Drug companies promoting off-label uses of their drugs are the modern day equivalent of “snake oil” peddlers. And now they want legal protection for their actions.

If you’re not familiar with the term, a “snake oil” peddler was known in the Old West as a traveling salesman who went from town to town selling some medicine, usually bogus, with boisterous marketing hype and gimmicks.

Its modern equivalent are drug company salesmen who travel from doctor office to doctor office spreading the company’s latest gospel on why some drug should be prescribed for some purpose for which it has not been rigorously tested or approved.  Physicians have long gone along, most often with no serious problems. However, Drug companies also have a history of exploiting “off label uses” to boost a drug’s profitability callously and deliberately at the cost of patient lives.

One of the best examples of this were combination hormone drugs approved to treat serious menopausal symptoms but marketed aggressively for decades as a way for women at the end of their reproductive years to protect against heart disease and “stay young forever.”   In 2002, the Women’s Health Initiative shocked the world with findings that the drugs actually increased a woman’s risk of heart disease and breast cancer.

Thousands of women diagnosed with breast cancer sued, using, in part, the legal argument that the drugs were marketed for reasons for which they had not been approved by the U.S. Food and Drug Administration.  Federal regulations require that drugs sold in the U.S. be thoroughly tested for their intended use and only marketed for this use. This has been a cornerstone of consumer prescription drug safety in this country.

Drug companies, however, are marshaling forces to legally challenge the FDA’s rules about “off label” marketing. They are arguing in several court cases and legal filings that they cannot be sued based on what they say about their drug because the First Amendment protects their right to “free speech.”

The U.S. Supreme Court has signaled this argument may have some traction.  It recently issued an opinion in a Vermont case that speech used in drug marketing is a form of expression protected by the First Amendment. Within weeks, a federal appeals court in New York is expected to make another decision based on this free speech defense. These and related legal developments “may put the FDA’s ban on off-label promotion in some jeopardy,” says Richard Cooper, a former FDA chief counsel quoted in the Wall Street Journal.

Even school children are taught that “free speech” does not include the right to cry “fire” in a crowded theater, however.  It’s unthinkable that drug companies should have the right to cry “safe” when talking about drugs whose safety is questionable. In old movies, “snake oil” salesmen inevitably get run out of town by angry citizens. It may be time to organize.

Robert Jenner brings to the My Advocates medical and legal team more than 26 years experience representing injured consumers nation-wide against the manufacturers of dangerous prescription drugs, defective medical devices, tainted blood products, and other unsafe products. Mr. Jenner has been honored by his peers for inclusion in “The Best Lawyers in America” and “Maryland’s Super Lawyers”(named in Top 50). READ FULL BIO