The TEVA petition with the FDA

As you know TEVA has requested that licensing of new drugs are delayed until the safety of any new drug is adequately reviewed, with an effect of trying to delay BG-12 and Alemtuzumab (Lemtrada), although they are clearly aiming at the BG-12. They are claiming that it causes renal problems and also problems such as PML.

For those of you who want to read this sorry state of affairs then here is the alleged Teva letter to the FDA
(I make no warrant that it is the actual letter, but the names of the intended recipients at the FDA are familiar)

One wonders if this is really the actions of a concerned citizen or is a cynical attempt to halt the progress of BG-12, which may eat into the profits of glatiramer acetate. 

Dear Oh Dear, how low we stoop, maybe this will come back to haunt them in the future and bite them in the a**e/a*s (UK/US spelling)


Wonder what will happen next, maybe someone will request delaying licensing of drugs until marked efficacy of any new drug above placebo is shown. What could that do for re-formulation of agents past their sell-by-date i.e. past the patent life of the original. Should we be expecting more? 

Alternatively maybe they will start asking the FDA to make companies show that their new drugs actually impact on disease progression over the long term.....maybe 5 or 10 years rather than influencing just relapse rate over a few months......Yes maybe we should set the bar higher.

Well this is what you readers think about Teva's antics!



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