Week in Review: One Man vs. the FDA’s Gag Rule

February 10, 2018

Howard Root was facing five years in prison, all for the crime of speaking the truth. And it took him five years, 121 lawyers, and $25 million to fight off the tremendous force of a federal prosecution.

As CEO of a medical device company, Root was subject to the Food and Drug Administration’s gag rule, under which pharmaceutical companies can be charged with a crime simply for telling a doctor about a legal, alternative use for an approved treatment, even though that information could help improve—and even save—people’s lives.

So-called off-label treatment—treatments used for conditions, patients, or dosages other than what the FDA approved that medicine to treat—is legal. But the government routinely censors pharmaceutical companies—which know the most about their drugs—from sharing information about legal off-label uses of their products.

In Root’s case, he found himself the subject of a federal criminal prosecution over the truthful words spoken by a few of his company’s salespeople about an FDA-cleared medical device that constituted only 0.1% of the company’s sales and never harmed a single patient. After a five-week criminal trial wherein the government’s case was so weak that the defense didn’t even call a single witness to testify, the jury returned “not guilty” verdicts on all charges.

Although he was fully vindicated, Root decided to sell his company and retire rather than continue under the threat of the FDA’s gag rule. Now he speaks out against prosecutorial misconduct and chronicled his experiences in a book, “Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds’ Hit-List.”

Root was part of an event at the Cato Institute this week where he joined Goldwater Institute Executive Vice President Christina Sandefur and others in discussing the harmful effects of the FDA’s gag rule. As Sandefur explains, states can take action to combat Washington’s heavy hand and protect patients.

States are stepping up to protect the rights of doctors and pharmaceutical companies to freely share research and information about legal medical treatments. The Free Speech in Medicine Act passed the Arizona legislature last year with unanimous, bipartisan support. This year, several states have already introduced similar bills, with more states to come.

Lawmakers in other states can—and should—follow Arizona’s example, restoring the right to freely exchange truthful information about legal treatments, and providing healthcare providers and payers with the tools they need to make informed healthcare decisions for patients.

Read more about how your state can protect free speech in medicine here.

Liberty in the News this Week

• • Frederick Douglass escaped slavery to become one of America’s greatest voices for freedom. In his new book, Frederick Douglass: Self-Made Man, Timothy Sandefur, vice president for litigation at the Goldwater Institute’s Scharf-Norton Center for Constitutional Litigation, tells Douglass’s life story, his activism, and his important work as an intellectual. Sandefur will be speaking in Phoenix on February 12.
  • Last year, Arizona enacted Proposition 206, the Fair Wages and Healthy Families Act, a mandatory $12-per-hour minimum-wage law. A new Goldwater Institute report reveals that, while well-intentioned, the law is a misguided policy that harms the people it is supposed to help, including taxpayers.
  • This week, the Goldwater Institute joined with 100 non-profit organizations in urging Congress to pass a law to protect the privacy of America’s non-profits and their donors. Under existing IRS procedure, every 501(c) organization in the country must disclose sensitive identifying information about their contributors, leading to harassment and intimidation by their ideological opponents.