Special Report

A Dangerous Practice: How Drug Companies Bend FDA Rules

If the medication that you use hasn’t been approved by Food and Drug Administration to treat your ailment, you likely are paying extra for a prescription that might do more harm than good. However, drugmakers want even more freedom to market the use of so-called off-label prescriptions.

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Half of all consumers believe that when a doctor prescribes a medication, it has been tested and proven to work for the disease or symptom that a patient has, a survey indicates. Sadly, those consumers are sorely mistaken.

At least 21 percent of all medications that U.S. adults use are prescribed to treat ailments that Food and Drug Administration won’t allow drug companies to list on the medication’s label. These so-called off-label prescriptions are perfectly legal even though three-fourths of the time no independent scientific evidence exists to show that an off-label prescription works for the condition for which it’s used.

Although FDA regulates drug companies, it doesn’t regulate the practice of medicine. As a result, doctors are free to prescribe any treatment, no matter for what FDA originally approved it, says Allen Shaughnessy, who is a professor of medicine at Tufts University School of Medicine. “If a doctor wants to give you a pill and tell you, ‘Put this under your arm and dance on a gravestone at midnight,’ FDA can’t do anything about it,” he says.

Such an environment motivates drug companies to feed new excuses to doctors to get them to prescribe their medications for ever-expanding treatments, which allows the drug companies to boost sales of their medications without having to commit the time and expense of getting FDA approval. As a result, a drugmaker can take the path of least resistance to get FDA approval, then go hog wild on off-label use to rake in big cash even though such an approach frequently works against a patient’s best medical and financial interest, says Dr. Adriane Fugh-Berman, who is the director of PharmedOut, which is a pharmaceutical-industry-watchdog project at Georgetown University.

Off-Label Prescriptions That You Should Avoid

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Without question, circumstances exist where off-label prescriptions deliver benefits for consumers, particularly in the case of cancer medications, where off-label use is considered to be an acceptable practice because of the number of experimental treatments that are used for cancer. Off-label use of medication also is the standard for children’s care, because FDA doesn’t approve any medication for children. (See “Acceptable Off-Label Prescriptions.”)

Acceptable Off-Label Prescriptions

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However, in all too many cases, an off-label prescription is the result of a drug company’s attempt to sell a medication for an unproven and sometimes unsafe use just so the company can fatten its bottom line, independent health-care experts tell Consumers Digest. At the very least, drugmakers appear to be guilty of abusing a prescription-medication system that’s designed to give doctors the flexibility to do what’s best for their patients. The manipulative practices that drug companies employ could become even more widespread in the years ahead if the U.S. Supreme Court is asked to hear a dispute regarding whether FDA restrictions for marketing of medications for off-label use violate the free speech of drug companies. A ruling that favors drugmakers would open the floodgates to more off-label marketing and allow drug companies to push off-label use of medications even more broadly and with less evidence of the medications’ efficacy, experts say.

BEHIND THE SCENES. Here’s how off-label prescriptions commonly materialize, according to the 14 independent experts whom we interviewed: A drug company creates a medication that FDA approves to treat a particular ailment. When a doctor prescribes the medication for that FDA-approved use, it’s called on-label use, because the label that’s on the medication’s container or that’s attached to the prescription that you pick up at the pharmacy says FDA has approved it for that particular ailment.

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