FDA audits VERTEX for off label promotions

[Anonymous]

Heard you'll be expecting a FDA audit of promotional talks prior to Telaprevir approval. Without a FDA approval there should be no such promotion of unapproved drugs- dinners with sales/marketing slides and promotional employees present. Violation of this policy will ban your drugs from Government programs. Good luck explaining your aggressive sales presentations Vertex - rules apply to you too! FDA is watching you've been turned in by multiple KOL's with questions about your slides and verifying the FDA label on them. Good luck when your 2011 audits come through and the dates on your MD's checks are prior to the FDA approval also. You don't have an approved drug yet!

 

[Anonymous]

Heard you'll be expecting a FDA audit of promotional talks prior to Telaprevir approval. Without a FDA approval there should be no such promotion of unapproved drugs- dinners with sales/marketing slides and promotional employees present. Violation of this policy will ban your drugs from Government programs. Good luck explaining your aggressive sales presentations Vertex - rules apply to you too! FDA is watching you've been turned in by multiple KOL's with questions about your slides and verifying the FDA label on them. Good luck when your 2011 audits come through and the dates on your MD's checks are prior to the FDA approval also. You don't have an approved drug yet!

My God you sound like a baby.

 

[Anonymous]

Heard you'll be expecting a FDA audit of promotional talks prior to Telaprevir approval. Without a FDA approval there should be no such promotion of unapproved drugs- dinners with sales/marketing slides and promotional employees present. Violation of this policy will ban your drugs from Government programs. Good luck explaining your aggressive sales presentations Vertex - rules apply to you too! FDA is watching you've been turned in by multiple KOL's with questions about your slides and verifying the FDA label on them. Good luck when your 2011 audits come through and the dates on your MD's checks are prior to the FDA approval also. You don't have an approved drug yet!

Get a life

 

[Anonymous]

Obviously Merck has forgotten about all the "market development" they did when Januvia was waiting for approval.