Excellent Resource Relating to Pharmacy Law: Pharmaceutical Law: Regulation of Research, Development, and Marketing, Michael E. Clark, Editor-in-Chief; ABA Health Law Section

Pharmaceutical Law: Regulation of Research, Development, and Marketing

Main Volume Information

Pharmaceutical Law: Regulation of Research, Development, and Marketing is the only resource available that provides expert commentary and authoritative insights into a comprehensive range of pharmaceutical law issues. In fact, no other single volume discusses these complex issues in so much detail and offers the information required by transactional health care attorneys to adequately advise clients on the opportunities—and the liabilities—in this industry. This treatise addresses the considerable fraud-and-abuse risks unique to this submarket of the health care industry; covers off-label marketing—selling a drug for a purpose other than its intended use; and explains and discusses other hot risks areas, including the potential for antitrust, securities law, and other compliance violations.

The Medicare Part D drug benefit, coupled with the confusing and cumbersome methodology used for reimbursement, has added pressures to the already strained Medicare budget, increasing regulatory scrutiny and creating traps for the unwary and uninformed. Other increasingly important areas—including reimbursement and regulation, civil and regulatory liability under the securities and antitrust laws, and compliance and corporate governance issues—also are receiving increased attention from regulators.

Pharmaceutical Law: Regulation of Research, Development, and Marketing is a reference attorneys will turn to time and again for answers and guidance in all areas of pharmaceutical law.

Supplement Information

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

Ordering information found here