Is the FDA violating the right to free speech?

Take-home message: I am grateful that my ophthalmologist friend and I live and practice in countries where we are free to speak our minds.

By Peter J. McDonnell, MD

“I disapprove of what you say, but I will defend to the death your right to say it.”

-Evelyn Beatrice Hall (although often misattributed to Voltaire)

My friend (a very skilled ophthalmologist) lives in a country that has been having some difficulties lately: lack of economic growth, fiscal mismanagement, and governmental corruption. Tomorrow, he plans to attend-along with a million or so of his fellow citizens-a public protest calling for a change, via constitutional means, in the political leadership.

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This does not worry me too much because he lives in a country where people can peacefully assemble and give speeches denouncing what they perceive to be corrupt or incompetent government officials without fearing that they will be tear gassed, beaten, imprisoned, or worse.

Dr. McDonnell

My own country is famous for its defense of “free speech.” We Americans can spout things from our pie holes that are incredibly ridiculous and inane and get away with it (for proof of this, simply listen to some of the candidates aspiring to the presidency of this fair land).

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We are not supposed to yell “Fire!” in a crowded theater, when there is no fire, because of the physical danger that would pose to innocent moviegoers that could be hurt in a stampede to the exits. But along with some other mostly reasonable exceptions designed to protect the safety of others, we can pretty much say what we want.

Next: "Federal judges are saying the FDA has violated the sacred American right to free speech"

Freedom of information

So, it is with interest that I read news reports about a dispute within the U.S. government on the issue of free speech. The dispute is between the federal courts and the FDA as to whether employees of pharmaceutical companies may speak the truth to physicians if that truth might lead the doctors to use a medicine for an off-label indication, for which the FDA has not deemed the drug to have been proven safe and effective.

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The FDA interprets the law as requiring the agency to make certain that drugs are marketed only for conditions for which they are approved (by the FDA) to treat. The agency has therefore criminally prosecuted companies and individual salespersons and other employees of companies and demanded large fines for sharing information with physicians, even if that information is obviously truthful, that includes information about unapproved use of the drug.

Now, federal judges are saying the FDA has violated the sacred American right to free speech. In January 2013, the federal appellate court in Brooklyn, NY, rules that Frederick Cordonia, a drug company employee, could not be denied the ability to provide truthful information.

The FDA did not appeal the decision, but subsequently tried to stop a company called Amarin Pharma from sharing information that its fish oil-derived drug (Vascepa) could reduce serum triglycerides is people with elevated levels (the FDA wants the company to only speak about people with “severely elevated” levels).

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In a separate court, U.S. District Judge Paul A. Engelmayer has recently ruled that the First Amendment allows Amarin to engage in “truthful and non-misleading speech” about what this drug can do.

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I take it on faith that my governmental employees, FDA staff, and federal judges are doing their best to follow the constitution and our laws as they best interpret them. And I am grateful that my ophthalmologist friend and I live and practice in countries where we are free to speak our minds.

P.S. In the interest of full disclosure, the author of this editorial is a co-founder of a start-up pharmaceutical company and a board member of Allergan plc.

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