Recent toughening of FDA regulation, particularly over the drug manufacturing process, is said to be a factor. Should this count as surprising? [LATimes]
Recent toughening of FDA regulation, particularly over the drug manufacturing process, is said to be a factor. Should this count as surprising? [LATimes]
8 Comments
Here are some of the drugs that are critically short. Note these are all generic and needed in the ER. Narcan, succinylcholine, neostigmyne, propofol. If you are in a bad car accident, pray that some one has stashed some somewhere away to save your life.
The Federal Government is guilty of colossal medical malpractice. This is an under-reported national disgrace.
Over-regulation and grotesque mismanagement by Washington is the cause of Third World supply problems for basic medicines.
And these are the lunatics we are giving vast new powers to in ObamaCare? Are we insane?
To answer Smart Dude: I sometimes think that insanity really is the only explanation for what goes on in Washington. It would explain the irrational, disconnected-from-reality policies they adopt, and their utter imperviousness to the disasters they cause in the real world. It is very much like their minds are living in some made-up fantasy world and not the real one.
I like this paragraph in the linked article:
“The drug shortages have gained the attention of members of Congress. This month, Sens. Amy Klobuchar (D-Minn.) and Bob Casey (D-Pa.) introduced legislation that would require drugmakers to give the FDA an early notification “when a factor arises that may result in a shortage,” according to a joint statement.”
In other words, when critical shortages of pharmaceuticals arise because of a tough new regulatory environment in Washington, the impulse of those in Congress is to address the problem by adding more regulations – i.e., by adding another bureaucratic compliance requirement. And how, exactly, will notifying the FDA help with the shortage? And what if the “factor” that’s causing the shortage is the FDA’s rules themselves – will the company find itself facing investigation and retaliation if it is perceived as blaming the FDA for the shortage?
@GregS: Yes, the FDA’s attitude so far has been “compliance at any cost”; why would they care about drug shortages?
Indeed, given that their attitude is “selling these products is dangerous and irreponsible due to your lack of knowledge about their contents”, the FDA would be happier to learn that there would be a shortage; that means that there’s less of this hazardous product on the market!
I can prepare the definitive Klobuchar-Casey mandated early notification for all pharmaceuticals in advance:
“A factor has arisen that may result in a shortage of (fill in the name of any medication). The United States Congress, The Food and Drug Administration, and a vast array of other lunatic, utterly incompetent, completely unaccountable federal bureaucrats has disrupted the manufacture and distribution of (fill in the name of any medication).”
[…] I’ve got a new post up at Cato at Liberty on the avoidable medical crisis brought about in part by an FDA crackdown — and how the government might manage to make it still worse. I quote commenter “Greg S.” from our earlier thread. […]
[…] prompts Overlawyered commenter Greg S. to write: In other words, when critical shortages of pharmaceuticals arise because of a tough new […]