Cardiovascular Polypills Flounder under FDA Regulations

Fixed-dose combination (FDC) products may be grossly under available for cardiovascular conditions. Although solid clinical evidence supports the safety and effectiveness of multiple single-agent drugs to treat chronic diseases such as cardiovascular disease (CVD), diabetes, and hypertension, the real-world efficacy of these regimens is held back by their complexity— a key factor in poor medication adherence and health outcomes. Combining several medications into 1 polypill can overcome these obstacles. However, strict regulatory hurdles have had a chilling effect on the availability of these adherence-promoting medications.