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  • Regulatory NewsRegulatory News

    European Regulatory Roundup: Merck Accused of Blocking Remicade Biosimilars (25 May 2017)

    Welcome to our European Regulatory Roundup, a weekly overview of top EU regulatory news. Merck Accused of Blocking Remicade Biosimilars, Using Abusive Discount Scheme The UK’s competition watchdog has accused Merck of running an abusive discount scheme to defend Remicade against biosimilar competition. Merck has a chance to respond to the provisional decision before the watchdog rules whether it has violated competition law and faces a fine. Officials at the Co...
  • 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...
  • FDA Scores Legal Victory Against Whistleblowing Case as Lawsuit Continues

    US medical device regulators scored a minor legal victory on 9 November 2012, prevailing at least temporarily against the National Whistleblower Center (NWC), which is representing several current and former employees of the US Food and Drug Administration (FDA) in a lawsuit alleging the agency violated their rights to privacy by engaging in surreptitious surveillance against them. NWC has been fighting FDA in the court system to obtain documents about the case, and ...
  • Bills Strengthen Whistleblower Protections for Government, Private Sector Employees

    • 03 October 2012
    Two pieces of legislation introduced in the US House and Senate this past week aim to protect government and private sector whistleblowers who call attention to alleged wrongdoing. The first bill, the Whistleblower Protection Enhancement Act of 2012, would protect the release of certain information by government employees. "Federal employees and the American people must feel confident that those with the courage to come forward to disclose wrongdoing will be prote...
  • Department of Justice Seeks Dismissal of Whistleblowers' Case Against FDA

    The Department of Justice (DOJ) has filed a motion to dismiss a lawsuit brought against the US Food and Drug Administration (FDA) by several current and former agency employees after FDA allegedly spied on their whistleblowing activities to members of Congress and other oversight agencies. DOJ's motion, filed on 1 October-almost exactly a year after the case was first filed-seeks dismissal based on a "lack of jurisdiction." Bloomberg explains DOJ argues that an...
  • Investigation into FDA Reveals 'Enemies List,' Extensive Monitoring Practices

    An investigation into the US Food and Drug Administration (FDA) by The New York Times has revealed the agency established an extensive monitoring program aimed at both restricting leaks of confidential information and establishing what The Times refers to as "an enemies list of sorts." The agency is currently under investigation--and is being sued by--various groups who allege the agency spied on its own employees, violating both whistleblower protection laws and v...
  • 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...
  • Senator: FDA Stonewalling Investigation into Secret Monitoring

    Senator Charles Grassley (R-IA) is not pleased with the US Food and Drug Administration (FDA). Grassley, who serves on the Senate Judiciary Committee, has been investigating FDA  for months after allegations were raised about the agency's handling of a whistleblowers within its medical device reviewing group, and whether the agency intercepted communications between  the whistleblowers and Congress. But those months have borne little other than frustration for...