FDA Issues Draft Guidance On Blood Pressure (BP) Response In Clinical Trials

Preparing for new BP guidance

• Part 1 in a 3-part blog series on recent cardiac safety regulatory developments

New FDA draft guidance on blood pressure response released in May 2018, entitled: Assessment of Pressor Effects of Drugs Guidance for Industry, is intended to help address blood pressure effect in drug development. If not already familiarized with it, now is a good time to do so as the final guidance — expected to be issued in as early as the first quarter of 2019 — carries important implications for drug developers.

The foundation for the draft guidance is that elevated blood pressure is known to increase risk of stroke, heart attack and death. Therefore, the effect of a drug on blood pressure is an important consideration in benefit-risk assessment in drug development.