kid u?
Smartfella
Lagniappe: If you want to practice your Written Law Understanding Skills, click on the link below and you can read this Unable To Be Understood Foolishness in its entirety. You will then be able to hone your skills on the 38,241 or 39,917 words contained in the law (I took 2 different counts and got 2 different totals)...
https://www.congress.gov/bill/115th-congress/house-bill/2430/text?format=txt
