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Redfairen

(1,276 posts)
Mon Jun 17, 2013, 11:35 AM Jun 2013

Drugmakers Opened to ‘Pay for Delay’ Suits by High Court

Source: Bloomberg

Drugmakers can be sued for paying rivals to delay low-cost versions of popular medicines, the U.S. Supreme Court said in a decision that rewrites the rules governing the release of generic drugs.

The 5-3 ruling is largely a victory for the Federal Trade Commission and the Obama administration, reversing a lower-court ruling that had effectively insulated pharmaceutical companies from liability. The FTC says those “pay for delay” accords cost drug purchasers as much as $3.5 billion a year. The industry says the deals are legitimate patent settlements.

The ruling may lead to lawsuits by wholesalers, retailers, insurers and antitrust enforcers. Bayer AG (BAYN), Merck & Co. (MRK) and Bristol-Myers Squibb Co. (BMY) units already have faced claims. The FTC says 40 pay-for-delay accords, also known as reverse payments, were reached in fiscal 2012 alone.

“A reverse payment, where large and unjustified, can bring with it the risk of significant anticompetitive effects,” Justice Stephen Breyer said in the court’s majority opinion.

Read more: http://www.bloomberg.com/news/2013-06-17/drugmakers-opened-to-pay-for-delay-suits-by-high-court.html

24 replies = new reply since forum marked as read
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Drugmakers Opened to ‘Pay for Delay’ Suits by High Court (Original Post) Redfairen Jun 2013 OP
Well, that's 2 for 2 today Cirque du So-What Jun 2013 #1
The courts have been weirdly sapient the last week, haven't they? (nt) Posteritatis Jun 2013 #21
This is good news, to a point AngryAmish Jun 2013 #2
Speaking as a member of the medico-industrial complex... MannyGoldstein Jun 2013 #3
isnt the point of the generic that the active ingredient be the same? La Lioness Priyanka Jun 2013 #4
That's what they need to demonstrate to pass FDA muster. MannyGoldstein Jun 2013 #6
Generics require the same active ingredient as brand. Liberal Veteran Jun 2013 #8
That is what the law says AngryAmish Jun 2013 #9
I hope you realize timdog44 Jun 2013 #11
The "10 years and thousands of deaths" - Have you a citation for that data? Thanks. pinto Jun 2013 #16
Sorry, I promised to cite my statements. timdog44 Jun 2013 #18
Hey pinto. timdog44 Jun 2013 #19
Thanks. pinto Jun 2013 #20
You are welcome. timdog44 Jun 2013 #22
Actually, I'm leery of broad brush assumptions about drug companies, R&D and FDA oversight. pinto Jun 2013 #23
I have to admit timdog44 Jun 2013 #24
Great news MannyGoldstein Jun 2013 #5
Holy crap. It's chicken and biscuits for trial lawyers tonight! nt msanthrope Jun 2013 #7
They'll just jack up their prices to offset whatever they're required to pay ... Myrina Jun 2013 #10
Another thing along this line. timdog44 Jun 2013 #12
this didn't hit the press the way it should have, but Obama when asked ways to cut the debt, dropped okaawhatever Jun 2013 #13
Good for the majority. And fuck you, Justice Roberts. hunter Jun 2013 #14
Frequently Asked Questions on Patents and Exclusivity (FDA) pinto Jun 2013 #15
Seems a pretty straight forward anti-trust ruling. pinto Jun 2013 #17

Cirque du So-What

(25,939 posts)
1. Well, that's 2 for 2 today
Mon Jun 17, 2013, 11:42 AM
Jun 2013

coming on the heels of the SC striking down AZ's draconian law requiring proof of citizenship in order to vote. Are the stars & planets in some peculiar alignment?

 

MannyGoldstein

(34,589 posts)
3. Speaking as a member of the medico-industrial complex...
Mon Jun 17, 2013, 11:47 AM
Jun 2013

I'm not sure that l'd particularly favor either name brands or generics.

 

MannyGoldstein

(34,589 posts)
6. That's what they need to demonstrate to pass FDA muster.
Mon Jun 17, 2013, 12:08 PM
Jun 2013

Of course, there are shenanigans sometimes. But the name-brand makers also engage in shenanigans sometimes, so it seems to me to be a wash with regard to which we can trust more.

Liberal Veteran

(22,239 posts)
8. Generics require the same active ingredient as brand.
Mon Jun 17, 2013, 12:48 PM
Jun 2013

The excipients in generics (non active ingredients) can be different however.

 

AngryAmish

(25,704 posts)
9. That is what the law says
Mon Jun 17, 2013, 12:50 PM
Jun 2013

However a big generics maker has plead guilty recently to rigging the tests for efficacy.

It makes me shudder.

timdog44

(1,388 posts)
11. I hope you realize
Mon Jun 17, 2013, 01:12 PM
Jun 2013

that name branded drug manufacturers have rigged their products to the point of many many deaths. So if you want to shudder, think in terms of that. The diabetes drugs, the anti inflammatory drugs, etc etc that know carry the black box warnings that are just ridiculous. If they are that dangerous, take them off the market. There are no new drugs that do anything any better than the good old standbys.
They use the US population as guinea pigs and then after 10 years and thousands of deaths the product gets either taken off the market or black labeled and they are fined a few hundred million dollars. That after they have made billions.

timdog44

(1,388 posts)
19. Hey pinto.
Mon Jun 17, 2013, 05:22 PM
Jun 2013

This is a partial list of citations. It is not fun reading and not easy to go through all the research. I was unable to substantiate the 10 year figure I talked about, sorry. But I will keep looking. Some of the articles will lead to that conclusion, though. The main point is that branded drugs are not safe all the time, and it is more profitable to pay a fine or a law suit and keep selling the drug. I will keep my eyes looking for more information and send you as I find it. Hope this helps.

http://www.philly.com/philly/blogs/healthcare/96577349.html

http://en.wikipedia.org/wiki/Rofecoxib

http://articles.mercola.com/sites/articles/archive/2003/11/26/death-by-medicine-part-one.aspx

https://en.wikipedia.org/wiki/Boxed_warning

http://drugs.about.com/od/medicationabcs/a/BlackBoxWarning.htm

pinto

(106,886 posts)
23. Actually, I'm leery of broad brush assumptions about drug companies, R&D and FDA oversight.
Mon Jun 17, 2013, 06:31 PM
Jun 2013

There's obviously market manipulation. And fraud at times. The Baystate Medical Center case is a good example. That's a clear case.

Yet I don't buy any broad FDA collusion in market manipulation or fraud.

The SCOTUS ruling clearly points to anti-trust violations. It was apparently made under FTC standards, appropriately. They are the regulatory agency in this instance.

(aside) Didn't read the mercola piece. I've little trust in their veracity or accuracy.

timdog44

(1,388 posts)
24. I have to admit
Mon Jun 17, 2013, 09:13 PM
Jun 2013

to being of an opposite opinion to you. I don't trust big pharma or the FDA as far as I can throw them. I believe there is big fraud there. They do not look out for our interests or rights. The FDA is populated by corporate pharma people who find their careers open when they leave the FDA, if in fact they need to. Physicians are paid to prescribe medications of which they know nothing. Most physicians who leave school feel they have done their share education. Problem is, that is what they are suppose to be - educators, not dictators.

Mercola is my go to guy. I read him a lot. I don't like his politics, but that does not mean I do not like his medicine and medical philosophy. I don't believe that "modern" American medicine is the do all be all of health care. What we do is sick care. And sick care is needed, but with the addition of a medical philosophy of the alternative kind which is more about preventative medicine. That is more cost effective monetarily and physically.

 

MannyGoldstein

(34,589 posts)
5. Great news
Mon Jun 17, 2013, 12:06 PM
Jun 2013

Alito recused himself, but otherwise the vote went the way we'd expect for a positive ruling: the far-right Kennedy split with his fringe-right brethren.

Myrina

(12,296 posts)
10. They'll just jack up their prices to offset whatever they're required to pay ...
Mon Jun 17, 2013, 12:50 PM
Jun 2013

The amounts of money they'll rake in in the time the generics are 'on hold' will more than offset anything they're required to pay in a resulting lawsuit.

timdog44

(1,388 posts)
12. Another thing along this line.
Mon Jun 17, 2013, 01:24 PM
Jun 2013

The big pharma companies have held on to their patents and prevented generics by just adding a little ingredient to the name brand, give it another name and whalla - new product, that does just the same thing. The drug business is a big ripoff in this country. They charge multiple times the price here than in other countries. Crying research and development. They spend more on advertising and paying off the doctors than any real research. It is a disgraceful enterprise. And it is disgraceful that the generic companies accept the money rather than do what they were organized to do. Greed on both sides.

okaawhatever

(9,462 posts)
13. this didn't hit the press the way it should have, but Obama when asked ways to cut the debt, dropped
Mon Jun 17, 2013, 02:23 PM
Jun 2013

the patent bomb. He said, basically we could revisit the patent laws which would save x amount of dollars. I know the rwingers heads spun. It was quietly dropped and no other resistance came from the gop that week. lol

hunter

(38,313 posts)
14. Good for the majority. And fuck you, Justice Roberts.
Mon Jun 17, 2013, 02:31 PM
Jun 2013
The ruling “weakens the protections afforded to innovators by patents, frustrates the public policy in favor of settling and likely undermines the very policy it seeks to promote,” Roberts wrote for the group.


I got hit by this anti-competitive practice while waiting for a med with an expired patent to go generic. These cases will probably be "settled" in some class action process, but it cost me some money, peace of mind, and I ended up taking a medicine that I could afford but was less effective, with the side effect of killing my libido. Individuals who opt out of whatever class action process takes place will, no doubt, be crushed by big pharm lawyers.

The medicine I take is (at last) available as a generic but I think the process that delayed the availability of the generic was criminal.

The big pharmaceutical companies pay more for advertising, bogus studies, and legal maneuvering than they do on actual medical research. I'd nationalize the worst of them, implement a "corporate death penalty" and turn their research departments over to public universities with federal funding. New innovative drugs would be given to world unencumbered by patents. Innovative drug developers, actual scientists and doctors (not CEOs, IP lawyers, and marketers...), would be awarded recognition and prizes for their work for medicines that actually save lives rather than medicines that are most profitable.
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