I was stunned when I saw this headline in the New York Times last week: “Court sides against FDA in ‘off-label’ drug promotion case.” In case you missed it, here is the lede: “The maker of a prescription fish-oil pill won an early victory Friday against the Food and Drug Administration over its right to publicize unapproved uses of its drug.”
The gist of the story is that the pharmaceutical company successfully claimed that restricting its ability to promote off-label use with (in the words of the court) “truthful and non-misleading information” violated its First Amendment right to free speech.
Let me be clear here. I am all for maintaining the longstanding prerogative that physicians and other licensed prescribers have to prescribe approved medications for unapproved indications. That's not what this is about.
This is about unleashing the marketing machines of pharmaceutical companies to push their products in a way that circumvents the safeguards built into the current FDA approval process. That process includes weighing all the available evidence, published and unpublished, to determine if a compound is “safe and effective” for the stated indication. An eloquent defense of that process by Jerry Avorn appears coincidentally in the current issue of the Annals of Internal Medicine.
Under the terms of the recent court ruling, it seems that a drug company could get approval of a new agent for 1 narrow indication, and then cherry pick limited data to market it for much broader use. This is a gigantic, dangerous loophole that does not serve the public interest.
Here's something else that appeared in the New York Times the same day: the obituary of Frances Oldham Kelsey, who, in 1960, was a physician at the then newly established Food and Drug Administration. It was Dr. Kelsey who blocked the approval of thalidomide in the United States. That courageous and unprecedented step prevented untold tragedies and strengthened the precedent to regulate pharmaceuticals.
Sadly, I fear she is already spinning in her grave.
What do you think?
Ira S. Nash, MD, FACP, is the senior vice president and executive director of the North Shore-LIJ Medical Group, and a professor of Cardiology and Population Health at Hofstra North Shore-LIJ School of Medicine. He is Board Certified in Internal Medicine and Cardiovascular Diseases and was in the private practice of cardiology before joining the full-time faculty of Massachusetts General Hospital. He then held a number of senior positions at Mount Sinai Medical Center prior to joining North Shore-LIJ. He is married with two daughters and enjoys cars, reading biographies and histories, and following his favorite baseball team, the New York Yankees, when not practicing medicine. This post originally appeared at his blog, Ausculation.