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  • DOJ Says Corporate Integrity Agreements Are Cornerstone of New Compliance Approach

    The pharmaceutical industry's reputation has been heavily battered over the course of the last two decades, in part because of a seemingly endless stream of massive multibillion-dollar settlements over charges of off-label marketing claims. Those fines, which have seemingly done little to curb illicit behavior, have been seen by at least some industry analysts as cost of doing business-not a deterrent. But the Department of Justice (DOJ) seems poised to change that dyn...
  • '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...
  • India's Drug Pricing Authority Announces Stiff Fines for Violators of Price Limits

    India's National Pharmaceutical Pricing Authority (NPPA) has released a new guideline indicating that companies that overcharge Indian consumers may be liable for recovery damages as high as the entirety of the product's sales in the country. The guideline, dated 12 October 2012, explains that it believes, "It is absolutely essential that manufacturers and marketing companies should not sell their scheduled formulations at unauthorized and illegitimate prices to earn u...
  • Study: Regulatory Noncompliance Plays Big Role in Record-Setting Fines

    Regulatory compliance woes have contributed to record-setting fines paid by pharmaceutical companies since 1991-more than $30 billion in total -- claims a new report published by the health advocacy group Public Citizen. The report, " Pharmaceutical industry Criminal and Civil Penalties: an Update ," follows an earlier 2012 report by the same group in which it found that nearly $20 billion had been recovered by federal officials from pharmaceutical companies since 1991, ...
  • Bill to Enhance Fines, Penalties for Falsifying Medical Products Passes Congress

    • 24 September 2012
    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...
  • US Looking to Alternate Methods to Punish Drug Companies For Regulatory Non-Compliance

    US government officials are looking to clamp down on regulatory violations by the pharmaceutical industry-which has already paid $8 billion in fines over the last decade-by going after individuals within the companies more aggressively, reports USA Today. The US Department of Justice, in particular, is ramping up its use of the Park Doctrine-a legal doctrine that holds individuals within a company responsible for the actions of a company. Senator Chuck Grassley (R-IA) ...
  • Big Pharma Faces Prospect of Big Fines in 2012

    • 23 January 2012
    Some of the world's largest pharmaceutical companies are facing "costly settlements" during 2012 thanks to aggressive investigations and enforcement by US agencies and a wide-ranging list of improper activities allegedly perpetrated by the pharmaceutical companies, according to an analysis by The Financial Times . US agencies are currently separately investigating Pfizer, GlaxoSmithKline, Merck, Baxter, Bristol Myers Squibb, Eli Lilly, AstraZeneca and Smith & Neph...