U.S. Marshals Seize Auralgan Otic Solution

U.S. Marshals Seize Auralgan Otic Solution

www.prnewswire.com

U.S. Marshals, at the request of the U.S. Food and Drug Administration, yesterday seized all lots of Auralgan Otic Solution, a prescription drug used to treat pain and inflammation associated with ear infections, from Integrated Commercialization Solutions Inc. (ICS) in Brooks, Ky. Auralgan is manufactured for Deston Therapeutics, located in Chapel Hill, N.C., and is warehoused at ICS.

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They seized $16.5 million worth of this product.

Can someone please explain to me how this drug got to become a prescription drug without FDA approval to begin with? Also, what took them so long if this was so important?

On Feb. 5, 2010, the FDA issued a Warning Letter to Deston, citing the company for distributing unapproved new drugs and misbranded drugs. The FDA also warned Deston that Auralgan was an unapproved new drug in April, June, and September 2010, and the company continued distributing the drug in violation of the Federal Food, Drug, and Cosmetic Act. Today's action is part of the FDA's Unapproved Drugs Initiative, established in 2006 to get unapproved drugs either approved or off the market.

Here's the write up about Auralgan at WebMD: www.webmd.com...

What's really going on here? Is this typical? How many prescription drugs are out there that are not FDA approved?!


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(visit the link for the full news article)

The only thing I can ascertain is that the main ingredients are already FDA approved or that it is approved somewhere else. Nonetheless, your question is valid. What is even more scary is that it has been on the market long enough such that a generic was developed. And guess what? Auralgan Otic: $200 Generic: $12.

I understand that companies offset research by charging more, however, the ingredients here are common medicinal ingredients (i.e. how much research do you need). Corporate profits.

Perhaps, someone in the FDA did not get paid off.

I'm not sure why this stuff should be a prescription med.
The ingredients do not look like bad stuff.
Maybe they think people will eat it for the "cain".

There used to be a sunburn lotion called Solarcain.
It felt cool and did relieve any pain due to sunburn...but then it did wear off.
So far as I know no one injested it, but it has not been on the market for many years.

Its due to the power that Big Pharma has over the DEA and the FDA along with the fact that if people begin medicating theirselves then Big Pharma loses money. Same with legalization of marijuana, Big Pharma can't have people growing their own proven medicine. Its corruption and nothing more, in this case the USMS being the puppets of the DEA. Also if the DEA gains approval (which they usually do) to call anything a "drug" then they can regulate it and thereby allow for Big Pharma to investigate it, determine if THEY can commercialize it then make money off of it.

was it really prescription-only? or was it just "doctor approved"(quote emphasis)? could be a mis-branding to get it off the shelves for other reasons. unapproved drugs have generally been around for years and appear to be benign other than what's advertised for. it's probably just this particular company was unapproved, and various prescription selling drugstores took it as just another type of the same thing that's been around forever and frankly doesn't need FDA approval.

on a side note, the FDA approval system is a joke anyways when it comes to medication, and that's coming from someone with years of medical experience.

reply to post by alyoshablue

I read somewhere that 600,000 prescriptions have been filled. In addition, your point about the cost is right on. This sure does seem to be more of a case of a vendetta or something rather than an actual concern for public safety.

It all has to do with "Justice"being see being done.
They are using this to cover the far greater crimes that they are committing every day,
The gov is just doing a publicity stunt here.
There is all kinds of people who have used the product safely.
The only ingredient i am usure of isd the antriphyne??sic
Is this a scheduled narcoric perhaps?

reply to post by stirling

Pain reliever, it sounds like, and fever reducer.

some seem to be missing a point here.
Integrated Commercialization Solutions is
a middle man company. They are part of
a international supply chain. They have
contracts with many big pharma companies
and they assume the responsibility in cases
such as this where the big pharma companies
are not affected.

This is basically like arresting the drug pusher
on the street corner, while the syndicate gets
a free pass.

This is just a small hiccup in the distribution
network. Tomorrow there will be 5 companies
set up to take it's place. It's too profitable
not to.

reply to post by boondock-saint

I understood that part. But their reason was still that it was not FDA approved. And if you're right, and there are five more pumping it out tomorrow, that's even worse.

Originally posted by ~Lucidity
I understood that part. But their reason was still that it was not FDA approved. And if you're right, and there are five more pumping it out tomorrow, that's even worse.

I never said the drug companies were morally right.
All I'm saying is that where there is a demand,
there will be a supply, even if it is illegal.
This is one of the reasons why making
all drugs legal will never work. It may increase
market competition, but that competition can be
wiped out and controlled on another level
by bribes to the overseers.

The world has no idea of how many super-beneficial products are withheld from the public because the holders refuse to jump through the substantial hoops that the FDA has demanded. It costs a fortune to get a product approved.

Last Summer, I accompanied a group on a project in the high desert of Nevada. I got lobster red - sunburned - and I was on fire by the end of this one day.

I was in pain and when I mentioned I was in for a miserable night - he told me he had some stuff back at the room and that I would be pain free upon our return, that I wouldn't lose any skin, and that I would not have any evidence of sunburn within a couple hours.

We got back, he handed me the "homemade" ointment, and my pain was gone within minutes, I was able to take a nice shower an hour later, and my skin just darkend without any hint of sunburn.

Lobster red, blistering sunburn to tan in two hours. I begged, and he gave me 200ml.

Instant sunburn cure - and it will never see the light of day.

A damned shame.

reply to post by FarArcher

You know, there are probably thousands of examples like this. While most would agree there has to be some regulation with pharma, but the FDA really has taken it to a twilight-zone level. The corruption and greed really have given the FDA a very bad reputation. The agency badly needs a revamping and refocus on their mission and classifications.

Ultimately, it's up to the people to choose what they're willing to risk for relief or a cure. There are risks even with "approved"drugs. Some even cause cancer, stroke, death. The physician and patient decide whether it's worth the risk. And that it is not "approved" should not necessarily prevent people from getting some new drugs. They need a fastpath for potentially lifesaving medications that allows the consumer some choice (sign a waiver not to sue if that's the only hold up!)

Ugh I could go on forever but just wanted to reply to you and say I can relate.

reply to post by ~Lucidity


Actually, the FDA's "Federal Food, Drug and Cosmetic Act" of 1938 simply required that a drug be considered safe. It wasn't until the Thalidomide tragedy that the "Drug Efficacy Amendment" was enacted in 1962. It was this act that required a drug's efficacy be proven. So, between 1938 and 1962, hundreds of drugs made it to market, bypassing the 1962 regulation. It is these drugs that are being pursued by the FDA's Unapproved Drugs Initiative.

Article about unapproved drugs:
www.usatoday.com...
List of laws changing FDA procedure:
en.wikipedia.org...
This is info on the 1962 amendment that the first link references:
en.wikipedia.org...
No doubt that Big Pharma is a beast at best, however, these drugs simply made it to market before they would have been caught by the 1962 amendment.

reply to post by chasingbrahman

Thanks, Interesting number...2%. Also interesting, as I alluded to earrlier, is how while the FDA considers them unsafe and/or unapproved and cries they have no resources to get these off the market and/or approved doctors keep prescribing them and pharmacists keep ordering the drugs and filling these prescriptions. Odd.

A person might be perfectly justified in assuming that a physician who prescribes them a drug is aware of all the drug's ingredients, side effects, interactions, and FDA status. That could be a deadly assumption. I'm sure some physicians do take this very seriously, but there are probably many who do not. Others might simply be unaware, or they might simply disagree that there is cause for concern—in their experience. .

There appear to be so many levels of disconnect here.

reply to post by ~Lucidity


Agreed. I work for a private firm that audits medical claims for signs of fraud, waste and abuse. Upon reading this article, I ran some queries to determine how many claims were processed during 2010 for this drug in just our four largest healthcare providers. Without discussing numbers and compromising identities, suffice it to say that this drug was prescribed with the frequency of your average antibiotic. Upon notifying co-workers (having careers as pharmacists and pharmacy techs prior to their tenure here) of this news, nobody knew this drug wasn't approved. Nobody.

reply to post by chasingbrahman

Ugh if they don't regulate themselves, how do we? And with docs it's probably even harder to pin down, as self-protective and guarded as they are. I guess this just points out another area we have to self-protect in too. Challenge your doctor over every prescription and make sure he or she is aware and can explain. In the end the only one you can really rely on is you. Shame we have to be at this level, and an even bigger shame is that so many people probably don't know all this. My own doctor is already annoyed with me but understands. I liked to think of myself as pretty savvy, but this one really blindsided me. Bad assumption on my part and a hole in knowledge. But it's on my list now. And even having said that what faith do I even have in the stuff that is FDA-approved? Not a lot, even though it's better than nothing.

reply to post by ~Lucidity


The killer is any attempt I make to acquire a listing of unapproved NDC's (Nat'l Drug Code) is fruitless. It's almost as if nobody wants anybody to know about what's unapproved except for the pharmaceutical firm. Just emphasizes the binding relationship of the FDA and big pharma.

reply to post by chasingbrahman

Geez. That's mind boggling. You should write a thread about this, as you know so much about all the ins and outs. It would be a great public service. Too often we just label the FDA "bad" and carry on. But this all goes so much deeper than just them and their symbiotic relationship with the pharmas.