FDA issues serious warning letters to Biogen and Teva

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FDA issues serious warning letters to Biogen and Teva

Postby cheerleader » Thu Mar 22, 2012 4:55 pm

For false claims and overstatement of effectiveness in advertising and unsubstatiated benefits to patients, and for understating side effects and risks.
Apparently the "happy people with MS" we see in those glossy brochures are not allowed.
Anecdotal evidence which is unsupported by research is against the law.

These are serious letters---
Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice.

Here's the one to Teva:
http://www.fda.gov/downloads/Drugs/Guid ... 296204.pdf

And the one to Biogen:
http://pharmalive.com/News/index.cfm?articleid=831521

Haven't seen this in the news, on any other MS sites, or really anywhere except Facebook...
Thought people might want to know,
cheer
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
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Re: FDA issues serious warning letters to Biogen and Teva

Postby euphoniaa » Thu Mar 22, 2012 6:04 pm

cheerleader wrote:Haven't seen this in the news, on any other MS sites, or really anywhere except Facebook...
Thought people might want to know,
cheer


HarryZ posted the Copaxone one in the Copaxone forum on Wednesday. :smile:
Dx'd with MS & HNPP (hereditary peripheral neuropathy) 7/03 but must have had MS for 30 yrs before that. I've never taken meds for MS or MS symptoms except 1 yr experiment on LDN. (I found diet, exercise, sleep, humor, music help me the most.)
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Re: FDA issues serious warning letters to Biogen and Teva

Postby cheerleader » Thu Mar 22, 2012 6:45 pm

euphoniaa wrote:
HarryZ posted the Copaxone one in the Copaxone forum on Wednesday. :smile:


thanks, euphoniaa! Should have looked there first, Harry's on the ball :)
Surprised to see the Biogen letter being publicized by Teva in the Israeli press....guess they wanted to show they weren't the only ones! (They failed to mention the Copaxone warning.)

http://www.globes.co.il/serveen/globes/ ... 9&fid=1725


cheer
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dx dual jugular vein stenosis (CCSVI) 4/09
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Re: FDA issues serious warning letters to Biogen and Teva

Postby Leonard » Fri Mar 23, 2012 2:43 am

cheerleader wrote:For false claims and overstatement of effectiveness in advertising and unsubstatiated benefits to patients, and for understating side effects and risks.
Apparently the "happy people with MS" we see in those glossy brochures are not allowed.
Anecdotal evidence which is unsupported by research is against the law.

These are serious letters---
Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice.

Here's the one to Teva:
http://www.fda.gov/downloads/Drugs/Guid ... 296204.pdf

And the one to Biogen:
http://pharmalive.com/News/index.cfm?articleid=831521

Haven't seen this in the news, on any other MS sites, or really anywhere except Facebook...
Thought people might want to know,
cheer


Hi Joan,

thank you.
do you see a tendency here?
is the FDA getting tougher on them?
that could be a very important sign ...
we should keep a watch

Leo
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Re: FDA issues serious warning letters to Biogen and Teva

Postby HarryZ » Fri Mar 23, 2012 6:23 am

cheerleader wrote:For false claims and overstatement of effectiveness in advertising and unsubstatiated benefits to patients, and for understating side effects and risks.
Apparently the "happy people with MS" we see in those glossy brochures are not allowed.
Anecdotal evidence which is unsupported by research is against the law.



Hi Cheer,

As Euphoniaa pointed out, I posted the Copaxone letter on that forum but am wondering how I missed Biogen's (my favorite company!!) warning letter :-) Must be slipping in my old age!

While these letters are more severe than ones I have read in the past, they are not new in the MS drug marketing wars. These companies know very well they are breaking FDA guidelines but as their sales reps have been known to say, "it's part of doing business." Stealing a few percent of the MS patient market away from your competitor can mean millions of dollars of additional revenue. To them, getting a slap on the wrist or kick in the butt for false advertising information is worth it.

The real damage here is to the new MS patients who may see this and think that by taking these drugs, all will be well. We know differently and so will these new patients who eventually will discover that the information they read was nothing but slick marketing.

Unfortunately, I have seen this "game" going on for many years now and is one of many reasons why I detest the CRABs and the companies that make them. But as some people have said in the past, I must have an agenda and am a negative person!!

Take care.

Harry
Last edited by HarryZ on Fri Mar 23, 2012 7:02 pm, edited 1 time in total.
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Re: FDA issues serious warning letters to Biogen and Teva

Postby munchkin » Fri Mar 23, 2012 9:14 am

How does the MS Society justify placing their ads when the ads are false? Is this something members of the MS Society can influence? This is wrong and I think there needs to be more of us with MS and our supporters protesting in general about the issues of treatment, research, and how we are regarded by the medical community.
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Re: FDA issues serious warning letters to Biogen and Teva

Postby HarryZ » Fri Mar 23, 2012 11:58 am

munchkin wrote:How does the MS Society justify placing their ads when the ads are false? Is this something members of the MS Society can influence? This is wrong and I think there needs to be more of us with MS and our supporters protesting in general about the issues of treatment, research, and how we are regarded by the medical community.


The NMSS gets their palms "greased" often by the makers of the CRABs. Some of the stories I've heard on how they operate would make you sick!

Harry
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