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  • Regulatory NewsRegulatory News

    Final Rule on Clinical Trial Transparency: Will it be Enough to Encourage More Compliance?

    The National Institutes of Health (NIH) on Friday issued a final rule that its leaders said is expected to result in “rapid increases” in the percentage of trials registered and shared via  ClinicalTrials.gov , though it remains to be seen if the $10,000 per day penalties that can be assessed by the US Food and Drug Administration (FDA) will be strictly enforced. Writing in a JAMA Viewpoint on Friday, NIH Director Francis Collins and other senior leaders said: “Inves...
  • 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...
  • 'Record-Breaking Year' for Fraud Recovery Has Roots in Regulatory Missteps

    2012 was a record year for regulatory-related pain and government gain, claims a new report out from the US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG), the office responsible for overseeing fraud prevention and recovery efforts. The report , jointly authored by OIG and the US Department of Justice (DOJ), explained that 2012 saw the highest-ever amount of fines recovered from those who had defrauded or attempted to defraud the g...
  • OIG Report Details Scope of Fines Levied on Pharmaceutical Manufacturers in 2012

    • 29 November 2012
    • By
    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...
  • China's SFDA Issues Rule on Imposing Administrative Penalties

    China's State Food and Drug Administration (SFDA) issued a  notice  to the Provinces and Autonomous Regions regarding the application of its Administrative Punishment law, which sets forth the rules for imposing sanctions for violations of the laws and regulations governing drugs and devices.  Local authorities are allowed leeway in deciding the severity of the penalty that is to be imposed on a case-by-case basis, taking into consideration the nature of ...
  • Bill to Enhance Fines, Penalties for Falsifying Medical Products Passes Congress

    • 24 September 2012
    • By
    A piece of legislation set to increase the amount of fines and severity of penalties for counterfeiters and thieves of medical products has passed both the US House of Representatives and Senate by unanimous consent. The legislation, known at the Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act of 2010 (SAFE DOSES Act ) , was first introduced in March 2012 by Rep. James Sensenbrenner (R-WI). As reported by Regulatory Foc...
  • Pending Legislation Would Enhance Penalties for Theft, Falsification of Medical Products

    • 25 June 2012
    • By
    A piece of legislation scheduled to be voted on by the US House of Representatives this week would enhance fines and prison time for those found guilty of stealing medical products, including pharmaceuticals and medical devices. But the law contains a provision that could complicate efforts by third-party researchers to obtain and study counterfeit medicinal products for investigative purposes. The legislation, known as the Strengthening and Focusing Enforcement to Det...
  • Agency Looks to Overhaul Voluntary Fraud Reporting Program

    • 18 June 2012
    • By
    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 ...