Methodological and Regulatory Considerations for Updated Guidance on the Pressor Effects of Drugs

Elevated blood pressure increases the risk of adverse cardiovascular events and death. Accordingly, characterizing the off-target blood pressure effects of drugs is an important component of regulatory benefit-risk assessment and post-marketing clinical decision-making. The U.S. Food and Drug Administration (FDA) released draft guidance in May 2018 outlining these considerations and seeking discussion regarding opportunities to improve or reassess methods and analytical techniques to measure and interpret the pressor effects of drugs. Toward this effort, the Duke-Margolis Center for Health Policy—under a cooperative agreement with the FDA—convened a public workshop to bring the stakeholder community together to discuss these opportunities. The following are summary statements and recommendations discussed at the workshop to improve blood pressure assessment throughout the product lifecycle, from development and regulatory review to clinical care.