Speak Out: Should pharmaceutical companies be able to market their products for off-label use?

April 1, 2009

"I don't subscribe to the theory that reps who come to our office have a tremendous impact on what we do anyway."

It may impact the primary care arena because general practitioners can't know every aspect of every drug for all of the conditions they are treating, but urologists are treating few conditions with pharmacotherapy, and we're aware of the appropriate indications."

David Wright, MD
Rock Hill, SC

Would I be comfortable with marketing them? That depends on whether there is evidence in the peer-reviewed literature. If there are studies that say it's reasonable and beneficial to use these drugs and we know the side effects, even if the drug is not approved for the specific purpose, then it would be reasonable to consider marketing it."

Anthony N. Avallone, MD
Goshen, IN

"Although drug reps aren't supposed to market to physicians, if we have questions, they give you some input 'off the record.' Certainly, a lot of data are available. There's definitely a place for off-label use, and physicians are equipped to make those decisions.

I don't know if marketing urologic drugs for off-label to general practitioners would be the best thing. Some, like the alpha-blockers, are commonly known, and familiarity with off-label uses could save some unnecessary trips to the urologist. On the other hand, primary care doctors have so many drugs they have to deal with, that for specialty medical issues, it could be a lot for them to handle off-label as well as on-label use of urologic medications."

Aaron Berger, MD
Chicago

"It's a fine tightrope. 'Marketing' has one connotation, while 'educating' physicians about off-label uses has a different meaning.

Physicians are pretty intelligent, and it's reasonable for companies to provide information about off-label uses that have been given some merit through peer-reviewed journals and other routes, without their having full FDA approval.

Being in a large group, information is readily shared, but if you're in a busy smaller practice, doctors might not be aware of a drug's potential unless reps educate them. But they shouldn't be trying to push the drugs for off-label use."

John Wrenn, MD
Greensboro, NC