In March, I posted about the pharmaceutical company Amarin’s legal battle with the federal Food and Drug Administration over the company’s right to share truthful information about the so-called “off-label use” of its products. Although that case eventually settled in Amarin’s favor, it represented another missed opportunity for the Agency to establish clear guidelines for speech.
Today, Reason TV has posted a new video about yet another FDA attempt to punish a company for sharing information about its products’ off-label use. Although Vascular Solutions, a company that develops life-saving medical devices, was finally vindicated, the 5-year, $25-million legal battle took a toll.
Vascular Solutions CEO Howard Root writes of what he calls his “unjust prosecution” here:
I took the entrepreneurial plunge in 1997 when I started Vascular Solutions. Over the last 20 years, I’ve led the company in developing over 100 new medical devices that are used worldwide to improve the lives of patients suffering from vascular disease. In the process, we’ve created more than 500 well-paying American jobs and never received so much as a warning letter from the Food and Drug Administration (FDA).
But over the past five years, the Department of Justice has tried to convict me of a felony that could have put me in prison for years. My “crime”? The prosecutors thought it was “off-label” for our salespeople to talk with physicians about using just one version of just one of our more than 100 medical devices to treat perforator varicose veins rather than saphenous varicose veins.
They believed this was a felony even though our device was FDA-cleared for treating all varicose veins, over two-thirds of our salespeople never sold even one unit of it, sales constituted only 0.1 percent of our total sales and not a single patient was harmed.
It’s time for the FDA to stop treating innovators like outlaws and instead respect the constitutionally protected right to share truthful information about legal activities.