• Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA to Punish Clinical Trial Data Fraudsters (16 August 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Promises to Punish Clinical Trial Fraud, Outlines Vision for Future of Drug Regulation Chinese regulators are working with the legal system to ensure clinical trial data fraud is punished in the courts. The initiative, which is a near-term priority for officials, forms part of China’s vision for the development of its drug regulatory system between now and 2020. Chi...
  • Mischaracterization of Regulatory Problems Leads SEC to Charge Medical Device CEO with Fraud

    The US Securities and Exchange Commission (SEC) has announced it has charged a medical device executive for purportedly lying to investors about how regulators with the US Food and Drug Administration (FDA) had characterized an imaging device made by the company, which at the time had just been denied clearance under the 510(k) pathway by FDA. Background Under US law, to the extent that corporate officials communicate with their public investors, they must be truthful. ...
  • FDA: 'All Natural' Claims Usually Code for 'Fraudulent Product'

    Talk to a regulatory professional-any regulatory professional-involved in the regulation of healthcare products in the US, and one thing you're unlikely to hear is an explanation of how simple the entire process is. Evidence is rarely black and white; treatments, even when amazing, rarely outright cure a patient; claims are nuanced; safety risks are myriad and are often poorly understood for years after being introduced to the public. And while these sentiments are gene...
  • '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
    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...
  • EU Health Commissioner John Dalli Forced out in Wake of Fraud Probe

    The EU's Health Commissioner, John Dalli, has resigned from the European Commission (EC) following an investigation into his handling of a review of a policy on tobacco-the latest black mark for EU health regulators who have seen a number of high-profile scandals and resignations in the past two years. In the press statement , the EC said Dalli's resignation followed a complaint made by Swedish Match, a tobacco manufacturer which claimed Dalli had traded favors with a M...
  • 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 ...
  • Chemist Sentenced to Prison for Insider Information

    A chemist formerly employed by the US Food and Drug Administration (FDA) was sentenced 5 March to five years in prison after using insider information to earn $3.78 million , reports Bloomberg . The chemist, Cheng Yi Liang, formerly of FDA's Center for Drug Evaluation and Research (CDER), pled guilty last year to one count of securities fraud and one count of making false statements. According to court document, Liang used his position inside FDA to make trades based...
  • New Insurance Product Covers Exposure to Health Fraud Cases

    • 05 March 2012
    Worried about your exposure to healthcare fraud? A new product is looking to protect employees at pharmaceutical, biotech and medical device companies-among others-that are worried about being the subject of health fraud investigation and subsequent action under the Park Doctrine, writes the Philadelphia Inquirer. The Park Doctrine holds that executives who fail to act in accordance with their responsibilities can be held personally responsible for fraud perpetrated ...