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  • Regulatory NewsRegulatory News

    US Special Counsel Finds FDA Whistleblower's Device Approval Concerns Unsubstantiated

    The claims of an anonymous whistleblower within the US Food and Drug Administration (FDA) that employees of the Center for Devices and Radiological Health (CDRH) created public health dangers by approving the use of a digital mammography device and several colonography devices were found to be unsubstantiated, according to a letter sent by the US Office of Special Counsel (OSC) to President Barack Obama. Background Six staff scientists, former employees of CDRH's Office...
  • Landmark Whistleblowing Protection Bill Passes Congress, Awaits Obama's Signature

    The House and Senate have both passed a new law that would grant new protections for federal whistleblowers, winning praise from government oversight groups and even a whistleblowing protection agency within the government itself. The bill, the Whistleblower Protection and Enhancement Act (WPEA) , had been stalled since late October after it passed both chambers of Congress in slightly different forms. The hang-up regarded protection for intelligence whistleblowers, suc...
  • Agency Takes Aim at FDA in Whistleblowing Guidance

    A federal agency tasked with protecting whistleblowers has released a new guidance to other federal agencies urging them to "heed whistleblower rights when monitoring employee communications"-a warning seemingly directed squarely at the US Food and Drug Administration (FDA). FDA has been under investigation by various agencies and legislators since January 2012 after six former employees of its Center for Devices and Radiological Health filed suit in federal court allegi...
  • Public Health Service Employees Not Subject to Whistleblower Protections

    The US Food and Drug Administration (FDA) counts among its ranks hundreds of Public Health Service (PHS) employees-members of a uniformed service charged with upholding and promoting public health and advancing public health science. While these employees are easily recognizable as a result of their military service uniforms, the federal government does not recognize a basic protection for these employees: whistleblowing protections. A Washington Post report details h...
  • FDA Asked To Explain Email Monitoring Policies

    Senator Chuck Grassley (R-IA) and Representative Darrell Issa (R-CA) sent a letter to the US Food and Drug Administration (FDA) about their monitoring of nine employees who worked for the agency. The letter demands a comprehensive explanation of all FDA monitoring policies after the agency kept tabs on emails sent by the nine workers to federal watchdog agencies. In the letter, sent to Office of Management and Budget (OMB) Acting Budget Director Jeffery Zients, Gras...
  • Investigation into FDA Handling of Whistleblowers Widens

    The US Office of Special Counsel (OSC) announced on 15 February that it had opened an investigation into the US Food and Drug Administration's (FDA) handling of whistleblower complaints made by employees of its Center for Devices and Radiological Health (CDRH). The new investigation adds to two already launched by members of Congress and a lawsuit filed by six of the whistleblowers in the US District Court in Washington, creating a situation that could become politicall...