In an ideal world, "off-label" drug use--the prescibing of drugs in a manner for which they are not approved--would be employed by doctors looking to innovatively and safely treat their patients in cases that call for such treatment. For example, many doctors prescribe drugs "off-label" when treating cancer, and these treatments have often proved beneficial to patients. However, for off-label use to be successful and safe, prescribing doctors need to take innumerable things into consideration: a patient's age, medical history, condition(s), and the possible side-effects of a drug not tested for what its being used for.
You would hope that doctors would make these decisions using unbiased information. Unfortunately, not only is much off-label use not supported by data, it is often drug companies -- focused on the bottom-line -- which heavily influence what information doctors get about the off-label uses of various drugs.
While off-label use is a common and legal practice among physicians and psychiatrists, it is illegal under FDA regulations for drug manufacturers to directly promote their product for off-label uses. That's because "off-label" prescriptions may be more detrimental than no treatment at all. For example, many drugs not approved for children are consistently and increasingly prescribed to children to treat ADHD, social, and mood disorders. These drugs can have negative effects on their developing systems.
Despite the FDA’s ban on the “direct” promotion of prescription drugs for off-label uses, drug manufacturers such as Pfizer and Allergan (the company that produces Botox) have employed a wide range of indirect methods to push their products for such uses. Pfizer illegally promoted four drugs for uses other than what was FDA approved. Allergan was recently prosecuted for, essentially, bribing its “top injecting” doctors to prescribe Botox off-label. Prosecutors cited instances in 2005 and 2006 when Allergan paid over 200 doctors $1,500 each to attend a weekend-long event named the “Allergan Institute of Distinction” whose purported goal was to “elicit feedback from doctors about their experience with Botox.” According to prosecutors, doctors “provided no consulting services.” Perhaps Allergan thought that $1,500 would make these doctors more imaginative when it came to finding other uses for Botox. Better not to take chances in that regard, however—documents compiled by the prosecution also state that the “Allergan Institute of Distinction” included presentations on off-label uses of Botox.
Last month, Allergan paid a $600 million settlement to the government. In 2009, Pfizer paid $2.3 billion for what the justice department labeled “fraudulent marketing.” That seems like an astronomical sum, one that would make a company think twice about practicing less-than-morally-sound marketing strategies. But for a company such as Pfizer that is worth nearly $110 billion, and has reaped billions in profits from selling drugs for off-label uses, $2.3 billion may just be a slap on the wrist. Although they’ve vowed to “meet the high standards that patients, physicians, and the public expect,” what’s stopping them from finding other ways to market their product, possibly at the expense of patients? If money is the object—and it clearly is—it’s not unreasonable to assume a drug company will continue to use whatever means necessary to promote their product, especially if the fines they may incur don’t exceed profits.
The FDA seems to have no plan for making penalties and boundaries for drug manufacturers more explicit; in fact, recent trends suggest that the FDA is leaving much of the regulating to manufacturers. What is going on here? Most likely, the FDA doesn’t want to get into trouble for encouraging doctors to use drugs under conditions for which they aren’t clinically proven, but neither does it want to make off-label use completely illegal, for fear of stymieing medical innovation. However, the middle road they’ve created allows drug companies to take advantage of various loopholes, and not in the name of medical innovation.
All this makes it ever more important that we know which doctors have financial ties to pharmaceutical companies before they write up those prescriptions.