Drug Law: Understanding the Essentials of FDA's Authority over Innovative and Generic Pharmaceuticals

Course Description:

FDA authority over both innovative and generic pharmaceuticals is not only pervasive, but imposes duties on industry that, if not followed, expose drug companies and their officials to severe penalties, up to and including criminal prosecution.

This two day interactive course will review the foundations for FDA’s authority over pharmaceutical companies and will focus on the three central roles of the FDA relative to drug companies. These include: FDA serving as the gatekeeper to the marketplace, primarily through the drug approval process; the agency’s status as the “cop on the beat” that enforces the FDA’s requirements through both administrative actions (e.g., warning letters) and judicial proceedings such as seizures, injunctions and criminal prosecutions; and, finally, the FDA serves as the sentinel of health issues through its role in overseeing industries’ reporting of adverse events through the process referred to generally as pharmacovigilance.

To ensure your firm does not run afoul of the FDA’s requirements, a detailed understanding of those duties is essential. Attendees at this seminar will leave with the tools necessary to help ensure their companies stay in the agency’s good graces, so they can continue to succeed in the marketplace.

Learning Objectives:

Key goals of the conference will include learning:

• The basics of the FDA statutes and regulations governing the entry into the marketplace of prescription and over the counter drugs
• Key differences between the full new drug application (NDA), the 505(b)(2) NDA, and the abbreviated NDA (ANDA) applicable to generic drugs
• The route to the OTC market: Rx to OTC Switches vs. the OTC Monograph System
• The Orphan Drug Act—incentives for treatments for rare diseases
• FDA regulation of drug promotion and advertising
• Understanding the FDA’s enforcement authority, both administrative and judicial
• The basics of drug good manufacturing practices (GMP) and quality requirements
• Pharmacovigilance requirements, including adverse event reporting
• The investigational new drug process and clinical trials
• General controls, such as registration and listing

Michael A. Swit's practice focuses on solving the legal challenges confronted by the pharmaceutical, medical device, and other life sciences industries in tackling the myriad of legal mandates enforced by the U.S. Food & Drug Administration. Mr. Swit has extensive experience counseling life sciences firms on the demands of compliance with FDA's statutory and regulatory requirements to develop and market safe and effective drugs, biologics, medical devices, IVDs and other products. He also has advised regulated firms on a wide range of FDA regulatory matters, including drug and device approvals, food labeling and safety issues, dietary supplement health claims, and regulatory issues in corporate acquisitions. His experience includes FDA development strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts.