The article is sidebar to our coverage last year of FDA’s development of guidance on “good reprint practices” that would set goalposts for firms that wanted to distribute reprints of journal articles about their drugs that discuss uses not approved by the agency. The rest of our coverage about the draft is here, here, and here. FDA just finalized the guidance, and you can find coverage of that here and here. And don’t miss our related coverage of Lilly’s $1.4 billion settlement for off-label promotion violations (here and here).
So, yes, we write a lot about reprint issues, and maybe that’s the reason this particular article didn’t get the attention it deserved, or perhaps there was just a glitch in our page view accounting. Whatever the cause, we thought we’d give people another chance to read the piece. Because, as the Lilly settlement shows, issues that seem small at the time can become quite significant. Here’s hoping that our least read article of 2009 doesn’t become your billion-dollar problem in 2010.
Orphan Drugs Are Rare Area Of Agreement In Off-Label Debate
While promotion of off-label drug use is a flashpoint issue, off-label drug use for rare or orphan diseases is not. Regardless of where people come down on FDA's draft guidance, they generally supported patients with limited access to approved drugs. For example, in an April 17 article in the New England Journal of Medicine which is generally critical of off-label promotion, Aaron Kesselheim and Jerry Avorn state that "In certain patient groups, such as children and patients with rare diseases, off-label use may reflect the standard of care."
Indeed, the National Organization of Rare Disorders -- which has often tangled with the pharmaceutical industry on issues related to patent extensions and consumer advertising -- in this case joins many drug firms in advocating for the draft guidance. The association did not submit comments to FDA, but, "I would ask Congress to keep in mind patients with rare diseases," Diane Dorman, NORD's VP-public policy, said at an April 16 media briefing sponsored by industry supporters of the guidance.