FDA denies Cephalon

The US Food and Drug Administration has chosen to deny the drug company Cephalon’s request to have Nuvigil granted as an off label prescription for jet lag.

In a reply to Cephalon’s request which the FDA deliberated over for close to three months the FDA found fault with some of the data presented by Cephalon. The FDA raised questions  over the PGI-S data (Patient Global Impression of Severity). Cephalon’s Chief Medical Officer’s response was to schedule a meeting  with the FDA to resolve the matter in the near future.

In this instance it would seem that the FDA has seen reason. Taking an inconvenience and turning it into a treatable illness is not a recipe for success unless you are a drug company. Common sense has  prevailed, but the question is for how long?

How long before Cephalon or another drug company looks to exploit the challenges of jet lag with another drug and turn it into an all out frenzied feeding ground for revenue hungry drug companies. I’m certain that other pharmaceutical companies were watching this outcome with keen interest . No doubt they will be keeping an eye on Cephalon’s next move.

Drugs more drugs and more drugs has never been the answer.  What we need now more than ever is a holistic solution especially when considering a greater percentage of flight diversions are due to medical emergencies.  Giving everybody carte blanche to drug themselves when getting on a plane is not a recipe for  safe flying nor will it sit well with the airlines who incur additional fees for diversions and extra expenses to their schedules.

A healthy solution is the only solution worth considering and it starts with seeing jet lag for what it really is.


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