Evolution in Strategies for Getting FDA Approvals
Pharma must adjust rapidly to a new regulatory world dominated by FDA’s new drug safety authority. Post-marketing risk management plans are likely to be the key to surviving in the new climate. But beware: they change the relationship of pharma companies to doctors and patients. And they also drastically change the nature of pre-approval filings to FDA.
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FDA's new drug safety authorities suggest that the focus of drug development and lifecycle management strategies need to change. It is no longer a question of what it takes to get approval from FDA, but rather what kind of approval you can get.
The world of post-approval research is going to get more public, more crowded, and more dangerous to pharma. Post-marketing surveillance, transparent clinical trial results and mandated post-approval studies mean the traditional world of marketing-oriented Phase IV is about to change dramatically.
The market resurrection of Tysabri demonstrates the power of risk management but raises a tough question: how far can FDA and industry go into the practice of medicine? Biogen Idec declare they are nt trying to tell doctors how to practice. The strict rules of the risk management plan suggest otherwise.