A beneficiary of off-label medicine

Cross-posted by Forbes.com at WLF’s contributor page

Texas Governor Rick Perry is the latest beneficiary of so-called off-label medical therapy. Earlier this week, USA Today reported that Perry’s back surgery last month involved a stem cell therapy that is currently approved by the Food and Drug Administration (FDA) solely for bone marrow transplants.  The procedure went smoothly, however, and Perry’s health is now much improved thanks to his doctor’s knowledge of the therapy’s off-label application.

Unfortunately, off-label success stories like Perry’s are less common than they should be.  The reason is simple:  drug companies are prohibited from pro-actively sharing information about their products for uses beyond what the FDA has approved.  If a drug company discovers that its drug can be used to treat disease X, but it has only been FDA approved for disease Y, the company has to essentially remain mum about its solution to X.  Without this useful information, doctors are less likely to know about the drug’s beneficial alternative applications.  This ban on off-label communication is an offense to both American patients and American notions of free speech.

The prohibition on off-label drug communications has likely caused unnecessary pain to patients, especially those suffering from cancer and HIV who could benefit from off-label drug and therapy uses.  But by banning off-label drug speech, doctors have fewer chances to become aware of these applications. Importantly, conveying information on off-label drugs to doctors is illegal even if the information is entirely truthful and has been corroborated by independent scientists and doctors.  Instead of providing doctors with as much information as possible, the FDA is doing its best to keep them in the dark.

The FDA’s off-label speech policy also imposes a huge drain on pioneering drug companies, which, in turn, adversely affects American patients.  Instead of investing money in new life-saving drugs, these companies are adding more and more corporate training programs and oversight positions to protect against lawsuits and criminal investigations.  When these lawsuits do strike, the legal fees are enormous, but the penalties and settlements are even larger.  Consider the following recent settlements:  Pfizer Inc, $2.3 billion (September, 2009); Eli Lilly, $1.4 billion (January, 2009); Cephalon, $425 million (September, 2008).  None of these lawsuits requires any actual intent – pharmaceutical companies can be sued for millions or billions of dollars even if they only unwittingly or accidentally shared truthful information with a doctor about off-label drug uses.  Even worse, companies and their executives can be criminally prosecuted when marketing representatives or other personnel blatantly violate company policies on off-label speech.

Lastly, the ban of off-label communication seems to contradict our notions of free speech.  The government should prosecute the dissemination of false information from drug companies.  But the truthful and consensual flow of information from one party to another is the cornerstone of free speech, even if it is commercial speech.  By banning this speech, the FDA seems to suggest that doctors and patients are witless children who cannot independently process this information and then make well-informed decisions.

No matter what the future holds for Governor Perry, his elevated profile has already proven beneficial to the country by demonstrating the benefits of off-label therapy.  Instead of stifling this information behind absurdly draconian laws, we should let drug companies freely share truthful information with America’s doctors.