Beware of generic drugs

Well I get plenty of generics. I mean if there are problems with the pills I take they would have been found long ago.

Speaking of which....how often does a drug make it into the generic stage and only then does a huge side effect get discovered?
 
Maybe if the FDA had required a warning for the brand name drug (which is chemically identical to the generic) this wouldn't be an issue. Agree that the law is silly, but it is the right decision according to the law. Also, if the state hadn't had a law that conflicted with a federal law, this wouldn't have been an issue either.
 
Travis said:
Well I get plenty of generics. I mean if there are problems with the pills I take they would have been found long ago.

Speaking of which....how often does a drug make it into the generic stage and only then does a huge side effect get discovered?
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I heard on Thom Harman show that the laws have changed in such a way that a person should beware of any drug that hasn't been in the market for, at least, ten years. Basically, they claim that Big Pharma is using the public for it's clinical trials.
 
thaiboxerken said:
SCOTUS decided that generic companies are immune from law suits if the brand name didn't have warning labels of side-effects.
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Reading the article, the reason for this is that they cannot legally add warning labels that the brand-name product didn't have.

If they're not allowed to add warning labels on their product, it makes sense that they can't be sued for not adding warning labels to the product.
 
Brian-M said:
Reading the article, the reason for this is that they cannot legally add warning labels that the brand-name product didn't have.

If they're not allowed to add warning labels on their product, it makes sense that they can't be sued for not adding warning labels to the product.
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I can agree with that logic. I have to wonder why, then, that lady should not have been able to sue the brand name company, since they originated the product.

Seems like the laws need to changed.
 
Had she, she may have had a case. Though that is what I gathered from other sites that discussed the case. The biggest problem was she sued under state law, and the state law goes against federal law. That being the ultimate problem.
 
Wow, disturbing, but apparently not common at all. In fact, the only way that a generic can be labeled as such under FDA guidelines, is if they're identical. Certainly a scary scenario either way.
 
Drugs are often taken off the market for severe side effects up to a decade after being made publicly available. Take Serzone as an example. It was on the market for about eight years until it was found to have serious hepatoxic effects. The pharmaceutical company that developed it lost a massive class action suit and took their version off the market permanently but other companies continue to sell it today, ten years after the medical community had acknowledged its dangers. Other drugs have been found to be effective during FDA-compliant trails and then, on postmarket analysis, have been found to be ineffective for what they have been marketed to treat (see Neurontin as an example.)

As for drugs being tested on the public, this is acknowledged to be a core part of the FDA's clinical trial phases. An FDA-compliant trial necessarily includes continuous postmarket assessment, which is behind many of the black box warnings we see on package inserts. The FDA is continuously monitoring side effects and efficacy on postmarket drugs and has a defined process as to how this process is handled. Put simply, a trial phase that includes thousands of participants over several years cannot compare with results seen in tens of thousands of participants over a much longer time frame.

http://patientnetwork.fda.gov/learn...lopment-process/step-5-fda-post-market-safety
 
http://www.scotusblog.com/case-files/cases/mutual-pharmaceutical-co-v-bartlett/


http://www.scotusblog.com/?p=166652
As the case came to the Court, the issue was whether it mattered that the verdict here was based on a “defective design” claim instead of a “failure-to-warn” claim. Counsel for Bartlett (Court veteran David Frederick) ably contended that this case was different because it was a matter of strict liability. Because the recovery here did not depend on negligence, he argued, it should be regarded more as cost-shifting than conduct-altering.

As the argument suggested, the Justices in the PLIVA majority were having none of this. Justice Alito, writing for the majority, honed in on the main point Mutual Pharmaceutical’s counsel Jay Lefkowitz emphasized at argument – that the New Hampshire tort depends on a finding that the product is “unreasonably” dangerous. Because the tort turned on “unreasonable” danger, it involved an assessment of the product’s quality, not simply a shifting of the risks associated with the product. In the Court’s view, there were only three bases for assessing liability under the New Hampshire standard: that the product was not sufficiently beneficial to patients, that it was excessively dangerous, or that the warning was inadequate. Because the Court held in PLIVA that the generic manufacturer had no discretion to change any of those three product attributes, the Court held the claim pre-empted. Justice Alito buttressed that point by emphasizing the actual proof at trial – which pointedly criticized the FDA-specified label.
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the corps have already pulled the teeth of the FDA and so, we should urge our representatives to change the way the FDA works.

(As if, my new congressmen is a shill) I might write my Senators.
 
thaiboxerken said:
I heard on Thom Harman show that the laws have changed in such a way that a person should beware of any drug that hasn't been in the market for, at least, ten years. Basically, they claim that Big Pharma is using the public for it's clinical trials.
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Thom Harman is wrong. There have been no law changes to support this claim.

If anything, the introduction of post-market monitoring improves public safety. The recalls cited above may not have happened a generation ago.

The possible exception is the introduction of fast-tracked approvals, which were a concession to public protests ("Why do we have to wait for all these clinical trials to finish? Why can't we just buy the drugs as soon as a scientist thinks them up?")

I don't think there's any special increased risk associated with selecting a generic brand. Per the legislation cited, if they alter the formula, they are required to conduct new testing and amend the disclosure of side effects.
 
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Who was it that argued that more lives would be saved by putting good drugs on the market without testing than would be lost by putting bad drugs on the market without testing?
 
thaiboxerken said:
I heard on Thom Harman show that the laws have changed in such a way that a person should beware of any drug that hasn't been in the market for, at least, ten years. Basically, they claim that Big Pharma is using the public for it's clinical trials.
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Much as I like Thom Hartman, that's very misleading.

If side effects only show up in 100,000 people, you can't exactly test that many before releasing a drug to market.

Prescribers know that, and a good health care provider prescribes older drugs unless there aren't any good options.
 
Travis said:
Who was it that argued that more lives would be saved by putting good drugs on the market without testing than would be lost by putting bad drugs on the market without testing?
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I don't think that's exactly true but there have been arguments that the sensationalized new-drug deaths that resulted in drugs being removed from the parket limited a prescriber's options to help a patient all the while other equally dangerous drugs are on the market, risks known, and it's just a matter of applying a good risk/benefit analysis.
 
thaiboxerken said:
SCOTUS decided that generic companies are immune from law suits if the brand name didn't have warning labels of side-effects.

http://cumberlink.com/news/opinion/...cle_e4e75b1e-e5c2-11e2-b44a-001a4bcf887a.html

Basically, the conservatives of the SCOTUS are giving corporations power over the people. Surprise.

So now, the message is simple. Don't take generics because you can't sue them if things go bad.
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It looks to be a tad more complicated than your OP suggests:

Basically, the majority said that since generic-drug manufacturers are required by law to use the same active chemical ingredients and warning labels as the name-brand manufacturers, they cannot be sued if the drug turns out to be dangerous or the warning label inadequate. Since the label for Clinoril did not warn about Stevens-Johnson, Mutual’s sulindac could not legally include such a warning, and thus could not be held legally accountable for its absence.

In short, if Bartlett had been injured by Clinoril, she could have sued and won under New Hampshire law. By taking its generic equivalent, she lost the right to sue.
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Just because you could sue over failure to warn, doesn't mean you'd win. I'm pretty sure you'd have to prove the drug company knew or should have known about the risk.

This ruling, the way I read it, is saying generic manufacturers are allowed to rely for a large part on the research the original drug makers are responsible for. If not then generics would be a lot more expensive.

I don't think this favors corporations because the drug makers who don't want generics to compete with their products would love to see the generic drug makers have to spend as much on R&D as they originally did.

It is something the public needs to be aware of, so it's good to bring this to everyone's attention.
 
Travis said:
Who was it that argued that more lives would be saved by putting good drugs on the market without testing than would be lost by putting bad drugs on the market without testing?
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I've never heard that argument, actually. Are you asking about the rationale behind fast-tracking?
 
thaiboxerken said:
I heard on Thom Harman show that the laws have changed in such a way that a person should beware of any drug that hasn't been in the market for, at least, ten years. Basically, they claim that Big Pharma is using the public for it's clinical trials.
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But that would still be under patent protection and thus not relevant here.
 
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