What Should be Required for FDA Approvability of a New Antihypertensive Drug? What is the FDA’s Viewpoint?

Abstract

I will try not to repeat what has been said earlier. The current guidelines and current policy on what is needed to market an antihypertensive drug are fairly clear. Antihypertensive drugs are approved on the basis of a demonstrated ability to lower blood pressure to a reasonable degree and a reasonably complete characterization of a drug’s pharmacokinetic and pharmacodynamic properties, with particular emphasis on dose-response and on patient characteristics that can alter this response. We have not, up to now, sought evidence of diminished end-organ damage or mortality for each new agent, relying instead on the past studies that showed such benefits of lowering blood pressure.