July 01, 2009
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Off-label medical device use should always be in the patient’s best interest

Devices used off-label may also not be as effective or safe as with their original labeled indications.

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LAS VEGAS — The responsibility to correctly use FDA-approved devices and drugs in an off-label manner lies with physicians. They should therefore familiarize themselves with the laws dictating which product usages are allowed and not allowed, the chairman of the orthopedic department at the Mayo Clinic said.

“If you are going to use a product in an off-label manner, it is your responsibility to your patient to make sure your plan is satisfactorily supported by evidence of safety and potential efficacy,” Daniel J. Berry, MD, of Rochester, Minn., said.

In a symposium at the American Academy of Orthopaedic Surgeons annual meeting, Berry reviewed the basics of using orthopedic devices off-label.

Daniel J. Berry, MD
Daniel J. Berry

What is allowed

Berry’s goal was to help practicing orthopedists, like himself, better select appropriate, efficacious treatments for their patients.

“When you are dealing with these problems, it appears to me there are a number of different perspectives to consider,” he said.

Using simple language, Berry defined permitted off-label use: “You are allowed to use the products that are FDA approved for one indication for another indication.”

Such usage is recognized by the FDA.

Off-label use of a medical device differs from using a non-FDA approved product.

The latter is against the law, except under certain circumstances according to Berry.

Not allowed

“Remember, you are not allowed to use a non-FDA approved product without further regulatory approval and … you are not allowed to use any devices on or off label when your primary interest is to test a hypothesis or obtain generalized results unless you have an appropriately approved research protocol. That is a study. That is different,” he noted.

Level of evidence

Berry highlighted the difference between using a product in an off-label manner and using it for an off- label manner.

“The safety and efficacy of off-label use may not be as well established for a specific indication with the high a level of evidence required for on-label use,” he said.

Distinguishing between the two types of usage also requires being knowledgeable of indications and familiar with current practices.

Documentation, data

Berry encouraged his colleagues to seek support for any off-label use of devices they are considering from clinical or basic science data to research results, particularly any available prior to a regulatory ruling.

He also suggested identifying and considering existing on-label treatments before ultimately deciding to use a device in an off-label manner.

However, in the process of evaluating whether to use a product in an off-label manner, Berry said physicians should consider the source of the supportive data they review.

Partner with patients

There are regulations which govern how companies can lawfully disseminate information about off-label use of their products. Information provided may be subject to bias if it is not comprehensive or if the company only provided the physician with certain documents and not others, Berry explained.

“Physicians should not rely solely on information from the manufacturer when deciding about using of an off-label use of a product. To me, that is doing your due diligence before making a clinical decision,” he said.

Having discussions with patients about possibly using a device or drug in an off-label manner is valuable in many circumstances. “We are always bound by legal statute and for ethical reasons obligated to act in the best interest of our patients,” Berry said.

For more information:
  • Daniel J Berry, MD, is chairman of the orthopedic department at the Mayo Clinic. He can be reached at 200 1st St. SW, Rochester, MN 55905; 507-284-4204; e-mail: griffin.faye@mayo.edu. He receives royalties, speakers bureau, consultant payments from DePuy, a Johnson & Johnson company and he receives institutional support from DePuy, Smith & Nephew, Stryker and Zimmer.
Reference:
  • Berry DJ. Bringing it all together: Acting in the best interest of the patient. Symposium U: Off-label device use: When clinical need outpaces regulatory approval. Presented at the American Academy of Orthopaedic Surgeons 76th Annual Meeting. Feb. 25-28, 2009. Las Vegas.