The right of pharmaceutical companies to speak freely with doctors about truthful information regarding their products’ uses is under attack, according to the Phoenix-based Goldwater Institute.
The institute highlighted the story of Howard Root, a Minnesota CEO who created a billion-dollar medical device company, to illustrate its point.
Root, founder and former CEO of Vascular Solutions (VSI), a Minneapolis-based company that manufactures medical devices to treat vascular disease, was facing three years of prison time and the destruction of his company because of federal prosecutors.
It all started after some VSI sales representatives, against Root’s orders, discussed with doctors the potential off-label uses of one of VSI’s medical devices, the Vari-Lase short kit. The Food and Drug Administration (FDA) claimed such a discussion was illegal.
After years of battling the government, a jury acquitted Root and VSI of all criminal charges in 2016.
The cost to Root was great: $25 million spent on legal fees to defend himself, his employees and VSI. The value of VSI’s stock plummeted, and medical devices that might have saved countless lives went undeveloped during years of court proceedings, the Goldwater Institute argues.
After Root’s four-year ordeal, the institute developed a blueprint report, “The Free Speech in Medicine Act” for other states to implement in order to protect the free-speech rights of pharmaceutical, manufacturing, healthcare providers and companies.
“The U.S. Constitution provides a floor of protection for individual rights, not a ceiling, leaving states free to enact laws that protect those rights more broadly than the federal Constitution does,” the report states.
The FDA generally approves a new drug or device for a single condition and after a long and expensive review process involving years of clinical studies. Once approved, doctors generally can discuss the use of the product/drug/device or prescribe it to treat patients with other ailments. Such a practice is called “off-label.”
Various medical journals cite the use of off-label drugs accounting for 20 to 25 percent of all drugs legally prescribed.
Yet, if drug and device companies promote “off-label” devices or products that have not been approved by the FDA for their specifically intended purpose, even if the promotions are true, the federal government claims they are breaking the law.
As a result, drug companies have paid billions of dollars to settle both civil and criminal allegations brought by the federal government over the use of off-label marketing. Corporate executives also have been criminally prosecuted on fraud and conspiracy felony charges because of off-label claims made by their company’s sales representatives, even if the executives had no knowledge of them.
When it comes to making choices about their healthcare, “people need to have more information so that they can make informed decisions – not less,” Goldwater Institute Executive Vice President Christina Sandefur said. “What the FDA is doing is taking important information away from doctors and away from patients.”
“Government can restrict conduct – it can make it illegal to perform brain surgery or prescribe drugs – but it can’t restrict communication without surviving First Amendment scrutiny,” says Dana Berliner, litigation director at the Institute for Justice, a libertarian nonprofit law firm.
The Second Circuit Court of Appeals and the U.S. Supreme Court have both found that drug companies and company sales consultants have constitutionally protected rights to free speech – including discussing the off-label uses of products, free speech advocates note.