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

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.

Course Outline:

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
        • The DESI Review
      • 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
    • GMPs
    • 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
      • Inspections
      • Warning Letters
    • Judicial Compliance Powers
      • Seizures
      • Injunctions
      • 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, 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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I thoroughly enjoyed the seminar! The content of the seminar was excellent.
- Associate Director, Pfizer Global Supply

ComplianceOnline is doing well with organizing seminars and webinars.
- Associate Director, Dr Reddy's Laboratories

Seminar was very good, informative and a lovely speaker making a tedious topic interesting. Overall the subjects are well chosen and the program was well organized and coordinated.
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The seminar is good. ComplianceOnline is doing well with organizing seminars and webinars.
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The event was really well organized and ComplianceOnline staff helped make it a smooth process from initial registration, hotel bookings and seminar materials and stationery. I will be asking my company to send more employees to attend ComplianceOnline seminars.
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- Regulatory Advertising Officer, Health Canada

Interaction between the speaker and audience was interesting.
- DVM, Merial

This was tremendously informative and very full of interesting insights. I especially enjoyed going over the warning letters.
- Program Manager, Regulatory Affairs, Genentech, Inc.

Instructor is experienced and was willing to share his experiences.
- Marketing Manager, Minerva Surgical, Inc

Seminar covered more latest up- to- date information.
- Regulatory Affairs Specialist, AccessClosure, Inc

Michael has a good accessible presentation style and was very colloquial. He welcomes questions from attendees and has the answers also. He also promoted good interaction between attendees.
- Sr. Counsel, Siemens Medical Solutions USA, Inc

I had registered for a seminar but unfortunately I was not able to attend. The company was very understanding and extremely helpful. I plan on attending a future event soon.
- Director of Regulatory Affairs, Nickell Physician & Pharmacy Services

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Local Attractions

The Philadelphia Museum of Art sits majestically on a rise at the end of the Benjamin Franklin Parkway. The vast collections of this temple of art make it the third-largest art museum in the country, and an absolute must-see on the city's cultural circuit.

Among its impressive holdings in Renaissance, American, Impressionist and Modern art, some standouts include a great Rogier van der Weyden altarpiece, a large Bathers by Cezanne, a room devoted to Philadelphia's own Thomas Eakins, and Marcel Duchamp's notorious mixed-media Bride Stripped Bare by her Bachelors (The Large Glass), exactly as the dada master installed it.

With more than 3,600 acres of rolling hills and well-worn trails, Valley Forge is now a magnet for runners, bicyclists and picnickers as well as history buffs.

The vast expanse of open space links the Schuylkill River Trail to the Horse Shoe Trail, turning the park into a major hub in a 75-mile system linking Philadelphia to the Appalachian Trail.

The Liberty Bell has a new home, and it is as powerful and dramatic as the Bell itself. Throughout the expansive, light-filled Center, larger-than-life historic documents and graphic images explore the facts and the myths surrounding the Bell.

The 160,000-square-foot National Constitution Center explores and explains this amazing document through high-tech exhibits, artifacts, and interactive displays. The Kimmel Theater, a 350-seat star-shaped theater, features “Freedom Rising,” a multimedia production combining film, a live actor and video projection on a 360° screen to tell the stirring story of “We the people.”

An innovator in designing hands-on exhibits before “interactive” became a buzzword, The Franklin Institute is as clever as its namesake. Its eminently touchable attractions explore science in disciplines ranging from sports to space.

Highlights include The Sports Challenge, which uses virtual-reality technology to illustrate the physics of sports; The Train Factory's climb-aboard steam engine; Space Command's simulated earth-orbit research station; a fully equipped weather station; and exhibits on electricity.

The Barnes Foundation was created in 1922, a school originating with Barnes’ educational experimentation in his Argyrol (pharmaceutical) factory. Barnes and The Foundation’s first director of education, John Dewey, were interested in fostering cognitive development through new approaches to education, and in heightening critical-thinking and problem-solving skills through the study of art. Barnes, like Dewey, was actively engaged in development of an intellectual framework and educational philosophies and practices with many of the best artists and thinkers of his day.

One of Philadelphia’s most famous pieces of public art is a bigger-than-life boxer… literally. Originally created for Rocky III, the sculpture is now a real-life monument to a celluloid hero. The fictional Rocky Balboa of Sylvester Stallone’s Rocky movies was immortalized in bronze in 1980. After filming for the movie completed, Stallone donated the statue to the City of Philadelphia.

Franklin Square, one of Philadelphia’s five original public squares laid out by William Penn in his original plan for the city, has undergone a dramatic renovation. The park now boasts several family-friendly attractions, including a miniature golf course, classic carousel, burger joint, storytelling bench, picnic area and more.

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