On May 31, 2018 the US Food and Drug Administration (FDA) released a draft Guidance for Industry entitled “Assessment of Pressor Effects of Drugs.” The purpose of the guidance is to advise sponsors with regard to their premarketing assessment of a drug’s off-target effect on blood pressure. Given that elevated blood pressure is known to increase the risk of stroke, heart attack, and death, a drug’s effect on blood pressure can be an important consideration in benefit-risk assessment. The guidance therefore recommends systematic characterization of a drug candidate’s effect on blood pressure during drug development.
This draft guidance is of particular interest to many members of CSRC since we held a think tank on this topic in 2012 and published a meeting report in the American Heart Journal the following year (Am Heart J. 2013;165:477-488). For 60 days after the draft guidance’s release, comments and suggestions regarding the document can be submitted to the FDA. All interested parties are encouraged to read the document and consider submitting comments and suggestions. The draft guidance is available here.
We are currently in the planning stages for a follow-up think tank that will be held after the 60-day open comment period has finished. More details will follow in due course.