RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    EMA Board Adopts New Policy on Whistleblowing

    With an aim to encourage whistleblowers and others to feel safe coming forward with possible details of improprieties, the European Medicines Agency’s (EMA) Management Board on Monday adopted a new policy detailing how the agency handles such allegations, including those that could have an impact on the evaluation and supervision of medicines. Since 2013, EMA says it has received a total of 43 of such reports detailing a variety of issues and allegations, from the manuf...
  • FDA Reissues Rule to Protect Whistleblowers from Retribution

    In January 2013, the US Food and Drug Administration (FDA) published something of an unusual notice in the Federal Register . The notice indicated that FDA would withdraw a final rule that had been published just a few months prior, thereby permitting access to records regarding scientific research misconduct proceedings involving its staff. Now the agency has announced the reinstatement of the final rule, saying the records are now exempt from certain requirements under...
  • 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...
  • Court Orders FDA to Release Thousands of Documents on Surveillance Program

    The US Food and Drug Administration (FDA) has been ordered by a federal judge to release thousands of documents to an attorney representing former employees of the agency who now allege they were the subject of an illegal surveillance program. Judge James Boasberg of the District Court of DC sided with the National Whistleblowers Center (NWC) at the 23 July hearing, and has ordered the agency to turn over more than 4,000 pages of documents related to the case to NWC by...
  • 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...