Pharmaceutical Law: Regulation of Research, Development, and Marketing, 2012 Cumulative Supplement

The 2012 Cumulative Supplement provides important updates on securities cases and developments involving fraud and abuse, HIPAA, and the FDA, including analyses concerning: Changes to the Organizational Sentencing Guidelines now in effect concerning the awarding of compliance credit based on the actions of high-level personnel The Stein decision and how it affects the government s ability to contest the indemnification of legal fees in enforcement actions The use of the Responsible Corporate Officer doctrine to target corporate executives for prosecution and exclusion, and amendments to the Sentencing Guidelines for such cases The Office for Civil Rights HIPAA Audit Program How the Patient Protection and Affordable Care Act may impact the scope of the FDA s oversight and regulatory authority Antitrust issues related to Accountable Care Organizations.