October 02, 2009

Botox Maker Sues FDA, Challenging Off-Label Marketing Rules

Seriously. Allergan, Botox's maker, yesterday sued the FDA in federal court in Washington, D.C., asserting that off-label marketing rules which prohibit drug makers from marketing drugs for unapproved uses violate the company's First Amendment rights. That's a novel argument and it'll be interesting to see how the court sorts it out.

Allergan told Reuters that the lawsuit is not connected in anyway to a criminal probe of the company over, wait for it, accusations of off-label marketing of Botox. And the moon is made of blue cheese.

I hope the court kicks Allergan's suit to the curb because if it finds in the company's favor, it would open the door to some epic problems and truly weird advertising campaigns. Even under current rules, off-label marketing has caused a lot of damage to patients (Zyprexa being perhaps the prime example) and it seems appropriate to have some kind of restrictions on the marketing of drugs that can be quite dangerous in some instances.

Posted by Philip Dawdy at October 2, 2009 11:20 AM
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Comments

Wow! I just wrote a post about Allergan's Latisse eye lash growth product.

Allergan's drug, Lumigan, for glaucoma, was being used OFF LABEL by spas and doctor's offices for eye lash growth, being that is a side effect of Lumigan.

NOW, they sell Latisse, and it is being heavily marketed on (internet TV so far seen my me)by Brooke Shields as a spokesperson.

The FDA has sent a letter

http://bipolarsoupkitchen-stephany.blogspot.com/2009/10/vanity-poses-health-risk-eyelash-growth.html
to Allergan:

"FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) issued a letter to Allergan, the pharmaceutical company behind Latisse, citing the "stark contrast" between latisse.com's efficacy statistics and risk information. At the time of the letter's release, the organization declared that the warning display "fails to present risk information with a prominence and readability reasonably comparable with the presentation of information relating to the effectiveness of the drug."

Latisse, which contains a prostaglandin (fatty acid derivative) called bimatoprost to grow longer and darker eyelashes, can cause hair growth outside the intended treatment area and bacterial contamination—two risks that the FDA says are omitted or minimized on the site."

Off-label use lawsuit by Allergan is simply absurd, hell we have a right to know what their marketing of products has in store for us, such as how they discovered Lumigan had a eye lash growth side effect thus tapping into the vanity market as a nice side show for BOTOX.

Give me a break!

Posted by: Stephany at October 2, 2009 12:29 PM

Allergan seems to be engaging in wishful thinking given the Supreme Court's ruling in Central Hudson Gas & Electric Corp. v. Public Service Commission of New York.

Posted by: Joe at October 2, 2009 03:33 PM

Morphine. It's not just for pain any more.

Wouldn't that be a logical conclusion of the argument they're making? Or am I missing something here?

Posted by: marlborojones at October 2, 2009 05:52 PM

If I were a judge I'd dismiss this as a frivolous lawsuit. Clearly the public's right to be protected from potentially harmful drug products unapproved for all but certain uses-- not to mention from false advertising-- trumps corporate free speech to say anything they want about their products to anyone they want.

Posted by: Miranda at October 3, 2009 12:38 PM

I find it ironic they want freedom of speech when they (pharma companies such as Lilly/AstraZeneca/GSK for example) so blatently lie and withhold truth that can get their product canned and not approved by the FDA.

Posted by: Stephany at October 3, 2009 02:47 PM

I'll write it here.

I've just talked to an American woman at Second Life, yes we find amazing people at this thing, and I started to talk about psych-medications...
and for the first time I don't know why what I said was not "as if I wasn't there".
She works with women who was abused, I found out later, and she said to me "You speak like you have experienced." I said "yes." and told my story.
I told her about my blog and all my friends, told, of course, about Furious Seasons and Philip Dawdy.
Told her about my two years of withdrawal and tears came.
I believe that it will never go away and sometimes I will have cry.
Not because I feel sorry for myself.
I told her: "The thing is that if my experience was of any value I would feel some relief, but knowing that more people are being put on these drugs kills me. And that's why all these people are bloging."

That's it. I'm very emotional and I prefer to leave it here and not create a post of my own.

It aches sometimes remembering some awful things I've been through.

Please, if you are a psychiatrist or have anything to do with this:
HAVE MERCY!

It has to stop.

She already has an idea and said that "it's criminal".

You will be seen as the worse of what human beings can be.
Spend all the money you have but it's not enough, never enough... blah blah blah...

Experience says: Nice speech for someone with a heart!

Posted by: Ana at October 3, 2009 05:13 PM

I hope the court will find American people's health more important than the right of a company to mislead these people. I am all for free speech, but I'm glad that I live in a country where companies aren't even allowed to market prescription drugs to patients directly (but they still have enough controversial marketing tactics nonetheless). Just as defamation is illegal despite free speech rights, so must be misleading marketing.

Posted by: Astrid at October 4, 2009 12:51 PM

"...but I'm glad that I live in a country where companies aren't even allowed to market prescription drugs to patients directly..."
Astrid

There is only one intermediate and some are payed by the companies.

"Just as defamation is illegal despite free speech rights, so must be misleading marketing."

I didn't understand it.
Seriously.

Posted by: Ana at October 4, 2009 11:26 PM
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