Drug Law: Understanding the Essentials of FDA's Authority over Innovative and Generic Pharmaceuticals
Michael A. Swit, Special Counsel, FDA Law Practice, Duane Morris LLP
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||Course "Drug Law: Understanding the Essentials of FDA's Authority over Innovative and Generic Pharmaceuticals" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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.
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
Who will Benefit:
This seminar will be beneficial to senior drug company management, as well as middle management and operations personnel from the following departments:
Legal, Regulatory, Compliance, Quality, Sales, Marketing, Manufacturing, Operations, R&D, Medical Affairs.
|Day One (8:30 AM - 4:30 PM)
||Day Two (8:30 AM - 4:00 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
- Introduction to FDA Authority over Drugs
- The evolution of drug law
- The 1938 Act
- The 1962 Amendments
- Waxman-Hatch Act – Generic Drug Approval Process
- FDA’s Organizational Structure for Regulating Drugs
- The New Drug Application (NDA) Process
- The Investigational New Drug (IND) process – legal requirements for researching new drugs, including Good Clinical Practices (GCP)
- The “full” NDA – bringing innovative drugs to the market – standards for approval
- Alternative approaches to approval – Accelerated, Fast Track and Breakthrough Therapies
- User Fees and Review Times
- The 505(b)(2) NDA – improving old molecules
- Changes to Approved Applications
- The REMS process – Risk Evaluation & Mitigation Strategies
- The Waxman-Hatch Act and Generic Drugs
- Pre-1984 and Generic Drugs
- Basics of Waxman-Hatch – “Sameness” and Bioequivalence Requirements
- Patents and Generic Drugs
- Market Exclusivity
- OTC Drugs
- Rx-to-OTC Switches
- The OTC Monograph System
- The Orphan Drug Act – Incentives for Rare Disease Treatments
- How to Qualify – the Designation Process
- Incentives – Exclusivity, Grants, Tax Credits
- General Controls
- Listing and Registration
- Clinical Trials Registries
- Pharmacovigilance and the Adverse Event Reporting Requirements
- Advertising and Promotion Requirements
- Fair Balance, Risk Communication and the FDA Advertising Regulations
- Direct-to-Consumer (DTC) Advertising
- Off-Label Promotion and the First Amendment
- Use of Social Media
- FDA Enforcement
- Administrative Compliance Powers
- Warning Letters
- Judicial Compliance Powers
- Criminal Prosecutions
Meet Your Instructor
||Michael A. Swit, Esq.
Special Counsel, FDA Law Practice, Duane Morris LLP
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.
He has been addressing critical FDA legal and regulatory issues since 1984. Before joining Duane Morris LLP, he served for seven years as vice president at a preeminent scientific and FDA regulatory consulting firm, where he developed and ensured execution of a broad array of regulatory and other services to clients, both directly and through outside counsel.
His multi-faceted experience includes serving for three and a half years as corporate vice president, general counsel and secretary of Par Pharmaceutical, a prominent, publicly-traded, generic drug company and, thus, he brings an industry and commercial perspective to his work with FDA-regulated companies. He then served for over four years as CEO of FDAnews.com, a premier publisher of FDA regulatory newsletters and other specialty information products for the FDA-regulated community. His private FDA regulatory law practice also has included service as counsel in the FDA practices of three international law firms, as well as a solo FDA practitioner.
He has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial activities, including, since 1989, co-directing a three-day intensive course on the generic drug approval process and editing a guide to the generic drug approval process, Getting Your Generic Drug Approved. A former member of the Food & Drug Law Journal Editorial Board, he also has been a prominent speaker at numerous conferences sponsored by such organizations as the Food & Drug Law Institute (FDLI), the Regulatory Affairs Professionals Society (RAPS), and the Drug Information Association (DIA).
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