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« DeepFx Forum (Exclusively for Encore UltraPulse Users) | Main | Needed: Clinical Education Programs for Dermatology »
Thursday
Jun122008

Is Cutera violating FDA guidelines? 

60minutes

Certainly I'm not a lawyer. So when I received this inquiry about Cutera selling in violation of FDA guidelines, I decided to post it here on the main page and see what the thoughts around it are.

Are Cutera, Palomar, Cynosure, Alma, and the rest of the IPL and laser technology companies violating the FDA's guidelines for selling medical devices to non-physicians? Does anyone care? Should non-physicians be able to own an IPL, cosmetic laser, or Thermage unit? Is this more about protecting a market or patient safety?

Happy to have Cutera respond. 

via email from T:

I have read this blog for over a year and a half and have been interested in the business and legal aspect of this industry.

There are many issues which intrigue me but a couple areas that stand out are: 1.) The legality of sale of prescription medical devices to "business people" and 2.) How laser companies such as Cutera are double dipping and hurting doctors business through their unethical sales practice… as well as violating FDA regulations with regards to selling prescription medical devices to business people under the guise of the use of a "medical director".

First, I know first hand that Cutera is selling prescription medical devices to business people directly.  As you know the FDA clearly states with regards to medical devices:

Medical Devices: Purchasers of medical device items hereby certify and assure that such items will be used or resold only under the conditions specified below:
Medical device items are subject to the laws and regulations administered by the Food and Drug Administration (FDA). Provisions of the governing statute, the Federal Food, Drug and Cosmetic Act appear in 21 U.S.C. 331, et. seq . In summary, the Act prohibits the movement in interstate commerce of medical devices that are misbranded or adulterated. The Act authorizes FDA to initiate criminal enforcement proceedings against companies and/or individuals responsible for violations of its provisions. Moreover, the Act authorizes FDA to initiate civil proceedings to seize, or enjoin the distribution of such items. Prescription devices are subject to additional Federal, state and other applicable laws. Federal law requires that prescription devices be in the possession of either persons lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device, or practitioners licensed by their state. Federal law also requires that prescription devices be sold only to or on the prescription or order of a licensed practitioner for use in the course of his or her professional practice, and that the devices are labeled in a specific manner. Refer to 21 CFR 801.109.

The area underlined above states the obvious and is in direct contrast to this “medical director” concept used by companies such as Cutera.  I have a copy of Cutera “medical director” form and no where does a doctor neither signs the form nor put their license on the form for the purchase of these devices.

These “medical directors” don’t own the business, the lasers are not used in the course of their professional practice” and yet Cutera and other laser companies continue to sell these devices in this manner.

This leads into my second point. As this is happening, it increases competition to “legal” laser clinic and medical offices that have the authority to own and operate these prescription devices.  These laser companies are selling their prescription devices to their “core customer base”, physicians and then turning around…even in the same town and selling to “non-physicians and increasing competition. As well, the AAD and other medical organizations allow these companies to display and exhibit at medical meetings. This is sickening.

It would seem to me that a site that is committed to the success and professionalism of the spa industry, such as medicalSpaMD could shed some light on the sale practices by the laser companies. You do a great job telling people how to run and market their clinics but if you really want to make a difference and help your fellow physicians succeed, it would helpful to eliminate the “illegal” practice and competition being perpetrated by laser companies.

Reader Comments (24)

Well I care. But it seems the FDA does not. I wonder what it will take for the FDA to care?

06.12 | Unregistered CommenterEMD

this is tricky because I know that a lot of medspas are set up where the med. director is the owner on paper, but they have a management llc set up behind it that really controls the money. just a thought.

06.12 | Unregistered Commenterdexter

One other thing.

The problems with sites such as this and blogs etc on the internet are that they allow everyone to blow steam and smoke but a few actually want to step up and do anything.

How many people in here are willing to put up some money, hire some lawyers and go after them in civil court? Any takers. I didn't think so.

This is the same reason why doctors are being screwed by insurance companies in the first place.

SHOUTING ONLY TAKES YOU SO FAR. People stop listening unless it comes with some backbone.

I for one would be happy to pitch in for some lawyers to take on cutera and all others who don't have your interest at heart one bit.

Don't get me wrong. If they are doing thing correctly then I give them credit.

06.12 | Unregistered CommenterEMD

Well said! Most companies are selling to all now- sign of tough times. Cynosure and Sciton need to be added to that action list as they are popping up in my area in non-md transactions. Sciton has done this 2x in my area. Not sure how it's structured on corporate papers, but technology is falling into the wrong hands....

06.12 | Unregistered Commentersp

also i may add that microdermabrasion manufacturers are ruthlessly selling to anyone . i know for a fact that image derm sells to even housewives if they have 10k . These companies need to stop asap . used medical devices online rarely asked me for proof of being purchased by a doctor. The FDA needs to be forwarded a petition to stop these laser companies- lets DO IT

06.12 | Unregistered Commentersingh

er... Microderm is not a medical treatment. It's just skin abrasion and no more medical than a block of sandpaper. We're really discussing things like IPL's, Lasers, Fraxel, and Thermage.

06.13 | Unregistered CommenterDermgal

Unfortunately, laser companies have no concern as to who they sell to. As long as someone is willing to pay, they (the laser Co's) will find the way to sell their product to them.

I myself served as the "medical director" of a spa franchise, started by two physicians, for the entertainment of their wives. There was no interest at all in the medical aspect of the practice.

I was given monthly "sales goals" not only on the IPL/injectable procedures, but on "product sales" as well -- including -- for crying out loud -- SPF creams and make-up.

There was a situation in which one of the owner's wives ordered me (her employee) to treat the "rosacea" on her hips with the IPL machine we had (our only equippment). I had already explained to her that IPL could not be used on her spider veins, esp with her Fitzpatrick skin type 4-5. You can all imagine the situation -- it was not pleasant at all, and it was not safe for her...

So I agree,medical grade devices should only be sold to physicians. And only to ones who have the training and interest in usind them, not just giving them away to whoever might be interested in creating a business. And this is all for the protection of the patient.

And I would be happy to support any petition in this respect.

PS: My patient/employer ended up with a serious focal hyperpigmentation, which was kept within a minimum area only because I insisted of doing a "test spot" prior to treating the entire area she wanted.

06.13 | Unregistered CommenterESG

ESG,

Sounds like you need some more training yourself, using an IPL device on Fitz's 4 or 5. My RN's and Laser Tech's better know what skin type they are treating before using IPL. It is not 2 or 3 - 3 or 4 - 4 or 5. The patient is either 2 - 3 - 4 - 5 not a combination of two skin types.

It is all in the training whether you are a MD, NP, PA, RN or Laser Tech.

06.13 | Unregistered CommenterSBJ

Here we again.

1. We have a doc here that sells out to some franchise and now feels that he is reformed so he can get on here and tell us what we already know.

2. We have another who gets in a pissing contest over verbage from him.

3. AND we have the laser companies laughing to the bank because they knew this would happen.

STOP BLOWING SMOKE, DO SOMETHING ABOUT IT.

06.13 | Unregistered CommenterEMD

EMD,

I think you are wrong. Blogs are great. Shouting sometimes leads to action . . . at least it feels good, is better than doing nothing and helps prevent indigestion and headaches!

What we need to do is blog and communication and make sure we give the best treatments possible and get the best outcomes with the fewest complications. We need to compete and out-compete the competition and stop whining about who they sell to and who is doing the treatments.

Let's start whining about the lack of training and the lack of support and the absence of "clinical exchange programs"! Let's start to whine and complain about something that matters and something that can be fixed easily.

I am a doctor and I don't care who does the treatments as long as they are done well and done safely. Training, education and support are the key ingrediants. The marketplace will take care of the rest. I am confident that I can get the best results possible. If an aestheticain can match my results, then he or she has the right to compete.

Just my opinion!

06.13 | Unregistered CommenterMDR

MDR

I admire your idealism, but you speak like a doctor not a businessman.

Yes I know you are a doctor, but now that you want to compete you must start thinking like a businessman or woman.

I agree with the training issues 100%.

Remember this. The PAs, NPs, Aestheticians and all want to a piece of the action.

Why do you want to give away the house?

06.13 | Unregistered CommenterEMD

EMB,

Because it is called Free Enterprise. MDR is correct the marketplace will take care of the rest.

06.13 | Unregistered CommenterSBJ

In a perfect world. you would be right

06.13 | Unregistered CommenterEMD

Too bad this isn't a perfect world :)

06.13 | Unregistered CommenterSleep Aid

In 2005 Cutera, Inc., attempted to broaden its customer base by marketing "qualified practitioners" who were not physicians. The company assembled a new sales team that focused on non-traditional aesthetic practitioners. According to the Annual Report filed by Cutera in 2005, the company acted according to the following guidelines: "federal regulations allow our products to be sold to, or on the order of, “licensed practitioners,” as determined on a state-by-state basis. As a result, in some states, non-physicians may legally purchase our products. However, a state could change its regulations at any time, thereby disallowing sales to particular types of end users. We cannot predict the impact or effect of future legislation or regulations at the federal or state levels."

In the original question posted it was asked whether these IPL and laser technology companies were violating the FDA's guidelines for selling medical devices to non-physicians? A second question to ask is whether these companies were violating State laws and regulations, and whether these companies were encouraging people to practice medicine without a license. States have the authority to restrict commerce, and regulate distributors who introduce prescription medical devices into commerce.

Misbranding a Class II medical device as an over-the-counter product for general distribution would violate State law. If you are aware of a distributor selling a laser or IPL device directly to a person who is not authorized to use the device you can inform the Department or Agency in your State that regulates medical devices. For example, in New Jersey, the Department of Health and Senior Services regulates drug and device manufacturers and distributors. The Department enforces State statutes and codes prohibiting device distributors from selling misbranded or adulterated products, or from other improper conduct. A private lawsuit may not be needed to prohibit illegal sales in your State.

Because the laws differ in each State, you should consult an attorney to determine what options are available.

MDR, I am a little surprise about your post. First, your comments "We need to compete and out-compete the competition and stop whining about who they sell to and who is doing the treatments." If you are a physician you should care about companies selling prescriptive devices or prescription drugs to those who don't have the authority nor training to use them...if not, why did you go to medical school? If the FDA is going to allow anyone to purchase and use prescriptive devices why do you need a medical degree? Secondly, why do you think most companies try to dominate a marketplace by reducing competition not increasing it as you suggest in your post. Remember when internet companies were selling music downloads without the musicians authorization...the musicians did sit around and whine about it they got pissed and did something to stop their music and talent to be commoditized by someone who didn't have the authorization.

You also said "Let's start to whine and complain about something that matters and something that can be fixed easily." So MDR, potentially violating FDA regulations, increasing competiton and allowing those who are not trained properly are nothing to whine about? What is so difficult about asking FDA regulated companies to comply with the regulations. Why only fix the things that are easy? Why not fix both?

A great practioner, who has the degree and training to treat patients should not be put out of business nor should they have to compete with those who don't have the training, authorization or degree to compete with them in the first place. If one practioner is better in their ability to treat and build a business than another...that's fine, the marketplace will bear this out. But this other type of competition is not.

Q

06.14 | Unregistered CommenterQ

Andrew,

I saw this information on a site run by a couple lawyers who focus their practice on medical device and prescription drug law: druganddevicelaw.blogspot.com

For medical devices, there's a law that expressly says that the FDA's regulation of medical devices displaces state law. Thus, for medical devices, the spat is about "express" preemption. The relevant statute, 21 U.S.C. § 360k(a), provides:

§ 360k. State and local requirements respecting devices

(a) General rule

Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.


I believe the FDA designates who can purchase a prescription medical device and the state designates who can use said device. Is that correct?

Q


06.14 | Unregistered CommenterQ

Q,
Federal and State regulations both control who can purchase a prescription medical device and who can use said device. The preemption clause you quoted is not so encompassing to usurp the State's enforcement of any regulations that are identical to FDA requirements and preemption does not apply if State regulations address issues not expressly included within FDA regulations. The FDA regulates "Indications for Use" which permits a device to be marketed according to FDA approved guidelines. FDA guidelines permit FDA officials to designate whether a patient can use a device independently. However, FDA regulations usually do not specify who cannot use a prescription medical device, and therefore, States often adopt restrictions identifying health care practitioners who are not permitted to use certain type of devices. For example, New Jersey expressly prohibits physician assistants, nurses, and other health professionals from using laser or IPL devices for hair removal, requiring all such procedures to be performed by physicians holding a license with the State Board of Medical Examiners. Federal law does not preempt State law in this circustance.

Moreover, the FDA itself does not bar States from enforcing its own laws that are similar to FDA provisions that prohibit selling misbranded or adulterated medical devices. The State has the authority to commence an enforcement action against a distributor that sells medical devices to persons who are unauthorized to use such devices. Accordingly, product sellers must comply with both FDA regulations and State regulations, and must evaluate who cannot use their device in each State.

Q,

Well said. I get so emotional about this.
It's like a slap in the face.

06.14 | Unregistered CommenterEMD

Good points, Q.

06.16 | Unregistered CommenterMDR

Good points, EMD.

That's why I love these blogs!!!!!!!!!!! The truth usually percolates to the top when things get discussed openly and honestly.

06.16 | Unregistered CommenterMDR

The question is where do we go from here?

06.17 | Unregistered CommenterEMD

EMD...good question. I have written the AAD, AMA and I think letters and emails should be sent directly to Cutera and others who conduct business like this. To allow companies like Cutera, who's customer base and essentially the bulk of their business comes from licensed professional, to display and conduct business at AMA, AAD and other medical meeting events is a joke. They speak of begin good corporate partners...to whom? Write the AAD and any other medical body that has meetings and allows Cutera or other compaines who practice this way to NOT be part of their meetings. I am aware to companies like Cutera, its all about sharehold value (they have also sued Cutera), you have to hit them where it hurts...don't allow them to display and exhibit at medical meetings, where they do the bulk of their new product launches, discuss the lastest and greatest devices and techniques to enhance their device sales. If they want to have their cake and eat it to, let them eat it by themselves!

Also send the CEO and his brother the VP of Sales a message...don't see the Cutera rep or any other device company that sells its products to the lay public or unauthorized parties. Cutera CEO is Kevin Connors...the VP of Sales is John Connors, the address is: Cutera Inc.
3240 Bayshore Boulevard Brisbane, CA 94005

Q

06.20 | Unregistered CommenterQ

why don't you be fair about things and name ALL the laser/IPL makers (like Syneron and Lumenis and the plethora of tier 2/3 manufacturers) - they all sell to non-MDs in areas where it is legal. in fact, most countries have a fair business practices act - it's not like a restaurant/bar where you can refuse sevice/sales when you want....and what company does that anyway?

06.6 | Unregistered Commenterdavid

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