Your business in court: 2009-2010

Area of Science:

• Pharmaceutical Law
• Regulatory Affairs
• Corporate Compliance

Background:

• The Food and Drug Administration (FDA) is intensifying its transparency initiatives and enforcement activities.
• The legal landscape for pharmaceutical product liability and state law preemption is evolving.
• Fraud and abuse enforcement poses significant risks, including criminal penalties for corporate officers.

Purpose of the Study:

• To analyze key regulatory and legal developments impacting the pharmaceutical industry.
• To highlight the growing importance of corporate compliance programs.
• To assess the enforcement trends of various regulatory bodies.

Main Methods:

• Review of recent regulatory actions and legal decisions.
• Analysis of enforcement trends by the FDA, FTC, and SEC.
• Examination of Supreme Court rulings affecting shareholder litigation.

Main Results:

• Increased FDA enforcement and focus on transparency.
• Ongoing legal challenges regarding state law preemption in pharmaceutical litigation.
• Continued enforcement of fraud and abuse laws, with personal liability risks for executives.
• Federal Trade Commission (FTC) challenges in preventing "reverse" payments to delay generic drug entry.
• Securities and Exchange Commission (SEC) enforcement of the Foreign Corrupt Practices Act (FCPA).
• Supreme Court decisions expanding shareholder rights in cases of concealed information.

Conclusions:

• Senior corporate officers must ensure active oversight of effective compliance programs.
• The pharmaceutical industry faces a complex and evolving regulatory and litigation environment.
• Proactive compliance is crucial for mitigating legal and financial risks.