BEST PICTURE EVER!

oh man, why does that cartoon guy look so familiar, i'm thinking '80s...

@jscott73:
That thing was in He-Man!

...And as a result, the FDA testing-and-approval process would take 20 years, in order to avoid lawsuits from insufficient product testing.

Orko

@RAREBREED: That's what I was thinking, but he was a late-comer right, like after She-Ra.

The doctors should have some liability. They know the risks when they give patients these drugs.

I would say the liability should be like this:
60% Drug Companies
30% Doctors
10% FDA

@jscott73:

He was the comic sidekick - kind of He-Man's Scrappy Doo.

This actually makes a certain amount of sense. The problem is, how do we then encourage the correct behaviors of a) due diligence and b) full disclosure? It would be quite hard to motivate the FDA to act more responsibly than it does, because there are no carrots and sticks we can use on a government agency. The tone of the agency is set by the executive branch.

Companies still need to be held liable for not releasing negative information they have discovered, that's endangerment plain and simple, but the fact is the court system is poorly positioned to decide whether or not a company has performed sufficient and satisfying research. It requires a team of experts to evaluate that, and after the team of experts signs off, if no further negative evidence exists, why should the company think they need to do any more?

It's a vexing problem. How do we keep the team of experts that is able to evaluate scientific value without giving up all of our incentives and punishments to encourage correct behavior? Should FDA scientists/administrators go to jail if they have behaved improperly? Sometimes it is easy to show they have ignored research and acted with conflicts of interest, but how can the court detect whether or not they are just acting dumb?

Maximum profits, minimum responsibility.

It's fun that the battle cry of big business is usually "less government involvement," but the second it's in the best interest of an company's bottom line to blame the government for a "lack of oversight and responsibility" they're the first ones to say its the government's fault for not regulating the industry enough.

,If this passes I see no new drugs being approved ever. I would support it if the drugs companies agree to turn over 50% of the profits to the FDA. That way the FDA can no longer use lack of funding as an excuse.,

J&J should have been pro-active in adding the warning on the label, without needing to be required to. It's their own fault.

@JustAGuy2: Since when do comic sidekicks (scooby and shaggy and et-al) have comic sidekicks (scrappy)

@fordpickup: Exactly. The most offensive thing about this argument is that its champions ("Why doesn't the government do its job better?") are exactly the ones who turn around and lobby the government (or, hell, vote in Congress) to gut the FDA and other regulatory agencies. They should be ashamed of themselves. It's monstrous, and beyond disingenuous.

@fordpickup: precisely, they are like a bully in school doing what they want until someone stands up to them then they hide and run behind the teacher.

@r081984: Doctors relay on what the drug companies and FDA tell them. Why should they be punished if the drugs companies fail to disclose information

This is like a drunk driver saying that the cops are responsible because they didn't pull him over before he hit another car... idiotic!

@hypochondriac: Or, do make it funnier, if I were someone in charge of the FDA I would just reject everything put forth by the FDA. New drug? Rejected. Bottle of water? Rejected.

Of course, what this does is puts as much of the responsibility on the FDA as possible and, by extension the taxpayer. Which is awesome for J&J because if a drug gets approved they get to roll around in fat sacks of money and when it turns out they fucked up and people developed explosive gonorrhea they get to say, "nuh uh, not my fault" and then the taxpayers get fucked again!

hoorj the system works!

Wow. Is this the new corporate strategy. Dump responsibility for everything on the government? Sub prime loans, medical disability, bad drugs?

Dump all stock in J&J, i have a feeling they will never have anything approved for sale EVER within the United States.

Am I wrong in thinking that government agencies are immune from lawsuits?

Oh this is bullshit.

Great idea - let's have one of the most politicized and underfunded agencies (relative to responsibilities) responsible for every drug that enters the market. How about holding the company that omitted data from the studies they submitted with their application liable to the government?

@magic8ball: No you are not wrong. That would be the baseball sized, nail studded butt plug for the consumer.

This means all a drug company has to do is mislead the FDA into approving a drug... and then blame the FDA for approving it if there are problems.

And yes, they already do this, but they weren't shielded from lawsuits, which was some deterrent from covering up the drug study results which could hinder the introduction of a new pharmaceutical.

With the FDA as the only agency on the hook, you can expect penalties for misleading the public and the FDA to drop from hundreds of millions of dollars to government-size fines of $50,000 here and $30,000 there.

How conveeeenient! (Church-Lady emphasis)
Big Pharma is being protected by the FDA which is run by ex-Big Pharma heads. There's a revolving door between all of the govt. agencies and big industry. i.e. Big oil heads run the EPA, etc. etc. ad nauseum.
Well, isn't that SPECIAL?!

Okay, wait... Drug companies lobby congress to make drug authorization quicker and easier, forcing the FDA to rely on the drug companies internal studies about their products rather than preforming long and costly independent studies. Then, the drug companies alter their studies and intentionally avoid disclosing negative side effects to the FDA to avoid the FDA attaching warning labels. Then when the companies get sued they're not liable because the FDA failed to provide warnings with the faulty and unreliable data provided by the drug companies?

I mean, seriously? I'm ready to line some motherfuckers up against the wall if this bullshit goes down.

@rmz: I'm not sure that the FDA can be sued for product liability.

There is some discussion about that going on here: [cr4.globalspec.com]

Basically it's a question as to whether the FDA can be held legally responsible.

There is a case where the FDA was sued in 2007, I don't know the outcome, but that wasn't for monetary damages, it was to force them to withdrawal the OTC designation of the "Morning After Pill" : [www.lifesitenews.com]

@anonymousryan: I know. It's unreal. Kafka-esque.

And then if this somehow goes into effect, any time food is tainted, it would have to be the fault of the FDA as well, because they didn't catch the company fucking up.
Yeah J&J, it's called self-regulation. If you think there's a problem with your product, you may want to tell people about it, even if the FDA doesn't catch it. Imagine what would happen if we had something like 100s of spinach factories patrolled by one terribly unequipped, understaffed, and underfunded agency! Why, we'd have massive amounts of e. coli infections and who knows what else?? Thank God the spinach factories are there to protect us, Joe Consumer.
Wait.. what? Where am I? Goddamnit Mr. Mxyplyx!!!!!!!!!

@r081984: or rather they should know the risks.

I think if the companies are not responsible for the drug and it falls all on the FDA than the drug companies will not have any quality control and just release a drug saying it will do x when they really have not clue.

Man, Orko has sold out to Johnson and Johnson. That's sad. If He-Man starts doing Viagra commercials, I might as well throw in the towel.

@anonymousryan: Ding ding ding, we have a winner.

Right on the money, Anonymousryan. They made the FDA rely on the drug companies, and now the drug companies don't want to be responsible for their own data...

@Grrrrrrrrr:

By the power of Viagra, I have a bonerrrrrrrrrrrr!

*ahem* *adjusts tie*

Love this quote:
"Johnson & Johnson knew that F.D.A. does not have the funding or the manpower to police drug companies," Ms. Abaray said.

Um, shouldn't we change the name to the "Food Administration" then?

</snark>

@rmz: No, I don't think so. I don't think the FDA has waived its sovereign immunity -- you simply *can't* sue the FDA.

This surely won't become the national policy, even if some Ohio court gives Johnson & Johnson what it wants. The result would be unfettered marketing of drugs with almost no oversight (the FDA is a joke), and no avenue of redress for the percentage of consumers who are guaranteed to be injured by reckless drug marketing.

@r081984: Did you purposefully leave out "the consumer" in your percentage chart?

This blows my mind. The pharma companies are destroyed by law suits. This country will let people smoke and drink all they want. All because there is a little warning on the bottle. But the second one person dies from a controled drug....All hell breaks.

Vioxx is a good example. A product the declared most of its risk, caused problems with very few people.

Doctors knew what they were giving out and people knew what they were taking. Yet, they still get paid by Merck.

@differcult: Easy, because people know what alcohol and cigarettes do ahead of time. How many people knew Vioxx would give you heart problems instead of just fixing whatever it was supposed to fix.

Donald Rumsfeld was CEO of Searle (Acquired by Monsanto) he, through his government connections, gets Nutra-Sweet FDA Approved and put on the market, despite protests from the National Beverage Association.
So when it is finally verified that Nutra-Sweet is deadly, and causes a launry list of side effects, are we going to now hold the FDA accountable?

Apologies for typos. I am having surgery on my eye this week. All blurry. Didn't see typos until too late.....

@suburbancowboy:

Where are the eye pills when you need them? Fucking FDA, goddamn them.

@cde: While I don't agree with J&J's approach here. The FDA should not be solely liable, but I do believe they hold some liability when they approve the drugs, because using your example; J&J cannot change the label whenever they want, it has to be submitted to and approved by the FDA before any changes can be made to it. Also, while I don't agree with it, many pharmaceutical companies pay the FDA to review their submissions. If the companies are paying for the review, not only by paying taxes but directly paying for the review, shouldn't they get some sort of partial protection? What are they paying for then? Should there just be free market drug production and let the market weed out the bad apples? They'd get sued out of business and the FDA wouldn't be needed right?

So, let me see if I have this straight. J&J informed the FDA of an issue that should lead to a labeling change. FDA did not act promptly to require the change. J&J didn't change the label until FDA required it. So, it's all the FDA's fault, because of course J&J couldn't change the label until the FDA required it. Uh, what?

The US Supreme Court handed down a ruling in February that applied pre-emption to the makers of medical devices. In the case in question it was a manufacturer of stents, catheters, and pacemakers.

It is a pretty small leap to apply the recent Supreme Court precedent to this pharmaceutical case. In the event that this state case isn't decided in favor of J&J, the likelihood of it being appealed is about 100%. The likelihood of it subsequently being settled in the Supreme Court is not far from that. Whether or not you agree with the conclusion, it doesn't logically follow that medical devices should be pre-empted and drugs should not, so expect the Supreme Court to have the final word on this.

I have to wonder if there aren't going to be some unintended consequences for J&J, et al. If the FDA is going to basically indemnify the makers of any product they approve, I expect that approval process to be radically different from what it is today.

@chemman: The whole label thing should be that they can't add information that contradicts the FDA required information, or remove required FDA information, but they should be able to add more information/warnings. Fda says albinos shouldn't take it, manufacturer says redheads shouldn't take it either.

Then again, the issue is that even though they pay the FDA, if they hid or otherwise obscured the information the FDA needed to provide valid warning labels, they should 100% be liable. People should still be able to sue the company, but if in court, it was found that the company provided full, acurate disclosure of the condition but the FDA ignored it, then the FDA is liable and pays both the person/class suing and the company's legal fees.

Then again, if the company truly feels that the side affect is truely a problem or of great merit, they should petition the FDA to include it on the warning.

@JiminyChristmas: But it does logically follow. Medical devices do not cause random problems. At most, the only problem they create is infection/rejection by the body. A pacemaker isn't going to make you develop kidney or liver problems. Drugs/Chemicals intended for the heart would, and can.

@cde:

Yeah, I don't really see a problem with adding additional warnings that aren't approved by the FDA. Obviously the drug makers would have a problem with that though, since any additional problems that they have to admit to will cause 1 less person to buy their product. So in reality, although self regulation is by far the most effective way for EVERYONE, the self interest of just 1 company makes that impossible, let alone every single company out there.
The funniest part about it is that J&J didn't want the label on there and probably would've done everything possible to keep it off so it can sell more product, but the FDA did it for them, so when they get caught.... hey, blame the FDA! We totally warned them and stuff, we swear!