on drug labels

[acroyear]

Court Ruling Exposes Drug Makers; Debate On Impact Begins:

Wyeth argued that the FDA's approval of the drug's label prevented such a suit because federal laws and regulation pre-empt lawsuits filed under state law.

The court rejected that argument, saying Wyeth's interpretation was "based on the fundamental misunderstanding that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling."

To which I say, GOOD. Until this society feels like actually paying the FDA's real tab for what it really costs to certify a drug, costs the FDA doesn't totally make up by the registration fees paid for by the company, the FDA just becomes a rubber stamp to what the drug-maker claims.

You have your choice:

• deregulate, have government agencies be a rubber stamp, and hope the threat of a lawsuit prevents people dying (hint: it doesn't, as you can ask any of the peanut butter victims of the last 6 months and the hundreds of millions of dollars wasted on this never-ending wave of recalls).
• have REAL regulation, with real teeth behind it, in spite of the costs and the time spent, because that will greatly increase the safety of what we consume.

but you can't have the former and then act like you have protections of the latter.

better still for now that we make it clear we're increasingly in the former, and will be for some time so long as one particular political party has anything to say about it.

every industry that has been "deregulated" (whether by direct act of congress or indirectly through the loss of funds needed for enforcement) has undergone a massive public financial or safety fiasco.  banks, S&Ls, telecom, tobacco, pharmaceuticals, environment effect of industry, industrial-scale food inspections; the list goes on and on...

...while other things get regulated to be illegal that are nothing of anybody's business (hint hint, the OTHER political party).  i don't care how much you hate transfats - as long as the menu items are clearly labeled (as "undercooked meat" always is), get the hell outta my kitchen except to look for unclean dishes and rats.  and btw, french slow-heat cooking styles are perfectly safe and healthy and have been for a thousand years.

meanwhile...

Court Ruling Exposes Drug Makers; Debate On Impact Begins:

Though the claim - that a manufactured failed to inform a consumer of risks - is key to many pharmaceutical-related cases, other pre-emption claims are still possible and remain protected, for example those claiming damage from a design defect.

Last year, the Supreme Court ruled, in a case involving Medtronic Inc. (MDT), that federal law bars lawsuits "challenging the safety or effectiveness of a medical device," as long as the device is marketed in a form that received FDA approval.

Weisburd said the Wyeth decision leaves companies with uncertainty and exposes them to different state-based standards that may second-guess the warnings on a label. For example, he said, drug makers could face lawsuits for providing too little information on a label or for giving too much because it will obscure the most important warnings.

"What is a company supposed to do?" he said.

This has, recently, become a problem with the Court under Roberts, who has expressed this idea that decisions should be weighed to be as low-impact as possible on constitutional interpretations (mind you, just like Scalia's "originalism", it's an ideology perfectly thrown away by Roberts when it gets in the way of a political decision he wants to make).  The Court has in the last 3 years set up a number of conflicting rulings that instead of making lower-court cases open-and-shut, increase the indecision and the potential for appeals, as if the Court was practically in the job of giving itself "job security for life"...which is, of course, ridiculous since they already have that...