Internet petition wants Congress to oust CDRH head Shuren

A group of upset citizens are petitioning for the removal of FDA Center for Devices and Radiological Health head Dr. Jeffrey Shuren, stating dissatisfaction with the control of devices such as Bayer‘s (ETR:BAYN) Essure and power morcellators. The movement, which started as an email campaign last October in which 100s of angry individuals sent templated letters to Shuren asking him to revoke the PMA for Bayer’s Essure has now manifested into a petition to congress to fire him for “putting industry concerns before patient safety,” according to MD+DI. The movement is being led by LASIK activist and former CDRH advisory committee consumer representative Paula Cofer. “Under the current leadership of Jeffrey Shuren, M.D., the FDA’s Center for Devices and Radiological Health (CDRH) — the arm of the agency that oversees medical devices — has become mission-corrupted, placing industry interests over public health. Failures of the CDRH have harmed countless people and led to many preventable deaths. CDRH is “captured” by industry. Division managers at the CDRH have close working relationships with representatives of medical device manufacturers,” Cofer wrote in an online petition to remove Shuren. The petitioners state that patient advocacy groups and whistle-blowers who reach out to the CDRH to raise a red flag on medical device issues are shut out and ignored, and that MedWatch reports of device-related injuries “fa...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Business/Financial News Food & Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Source Type: news