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Originally posted by Aloysius the Gaul
reply to post by liveandlearn
Interesting - so it doesn't protect "big pharma" at all then - the original "brand name" manufacturers CAN be sued, but the generic ones cannot because they are making a product that they have been told is OK to make.
n short, the Court ruled that the FDA has ultimate authority over pharmaceuticals in the US. And if the FDA says a drug is safe, that takes precedent over actual facts, real victims and any and all adverse reactions.
Held: State-law design-defect claims that turn on the adequacy of a drug's warnings are pre-empted by federal law under PLIVA.
Here, it is impossible for Mutual to comply with both its federal-law duty not to alter sulindac's label or composition and its state-law duty to either strengthen the warnings on sulindac's label or change sulindac's design.
Here, however, redesign was not possible for two reasons. First, the FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, and labeling as its brand-name drug equivalent. Second, because of sulindac's simple composition, the drug is chemically incapable of being redesigned. Accordingly, because redesign was impossible, Mutual could only ameliorate sulindac's "risk-utility" profile by strengthening its warnings. Thus, New Hampshire's law ultimately required Mutual to change sulindac's labeling.
(3) But PLIVA makes clear that federal law prevents generic drug manufacturers from changing their labels. Accordingly, Mutual was prohibited from taking the remedial action required to avoid liability under New Hampshire law. (Case cites and page references removed)
“Today’s court decision provides a disincentive for generic makers of drugs to monitor safety of their products and to make sure that they have a surveillance system in place to detect adverse events that pose a threat to patients,” Michael Carome, director of Public Citizen’s Health Research Group, said in an interview.
He pointed out that, in many cases, the potentially dangerous side effects of medicines have not come to light until decades after they were approved and often after there was no longer a branded version on the market.
With the threat of litigation removed, “groups that think this undermines patient safety could be onto something,” said David Maris, an industry analyst with BMO Capital MarketsTe. “The blanket protection that they are under now is that if the FDA says you are approved, as long as [generic-drug makers] don’t introduce new problems into the drug, then they’re fine.xt”
Originally posted by SpaDe_
Still think it's possible to change the system from within and without any violence? I laugh at the people who think there is a way.edit on 7/9/2013 by SpaDe_ because: (no reason given)
I'm not sure that's what the Court is saying, but I'd love to talk with you about it, if you'd like.
So basically what they are saying is that unless you buy the extremely over priced "name brand" versions of your medicine you have absolutely no protection from the law. Thanks Big Pharma! Your dedication to thinning out the 99% is astounding! Freakin' jerks!
In that case, you can go after whoever was responsible for, or should have known of the contamination. Maybe it was in the production process. If so, the generic company is fair game. Sue their pants off. (Umm, 'scuse me ladies.) Sometimes, the product degrades over time or through improper storage. In that case, you've got good targets as well. Did the company keep it warehoused improperly? Did the shipping company do something wrong? Should the pharmacist have checked it?
And besides that what happens if the medication is somehow tainted or contaminated? Does this ruling encompass that as well?
But there have been drugs considered safe by the FDA that have turned out to have some bad side effects in the long term or had unknown side effects in a certain percentage of users that had not been considered. No one, not the FDA nor the pharmaceutical companies, checks for every possibility. . .
This just sucks big time for those dependent on drugs and gives pharmaceutical companies a lot of leeway to do just about anything they want. There is something seriously wrong here. Trust me, I am the FDA.
Originally posted by Merlin Lawndart
Monsanto is exempt, big pharma is exempt, the Fed is exempt, none can be held accountable in court. You know what these people aren't exempt from? People taking to the streets, dragging them out of their homes and publicly lynching their asses.