On 12 January, US Food and Drug Administration (FDA) officials released finalized recommendations for drug makers that wish to provide medical literature to doctors about unapproved uses of their products. It’s no small matter, since over 20% of US prescriptions are written for ‘off-label uses’.
Earlier guidelines required companies to commit to submitting an application to the FDA for the unapproved use before sharing peer-reviewed journal articles or reference publications about it. However, the new recommendations permit sales representatives to share data about uses that companies don’t plan to submit for FDA review.
Additionally, the finalized version of the new guidelines does not require that drug companies provide peer-reviewed materials that reach different conclusions about the unapproved use.
The revised policy recommends that that peer-reviewed materials given to doctors are not “marked, highlighted, summarized, or characterized by the [company] in any way”. Such actions could be considered ‘off-label promotion’ of drugs, which is what US pharmaceutical giant Eli Lilly did when it used catchy slogans to persuade doctors to prescribe the antipsychotic Zyprexa for unauthorized use in elderly patients (Lilly pleaded guilty to violating US law on 15 January). This practice is still illegal. However, I doubt the relaxed guidelines will help companies provide an unbiased view of their drug’s safety and clinical effectiveness—something that certain companies apparently need help with.
Photo by zimpenfish