I think jotronic has a very good point here. Accuracy and precision is very important, especially when you are representing a clinic using the product in question.
The term “regenerative medicine” is a fairly broad one, and the fact that ACell describes themselves as being in that field does not imply that they are suggesting in anyway that their product has been FDA approved for regenerative purposes.
Acell is indicated by the FDA only for wound-management. While obviously wound-management and regenerative medicine have some overlap, to suggest that the FDA has in any way approved or indicated Acell for regeneration of the sort that people are discussing here, such as full or partial regeneration of hair follicles, is disingenuous.
The statement that you originally made, that ‘ACell was approved by the FDA as a regenerative medical product.’ is simply false.
There is a simple, core basic truth here. It is unlawful for a company to make false claims about their product/products, medical or otherwise. ACell would not claim on their Website or literature that their brand of extracellular matrix has regenerative properties without FDA approval of such statements and claims. FDA Website
"False or Misleading Labeling
Section 502(a) declares that a drug or device is misbranded if its labeling proves false or misleading in any particular. This phrase “false or misleading” is not confined in meaning to untrue, forged, or deceptive. In fact, the word, statement, or illustration may be true in the strict sense of the word; however, the labeling can be deemed by the FDA to be in violation of the law if it proves deceptive to the customer. It is not a necessary condition that the labeling should be flatly and baldly false; the work “misleading” in the Act means that labeling is deceptive if it is such as to create or lead to a false impression in the mind of the reader. A “false impression” may result not only from a false deceptive statement, but may also be instilled in the mind of the purchaser by ambiguity or misdirection. It may also be caused by failure to inform the consumer of facts that are relevant to those statements actually made. In other words, the label that remains silent as to certain consequences may be as deceptive as the label that contains extravagant claims."
Extracellular Matrix products have very limited effectiveness in the strip surgery field, so it’s little wonder Jotronic is downplaying the effectiveness of ACell.
Shouldn’t the important debate be one regarding the effectiveness of extracellular matrix products?
Over the years various industries have noted the weight and effectiveness of the words “FDA Approved”. It injects a sense of confidence and trust that the consumer can feel good about. If the FDA “approves” of something, it must be an indicator that the product is not only safe but it does what it claims to do.
Remember the laser hair restoration fad from several years back? The lasercombs, the helmets, the doohickys? There was only one company that received FDA 510K clearance for their product; the Lexington Laser Comb. Once that happened it opened a flood gate of competing products stating that the technology (note, not their own particular product)was “FDA Approved”. This was an obvious lie but it was very effective because I had countless people calling me saying that they were told their laser thingy was FDA approved and I had to explain why it was not. It was a massive waste of my time but I at least helped to educate a few people about these pieces of junk. Turns out, they are no different than laser pointers. Same class of laser, same wattage variances, no different than a laser pointer you can get from Office depot for ten bucks. The amount of laser cap BS at the ISHRS conference last month in San Francisco, in the vendor section, was a joke.
The laser comb was cleared by the FDA with a 510K clearance because it was engineered and built in a similar fashion with no unique technology to any similar products that were marketed before 1976. In 1976 congress granted the FDA governing authority over medical devices. Problem is, before 1976, there were so many products on the market that the FDA could not possibly hope to take them all off of the market and evaluate each and every piece of medical equipment for an actual approval. So a 510K clearance was created and is essentially a grandfather clause that allows any new product to gain clearance if it shows “substantial equivalence” to products ALREADY ON THE MARKET BEFORE 1976!
This means that in order to gain clearance, regardless of the super human properties that the product may have, the manufacturer must downplay their product as being no different than anything else on the market before 1976. They have to show similar manufacturing, similar materials in the engineering of the product and a similar intended use. The moment they mention anything outside of these parameters as being one of the intended uses for the product, BAM!, they set the whole process back by years, and millions of dollars, in order to prove the claims.
510K clearance is the fast track to being allowed to sell a medical device in the US (and this is a medical device). Had Acell tried to push this through the FDA as being a regenerative medical device then they would have to prove without a shadow of a doubt that indeed that is what this product does, which it does not except in some cases. What ACell CAN do, but not always, is help to create a more ideal environment for healing.
What Acell the company does or does not do or say on their website is irrelevant. YOU stated “FDA approved for regenerative medicine”. No where on the FDA website does Acell show FDA approval for ANYTHING much less “regenerative medicine”. It is FDA cleared under the 510K clearance protocol for wound management and is no different, in the eyes of the FDA, as any other wound management device that has incorporated porcine derived ingredients over the past forty years.
There is one basic core truth here, and that is that Acell does not have the sort of FDA approval you claimed.
The passage you quoted regarding false claims is completely irrelevant to the discussion. Nobody is saying that Acell is making false claims. They weren’t the ones claiming to have FDA approval for regenerative purposes. You were.
There is nothing wrong with making an honest mistake, and retracting your claim once you realize you were wrong. It is a bit concerning however that the representative of a clinic using the product in question is so unconcerned with the accuracy of his claim that the product has FDA approval.
It is also concerning that rather than effectively addressing the issue, you try to imply that jotronic’s statement is less legitimate because he happens to work at a clinic that performs strip surgery. That simply has no bearing whatsoever on the accuracy of his statement.
FDA records are online and easily accessible. A quick Google search will provide you with the 501k clearance documentation for Acell (including the predicate device that Acell and the FDA felt were functionally similar). If you really believe that Acell has some sort of FDA approval over and beyond this, please show us the approval documentation. Of course, you will find none, because none exists.
None if this is to say that Acell isn’t effective for regenerative purposes of the sort your clinic is investigating. It may well be, and the investigation is very much worth undertaking. However, to claim that Acell is FDA approved is simply incorrect.
If you want to demonstrate the effectiveness of Acell (and I do hope it is effective) then why not share the specific results of your experimentation (graft and regrowth counts, close up photos of tattooed areas).
[quote][postedby]Originally Posted by jotronic[/postedby]
Over the years various industries have noted the weight and effectiveness of the words “FDA Approved”. It injects a sense of confidence and trust that the consumer can feel good about. If the FDA “approves” of something, it must be an indicator that the product is not only safe but it does what it claims to do.
Remember the laser hair restoration fad from several years back? The lasercombs, the helmets, the doohickys? There was only one company that received FDA 510K clearance for their product; the Lexington Laser Comb. Once that happened it opened a flood gate of competing products stating that the technology (note, not their own particular product)was “FDA Approved”. This was an obvious lie but it was very effective because I had countless people calling me saying that they were told their laser thingy was FDA approved and I had to explain why it was not. It was a massive waste of my time but I at least helped to educate a few people about these pieces of junk. Turns out, they are no different than laser pointers. Same class of laser, same wattage variances, no different than a laser pointer you can get from Office depot for ten bucks. The amount of laser cap BS at the ISHRS conference last month in San Francisco, in the vendor section, was a joke.
The laser comb was cleared by the FDA with a 510K clearance because it was engineered and built in a similar fashion with no unique technology to any similar products that were marketed before 1976. In 1976 congress granted the FDA governing authority over medical devices. Problem is, before 1976, there were so many products on the market that the FDA could not possibly hope to take them all off of the market and evaluate each and every piece of medical equipment for an actual approval. So a 510K clearance was created and is essentially a grandfather clause that allows any new product to gain clearance if it shows “substantial equivalence” to products ALREADY ON THE MARKET BEFORE 1976!
This means that in order to gain clearance, regardless of the super human properties that the product may have, the manufacturer must downplay their product as being no different than anything else on the market before 1976. They have to show similar manufacturing, similar materials in the engineering of the product and a similar intended use. The moment they mention anything outside of these parameters as being one of the intended uses for the product, BAM!, they set the whole process back by years, and millions of dollars, in order to prove the claims.
510K clearance is the fast track to being allowed to sell a medical device in the US (and this is a medical device). Had Acell tried to push this through the FDA as being a regenerative medical device then they would have to prove without a shadow of a doubt that indeed that is what this product does, which it does not except in some cases. What ACell CAN do, but not always, is help to create a more ideal environment for healing.
What Acell the company does or does not do or say on their website is irrelevant. YOU stated “FDA approved for regenerative medicine”. No where on the FDA website does Acell show FDA approval for ANYTHING much less “regenerative medicine”. It is FDA cleared under the 510K clearance protocol for wound management and is no different, in the eyes of the FDA, as any other wound management device that has incorporated porcine derived ingredients over the past forty years.[/quote]
Excellent educational post Joe, really deserves to be sticked or become a permanent feature story on Hairsite.
[quote][postedby]Originally Posted by licht[/postedby]
It is a bit concerning however that the representative of a clinic using the product in question is so unconcerned with the accuracy of his claim that the product has FDA approval.
[/quote]
I could understand someone such as yourself and Jotronic nit picking if regenerative medicine were a fairy tale. The motive of your criticism relates to the threat regenerative medicine poses to the strip surgery industry.
If ACell didn’t have regenerative properties, it would be nothing more than an overpriced bandage. Who would buy it?
If you have ever consulted with a representative of a government agency, you know that they are people who want a life just like everyone else and commonly have stacks of paperwork virtually no one on earth would want to deal with. They are motivated to keep their job as free from unnecessary complexities as are for instance, those seeking FDA approval of products. FDA approval even at the most basic level is not a walk in the park as Jotronic suggests. I personally know someone whose job involves securing FDA approval for medical devices. He often consults with FDA representatives by phone during the process. The paperwork and hoops to jump through are mind boggling. FDA representatives are made well aware of the details of products presented to them. The FDA is not going to create an elaborate customized category for every product presented to them. If a product qualifies under simpler, more generic guidelines, that will be the route taken. That’s in everyone’s interest. I have no doubt that the FDA representatives involved in ACell’s approval process are well aware that ECM has regenerative properties. ACell already has multiple FDA approvals allowing its ECM to be placed in humans.
Is ACell approved by the FDA for sale to physicians in the United States?
Yes
Do ACell’s extracellular matrix products have regenerative properties?
Yes
CITNews works at Dr. Cole’s office
Cole Hair Transplant
1045 Powers Place
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I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com
This is absolutely untrue, and a totally unnecessary ad hominem attack. While I can’t speak for jotronic, I can say that I have no interest whatsoever in the effect that regenerative medicine poses to strip surgery. None whatsoever. I’m only interested in making sure that the information here is as accurate as possible. That you would imply otherwise simply to try to cast doubt on the points I am making, indicates that you obviously not able to counter what we are saying using facts and reasoning.
[quote]
If ACell didn’t have regenerative properties, it would be nothing more than an overpriced bandage. Who would buy it?[/quote]
Nobody is saying that ACell doesn’t have regenerative properties. Once again, you are misdirecting the argument. We are saying that, contrary to your claim, the FDA has not approved Acell as a regenerative product.
Once again, misdirection. Jotronic did not, as far as I can tell, suggest that FDA approval was a walk in the park. How difficult or easy it is to get FDA approval for a product is not relevant at all. What is relevant is whether or not that process has been followed for Acell with regards to regenerative medicine, and it hasn’t. Just because the process is onerous doesn’t somehow give you the right to claim that Acell is FDA approved for regeneration when it is not.
First, Acell was not approved. It was cleared for sale. These are two very different things. Approval implies that the product has demonstrated its efficacy for a certain indication through a process of double-blinded, placebo-moderated clinical trials. Acell has not gone through that process.
The differences between clearance and approval when it comes to medical devices is given in a very clear way on the FDA website. FDA approval is a far more rigorous process which involves, among other things, that proof of efficacy of the claims in question be made. That process was not done for Acell.
This is ridiculously faulty reasoning. The fact that Acell is cleared for sale in the United States, and that it seems to at times exhibit regenerated properties in no way implies that the product is FDA approved for regenerative purposes.
The FDA has made absolutely no statement, implied or otherwise about ACell’s efficacy as a regenerative product by giving clearance for its sale. Clearance was given simply based on its similarity to a predicated product which also had 501k clearance.
I should also note that it is worrisome that you consider it nitpicking that we are concerned when the representative of a clinic who uses a particular product makes false statements about that product’s status with the FDA. This is no small matter.
Once again, your statement "The statement that you originally made, that ‘ACell was approved by the FDA as a regenerative medical product.’ is simply false.
[quote]
Once again, your statement "The statement that you originally made, that ‘ACell was approved by the FDA as a regenerative medical product.’ is simply false.[/quote]
If you look up the the word “approve”, there are several definitions:
to speak or think favorably of; pronounce or consider agreeable or good; judge favorably: to approve the policies of the administration.
to consent or agree to: Father approved our plan to visit Chicago.
to confirm or sanction formally; ratify: The Senate promptly approved the bill.
Within the context of FDA policy and language, I agree with you. By stating “ACell was approved by the FDA as a regenerative medical product”, I wasn’t attempting to mislead anyone as you imply. Rather I was using the number 2 definition of the word “approve” appearing in the dictionary:
The FDA has given consent and has agreed to allow, the company, ACell to sell their brand of regenerative, extracellular matrix products to physicians. This is what I meant and it was not my intention for it to collide with FDA terminology or cause misrepresentation or confusion.
Representatives of Clinics strive to be as accurate as possible, but simply don’t have the time or resources to consult with an attorney, scientist or government representative before every post they make in the forums. Minor errors in the wording of statements will occur from time to time.
I could seriously nit pick statements Jotronic has made in the past, even Dr. Hasson. We don’t agree on a lot of things. I prefer to keep things positive and report news that benefits hair loss sufferers.
My whole reason for bringing up the FDA was to diffuse some of the hope hair loss sufferers have in unproven experimental products. I believe that ECM products will play an important role in the future improvement of hair loss treatments.
CITNews works at Dr. Cole’s office
Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com
My whole reason for bringing up the FDA was to diffuse some of the hope hair loss sufferers have in unproven experimental products. I believe that ECM products will play an important role in the future improvement of hair loss treatments.
Your statement looks very worrying to me especially considering you are a rep. of major clinic - what excatly do you mean you were bringing FDA up just to diffuse some hope in unproven experimental products??
On top of that Dr Cole has supposed to prove ECM mentioning for more than 2 years that he has experienced regeneration using Acell ( recently i have red somewhere an average of 50% regeneration ) or is it a result of my misunderstanding?? Personally I am still waiting for the pics and it s more than 2 years you are going on with this acell regeneration without any facts to prove that.
[quote][postedby]Originally Posted by Dmark[/postedby]
My whole reason for bringing up the FDA was to diffuse some of the hope hair loss sufferers have in unproven experimental products. I believe that ECM products will play an important role in the future improvement of hair loss treatments.
Your statement looks very worrying to me especially considering you are a rep. of major clinic - what excatly do you mean you were bringing FDA up just to diffuse some hope in unproven experimental products??
On top of that Dr Cole has supposed to prove ECM mentioning for more than 2 years that he has experienced regeneration using Acell ( recently i have red somewhere an average of 50% regeneration ) or is it a result of my misunderstanding?? Personally I am still waiting for the pics and it s more than 2 years you are going on with this acell regeneration without any facts to prove that.[/quote]
We HAVE posted pictures of extraction sites growing hair. Dr. Wesley included a picture showing follicle regeneration in his Pilofocus video. Dr. Cooley has had success with follicle regeneration. Dr. Mwamba in Belgium is reporting follicle regeneration with an extracellular matrix product, just to name a few. When we post photos, a common criticism is, “You left the follicle of the growing hair in the extraction site when you removed the graft.”
Many doctors getting follicle regeneration don’t want to come forward simply because they don’t want to take heat in the forums. Dr. Cole told me privately that he has a difficult time himself, believing that he is getting follicles to regenerate with ACell. Dr. Cole began using ACell to improve hypopigmentation of extraction sites. When he began seeing donor sites where he extracted, for example, 3,000 grafts looking fuller than they should, he began counting hairs. The hair counts in extraction sites would begin when patients came back 8 months to one year post-op for an additional shaven procedure. Dr. Cole keeps track of follicle regeneration in an Excel spreadsheet.
As more doctors start using extracellular matrix products, it’s only a matter of time before the hair loss community accepts the reality of follicle regeneration.
My view of ACell is that it’s not in the experimental phase, but rather, a phase of widespread use by doctors in many fields of medicine where delivery methods and product effectiveness is being improved.
CITNews works at Dr. Cole’s office
Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com
WOW!! you are declaring completely opposite things in each reply !! Now you don t want to bring up any hope anymore but everything is proven and apparently also Dr Cooley and Dr Mwamba has proven that - is the same Dr Mwamba who went to the Dr Nigam who also has proven regeneration right ? Only us bald guys we havent proven any of these regeneration cures that seems many doctors have at the moment!
Sorry which evidences you have provided ?? The one attached above?? Do you believe those are evidences ?? If you really believe those are evidences good enough you really joking!
I am very disappointed as i tought at least Dr Cole clinic were belongin to the few serious and trustworth clinics worldwide but at this point this clnic has lost all his credibility to me saying the same bs for the last 2 years.
So Dr. Cole and some others may be seeing a certain degree of regeneration occurring, but they aren’t willing to tackle all the implications of making that the central thing their HT work has going for it. I find that scenario entirely plausible.
I think Dr. Cole is getting ahead of himself making claims of 50% regeneration. But IMO the guy generally seems to go out on limbs when he talks on lots of HT topics. Making some big unproven regeneration claims does not seem uncharacteristic of him in that sense.
The whole thing would feel much more dishonest if Cole & other FUE docs were making a big sales push out of the idea that Acell is regenerating donor hair. Also, if they were promising airtight proof in all sorts of specific ways and never delivering it.
But so far I don’t see that stuff happening. I just see assertions that some donor regeneration is believed to be happening at this stage. These clinics seem to basically still be attracting patients on the idea that they will receive a traditional FUE transplant, and giving patients the option of messing with Acell for possible extra benefit.
[quote][postedby]Originally Posted by Dmark[/postedby]
WOW!! you are declaring completely opposite things in each reply !! Now you don t want to bring up any hope anymore but everything is proven and apparently also Dr Cooley and Dr Mwamba has proven that - is the same Dr Mwamba who went to the Dr Nigam who also has proven regeneration right ? Only us bald guys we havent proven any of these regeneration cures that seems many doctors have at the moment!
Sorry which evidences you have provided ?? The one attached above?? Do you believe those are evidences ?? If you really believe those are evidences good enough you really joking!
I am very disappointed as i tought at least Dr Cole clinic were belongin to the few serious and trustworth clinics worldwide but at this point this clnic has lost all his credibility to me saying the same bs for the last 2 years.[/quote]
Not sure what you’re talking about regarding opposite replies. Can you provide an example?
The photo earlier in the post is one Dr. Wesley included in his Pilofocus video. This is not an example of our clinic’s success with follicle regeneration.
I’m having a similar discussion in another forum… Men placed their hopes in the research Aderans engaged in for about eight years. The first year they produced a video that implied they could already multiply hair. Years later, they have nothing. Histogen did not provide convincing photography of their product success at last year’s ISHRS meeting. This year they were a no-show in San Francisco. It’s not that we don’t want Histogen to be successful. I hope they flat out discover a cure and their employees become millionaires and billionaires.
I’m just trying to bring a realistic focus here. Nearly anything can happen. Perhaps Histogen will overtake extracellular matrix products with regards to overall effectiveness in the field of hair restoration. The truth is as of December 1, 2013 extracellular matrix products are the dominant player/leading product in the field of hair restoration with regards to regenerative success.
CITNews works at Dr. Cole’s office
Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com
Obviously, words can have different meanings in different contexts. When we are talking about “FDA approval” in terms of a medical product or device, the meaning is specifically defined by the FDA, and the word has very specific and important implications about the rigor to which that product has been put, in terms of proving its efficacy and safety in that area. It implies a level of testing and verification that has simply not been applied to ACell.
Other meanings of “approval” in other contexts are not relevant to a discussion about a product and its FDA status by a rep from a clinic.
I wasn’t attempting to imply that you were intentionally meaning to mislead people. I have a feeling that you simply didn’t know at the beginning, that you thought it was FDA approved, but it turned out not to be. Whatever the case is, at least now you know (and everybody else here does too).
The FDA has given consent to allow ACell to physicians, because of its similarity to wound-healing devices from before. We have to be very, very clear here that the FDA doing so does not imply in the slightest that the FDA believes this has been proven in any way whatsoever to have a regenerative effect of the sort that you are hoping for in your experiments. The FDA has made no decision whatsoever on ACell as a regenerative product. ACell has not gone through the requisite trials, and may never will.
It’s hard to really understand what your above sentence is supposed to be saying. ACell is, in terms of hair loss, or regeneration in general, an unproven experimental product as far as the FDA goes. The FDA has not approved it for those uses. When you brought up the FDA, especially in terms of approval, it implies that ACell has some sort of certification from the FDA that it does not. The FDA has simply cleared ACell for sale, based on its similarity to other products with respects to wound healing, and not regeneration in any broader sense.
So while again I couldn’t fully understand that last sentence, if you were trying to distinguish ACell from other unproven experimental products, then by invoking the FDA, you were in fact being misleading.
Again, I don’t think it was intentional. I think you just weren’t fully aware or informed about the actual FDA status of ACell, but now you know. You can cease to refer to ACell as FDA approved, cease to imply that the FDA has in any way vetted ACell for regenerative purposes at all, and then no harm, no foul.
All of this doesn’t mean that you can’t use it, or experiment with it. I think it’s great that some Doctors are experimenting with new techniques, and hopefully getting good results with it.
If you really want to demonstrate to us that ACell is successful in regenerating follicles, do so by applying some scientific rigor to the sample patients you are working with, and performing accurate graft counts and tattoo centered photographs.
The Title I’m responding to here is “Not True”. This opens up another question worthy of debate… Is a government agency’s determination or ruling regarding “truth” always reliable, accurate and moral?
Examples:
1.) A friend of ours is a tax attorney. While doing a client’s taxes, she came across an IRS policy statement that was unclear to her. She called the IRS office and spoke with an appropriate individual regarding a vague paragraph. The IRS agent gave an explanation that made no sense to her, so she called back and spoke to another IRS agent. This time she got a completely different answer. That answer didn’t make sense either so our tax attorney friend applied her own interpretation to complete her client’s taxes. She expressed to me that the IRS tax code is so complicated, the IRS doesn’t even understand it.
2.) We have a creek in our backyard that FEMA determined after a survey, endangered some properties in our neighborhood. later, two homes determined to be in the safe zone were flooded, one with 5’ of water. Other homes that FEMA required buy flood insurance, did not have any flood problems whatsoever when the floods came. We are one of the homeowners in our neighborhood required to buy flood insurance and our home has never flooded.
3.) A neighbor living in the Atlanta area bought a home in the close-by city of Alpharetta. Real estate paperwork was sent to California by error because a “GA” was interpreted as a “CA”. When the California taxing authorities got a hold of the real estate document, they saw that no California property taxes were ever paid. The homeowner of course protested and argued that the city of Alpharetta does not exist in California. That didn’t matter to the California taxing authority and they placed a lien on the man’s home. He contacted an attorney after going round and round and his attorney recommended he just pay the $8,000 (approx.) they required because it would cost more to fight them in court.
4.) Remember the film “Trading Places”. Aaron Russo was the producer of that film and also ran for governor of Nevada. At one time he was a big gold and silver trader. He got a notice from the IRS that a particular tax deduction he took on some previous year’s taxes was no longer legal. The IRS made the law retroactive, so even though he took a legal deduction in previous years, they required payment of recalculated previous-year taxes as if the legal deduction he took at the time had been illegal.
5.) A friend of ours, step father lives in Marathon Florida. He bought a Norwegian fishing vessel to restore and use like one would use a yacht. The first time out, he headed for Maine. He was constantly boarded by the coast guard because the ship was in a database of possible drug-running vessels. At that time the coast guard didn’t communicate between the various jurisdictions when a ship was “cleared”. Our friend’s step dad grew tired of the constant harassment by the coast guard and expressed his complaint. He was arrested and his boat was impounded. He was fined $85,000 and a judge didn’t seem to think that was wrong. This story ran in the Washington Post.
Debates can be similar to boxing. Remember Muhammad Ali’s rope a dope? Confuse and conquer?
Often real-world common sense carries more weight than government agency endorsement.
From the FDA glossary of terms
Biological Product
Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources — human, animal, or microorganism — and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.
FDA approves new drugs and biologics:
New drugs and biologics must be proven safe and effective to FDA’s satisfaction before companies can market them. FDA does not develop or test products; FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers. If FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the risks for the intended use.
The above could be interpreted to mean that tissues (ACell is made from pig tissue) require approval before they can be marketed. The FDA gives a broad meaning to what is classified as biologics.
Is the FDA using the word approval in the context of their proprietary meaning such as “Approved of Cleared” or are they using one of the common dictionary definitions?
Discussions such as this can waste a great deal of time. Personally I believe that often times proving a product’s efficacy in real-world application has more legitimacy than an agency’s rubber stamp.
CITNews works at Dr. Cole’s office
Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com
[quote][postedby]Originally Posted by CITNews[/postedby]
The Title I’m responding to here is “Not True”. This opens up another question worthy of debate… Is a government agency’s determination or ruling regarding “truth” always reliable, accurate and moral?
Examples:
[/quote]
Honestly, I don’t see the relevance in these examples at all. Nobody is claiming that any government agency’s determination is necessarily accurate, reliable or moral. Nobody is claiming that the FDA is the be-all end-all arbiter of what works and what doesn’t.
We’re simply stating that your statement, that “ACell was approved by the FDA as a regenerative medical product” is outright false and misleading.
A very simple outline of the difference between “approval” and “clearance” in terms of the FDA is given here, on the FDA’s website.
There is nothing confusing about it at all, and nobody is trying to confuse this debate. ACell is not, as you said, approved by the FDA as a regenerative medical product. It is as simple as that.
When you quoted from the FDA’s website a passage that referred to approval, obviously they were using their own narrow and specific definition of the word approval, which means it has gone through a process demonstrating reasonable safety and efficacy for a particular indication. ACell has NOT gone through that process for regeneration, and is there for NOT approved by the FDA for that indication.
In fact, it hasn’t been approved for any indication, but rather cleared for use under the 501k pathway, because it is substantially similar to either device that existed prior to current legislation, or a predicate device that also achieved clearance under the 501k pathway.
To say that it has been approved for regenerative medicine is misleading, as it implies incorrectly that the FDA has in some way attempted to verify the efficacy of ACell in that field, which it HAS NOT.
I disagree very much that this discussion is a waste of time. Claiming something is FDA approved when it is not is no light issue. If you think that the FDA’s “rubber stamp” is illegitimate fine. Just don’t claim that a product has that “rubber stamp” when it doesn’t.
Good discussion. Can someone tell me why they call Acell a device? From the pictures I have seen, Acell is some kind of powder which to me is more in the category of medical treatment rather than a device.
When people talk about device, I am thinking of a gadget, for example lasercomb is a device.
[quote][postedby]Originally Posted by licht[/postedby]
Honestly, I don’t see the relevance in these examples at all. Nobody is claiming that any government agency’s determination is necessarily accurate, reliable or moral.[/quote]
If you don’t have confidence that the FDA’s determinations are necessarily accurate, reliable or moral, then why bother put the effort into defending their proprietary terms and regulations?
The FDA states on their Website that they do not test products.
I just spent some time in the office of an associate whose job involves working with the FDA with regards to medical devices. When I first stepped into his office this morning, I said; I have a question for you about FDA “Approval” and “Clearance”. By the look on his face, his blood pressure appeared to have shot up. He showed me the official FDA forms required for the most basic clearance. The form has a field that requires complete information related to how the applicant intends to market their product. I have no doubt ACell had to reveal to the FDA, marketing words and phrases they intended to use, such as “regenerative”. The FDA has essentially “black and white” guidelines regarding claims and false claims. You say it’s false and misleading to state that the FDA had to approve of the marketing claims made by ACell. Acell certainly wouldn’t make claims in their marketing without FDA approval. There’s that word again.
I stand by my statement that the company ACell wouldn’t claim on their Website or in their marketing material that their products have regenerative properties without FDA consent or to use the term generically, “approval”.
Scientists from ACell have been working with the US government on at least one regenerative medicine research project I’m aware of.
IMO, It appears to me that what you claim is “false” is a legalistic stretch and I also didn’t state that the FDA’s “rubber stamp” is illegitimate at all. I just stated that a government agencies declaration or evaluation isn’t ALWAYS reliable. That was the purpose of my previous post. And yes it is VERY relevant. Obviously not to you because it doesn’t support your tedious arguments.
CITNews works at Dr. Cole’s office
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I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com
Dr. Ron and Paul Shapiro refer to ACell as approved (ouch) on their Website.
Jotronic wrote: “Over the years various industries have noted the weight and effectiveness of the words “FDA Approved”. It injects a sense of confidence and trust that the consumer can feel good about. If the FDA “approves” of something, it must be an indicator that the product is not only safe but it does what it claims to do.”
ACell’s products are classified as a medical device. According to information on the FDA’s Website, medical devices are “Cleared” not “Approved”. So in other words, when the FDA gives a product the green light for sale, if it’s classified as a device, they “clear” it. On the other hand, certain drugs must undergo what the FDA calls an “approval” process.
So it’s not like a medical device will graduate some day to a higher status called “Approved”
The FDA on its own Website calls “Clearance” an approval process. It’s just a different term they use to distinguish medical devices from other products like prescription drugs:
"FDA Approval Process for Medical Devices
The 510(k) process applies to most Class II medical devices sold in the US and a small number of Class I and Class III devices as well. Technically, the FDA does not “approve” medical devices; they “clear” them for sale. Once a FDA 510(k) number has been granted, it does not expire. However, you must remain in compliance with all FDA regulations to continue selling your product in the US. The FDA may visit your facility at any time to conduct an inspection to ensure you are in compliance with the Quality Systems Regulation (QSR), 21 CFR Part 820. If you are not sure whether your product requires a 510(k), see our easy to understand 7-step guide. We will lead you through the process.
So technically it isn’t an egregious falsehood as some suggest to say that “Clearance” is approval. The FDA on its own Website refers to “Clearance” as an approval process.
CITNews works at Dr. Cole’s office
Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com
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