Friday, July 13, 2012

Friday Flailing: Medical Gasses and the Law of the Excluded Middle

Buried
Aristotle never actually said "principium tertii
exclusi"
, mostly because he didn't speak Latin.
under the mass of attention and conversations surrounding the ACA last week, the FDA Safety and Innovation Act (FDASIA) contained a number of provisions that will have lasting effects in the pharmaceutical industry.  What little notice it did get tended to focus on PDUFA reauthorization and the establishment of fees for new generic drug applications (GDUFA).

(Tangent: other parts of the act are well worth looking into: NORD is happy about new incentives for rare disease research, the SWHR is happy about expanded reporting on sex and race in clinical trials, and antibiotic drug makers are happy about extra periods of market exclusivity.  A very good summary is available on the FDA Law Blog.)

So no one’s paid any attention to the Medical Gasses Safety Act, which formally defines medical gasses and even gives them their own Advisory Committee and user fees (I guess those will be MGUFAs?)

The Act’s opening definition is a bit of an eyebrow-raiser:
(2) The term ‘medical gas’ means a drug that is--
‘(A) manufactured or stored in a liquefied, non-liquefied, or cryogenic state; and
‘(B) is administered as a gas.
I’m clearly missing something here, because as far as I can tell, everything is either liquefied or non-liquefied.   This doesn’t seem to lend a lot of clarity to the definition.  And then, what to make of the third option?  How can there be a third option?  It’s been years since my college logic class, but I still remember the Law of the Excluded Middle – everything is either P or not-P. 

I was going to send an inquiry through to Congressman Leonard Lance (R-NJ), the bill’s original author, but his website regrets to inform me that he is “unable to reply to any email from constituents outside of the district.”

So I will remain trapped in Logical Limbo.  Enjoy your weekend.

1 comment:

Sherry Watson said...

It was necessary for someone to write on Med Gas Safety Act and you grabbed the heart of millions by taking the initiative which is enough to bring the evolution. Thanks for bringing it in light.