New Goldwater Report Shines Light on One CEO’s Struggle against the FDA

February 26, 2019

Phoenix—Howard Root’s company specialized in making medical devices to treat patients with vascular disease. But as a new Goldwater Institute investigative report shows, overzealous federal prosecutors and regulators at the U.S. Food & Drug Administration (FDA) nearly killed Root’s company and destroyed his life’s work in a constitutionally suspect attempt to cling to their own regulatory power.

Goldwater Institute National Investigative Journalist Mark Flatten’s new investigative report, Gagged: Feds Use Criminal Charges, Threats to Silence Drugmakers, shows how limitations on drug and medical device manufacturers’ ability to communicate truthfully with doctors means that patients are left without the information they need to make treatment decisions with their doctors.

Prescribing a drug for a condition not listed on the label (known as an “off-label” prescription) is totally legal—and extremely common: About 1 in 5 prescriptions are off-label. But while it’s completely lawful for a doctor to prescribe a treatment off-label, in the FDA’s view it’s generally not legal for a drug or medical device company to talk with doctors about a treatment’s off-label uses. Federal courts have repeatedly rejected this view. Root, the former CEO of medical device company Vascular Solutions (VSI), found himself in hot water when a few of his company’s salespeople began speaking with doctors about off-label uses for one of VSI’s vein treatments. Root himself was slapped with criminal charges, including a felony, and the ensuing five-year ordeal nearly meant the end of VSI and Root’s career.

“The federal government takes the view that any communications about the off-label uses of medical products that the FDA has not specifically approved is a crime. This runs contrary to multiple court decisions that have held this is constitutionally protected free speech,” Flatten said. “As a result, people like Howard Root face years in prison and their companies have paid billions of dollars in fines and civil settlements because they engaged in speech that is protected by the First Amendment. This creates a huge chill on the industry and ultimately harms patients by limiting information about the benefits and risks of the legal uses of FDA-approved products.”

Root and VSI were acquitted of all criminal charges in February 2016, but the challenges to free speech in medicine continue. Many corporate executives have faced criminal prosecution on felony charges such as fraud and conspiracy because of off-label claims made by sales representatives, even if the executives did not encourage or even know about those pitches. The FDA and Department of Justice continue to prosecute drug and medical device company executives for First Amendment-protected speech that the courts have consistently ruled is protected by the Constitution. This stifles accurate communication about both the benefits and dangers of FDA-approved medications in a way that puts patients at risk of not getting the best treatment available.

“The most unfortunate part of stories like mine is the question of what might have been—the research and development that could have been done, the new devices that could have been invented—had healthcare companies like Vascular Solutions not come under unwarranted criminal investigations,” Root said. “Prosecutions for off-label communication don’t just stifle free-speech rights. They keep doctors and patients from learning about important treatment options, they drive business people like me out of the industry and they limit the innovation that’s crucial to saving lives.”

Read the full investigative report here. On Thursday, February 28, Flatten and Root will be participating in a Goldwater Institute panel discussion about how the FDA limits free speech—watch a livestream of the event at 6:00pm MST at facebook.com/GoldwaterInstitute.

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About the Goldwater Institute

The Goldwater Institute drives results by working daily in courts, legislatures and communities to defend and strengthen the freedom guaranteed to all Americans in the constitutions of the United States and all 50 states. With the blessing of its namesake, the Goldwater Institute opened in 1988. Its early years focused on defending liberty in Barry Goldwater’s home state of Arizona. Today, the Goldwater Institute is a national leader for constitutionally limited government respected by the left and right for its adherence to principle and real-world impact. No less a liberal icon than the New York Timescalls the Goldwater Institute a “watchdog for conservative ideals” that plays an “outsize role” in American political life.