Off-Label Botox Marketing Gets $600 Million Fine

Botox manufacturer Allergan gets $600 million fineAllergan has been slapped with a $600M fine for illegally marketing Botox for off-label use.

After a years-long investigation, the company pled guilty to one misdemeanor charge of “misbranding.”

Allergan had marketed Botox to physicians for treating migraine and headache pain. In addition to advertising the drug’s off-label uses, the company allegedly also instructed doctors on how to “miscode” Botox insurance claims.

Though Botox is commonly used to treat a variety of facial wrinkles, it is only approved to treat the vertical lines (shaped like the number 11) between the brows. It has also been approved for treatment of spasms, eye muscle problems, and excessive underarm perspiration.

Botox is widely used for off-label treatments, including TMJ treatment, facial cosmetics, cerebral palsy treatment, and headaches. However, the manufacturer is not supposed to market the drug for off-label uses.

But Allergan has never been shy when it comes to marketing. In fact, the company filed a lawsuit last year arguing that the FDA should not be able to limit the manufacturer’s marketing and communications with physicians.

“In the lawsuit, Allergan contends that the Government’s legal position that it is a crime for a pharmaceutical company to proactively communicate truthful information to physicians about off-label uses of its products violates the First Amendment and is inconsistent with the Federal Food, Drug & Cosmetic Act.”

Allergan Files Federal Lawsuit to Allow It to Share Relevant Information with the Medical Community on the Safe Use of BOTOX® for Common Therapeutic Off-Label Treatments

As part of this settlement, Allergan will drop that lawsuit.

The company has also been aggressively marketing Latisse, a new prescription medication that grows eyelashes. Ads feature celebrity users Brooke Shields and Claire Danes, showing off their longer lashes.

Of course, the warning included in their advertisements is enough to give the cosmetically-minded pause:

“LATISSE® may cause darkening of the eyelid skin which may be reversible. LATISSE® may also cause increased brown pigmentation of the colored part of the eye which is likely to be permanent.”

Read more: Botox maker to pay $600M to resolve investigation

Dental Botox: Should Dentists Offer Botox? (video)

Dental Botox: Should Dentists Offer Botox? (video)A The Wealthy Dentist survey found that 2 out of 3 dentists don’t have a problem with dentists offering cosmetic dental Botox®, Restylane or other dermal fillers to dental patients.

In many states, dentists have already been using Botox® to treat temporomandibular joint (TMJ) disorders and facial pain cases, but there is a rising tide of patients wanting to have cosmetic Botox® treatments and dermal fillers while getting their teeth cleaned, or whitened.

Some trained dentists have seen their dental practice revenue increase by over $100,000 a year by adding Botox® and dermal fillers to the treatments they offer their dental patients.

The most significant difference between general dentists and specialists responding to the survey was in how many are currently offering Botox® to their patients. Twice as many general dentists (17%) report that they offer Botox® as did specialists (9%).

Click on Play to see this short video and hear more of what dentists had to say about dentists offering Botox®  —

 

 
What do you think about dentists offering Botox®?

There’s Big Business in Dental Botox for Dentists

There's Big Business in Dental Botox for DentistsThe American Society for Aesthetic Plastic Surgery recently reported that Botox® injections were ranked as the top nonsurgical procedure for 2011.

In many states, dentists have already been using Botox® to treat temporomandibular joint (TMJ) disorders and facial pain cases, but there is a rising tide of patients wanting to have cosmetic Botox® treatments and dermal fillers while getting their teeth cleaned, or whitened.

In light of this trend, The Wealthy Dentist decided to ask if dentists should provide Botox® and dermal fillers to dental patients.

Of the dentists surveyed, 70% see no problem with dentists providing Botox® treatments and dermal fillers, while 24% felt that this was not an appropriate role for dentists. Only 7% felt it should be done for therapeutic reasons only.

However, dentists did have a lot to say on this subject and here are their comments:

Perfect fit for dentists

“This service is a perfect fit. Certainly therapeutic and cosmetic. I doubt that LPN’s, RN’s, CNP’s, NP’s have any thing close to the head and neck anatomy than a DDS/DMD. We have more experience, head and neck, than MD’s except for Plastic surgeons, ENT, Head and Neck Surgeons. The public including many in the medical field do not know our educational background. Derm. fillers, yes again for all the same reasons.” (Minnesota dentist)

“I see no problem as long as they receive proper training and carry sufficient malpractice insurance.” (Texas dentist)

“Dentists are the only doctors that inject the head and neck area more than any other specialty!” (Illinois dentist)

“I believe we as dentists should, with the proper education, be able to provide this service to our patients. I believe it would be a great value to our patients especially some of the full mouth rehab cases as well as the esthetic cases.” (Massachusetts dentist)

“I don’t provide it in my office, but I don’t have a problem with a properly trained dentist providing the service. Heck, most dentists are better trained and have more knowledge about head and neck anatomy than most general physicians or staff at beauty salons providing Botox® and other dermal fillers!” (Ohio prosthodontist)

Not worth the hassle

“Botox® is a very low ticket item that does not generate many new patients.” (Colorado dentist)

“The training too expensive. What insurance needs would we have to have?” (Ohio dentist)

“Insurance premiums are too much and I’m not sure my patients would want it.” (General dentist)

It’s a cash cow

“I have been teaching and doing this for over 7 years. Where else can one earn about $500 profit in under 5 minutes. Cosmetics pays.” (New Jersey dentist)

“I see it as a device to increase income rather than an admirable service.” (Texas dentist)

Would like to learn

“Do you know if the State of Maryland is going to prohibit this? I have invested in the training but have not bought the supplies.” (Maryland dentist)

“Looking into the training, but it is very expensive right now.” (California dentist)

Terrible idea

“Would dentists be providing these services if they weren’t motivated by the income? Would they do this on each other, or on their own family?” (Illinois dentist)

“It’s a terrible idea!” (General dentist)

“It’s just like telling hygienists/denturists/etc., that if they want to practice dentistry — go to dental school. Dentists should stick to dentistry. This may be called a grey area, but I don’t see it that way.” (Texas dentist)

Many U.S. states now allow dentists to perform Botox® and dermal filler treatments for both esthetic and therapeutic reasons.

Some trained dentists have seen their dental practice revenue increase by over $100,000 a year by adding Botox® and dermal fillers to the treatments they offer their dental patients.

Since dentists are expert at injections about the face, it would seem to be a prudent dental treatment to offer your patients if you think it would add value to their lives.

Dental Marketing for Botox Severely Restricted in UK

Dental Botox? Not in UK dental marketingDentists have been warned not to mention Botox or other prescription medications in their dental marketing and advertising by the UK’s Dental Defence Union (DDU).

Moreover, British dentists can’t so much as mention dental Botox treatment on the homepage of their dental websites.

Dentists are permitted to mention Botox and other prescription treatments only on pages within their dental website that patients choose to access.

In its warning report, the DDU is careful never to refer to Botox® by name.

“While a particular brand name of botulinum toxin may be a household name, dental practices cannot actually refer to it in publicity material as it is a prescription-only medicine.”

Dental marketing is one area where the UK is far more conservative than the US, with attitudes lagging years behind out own.

“To illustrate the pitfalls of practice promotion, this issue of the DDU Journal also includes a case study about a dentist facing a GDC investigation after his financial director placed an advertisement in the local telephone directory stating the practice was ‘a centre of excellence’ which ‘specialised in all aspects of dentistry’.

“The DDU was able to help the member draft a letter of response and the GDC accepted he had been unaware of the advert. However it warned him that as practice principal, responsibility for the advert rested with him and in future he must make absolutely sure no misleading statements were made.”

But the DDU advises dentists, “Phrases such as ‘centre of excellence’ should be avoided as well as any claim implying superiority over any other dental professional or practice.”

In the US, the standard is that you must not represent your services as superior to your competitors’, but the term “Dental Excellence” is found in countless practice names and internet dental marketing campaigns across the country.

So… does that mean that it’s okay for UK dentists to strive for excellence, but not to achieve it?

Read more: Beware the ‘B’ word warns DDU as it publishes advertising advice

Dentist Botox Treatment OK by Most Dentists

Dentist Botox treatment: yes or no?Botox is big business – and dentists think it’s appropriate for them to be a part of it. Two out of three dentists don’t have a problem with a dentist offering cosmetic Botox, Restylane or other dermal fillers, this survey found.

“Who on the face of this planet gives more injections and has more training in head and neck anatomy than dentists?” asked one dentist. “No one!”

In this survey of 144 dentists…

  • 62% see no problem with dentists offering Botox and dermal fillers
  • 7% think dentists should only offer Botox for therapeutic reasons.
  • 31% think this is not an appropriate role for dentists.

Here are some comments on Botox, Restlyane and dermal fillers from dentists:

  • “Fantastic idea! The AGD just passed a resolution supporting general dentists in education and performing these procedures.” (General dentist)
  • “Botox as an additional treatment to correct gummy smiles. Restylane to fill the fissures and wrinkles of the lips to perfect a cosmetic anterior dental prosthetic reconstruction” (Kuwait cosmetic dentist)
  • “Dentists, with the extensive head and neck training they have, should probably have been the first to administer Botox and fillers. Factor in the reality that most dentists are fairly artistic and without question perfectionists, they absolutely should be administering Botox and fillers.” (Minnesota dentist)
  • “For TMJ treatment if indicated.” (Prosthodontist)
  • “I am doing Botox now for my family, staff and a few select patients. I do dermal fillers for my wife. I practice in the state of Texas and I can’t get our dental board to ‘allow’ us to do these procedures. Insurance companies will cover me but for only what our dental board will allow.” (Texas dentist)
  • “In Texas, basically only an Oral Surgeon can do it—so let them take the risk and use this as a referral.” (Texas pediatric dentist)
  • “Why not go to a dermatologist or plastic surgeon for veneers or high tech mouthguards??” (Florida oral surgeon)
  • “Let’s have our physician friends extract teeth and place dental implants. This is a ‘busyness’ issue.” (Periodontist)

Read more – Botox Dentist Treatment: Most Dentists Approve

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