Why is Allergan Paying a $600 Million Fine to the FDA?
It appears that Botox, the wrinkle-killing drug, has another application: It relieves some patients of migraine headaches. Consider that:
- Botox has already been approved for migraine treatment in Britain.
- A Mayo Clinic doctor has conducted tests confirming its efficacy.
- Allergan, the producer of Botox, had $56 million in sales in 2007 because of doctors giving their patients Botox shots for headaches.
So why is the FDA harassing the drug company and exacting a large fine? Because (1) the FDA hasn’t approved Botox for headache treatments, (2) the agency accused the company of encouraging this off-label use and (3) the FDA doesn’t think you should be able to take any drug without first asking its permission.
These guys think they own you. They don’t work for you — like normal civil servants. Your role is to serve them.
Since when is enforcing the law “harassing”?
artk, have you ever read the Declaration of Independence. This nation was founded by people who resisted tyrants who were harassing ordinary citizens and violating their rights by “enforcing the law.”
Whether you call it enforcing the law or harassment, it is inhibiting (corporate) freedom of speech and physician discretion.
The end result is that less is being learned about the efficacy of treatments as fewer doctors are educated about the potential uses and get the chance to try them.
The drug approval process is extremely costly. The return on investment from taking an approved drug and clinically testing it for another use is often not worth the cost.
There was a blog post last year saying 50% to 70% of cancer drugs are prescribed off-label http://www.john-goodman-blog.com/richard-epstein-let-cancer-patients-have-access-to-all-drugs-that-are-not-toxic/
Earlier this year there was a blog post that explained one-in-five prescriptions is off label. http://www.john-goodman-blog.com/off-label-drugs/
The costs associated with bringing a new drug to market create incentives against innovative treatments. The stuff that makes the money is what people take every day for chronic conditions. So, there’s no incentive to find a “cure all.”
If we relax some of these restrictions on approval, it might be more profitable for drug companies to develop new treatments, since the required return is lower and the initial investment lower. There isn’t the big hurdle (and thus incentive to create repeat users).
It’s amazing that it is a violation of the criminal law for a drug company to distribute an article in a peer reviewed journal that reports on off label uses of that company’s drug. This is a free society?
Current migraine research suggests migraines are either a cortical or brainstem phenomenon. This usage of Botox would not fit well with current research.
Funny, the FDA has never harassed anyone about teh frequent off label use of drugs for peds patients.
Steve
For all you folks who didn’t read the article
“Allergan had systematically built Botox sales by promoting it for unapproved treatments to relieve conditions like migraines, pain, muscle spasticity and cerebral palsy in children”
“an aggressive marketing strategy, saying that Allergan financed and widely disseminated a video, featuring a well-known neurology professor, to promote Botox as a headache treatment; set up an educational Web site called the Neurotoxin Institute, registered by Ogilvy Healthworld, an advertising agency, to promote Botox treatments to doctors”
“paid kickbacks to doctors to induce them to prescribe Botox”
I can’t defend kickbacks, but what’s wrong with a drug company promoting legitimate uses of its drugs — especially when reputable doctors find that the off label uses are helping their patients?
Even more disturbing to me is the idea that patients should have to get permission from the FDA or anyone else to take a pill for a migraine headache.
Where in the Constitution does it say that people have come together to form a government so it can tell them what pills they can take? Somehow I missed that section.
So by all the comments here, I would assume everyone is also okay with medical marijuana? It too has multiple confirmed treatment capabilities and by suppressing it, it is keeping entrepreneurs from establishing a legal marketplace for this incredible drug and we do claim to be a free market society.
One could say it is our constitutional right to put anything in our body we so choose and not the business of the government and big Pharma. Yet, those same regulations that keep Botox from being used outside its original intent keep marijuana from being consumed by patients in true need.
Erik–is the FDA harassing the medical marijuana suppliers that have proliferated all over Colorado now that the state has legalized medical marijuana use use? I know of 17 years olds who have weed “prescriptions” for “pain.” Comes in a nice little pill container with label and all. Pot shops have people standing out on streets advertising.
I’m not aware of clinical trials of marijuana for pediatric pain use.
The point of the post on the article is that unlike marijuana at the federal level, off-label use of approved prescription drugs is perfectly legal. What sense, therefore, does it make for the FDA to prosecute companies for telling about it?
Linda,
17 year olds are not even able to enter a Medicinal Marijuana shop here in L.A. So I doubt that statement. There have also been numerous studies of marijuana over the last 20 years as you well know. You pointed to pediatric studies which have not been done to prove a point that none exist. That is a straw-man argument. Finally, it obviously is not legal for a pharmaceutical company to promote their drug off-label or the FDA would not be going after the makers of botox.