• 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...
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    India’s CDSCO Sets up Whistleblower Reward Scheme

    India’s Central Drugs Standard Control Organisation  (CDSCO) has set up a scheme for providing monetary rewards to informers who provide specific information leading to the seizures of spurious, adulterated, misbranded and not-of-standard-quality drugs, cosmetics and medical devices. This reward scheme will be applicable to both the informers and CDSCO officers involved. The plan calls for rewards of up to 20% of the value of the products seized, to a maximum of a...
  • CDRH Whistleblowing Scandal Back in Spotlight as Congress Again Takes Interest

    If US Food and Drug Administration (FDA) officials thought they had finally moved past a scandal that has embroiled the agency's medical device division for years, they apparently thought wrong. This piece has been updated with comment from FDA. See the FDA Comments' section . -Ed. Background On 26 February 2013, the US House Oversight Committee is set to re-examine a 2012 scandal involving FDA's Center for Devices and Radiological Health (CDRH) in which the agency ...
  • Reforms to FDA's Medical Device Disagreement Policies Needed, Says Report

    A new government report looking at scientific disagreements within the US Food and Drug Administration's (FDA) medical device branch recommends a number of changes at the agency after a series of high-profile disagreements between staff brought on unwanted media attention. The report, by the US Department of Health and Human Services' (DHSS) Office of the Inspector General (OIG), looked at a population of 36 reported scientific disagreements occurring at FDA's Center for...
  • 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...
  • 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...
  • Senator Grassley Expresses 'Concern' About FDA Treatment of Whistleblowers, Opens Investigation

    Senator Charles Grassley, a Ranking Member on the Senate Committee on the Judiciary has called for an investigation of the US Food and Drug Administration 's (FDA) actions relating to their treatment of nine whistleblowers. The staff scientists and physicians had brought up concerns about actions within the Center for Devices and Radiological Health (CDRH) to both the Congress and the White House in 2009, and have reportedly suffered reprisals from agency staff as a resu...
  • Whistleblowers Accuse FDA of Monitoring Correspondence to Congress About Medical Device Concerns

    A group of former staff scientists at the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) are accusing FDA of monitoring their interactions with Congressional staffers after FDA found that the staff scientists were submitting whistleblower complaints to Congress. Six staff scientists, former employees of CDRH's Office of Device Evaluation (ODE), first brought their concerns about the safety of some medical devices to FDA in 200...