Understanding the Legalities of Off-Label Use

Posted By Mike Meyer, Monday, May 20, 2019


By Alex R. Thiersch, JD, CEO of the American Med Spa Association (AmSpa)

The use of pharmaceuticals for treatments that are not specified by the U.S. Food and Drug Administration (FDA) is known as off-label use. This is a somewhat controversial practice, and many in the medical aesthetic industry may not fully understand why this is the case. However, if physicians use common sense and the medical information that is available, they can avoid legal entanglements. Here are a few things to keep in mind when considering off-label use in a medical spa setting.

Considering Use

In most cases, it is legal for a doctor to use FDA-approved medications in ways that are different from what the label specifically mentions. For example, Botox originally was specified by the FDA for use in the treatment of incontinence caused by spinal cord injuries or multiple sclerosis, migraines, upper limb spasticity, pain caused by cervical dystonia, axillary hyperhidrosis (sweating), blepharospasm (eye spasms) in children with dystonia, and strabismus (crossed eyes) in children. The reduction of facial wrinkles is not on that list, but it became by far the most prevalent use of the drug, and over the past 15 years, Botox has received three indications for cosmetic use. It is typically up a doctor's own medical judgment to determine if a medication can be used for other treatments.

Also, it's worth keeping in mind that the FDA does not govern the practice of medicine; it governs drugs. State medical boards govern the practice of medicine. Therefore, a board-certified doctor can determine how to use a particular drug.

"To be very, very clear, the FDA has no ability—zero ability—to have any control over how a physician practices," said Bradford Adatto, partner for ByrdAdatto, a Dallas-based healthcare and business law firm. "They are not in the business of regulating physicians. If you as a physician want to do something that's off-label, it doesn't affect you at all."

In fact, off-label use has led to medical breakthroughs in the past. Aspirin, for example, was originally specified only to treat headaches—after it was introduced, doctors discovered that it thins the blood, and they began using it to treat heart congestion. (It has since been specified by the FDA for use in heart patients.) In the medical aesthetic industry, doctors have been known to try to use fillers and Botox in innovative ways to try to solve unusual problems presented to them by patients.

Regulatory Issues

Should patients and medical spa staff members worry about their doctor conducting off-label treatment? Generally, the answer is no, as it is up to the doctor's judgment, and one can reasonably assume that judgment is informed by thoughtful research and years of experience.

"The physician has the ability to treat the patients based on their own medical knowledge, what other peers are doing, what is documented in medical journals that are out there or experiments they'e done," Adatto said.

However, doctors also have been known to use drugs on patients for more experimental purposes, and when that happens, state medical boards can intervene.

"If I, as a physician, am doing something that no one else is doing, and my medical board wouldn't approve of it—there's no medical journals on it, and I'm way off the skis of where everybody else is going, and I am just sailing in a direction where I'm all by myself—I could then be in trouble with my medical board for experimental use that's outside the community of care of that particular specialty," Adatto said. "You don't want to be going in a situation where a medical board does not approve of that or believes it is too experimental or is not within the typical standard of care for a patient."

If a physician is found to be using pharmaceuticals irresponsibly, he or she could be censured by the medical board and lose his or her medical license. In addition, he or she will need to explain his or her actions to the board.

Reckless Endangerment

In addition to facing sanctions from his or her state's medical board, a physician who engages in reckless off-label drug use may be subject to legal liability issues. If a physician is found to have harmed a patient with his or her off-label pharmaceutical treatments, he or she could be sued for malpractice. If the off-label use resulted in serious injury death, a doctor can even be subject to criminal prosecution.

You may remember the case of Dr. Conrad Murray, the personal physician for music legend Michael Jackson. Murray was found complicit in the Jackson's death because he improperly administered propofol—a drug specified for use as an anesthetic—in order to help the "King of Pop" sleep. He was found guilty of involuntary manslaughter and sentenced to four years in prison.

"Those drugs are usually only used for surgery, but there are other physicians who have used it to help calm individuals," Adatto said. "It just then goes back to, not that many doctors were using it—it was a very small community that was using it—hence the malpractice, and then the liability of jeopardizing your license for being so far off-label."

A doctor who is administering pharmaceuticals off-label also must be completely forthcoming with the patients being treated and obtain their express consent prior to providing these treatments. Misleading patients as to the specified use of the drugs being administered is another excellent way for a doctor to attract the attention of a state medical board.

"If you're saying that this drug has been approved for this, and the medical board considers that what you're providing is false or misleading information, that's another potential issue," Adatto said. "When you're treating a patient on the front end, you must get that consent in order and make sure that the patient understands that the drug has not been approved for this type of use."

In order to prove he or she has properly acquired consent for these treatments, the physician should be sure to get it in writing.

"We would always recommend to physicians that if you are going to be using a drug often for off-label, make sure you have a written consent that then describes that, so that a patient can also sign off on it, knowing that they received it both orally and in writing," Adatto said. "That's going to protect the physician, showing that they did tell this particular patient that they were using this drug for an off-label use, and the patient understood that and assumed some of those risks."

Sensible Solutions

Off-label use can be a particularly tricky issue in medical spas, since non-doctors are sometimes the ones administering these treatments. Everyone in a medical aesthetic practice must understand that off-label use is a medical decision that is to be made only by a doctor. For example, a nurse administering an off-label pharmaceutical must be following a doctor's order, and the decision needs to be established following proper delegation protocols.

If a doctor uses good judgment backed by research and is forthcoming with patients about why he or she wants to administer that drug in a manner that is not directly approved by the FDA, off-label use should result in no legal issues. However, obtaining patient consent is vitally important in cases such as these, so doctors should consult with their healthcare attorneys to verify that the consent they obtain will shield them from potential action.

In many cases, doctors who provide off-label treatments are simply attempting to help their patients. Providing them the leeway to do so has led to important medical breakthroughs and changed countless lives for the better. As long as doctors take the proper precautions, off-label use is perfectly acceptable from a legal standpoint.

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