Medical Device Safety versus Corporate Profits

Public Citizen’s work on the Food and Drug Administration Safety and Innovation Act (FDASIA)

The news is full of stories of malfunctioning devices and dangerous drugs that injure or kill patients and are on the market because of a lax approval process. Reports to the government of device-related injuries and deaths are up dramatically. In 2012, Congress considered sweeping changes to the way the industry was overseen, as part of a process that occurs every five years to reauthorize user fees that the drug and device makers pay the Food and Drug Administration to review their products for the market. But instead of considering improvements to device and drug safety, lawmakers endorsed industry-backed changes that risked more dangerous devices and drugs being given to patients, and therefore, more injuries and deaths. Public Citizen fought successfully to remove some of the worst provisions from the legislation, which was signed into law as the Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012.

Learn more about our work related to FDASIA