Addressing the Lack of Competition in Generic Drugs to Improve Healthcare Quality and Safety.

A lack of access to critical drugs in the USA, either due to exorbitant prices or shortages, has become a troubling norm that threatens the quality and safety of healthcare. In 2017, there were shortages of 146 commonly used drugs including electrolytes, chemotherapy, cardiovascular, and antibiotic agents. For example, there currently exists a shortage in intravenous fluids and injectable opioids (both in chronic short supply for years) that has been respectively ascribed to disruptions in pharmaceutical manufacturing by Hurricane Maria and manufacturing delays. These explanations, however, mask a more fundamental and avoidable cause: a lack of healthy competition in the generic drug market which is likely contributing to price hikes and shortages. By understanding this underlying cause, we hope to illuminate a pathway from our current state of complacency, where drug price hikes and shortages are routine, to a future state of effective action, where patients have reliable access to vital drugs. This article outlines a roadmap to influence incentives, regulations, new drug development, and ultimately stakeholder (i.e., patients, providers, and drug makers) behavior to enhance competition, with the ultimate aim of improving the quality and safety of healthcare for our patients.