[U] Now That The GOP-Led Effort On A Federal “Right To Try” Has Failed, Again…

At some substantial risk of returning to the weedy details that used to animate this blog, I will note that the GOP — despite controlling the White House, and the Senate and the US House — once again this afternoon failed to advance a federal “right to try” bill.

In the Senate, the measure is known as S. 204; in the US House it is known as HR 2368.

The House version would define “terminal illness” by reference to individual state laws, while the Senate version contains no definition of that indisputably critical term, at all.

So then. . . to my punch-line: the next time the Congress-critters decide to take the matter up, it would be a very good idea to define what the term means, in the bill — with nationwide effect, along the lines I’ve laid out, at right. Why?

Because there are some states that have no definition of the term that drives the whole process [including states such as Tennessee (which does have a law; but lacks these definitions), and all the other states that do not have a state “right to try” law, at all]. Without a definition, this piece of legislation is worse than useless — and all the state laws, in Louisiana, Texas, Tennessee and Indiana (for example) are for naught, since no prescriber may lawfully deliver any unapproved drug, without FDA oversight, and concurrence. [Excellent waste of red state and local dollars there, folks.]

And without the UNIFORM definition of what triggers the “right to try“, doctors will continue to be at considerable risk of liability, even under the patchwork of state laws — and even if they only prescribe inside the state with a law. Gee — that must be why. . . we have an FDA!

Less sarcastically, it simply makes no sense to say that a patient in Illinois may try a drug, while one in Indiana may not, since the latter did not define what “terminal illness” meant, at all.

To be clear, the House version needs to explicitly set a nationwide federal standard — not simply refer to (in some cases) non-existent state-level definitions — of the “trigger” condition.

It is actually pretty painful to watch these characters try. . . to legislate. . . anything. But next time, ’round — perhaps they will take (also soon to be former?) Commissioner Gottlieb’s advice, at FDA.

[A lower level issue to fix would be to allow a sponsor-independent Chair of any IRB to approve “right to try” requests — without full IRB meetings, since essentially all these drugs are in some trial stage (post Phase I) and are being run through ClinicalTrials.gov — and thus are also under the purview of the US FDA.]

As I toddle off to bed, in an unrelated update — I should point out that tonight’s Fifth Circuit ruling out of Texas, on sanctuary cities there — will have little meaning, to sanctuary cities around the nation, since the earlier Santa Clara County, California injunction remains in effect, nationwide, against Trump’s order on the subject. At this point, nationwide, it means next to nothing (as the Supremes denied cert. last month, out of 45’s camp — related to the dispute in California). Now you know.

Next life-time, indeed. Now. . . . Sleep well — all you growing little life scientists!



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