Scientific Exchange Calls for Some Talk of “Off-Label” Use

Today’s blog comes to us from Jonathan Wilson, President of GLOBALHealthPR US Partner and Chair, Spectrum.

The United States Food and Drug Administration (FDA) is rethinking its rules on what kind of information pharma companies can share with physicians regarding off-label use of their products. That’s good news for the practice of medicine.

At the moment, pharma company employees can talk about a drug only in the context of the condition indicated in its FDA-approved label. Anything they say about another, unapproved use of the drug is considered “misbranding” according to federal law, and subjects the company to civil and criminal prosecution.

Physicians who prescribe a drug to their patients need to know as much as possible about it, and drug makers are the experts on their products. But the billion-dollar settlements paid by large pharmaceutical companies for sales and marketing tactics that violate federal laws have had a chilling effect on those kinds of educational conversations between drug companies and their physician customers.

I can understand why the Justice Department has come down so hard.  Over the years, several top companies have admitted to a host of illegal tactics, including the promotion of off-label uses of drugs and kickbacks to and lavish spending on prescribers. It was essentially a free-for-all, and it caught up to them. The companies paid hundreds of millions of dollars each to the federal government to settle the cases.

The government crackdown caused the pendulum to swing too far, and it’s time for it to come back to the middle. Companies are barred from discussing basic scientific and medical information with physicians if it’s not related to the FDA-approved use of a drug, even if the information is true. Severely limiting the conversations between physicians and drug company reps is a restriction of free speech, and frankly, it stifles scientific exchange:

“You have a question about the drug my company makes and has tested in thousands of patients, a drug whose chemical structure I can describe better than I can remember my mother’s birthday, but the question involves an unapproved use? I’m sorry, Doctor, you’ll have to Google it.”

Speech is about ideas, and the exchange of ideas can lead to new thinking. To communicate the right story about a drug, you need to be able to discuss the science behind it, and yes, sometimes you need to step beyond the boundaries of the FDA-approved use. It’s amazing to me that the FDA can write a clearer press release about a new product or treatment than the company, all because we’re afraid to set off a legal firestorm.

A new model would free a company medical liaison to have an appropriate, balanced discussion with a physician, to share important, relevant information that would ultimately benefit patient care. The FDA is considering an update to its existing rules for how a drug company rep can respond to a physician’s question about off-label uses, and reviewing its guidelines for distribution of data about off-label uses, with plans to issue new guidance documents by the end of the year.

Do you think the FDA can set guidelines that allow drug companies to discuss relevant scientific information about off-label uses of drugs with physicians without illegally promoting the off-label use?

What should the guidelines say to enable the former and prevent the latter?

Note: This blog was first published in the Spectrum blog on July 22, 2014.