Health Law Section Publications: Pharmaceutical Law: Regulations of Research, Development, and Marketing
Michael E. Clark, Editor-in-Chief

Authoritative explanations of the complex inter-relationships between the pharmaceutical industry, healthcare delivery system, insurers, and regulators.

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 the detail required for transactional healthcare attorneys to adequately advise their 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
• explains and discusses the other hot risks areas--including the potential for antitrust, securities law, and other compliance violations

The new Medicare Part D drug benefit, coupled with the confusing and cumbersome methodology used for reimbursement, have added pressures to the already strained Medicare budget. This will only increase regulatory scrutiny of the industry and provide traps for the unwary and uninformed.In addition to the government's continued focus on fraud and abuse in this segment of the industry, other increasingly important areas--including reimbursement and regulation, civil and regulatory liability under the securities and antitrust laws, and compliance and corporate governance issues--will receive increased attention from regulators.

Now, with Pharmaceutical Law: Regulation of Research, Development, and Marketing, counsel who represent clients in this industry will have a reference they can turn to time and again for answers and guidance in all areas of pharmaceutical law.

The book addresses many issues that could lead to litigation or regulatory problems for their clients, such as:

• securities law reporting obligations of drug companies for material events (such as the rejection of approval of NDAs)
• fraud and abuse risks involved with marketing and promoting such products
• HIPAA's privacy regulations
• how to protect clinical research subjects

Order your copy today!

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