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January 17, 2011

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In other news, the authors of a recent academic study were found to be paid by corporations desiring a Longer Data Exclusivity Term for Conventional Drugs.

"And other researchers have elucidated the unexpected consequences of the Hatch-Waxman Act, which encourages nothing so much as ANDA litigation "

Also in other news this wasn't exactly unexpected save to the willfully blind.

While this study makes a convincing (and common-sense) case for a better deal for innovators, as long as the industry continues to serve as a political football for demagogues and makes things politicians would like to pass out cheaply to constituents, it has no chance of becoming embodied in legislation.

You know, 6, it may be easy to ascribe motives to lobbyists, etc., but academics have reputations that they prize even more than money. And I'm not talking about the authors of the study - I'm talking about the reviewers. That's why "peer-reviewed" means something - namely, that the data support the conclusions. So regardless of anyone's motivations, it is hard to argue that the paper is merely advocacy (which is what I do) - the folks who reviewed this paper thought it met the standards of their profession (economics) and while this conclusion may be wrong (that's the "subject to challenge, refutation, or affirmation by other academic researchers" part of the post) it will be honestly wrong.

As for the Hatch-Waxman litigation (which, trust me, is outside your skill set), the point was to promote generic drugs, not make patent lawyers rich. As much as we appreciate the opportunities to help our clients, most of us would prefer better drug development more.

Unfortunately true, Max.

Thanks for the comment.

The conclusion being correct or not was not at issue in my post Kev. But thanks for the man made of straw.

I like his hat.

And you're right, H-W is outside my skillset, but lawlmaking, and predicting the effect of a law that allows for more high stakes litigation is most certainly not.

It really doesn't take a rocket genius to make as much trouble as you guys manage to.

"In other news, the authors of a recent academic study were found to be paid by corporations desiring a Longer Data Exclusivity Term for Conventional Drugs."

Do you know the meaning of the idiom "straw man"? If your point wasn't to question the correctness of the conclusion (based on pro-industry bias), what does it matter who paid for it?

Try to keep up, 6. Either you are saying the support from the pharma industry makes the conclusions suspect or you're not. And if you're not, what's the point?

Frankly, I think Congress doesn't always anticipate the effects of the laws it passes - hence "the law of unintended consequences." I doubt Congressman Waxman or Senator Hatch thought that there would be > 400 ANDA cases filed per year or that significant money would be spent on such litigation.

Kevin,

Do you see what happens when you suffer fools gladly...?

I am working in this clinical research industry and we often talk about ICH-GCP. Protecting the rights of patients.. But do we practice what we preach? Data exclusivity will deny thousands of millions of patients the cheaper version of the drug through generics. We don't need to see a retrosceptive study which proves that the medicines should be costly and unaffordable for the patients. I totally am against Data Exclusivity!

"Do you know the meaning of the idiom "straw man"? If your point wasn't to question the correctness of the conclusion (based on pro-industry bias), what does it matter who paid for it?"

Yes. And it matters because it indicates the whole thing is nothing but propaganda, and it also matters because we should all take it with 2x grains of salt. Finally, while I have no specific dispute with the conclusion, there is good reason for those with enough information, or the ability to generate their own information, to review the matter independently to come to their own conclusions so that we may have more than just the industry telling us their point of view.

These are, after all, the same people mugging poor people at drug-point I'd wager.

"Try to keep up, 6. Either you are saying the support from the pharma industry makes the conclusions suspect or you're not."

Sure, they're suspect, but I didn't say they're wrong or right.

Dear je sus, all this over some off hand comment meant to do nothing but imply how the entire post is lolable at best due to the authors and their backers.

The best part is: I didn't even know if they were BIO backed. lulz. I just made it up! I just thought it would be funny if it were, it was a joke.

"Frankly, I think Congress doesn't always anticipate the effects of the laws it passes"

Of course they don't. The very first thing you'll learn when you participate in even a mock legislative body, or a local legislative body or observe an actual high level legislative body in action, is that most of the law makers are horrible at it nearly to, or entirely to, the point of being incompetent.

He ck, you can just pop CSPAN on and probably tell.

They're elected because they're popular and/or begged for money or were backed. Not because they're good at lawmaking, the job they're supposed to be doing. Save in some very few cases or in cases where we get lucky and the elected people just happen to be good lawmakers.

"I doubt Congressman Waxman or Senator Hatch thought that there would be > 400 ANDA cases filed per year or that significant money would be spent on such litigation. "

Have you ever met either of them? Even watched them on TV? They're not exactly folks I'd expect some successful landmark legislating from. But boy oh boy are they or at least they were media darlings.

"Do you see what happens when you suffer fools gladly...?"

Amen brother amen.

But, Dr. Intestar, not nearly as many will be denied drugs as there would be if there were no new drugs in the first place.

Name me a generic drug company that has developed its own innovative drug - until you do, I can't worry too much about the generic drug industry.

My (perhaps naïve) view on this is that if the achievement of the patent right requires the data, then that data belongs to the public at the end of the patent term. If any similar right (or extension of the patent right) is achieved through the use of the data, then likewise, that data belongs to the public at the end of the extended right.

If Congress mandates for policy reasons that generics can put product on the shelves for our consumption, and the safety and efficacy of what is being put out on the shelf is affected by the data, then there is a legal and moral imperative that the data belongs to the public.

While recognizing that the trade secret (think Coke) route is not available - there is a very good reason why it is not available.

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