Drug Serialization Trends and Developments


The sale and use of counterfeit medicines pose a real and potent threat to global health and commerce. Over the past decade, the threat of counterfeit medicines has increased, with incidents of counterfeiting reported in 123 nations. One watchdog group documented 2,193 incidents of pharmaceutical crime in 2013 alone, representing almost a 9 percent increase from 2012. This rise can be attributed largely to the growing online pharmaceutical marketplace that enables counterfeit drugs to permeate households. Counterfeit pharmaceuticals often lack active ingredients, depriving the patient of the medication they need. Even worse, counterfeit drugs have been found to contain poisons such as arsenic, shoe polish, nickel, and leaded road paint. While many counterfeits reach patients through online markets, these falsified medications have also penetrated legal supply chains.
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Corporate Counsel: You Might Want To Re-Examine That General Release


Drug makers are one of the most popular and no doubt most lucrative targets for whistleblowers under the False Claims Act.  In the last few years, GlaxoSmithKline, Pfizer, Abbott, and Eli Lilly have each reached settlements in excess of one billion dollars with the government for claims relating to off label marketing.  In an effort to reduce the likelihood of a qui tam action and to bring closure to a former employee’s tenure, drug makers and other employers often offer severance packages in exchange for the execution of a general release.  Employers depend on the language of a release to be effective in barring an employee from pursuing claims of discrimination, retaliation, or other wrongdoing.  However, a pair of decisions from the United States Court of Appeals for the Fourth Circuit create significant loopholes which could substantially limit the value of a general release to an employer and provide a cautionary tale to employers and whistleblowers alike.
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The Characteristics of a Great Compliance Officer


As a federal prosecutor for the past decade, I have prosecuted complex white-collar cases, coordinated extensive criminal investigations, and enforced federal healthcare laws. One of the most important duties of a prosecutor is the assessment of a corporation’s compliance program in order to uncover the extent of criminal activity and to make the determination of whether or not the entity will be prosecuted. The Department of Justice’s (DOJ) involvement in healthcare fraud investigations begins after allegations of criminal violations are alleged, thus giving federal prosecutors a unique vantage point and the opportunity to review decisions, audits, investigations and policies of corporate compliance programs.
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