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 2011 Cumulative Supplement provides important updates on securities cases, and developments involving fraud and abuse, HIPAA, and the FDA, including:
- The indictment of an FDA chemist for insider trading
- Foreign Corrupt Practices Act enforcement action against Johnson & Johnson related to unlawful payments and kickbacks
- The renewed importance of the Responsible Corporate Officer Doctrine
- The 2010 Amendments to the Organizational Sentencing Guidelines and their impact on how companies can benefit by structuring their compliance programs in specific ways
- The HITECH Act and its various requirements, including breach notification, restrictions on remuneration for PHI, and penalties
- The heightened emphasis on HIPAA Enforcement
- The Future of FDA Regulatory Authority and the FDA’s Initiatives for 2011–2015
- The expansion of FDA authority by Title VII of PPACA and the Biologics Price Competition and Innovation Act of 2009 (BPCIA)
Main Volume Information
2007/899 pp. Hardcover/Order #9995
Supplement Information
2011/Softcover/ISBN 9781570189951/Order #1995
Main Volume Information
Michael E. Clark, Editor-in-Chief, ABA Health Law Section
Supplement Information
Michael E. Clark, Editor-in-Chief, ABA Health Law Section