Thankyou Mr. Ed Silverman for penning down this pressing matter!

The December 3rd federal court ruling by US circut court of appeals on the case of illegally marketing narcolepsy drug Sodium Oxybate for off-label use and the final decision that pharmaceutical representatives now can tell physicians about "appropriate" off-label uses for their medications without penalty [hence legitimizing the practice] has raised many serious concerns for me at least.

I fear that on the cost of aspiring to safeguard the rights of freedom of speech, we may unintentionally cause more harm than benefit. One wonders that with sarcity of availability of any conclusive research on these off-label uses, how can the pharmaceutical companies be given liberty to promote uses for which we are not yet confirmed if the benefits out-weigh the risks.

In the exact terms of the verdict, marketing of "lawful, offlabel use" to physician is allowed, but who exactly will be delineating the specifications of lawful use for individual drugs remains to be seen. How will one ensure that the off-label use promotion for a drug remain same from one company to another? This will emerge as a mammoth problem in a third world country like mine where there is already a dearth of policy making and implementation in pharmaceutical sector.

We surely need more robust guidelines and ideally all off-label uses should at least be moderated /monitored on both pharmaceutical representative and physician level. I do sincerely hope the FDA and Dept. of Justice who have so far declined to comment on the verdict make up a case and consider a re-appeal.

Competing interests: None declared