General Discussion

godai

(2,902 posts)

58. Here you go...(response to #54)

Tue Jul 9, 2013, 04:12 PM

Jul 2013

The observed average differences between reference and generic products for AUC was 3.5% (JAMA,
Sept. 4, 1987, Vol. 258, No. 9). The second survey included 127
bioequivalence studies submitted to the agency in 273 ANDAs approved in 1997.
The three measures reviewed include AUC(0-t), AUC(0-inf), and Cmax. The observed
average differences between the reference and generic products were + 3.47%
(SD 2.84) for AUC(0-t), + 3.25% (SD 2.97) for AUC(0-inf), and + 4.29% (SD 3.72)
for Cmax (JAMA, Dec. 1, 1999, Vol. 282, No. 21).

http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm071436.pdf page x

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Generics aren't 'exactly identical' anymore than innovator separate lots of product are 'exactly identical'. Think about that. It's important to understand.

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Holy Shit! New Law: Drug Companies exempt from Lawsuits -Supreme Court Ruling [View all] Fantastic Anarchist Jul 2013 OP

I feel something tightening around my neck. factsarenotfair Jul 2013 #1

Our necks. Tell me again why who is President doesn't really matter? nt kelliekat44 Jul 2013 #62

It's the generic vs name brand distinction. geek tragedy Jul 2013 #2

Either way, generic vs name brand, the warning should be there. Fantastic Anarchist Jul 2013 #5

The solution is for Congress to write a better law. geek tragedy Jul 2013 #7

I work for a CRO ... Fantastic Anarchist Jul 2013 #11

And that's the rub--the warning for both is exactly the same. geek tragedy Jul 2013 #18

Which is confusing because ... Fantastic Anarchist Jul 2013 #21

The original manufacturer is the only one who can change the language. geek tragedy Jul 2013 #23

Okay, I have some more information. Fantastic Anarchist Jul 2013 #25

Except that the generic company doesn't choose its warning label. geek tragedy Jul 2013 #27

I don't understand why the labeling requirements would have to be the same ... Fantastic Anarchist Jul 2013 #29

Oh, we agree that the law is all screwed up. geek tragedy Jul 2013 #30

Generic must show bioequivalence and must have exact labeling as innovator. godai Jul 2013 #32

Thank you for the information. Fantastic Anarchist Jul 2013 #33

It's a very broad range. StrayKat Jul 2013 #36

And thank you, too, for more information. Fantastic Anarchist Jul 2013 #37

No, that's an old argument made by innovators. (Responding to#36) godai Jul 2013 #39

Read the article. StrayKat Jul 2013 #54

Here you go...(response to #54) godai Jul 2013 #58

Access Denied. StrayKat Jul 2013 #71

No restrictions on the link. godai Jul 2013 #73

You're last paragraph is a very interesting point. nt Fantastic Anarchist Jul 2013 #59

"it helps the original manufacturer by imposing extra costs on the generic competition." HiPointDem Jul 2013 #65

Look at this optimum phrase: Fantastic Anarchist Jul 2013 #3

Would it bother you to know that the line you cite at the top of your post does not appear anywhere onenote Jul 2013 #43

No, it wouldn't bother me to know. Fantastic Anarchist Jul 2013 #52

Why is it a strange question? onenote Jul 2013 #63

It's strange to ask if I'd be bothered by new information. Fantastic Anarchist Jul 2013 #74

Another reason Andy823 Jul 2013 #4

I certainly don't want any right-wingers in government ... Fantastic Anarchist Jul 2013 #6

Another ignorant "news" website that should be banned from DU.. snooper2 Jul 2013 #8

I tried to link to that site. It came up with an error message. Fantastic Anarchist Jul 2013 #10

Ok here is the article from a "liberal" site.. SomethingFishy Jul 2013 #24

That site was the only one that had the full article ... Fantastic Anarchist Jul 2013 #26

If anyone was napping, not realizing ours is a wholly-owned corporatist government, this ruling indepat Jul 2013 #9

Sue the doctors if,,,, kentuck Jul 2013 #12

Not sure how it would be the doctor's fault ... Fantastic Anarchist Jul 2013 #13

Link to the Supreme Court decision DeschutesRiver Jul 2013 #14

Thank you. Fantastic Anarchist Jul 2013 #16

personal bank acc'ts of justices need to be audited to see where the money's coming from!.... dmosh42 Jul 2013 #15

I'm totally supportive of that. Fantastic Anarchist Jul 2013 #17

Ya think? But it doesn't matter, they are absolutely above the law mountain grammy Jul 2013 #46

Supreme Court Justices are required to file financial disclosure forms onenote Jul 2013 #68

yes they are and Thomas's were brought up a few years ago mountain grammy Jul 2013 #76

... Scuba Jul 2013 #19

One of the first things Walker and his crew did here in EC Jul 2013 #20

Unbelievable. nt Fantastic Anarchist Jul 2013 #22

At what point will they figure out that Ilsa Jul 2013 #28

At least it wasn't acupuncture or homeopathy TM99 Jul 2013 #31

This is for GENERIC drug companies only. godai Jul 2013 #34

Big Pharma imports cheap drugs made in China, now with impunity! What a sick country we live in. reformist2 Jul 2013 #35

weird how the OP says one thing and the story is 180 degrees off nt friendlyFRIEND Jul 2013 #38

Thanks. Discussed yesterday. elleng Jul 2013 #40

Thanks for the clarification. At first glance I was like, WTF. That makes more sense. nt Incitatus Jul 2013 #44

Glad you appreciate it. elleng Jul 2013 #45

Thanks for the information ... Fantastic Anarchist Jul 2013 #53

"I love the smell of fascism in the morning!" AAO Jul 2013 #41

hyperbole much? ellennelle Jul 2013 #42

THANK YOU and HI, ellennelle! elleng Jul 2013 #47

thx ellennelle Jul 2013 #50

I'm quitting this thread too, I think; elleng Jul 2013 #51

I'm at work ... Fantastic Anarchist Jul 2013 #55

A few here want there to be a common enemy we can all rally around Rex Jul 2013 #61

Yeah, I guess so it goes, eh? Fantastic Anarchist Jul 2013 #75

I'm at a loss...something somewhere is freezing over. BornLooser Jul 2013 #48

I listened to Mike Papantonio talk about this last week. mountain grammy Jul 2013 #49

The crux of the argument makes sense as Elleng pointed out ... Fantastic Anarchist Jul 2013 #56

Just say NO to medications HockeyMom Jul 2013 #57

Okay. As you request. Now, how do I deal with this pesky HIV thing I have? Liberal Veteran Jul 2013 #64

I worked for years helping develop antiretrovirals. Avalux Jul 2013 #72

Holy Shit! This OP is sensationalistic crap. Avalux Jul 2013 #60

Somewhere in between zipplewrath Jul 2013 #66

Correct. Avalux Jul 2013 #69

the ruling doesn't make any generalized principle such as you claim. it's specific to this HiPointDem Jul 2013 #67

Ugly, Inc. Berlum Jul 2013 #70

Another great decision from Ralph Nader's US Supreme Court. Thanks Ralph! NT graham4anything Jul 2013 #77