Anoher reason Big Pharma is off base here is its assertion that once FDA puts its stamp on the product it is all OK. However, all the data submitted to FDA by the drug companies is used by the FDA to justify granting approval for marketing. If this data is inacurate, flawed, biased, or fraudulent and the FDA doesn’t catch it, then who should be held liable? The FDA?? I think not.

In all fairness, these things should have been disclosed to JAMA at the time, but really — if they were, and if they were acknowledged in the article, they would’ve been largely ignored. The problem with the CLASS presentation was in the lack of complete transparency . . . but all that aside, there wasn’t much to hide.

Great points!

Government of the people, by the people, for the people - doctors are people too! So are the people who work in pharma, but sometimes they forget that they are people and they behave like, well, like corporations….

1. Has there been under-utilization of specific drugs because of irrational fears? Absolutely. Has there been over-utilization of specific drugs because of irrational exuberance? Absolutely. For an example of an underused class of drugs, see pain relievers in the ’90s. Doctors were so afraid of abuse and addiction that they were failing to adequately respond to complaints of pain. In the past 8 years, many strides have been taken to make pain the “5th vital sign” and to treat it, and appropriate treatments, more seriously. For an example of overuse, see Nexium. Is there anything about an isolated enantomer that makes Nexium so much better than Prilosec that upwards of 60% of former Prilosec users currently use Nexium (at substantially higher cost)? Doubtful.

2. And we really are talking about who is going to pay for inevitable injury. Preemption will have little effect on the ability to bring a fraud claim. Unless the court abandons precedent, preemption will only address what the FDA is authorized to regulate - safety/efficacy balancing. A good question raised is whether the FDA’s regulation should be considered a minimum standard (potentially increased by the judgment of the states based on relevant facts), but I doubt that would be a good policy call. The FDA should establish THE standard — they are the agency dealing directly with the companies — they have the best ability to police marketing practices. The question to ask, I imagine, is how they can best accomplish that goal. Labeling changes take time, and time is of the essence when new safety risks emerge. Perhaps the FDA can undergo a form of informal adjudication and direct companies to act prior to official label changes. The FDA is admittedly arcane in its procedures. Perhaps preemption would be the kick in the pants the FDA and congress need to update the system.

3. Yes, patients and doctors are not really informed about the risks of drugs. Since the mid 90’s, pharma has moved away from fair balance, much to the detriment of the companies’ credibility. Currently doctors rely on competitors to hear about the side effects of competing products. This situation is far from ideal, and is probably not going to be fixed soon. The best agency to police this would be the DOJ, but I still think there is room for private claims for promotional practices short of outright fraud to the FDA (or to customers). Perhaps the best middle ground in the preemption debate would be to preempt strict liability claims for improper warning based on FDA labeling, but allow claims for improper warning based on the actions of individual representatives interactions with physicians — and hold the companies liable for their employees. That could be the kick in the pants the companies need to shape up promotional practices.

According to the brief filed on behalf of the respondant, when the FDCA was originally passed Congress contemplated a legislative inclusion of an individuals Right to Action that would include preserve an individual’s right to bring a lawsuit. This provision was not included in the final draft of that became law as according to the brief Congress at the time felt it was not necessary.
I am sure the Supreme Court will address this concern and grant it very little weight. The Supreme Court will conclude that the failure to include this provision in the law protecting an individuals right to private action makes this issue moot; they will ignore the reason Congress felt that the law was unnecessary and rule that since the actual law is silent on the issue of preemption the Agency’s current interpretation of preemption is covered under the Chevron Deference Doctrine and the Agency’s interpretation will be upheld. Therefore in the 3 scenarios you cited above my bet is with number three.
Just a guess.

Although it may have been posted here before, I have included an attachment to the briefs filed in this case for anyone interested in reading the various positions.

http://www.abanet.org/publiced/preview/briefs/nov08.shtml#wyeth

“(The argument raised in Levine is constitutional in nature, grounded in the Supremacy Clause of the Constitution. Clever legislators could, however, surely draft mere statutes that would effectively undo any protection that a favorable decision provided to drug companies. A filibuster-proof Senate would allow the dominant party, if it were so inclined, to introduce and pass that type of bill.)”

So hat tip to them, and a revision of my initial response to Marilyn in light of this comment.

“Forget the facts of this particular case for a moment. The real issue here is one of policy. Who should “pay” when the inevitable happens. Should the injured party bear the burden of the injury when they “willingly and knowingly” accepted the risk of the treatment? Should the drug companies subsidize these injured patients because they are profiting from selling their drugs?”

In my family’s case, after my mother had a fatal reaction to a medical device, I can tell you Medicare payed, hundreds of thousands of dollars. Thank God that my father wasn’t presented with the bill, but are you willing to pick up the tab for fraudulently researched and reported drugs and medical devices? That is what drug and medical device companies are asking you to do. They aren’t really concerned with having “fifty different entities regulating what they do” and they’re not really concerned with “not having enough money to continue with research and development”. They’re worried about having to be held accountable for what they place on the market for public consumption. The real question is, are we, the public, willing to remove their accountability?

What we know is that pts, and docs too, almost never read the label anyway. It’s also striking that, even though we hear about defensive “overwarning” by companies, it never seems to happen. Rather, companies generally seem to fight for minimal, not CTA, labels. Obviously, this is clearest in blockbuster arena.

You say - Who should “pay” when the inevitable happens. Should the injured party bear the burden of the injury when they “willingly and knowingly” accepted the risk of the treatment? Should the drug companies subsidize these injured patients because they are profiting from selling their drugs?

Given that in most cases the consumer can’t afford to pay, especially without insurance, wouldn’t the cost be transfered to you and I?
Is it true that the consumer really is willing and knowlegeable with regard to the products they consume? Especially products that show adverse events that were not studied or revealed.
Also a small point but your term “subsidize injured patients” is peculiar to me. Maybe you don’t see product litigation as a means to force safer product design onto the manufacturer. After all the source of the problem is the initial design and that is where the best countermeasure to loss is established.

You say - Patients likely are not at risk of losing the ability to bring a tort claim based on negligence or fraud. If a company sits on adverse safety data, an injured plaintiff will still (most likely) have the ability to bring a state claim.

A manufacturer is protected even for negligence or fraud under this preemption but even if they weren’t how would the patient know without the turning over of evidence in a law suit? If the FDA can’t get the truth I doubt that John Q. could.

You say - Also, increasing the severity of the warnings on medicines could cause inappropriate under-utilization. That’s why the FDA is supposed to balance risk/benefit — to maximize appropriate use.

Couldn’t it be argued that preemption will cause some manufacturers to inappropriatly over-utilize their product? And concerning the FDA’s responsibility to do risk/benefit analysis, I understand that this is rarely done.

Overall wouln’t you say that we have an inappropriately high level of injury and death caused by today’s drugs and devices? How would preemption cause that number to decrease rather than continue it’s yearly increase?