• Regulatory NewsRegulatory News

    EMA Appeals Decision That Ousted Former Executive Director

    The European Medicines Agency (EMA) is pressing forward with its plans to appeal a decision that annulled the appointment of its former executive director, Guido Rasi, Politico reports. Background On 13 November 2014, after hearing claims by Emil Hristov, who sought the executive director spot alongside Rasi in 2010, the EU Civil Service Tribunal ruled parts of the selection process were improper due to the composition of the pre-selection panel. During the hiring ...
  • Regulatory NewsRegulatory News

    FDA Ups Monetary Penalties for Regulatory Noncompliance

    The US Food and Drug Administration (FDA) has announced it will implement without change a regulation proposed earlier this year that is set to increase the monetary penalties for persons and companies found guilty of noncompliance with federal drug and device law. Background In 1990, Congress passed and the president signed into law the Federal Civil Penalties Inflation Adjustment Act (FCPIAA) . The law requires federal agencies to, at least once every four yea...
  • OIG Report Details Scope of Fines Levied on Pharmaceutical Manufacturers in 2012

    • 29 November 2012
    The US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG), the office charged with investigating potential legal violations and recovering funds for taxpayers, has had a busy year. In a report submitted to Congress this week detailing the agency's actions for the second half of the fiscal year (April through September), Inspector General Daniel Levinson said his agency had recovered just shy of $7 billion for taxpayers-nearly three ti...
  • Proposed Bill Exempts Minor First-Time Regulatory Violations from Civil Fines

    • 02 August 2012
    A new bill proposed in the US House of Representatives would provide relief to small companies and other entities found to be violating paperwork-based regulations for the first time. The bill, the Providing Assistance with the Paperwork from Excessive Regulations Act of 2012 , was introduced 26 July 2012 by Rep. Austin Scott (R-GA) . Under the act, first-time offenders would not be assessed a civil fine if they commit a "paperwork violation." Though the legislat...
  • Agency Looks to Overhaul Voluntary Fraud Reporting Program

    • 18 June 2012
    It happens to the best of us. Sometimes companies find they have managed to accidently defraud the federal government for several million dollars. For life sciences companies, this can often involve running afoul of federal regulations against the improper marketing of pharmaceutical products and medical devices, both of which have caused billions in fines to the industry in recent years. What happens next, explains the US Department of Health and Human Services' Office ...