F.D.A. Scientists Complain to Obama of 'Corruption'

[BigJimW]

While not e-cig directly related, it has everything to do with it, if the FDA wants to make the e-cig classified as a "medical device"

YouTube - F.D.A. Scientists Complain to Obama of 'Corruption'

 

[Surf Monkey]

Nothing new, really. The Bush FDA was rife with corruption as well. His first FDA chief had to resign after two months due to conflict of interest arising over his ties to drug companies. Later the Bush FDA was responsible for a whole slew of scandals involving everything from tainted meat to shady medical device approval. If the same thing is going on under Obama, it's bad. The whole agency needs to be cleaned out from top to bottom.

 

[harmony gardens]

I'd like to hear some more specifics, but this is pretty interesting.

It's surprising to hear that researchers are speaking out for pure science,,, I thought fudged results were common at the FDA.

 

[STILLSMOK9]

Sun,we are all waiting here!!
Where are you?

;-)

 

[Sar]

While not e-cig directly related, it has everything to do with it, if the FDA wants to make the e-cig classified as a "medical device"

I posted this just few hours on a different thread, but I think it will be more relevant here, so I'll repost. To me, this looks like someone wants to make it more difficult to get medical devices through review process. That would hurt e-cig chances of getting through because if FDA gots forced by politicians to make a ruling, getting the e-cig classified as medical device would probably be the best thing for e-cig.

Okay, so this is FDA's mission (from What We Do):

"The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation."

There is more, but the above is probably the most relevant part. Some e-cig manufacturers claim that e-cigs are smoking cessation devices, so it is possible that FDA would classify them as "medical devices". That would be much better than if they focused on e-liquid and classified that as a drug because medical devices are much easier to get passed through FDA.

Medical devices are regulated by FDA's Center for Devices and Radiologic Health (CDRH) and they consider long approval process as preventing innovation so to speed things up they group medical devices to 3 groups based on the perceived risk:

Group/class I is low risk and normally there are just special labeling and manufacturing requirements for such devices.

Class II is higher risk level and need pre-market review under something called "510k" process under which the manufacturer needs to show that the new device is somehow based on already existing approved device that is already available. There is usually no or very limited clinical data needed. There already are inhaler devices for nicotine so it is possible that e-cig could fall into this group.

Class III is for devices that are technically new, and the approval is much more elaborate.

The interesting point is that there is "FDA clearance" (as a result of the 510k review) and "FDA approval" that is really only for devices that go through the elaborate class III review. The e-cig doesn't need to get "FDA approval", it only needs to get "FDA clearance" which is relatively easy to get.

 

[DaBrat]

Sar
I would say that your post above gave me some piece of mind but it doesn't. If I believed the FDA would clear them for over the counter sale I would be ecstatic, however, although the nicotine patch and gum are both avail without prescription, the nicotine inhaler still is not. It requires a doctors prescription and at last check, they ran in the neighborhood of 240.00 per prescription/month thanks to big pharma. That price tag does not even include the physician's visit. Not covered by insurers either because the efficacy has not been proven.

I doubt that this device would succeed if it is placed in the same category as that inhaler and that inhaler doesn't even have the added benefit of all the pretty smoke. It is a nic cartridge pure and simple in a plastic bullet looking thing with a mouth piece.

Lets just hope that the fact that the ecig is marketed as a substitue for smoking and not a cessation device allows it to be carried OTC.

 

[harmony gardens]

The interesting thing is that you can shoot the darts at any point on the board you want. It all depends on the marketing claims that you make.

The FDA has no problem with Cheerios as a cereal, but stopped them from claiming a specific health benefit. If someone were to try to gain approval for a knife as a device to clean teeth, it might be rejected, but to spread butter, it would pass.

It's interesting that the technology for Ecigs is also used as a fog machine or to detect leaks in windows and doors.

The nicotine,,, now we'll have to see what they do about that one.

 

[Sar]

Sar
I would say that your post above gave me some piece of mind but it doesn't. If I believed the FDA would clear them for over the counter sale I would be ecstatic, however, although the nicotine patch and gum are both avail without prescription, the nicotine inhaler still is not. It requires a doctors prescription and at last check, they ran in the neighborhood of 240.00 per prescription/month thanks to big pharma. That price tag does not even include the physician's visit. Not covered by insurers either because the efficacy has not been proven.

I doubt that this device would succeed if it is placed in the same category as that inhaler and that inhaler doesn't even have the added benefit of all the pretty smoke. It is a nic cartridge pure and simple in a plastic bullet looking thing with a mouth piece.

Lets just hope that the fact that the ecig is marketed as a substitue for smoking and not a cessation device allows it to be carried OTC.

DaBrat, I am not sure what the rules are for something to be limited to prescription-only distribution. (But there are medical devices that do not need prescription.)

About e-cig being a nic cartridge, that is something that can go either way. The Federal Food Drug and Cosmetic Act distinguishes between drug and medical device depending on how is the intended purpose achieved -- either as a chemical reaction (drug), or not (medical device).

I was reading about what happens when the item could be either and it seems that in such case FDA has the authority to make the final determination. One example was a procedure that involved new type of injection of something and that could be either medical device (as a delivery system) or a drug (the thing that was injected). In that case FDA determined this to fall under medical devices. I am not sure if the nicotine inhaler was considered to be a medical device, but I'll try to find out.

With the current climate I think FDA will be forced to rule on e-cigs and if it does, there are not many outcomes possible. The surprise is that great majority of new medical devices only get the FDA clearance, in which case that would probably be the best for e-cig because right now it is extremely easy to get. In a way, that is probably part of the big complaint -- there is this disconnect between CDRH (medical devices) and Center for Drug Evaluation and Research (CDER) that regulates drugs. CDRH decided to take more permissive stance because medical devices have shorter development time and also shorter market life because improved versions are introduced relatively fast. Compare that to drugs which usually take forever to develop and have a very long lifetime on the market.

 

[ladyraj]

Sar, Thank you for your excellent and concise research on the "Substantially Equivalent" and 510(k)s. You have a true gift of reading between the lines!!! From what I've been reading, the drug process for the nicotine could also be described as "Substantially Equivalent" to the CDER and fast tracked or simply declared an OTC product.

Excerpt regarding medical devices in a kit with a drug:
"If the device kit contains items that are subject to
regulation as drugs, a substantially-equivalent determination by CDRH will not apply to the drugs in the kit. For information on applicable FDA requirements for marketing drugs in a kit, contact the Center for Drug Evaluation and Research."

From: A 510(k) Primer FDA's Premarket Notification Process (MDDI archive, Jan 96)

I found this guidance article for OTC human drug products:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM150994.pdf

Other links I've been reading:
510(k) Clearances

The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance

Maybe, the way to go would be OTC on nicotine and SE on the vaporizer. Regardless, I suspect that paperwork must be filed to test the waters. With the FDA's new responsibilities for tobacco it will take some time to be up and running and perhaps the e-cig will fly under the radar for awhile!

 

[harmony gardens]

Maybe, the way to go would be OTC on nicotine and SE on the vaporizer. Regardless, I suspect that paperwork must be filed to test the waters. With the FDA's new responsibilities for tobacco it will take some time to be up and running and perhaps the e-cig will fly under the radar for awhile!

Isn't each product evaluated on it's own merits?? In other words,,, SE's device would be evaluated separately from say a Janty Product? Just because SE claimed something with it's product, it shouldn't nessessarily apply to Janty's products, right??

If so, I think if a company would include 0 nic with the PV, and sell it as a vaporizer for PG or VG, flavors and all, they could then point people over to a separate product that contained nicotine that could also be used with the device, and do an end around,,, I know there's nothing original in what I'm saying here,,, but still,,,

We can hope!!

I think marketing students will be studying the SE case for a long time as an example of how to bungle up a product introduction. That said, they still seem to have stuff to sell.

 

[harmony gardens]

With the current climate I think FDA will be forced to rule on e-cigs and if it does, there are not many outcomes possible. The surprise is that great majority of new medical devices only get the FDA clearance, in which case that would probably be the best for e-cig because right now it is extremely easy to get. In a way, that is probably part of the big complaint -- there is this disconnect between CDRH (medical devices) and Center for Drug Evaluation and Research (CDER) that regulates drugs. CDRH decided to take more permissive stance because medical devices have shorter development time and also shorter market life because improved versions are introduced relatively fast. Compare that to drugs which usually take forever to develop and have a very long lifetime on the market.

Does it matter which catagory a product falls into, other than what claims could be made in marketing them??

Let's say a company decided to market them as a smoking cessession device, in order to get an insurance company to pay for the device as part of a prevention plan,,, and another company marketed a substantially similar product without seeking such approval,,, how would the FDA rule??

 

[Sar]

Does it matter which catagory a product falls into, other than what claims could be made in marketing them??

Let's say a company decided to market them as a smoking cessession device, in order to get an insurance company to pay for the device as part of a prevention plan,,, and another company marketed a substantially similar product without seeking such approval,,, how would the FDA rule??

Harmony, I don't think that the similar product would be allowed to be marketed as a cessation device without FDA stamp. (I think that is why CDRH makes it possible to get the simple clearance status, to allow for device innovation.).

But it would be interesting how would exactly the same device but used for a different purpose be treated. Lets say the company would make the PV work as artificial saliva lubricant just by using different eliquid. That would need FDA approval, but I am not sure if the company would be forced to design the device in such a way that would not make it possible to be "abused" as a nicotine distribution.

 

[taz3cat]

Nothing new, really. The Bush FDA was rife with corruption as well. His first FDA chief had to resign after two months due to conflict of interest arising over his ties to drug companies. Later the Bush FDA was responsible for a whole slew of scandals involving everything from tainted meat to shady medical device approval. If the same thing is going on under Obama, it's bad. The whole agency needs to be cleaned out from top to bottom.

I signed up for some FDA reports and I get reports everyday about recalls on Medicine, food, medcial equipemet, the list is endless and I wonder what they have missed.

I think the whole government has sold out for re-election money. I all about getting re-elected and hold power. Even if you have to get in bed with, Big Tobacco. They just keep giveing money to the big businesses and taxing the crap out of us litlle guys.

It dose not matter which party is in power. It is government for the few by the few.

 

[Surf Monkey]

I think it does matter which party is in power to an extent. It isn't that they can't effect changes in policy. They do. That's their job. But they're contending with the massive inertia of the lumbering federal government too. It can take decades to fix or clean up a broken agency. Decades to institute big policy shifts. A lot of contemporary presidential politics is involved with putting pieces in place that will out-last the presidency, only having their full impact years after he's left office.

So in my opinion the issue with the FDA is long standing institutionalized corruption that started back in the '70s and has gotten worse under presidents of both parties. Lots of agencies suffer from the same thing. The USPS for example, though it seems to have finally gotten somewhat better in recent years.

 

[happily]

I signed up for some FDA reports and I get reports everyday about recalls on Medicine, food, medcial equipemet, the list is endless and I wonder what they have missed.

I think the whole government has sold out for re-election money. I all about getting re-elected and hold power. Even if you have to get in bed with, Big Tobacco. They just keep giveing money to the big businesses and taxing the crap out of us litlle guys.

It dose not matter which party is in power. It is government for the few by the few.

I think it does matter which party is in power to an extent. It isn't that they can't effect changes in policy. They do. That's their job. But they're contending with the massive inertia of the lumbering federal government too. It can take decades to fix or clean up a broken agency. Decades to institute big policy shifts. A lot of contemporary presidential politics is involved with putting pieces in place that will out-last the presidency, only having their full impact years after he's left office.

So in my opinion the issue with the FDA is long standing institutionalized corruption that started back in the '70s and has gotten worse under presidents of both parties. Lots of agencies suffer from the same thing. The USPS for example, though it seems to have finally gotten somewhat better in recent years.

Technically, I say you're both right. I doesn't matter who's in power because they are all corrupt. Although it does effect which particular pet project's they will choose to fu** with. Either way it's the e-cig's on the chopping block right now and something tells me this all a stall tactic to by PM some time to get their production team rolling, now that they are finally losing more customers than they would like to see.

 

[denec]

keep in mind the FDA is in incompetent in many things, not just in how they are going to handle e-cigs

now they are going to go after tylenol and acetaminophen, becuase 72 people died in 2005 from OD, because they cannot read directions and are just idiotic, meanwhile hundreds of millions use it everyday with no problems whatsoever.



FDA Weighs Reduction of Painkiller ODs - TIME



Even if e-cigs are eventually allowed...by the FDA by a miracle, the minute someone is linked to some sort of death somehow by a nicotine overdose by an e-cig, people are going to be calling for it to be pulled off the shelves just wait and see.

 

[Surf Monkey]

People OD from OTC pain killers because Ibuprofen et al don't do much of anything. They take more and more of them hoping that they'll eventually do something about the pain... but all they do is destroy the liver and the victim dies. The best way to solve this problem would be to allow stronger OTC pain meds, not weaker ones.

 

[OutWest]

The remaining 40 deaths were connected with prescription acetaminophen drugs.

And my guess is that it's because the govt has gotten many doctors scared to prescribe the painkillers that actually work (codeine, demerol, darvocet, etc). Heck, when my dad had cancer the doc he was initially seeing wrote him a script for advil for cripes sake!

 

[Surf Monkey]

And my guess is that it's because the govt has gotten many doctors scared to prescribe the painkillers that actually work (codeine, demerol, darvocet, etc). Heck, when my dad had cancer the doc he was initially seeing wrote him a script for advil for cripes sake!

That's exactly what it is. I suffer from chronic headaches, punctuated by migraines. No doctor will prescribe me anything stronger than ibuprofen. "Drug seeker" paranoia is rampant in the medical world and driven by hysteria at the FDA. Pain killers like Codine and Demerol work great for my pain, but the only time I ever have access to them is when friends have surgery and give me a few (read virtually never.) It's asinine.

 

[denec]

And my guess is that it's because the govt has gotten many doctors scared to prescribe the painkillers that actually work (codeine, demerol, darvocet, etc). Heck, when my dad had cancer the doc he was initially seeing wrote him a script for advil for cripes sake!

That is a good point!


I think there is a two problems...one is...people not following directions if you read any bottle especially with acetaminophen, it says not take a certain amount in a certain period and not to drink so many drinks and not to mix with any other meds..

now if it is not working logic is not to increase how much tylenol you are taking but to call your doctor and if he will not give you something, now there is a problem with the system which i totally agree with, i know first hand

maybe the FDA should realize there is a problem and instead of punishing doctors for prescribing real pain meds, they should have less restrictive controls


of course you always have the bad doctors ruin it for everyone who really needs it