MICHAEL A. SWIT
FDACounsel.com
The Law Offices of Michael A. Swit
539 Samuel Ct., Suite 229
Encinitas, CA 92024
760-815-4762 ♦ fax: 760-454-2979
mswit@fdacounsel.com
http://www.fdacounsel.com
Also admitted in Virginia and the District of Columbia
Solving FDA Legal Challenges ... for the life of a Life Sciences Company
PROFESSIONAL EXPERIENCE
FDACOUNSEL.COM – THE LAW OFFICES OF MICHAEL A. SWIT, Encinitas, California
Partner
June 2003 to present
Sole practitioner serving as outside counsel to drug, device, biologics, biotech and dietary supplement
firms, including one major client that I serve as primary outside counsel on both FDA and general legal
issues. Advise regulatory clients on a wide range of FDA matters including drug approvals, dietary
supplement health claims, and regulatory issues in corporate acquisitions. During 1993 and 1994, also
in solo practice and represented prior employer, Pharmaceutical Resources, Inc. ("PRI"), on retainer;
work included PRI's continued compliance with 1992 Defense Department pact allowing PRI to
resume federal sales, and investigating former officers in cooperation with Justice Department criminal
probe of misconduct related to generic drug scandal.
HELLER, EHRMAN, WHITE & MCAULIFFE, LLP, San Diego, California
Special Counsel
May 2001 to May 2003
West Coast Member of FDA Regulatory Law Group within firm’s Life Sciences National Practice
Group, counseling drug, biologic, device, diagnostic, and other FDA-regulated firms on all aspects of
the FDA regulatory process, from initial development to post-approval marketing strategies. Served on
detail for over six months as in-house regulatory vice president for biotech client involved with
combination biologic/device product. Other key activities include: serving as principal FDA counsel
to major compounding pharmacy and keyed strategy to establish separate subsidiary to seek formal
FDA approval of specialty compounding formulations; working with several IVD firms active in
developing analyte specific reagents and related analytical device equipment to allow shift from
research to FDA commercial operations; extensive counseling on clinical research issues, including
drafting and negotiation of clinical research agreements; coordinating with transactional attorneys on
FDA due diligence aspects of financings and commercial transactions; review of marketing and
advertising materials; and advising on the Orphan Drug Act and related procedures.
MCKENNA & CUNEO, LLP, (NOW: MCKENNA, LONG & ALDRIDGE), Washington, D.C. and
San Diego, California
Of Counsel
March 1999 to May 2001
FDA legal and regulatory practice representing manufacturers, developers, and distributors of drugs,
medical devices, food, cosmetics and dietary supplements, with a particular emphasis on the generic
and brand name drug industries. Counsel on issues ranging from drug development and the clinical
research process through formal product approval to post-marketing compliance issues. Relocated to
firm’s San Diego office in June 2000 to spearhead efforts to better serve firm’s west coast FDA clients
as well as to expand the firm’s services to the biomedical and life sciences communities.
MICHAEL A. SWIT
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WASHINGTON BUSINESS INFORMATION, INC., Arlington, Virginia
President & CEO
April 1994 to September 1998
President of medium-sized publisher of 10 business-to-business newsletters primarily focusing on
federal regulation of pharmaceuticals, medical devices, and consumer products. Shared top executive
responsibility with founder/owner. Key duties included managing editorial department and leading all
acquisition efforts of company. Heavily involved in all other aspects of firm's operations, including
marketing, fulfillment, administration, and new product development. Introduced several new products
to company's book line and initiated development of company’s first software products.
PHARMACEUTICAL RESOURCES, INC., Chestnut Ridge, New York
Corporate Vice President, General Counsel & Secretary January 1990 to September 1993
Handled all legal matters for publicly-traded generic drug maker (NYSE:PRX) with annual legal
budget exceeding $1 million. Brought in -- as part of new management -- to spearhead firm's defense
of multiple and complex criminal investigations and civil litigations arising out of illegal actions by
former company officers in securing FDA approval of company's products. Successes included:

Coordinated company's cooperation with federal criminal and congressional investigations
leading to a plea bargain agreement that allowed company to stay in business;

Worked closely with outside counsel on SEC and corporate governance matters;

Handled all transactional activity from negotiating joint ventures to supplier agreements.

Counseled regulatory affairs, quality assurance and operations departments on compliance with
FDA, DEA, EPA and OSHA regulatory requirements. Oversaw several mass recalls.

Negotiated deal ending company's three-year suspension from federal government contracting;

Developed and oversaw first corporate ethics program; worked with H.R. department on labor
issues including numerous terminations and layoffs, all without any later related litigation;

Handled sale of subsidiary's Indiana facility and favorably renegotiated leases on New York
corporate offices.
MCKENNA, CONNER & CUNEO (now: MCKENNA, LONG & ALDRIDGE), Washington, D.C.
Associate Attorney
November 1988 to January 1990
Represented drug, medical device, food and cosmetic companies before FDA, DEA and in courts, with
strong emphasis on new and generic drug approval processes and regulatory issues impacting regulated
companies. Helped expand firm’s food, drug and medical device practice by bringing existing clients
and developing new ones, many still represented by the firm when I rejoined it in 1999.
BURDITT, BOWLES & RADZIUS (NOW PART OF BELL, BOYD & LLOYD), Washington, D.C.
Associate Attorney
January 1984 to November 1988
Food and drug lawyer for D.C. office of Chicago-based firm. Key activities included counseling on
FDA's implementation of Waxman-Hatch Act, the 1984 generic drug law, and advising on regulatory
and compliance issues, including FDA criminal investigations. Led consortium of clients fighting
FDA's withdrawal of new drug applications for generic versions of Persantine (dipyridamole).
MICHAEL A. SWIT
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WALSTAD, KASIMER, TANSEY & ITTIG (NOW: KASIMER & ANNINO), Vienna, Virginia
Associate Attorney
August 1982 to January 1984
Litigated complex construction and government contract matters from initial investigation through
trial. Counseled general contractors, subcontractors and architects/engineers at all levels of industry.
PRO BONO LEGAL WORK
NATIONAL ORGANIZATION FOR RARE DISORDERS (NORD)
Represented non-profit federation of over 100 voluntary health organizations that sponsor research and
support groups for rare diseases. Negotiated contract with major drug firm that pioneered NORD
program coordinating indigent patient drug give-away program. Member, NORD Board, 1986 to 1994.
PROFESSIONAL ACTIVITIES
LEGAL
Involved in myriad of legal professional activities ranging from serving on the Editorial Board of the
Food & Drug Law Journal to directing, for over ten years, an annual, 3-day, intensive course on
generic drug approvals. Have also spoken on diverse subjects relating to drug, biotech, medical device
and food industries and the FDA regulatory process, especially on clinical development, approval and
compliance issues. Speaking and writing activities are detailed in an addendum to this resume.
PUBLISHING
As president -- and still board chairman -- of a major newsletter publisher owned by my family, I was,
and remain, active in the newsletter industry’s major trade association, the Newsletter and Electronic
Publishers Association (NEPA). For two years, I served as an officer of the D.C. Chapter of NEPA,
first, in 1997, as Secretary/Treasurer, and, in 1998, as Vice President. In addition to participating in
many NEPA events, I moderated the Family Business Roundtable at the NEPA International
Conference in June 1997, and was on the panel on Electronic Publishing at the Newsletter Day
conference in San Diego in June 2000.
EDUCATION
EMORY UNIVERSITY SCHOOL OF LAW, Atlanta, Georgia
Honors:
American Jurisprudence Award, Contracts, 1980
Best Brief Award, 1981 Law Day Moot Court Competition;
Graduated 38th in class of 203 (top 20%).
J.D., June 1982
MICHAEL A. SWIT
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BOWDOIN COLLEGE, Brunswick, Maine
A.B., magna cum laude, May 1979
Honors:
High Honors in History for thesis, Chinese Political Vacillations and the Sino-Soviet Dispute,
1956-1962: A Model for Conceptualizing the Dynamics of Contention.
Dean's List -- 1975-1979.
BAR ADMISSIONS
Virginia, October 1982 (#22406)
District of Columbia, December 1984 (#383469)
California, November 2001 (#217806)
Federal courts: Eastern District, Virginia; D.C. District Court; Fourth Circuit Court of Appeals
ASSOCIATIONS
Legal
Member, California, Virginia and D.C. State Bars
San Diego County Bar Association
Industry
Association of Clinical Research Professionals (ACRP)
American Association of Pharmaceutical Scientists (AAPS)
BIOCOM (San Diego Regional Biotech Trade Association)
♦ Co-chair, FDA Committee (March 2002 to present)
♦ Planning leader, Ethics Session and Clinical/Regulatory Workshops, CalBioSummit, 2003
Drug Information Association (DIA)
Food & Drug Law Institute (FDLI)
Model Agreement Group Initiative (MAGI) – coalition devoted to improving clinical research
contracting process.
Orange County Regulatory Affairs (OCRA) Discussion Group
♦ Program Committee Member (2000 to present)
♦ Co-Chair, Drug Track, OCRA Annual Conference (2001, 2002, 2003)
Regulatory Affairs Professionals Society (RAPS)
San Diego Regulatory Affairs Network (SDRAN)
♦ Vice President, Programs, 2001 and 2002
♦ Planning Cmte., Feb. 2003 IND Conference
PERSONAL
Born July 30, 1956, Atlanta, Georgia; raised in Washington, D.C. Married Vera Caccioppoli, October
1987. Three sons -- Anthony, Joseph and Rafael -- born February 1996. Enjoy movies, photography,
travel, and both participating and watching sports, especially ice hockey, baseball, and basketball.
MICHAEL A. SWIT
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ADDENDUM TO C.V.
PROFESSIONAL ACTIVITIES
LEGAL SPEAKING AND WRITING
COURSES DIRECTED
Generic Drug Approvals -- Center for Professional Advancement (CfPA) annual three-day course held June
1989, September 1989 (Europe), 1990 (twice), 1991, September 1992 (Europe), December 1992, 1993, 1994,
1995, 1996, 1997, and 1999, 2001, 2002 (snowed out in 2000).
Prescription Drug and Device Advertising and Labeling, CfPA two-day course, October and December 1989,
New Brunswick, NJ and Ft. Lauderdale, FL.
SPEECHES AND PRESENTATIONS
The Development of Good Manufacturing Practices Under the Food, Drug, and Cosmetic Act, CfPA course on
"Good Manufacturing Practices in the Drug and Allied Industries," June 1987, St. Louis.
Orphan Drug Exclusivity, "Drug Exclusivity" Seminar, Food and Drug Law Institute (FDLI), March 1988,
Washington, D.C.
Orphan Drug Exclusivity, "Understanding the Orphan Drug Act," Seminar, FDLI, October 1988, Washington,
D.C.
Exclusivity, "Advanced Drug Law" Course; FDLI, Lecturer, October 1988 and May 1989, Washington, D.C.
Impact of Generic Drug Scandal, Regulatory Affairs Professional Society (RAPS) Seminar, July 1989,
Washington, D.C.
Importing Drugs, McKenna & Cuneo in-house seminar for embassy officials on Importing-FDA Regulated
Products, July 1989, Washington, D.C.
Determining the Regulatory Status of a Drug, RAPS Seminar on New Drug Applications, January 1990,
Washington, D.C.
Impact of FDA's Regulatory Activities on the Generic Drug Industry: Market Share Through Approvals vs.
Market Share Through Attrition, International Business Communications (IBC) conference on "Generic Drugs,
Competitive Strategies for Pharmaceutical Companies, " October 1992, Philadelphia.
FDA Enforcement: A Perspective from Industry on How to Prepare for and Respond to FDA's Knock on
Your Door, RAPS Annual Conference, October 1993.
Health Care Reform and the Generic Drug Industry, IBC Generic Drug Conference, October 1993,
Philadelphia, and January 1994, Orlando.
MICHAEL A. SWIT
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Boosting Awareness of Generics Quality Compared to Brand Name Drug, IBC Generic Drug Conference,
November 1998, San Diego.
Potential Legal Consequences of Product Recalls, FDLI Recalls Conference, March 1999, Washington, D.C.
Drug Imports and Exports, Introduction to Drug Law Course -- FDLI, June 1999, Washington, D.C.
Violations and Enforcement, Introduction to Drug Law Course -- FDLI, June 1999, Washington, D.C.
Challenges to Generic Drug Approvals, IBC Generic Drug Conference, September 1999, Washington, D.C.
Global Harmonization Issues and the Protection of Intellectual Property, Salud Americas 99, Conference on
Latin America’s Health Sector Policies, Regulation, and Investment Climate, sponsored by the Institute for the
Americas, October 1999, Philadelphia.
Legal and Regulatory Aspects for Purchasers of Drug Components, Drugs, and Devices, Course on Vendor &
Contract Supplier Qualification, CfPA, October 1999, New Brunswick, N.J.
Indemnification in the Clinical Research Context, at the Fall Seminar of the Charlotte Chapter of the
Association of Clinical Research Professionals (ACRP), October 1999, Charlotte, N.C.
An Overview of Global Harmonization of the Regulation of Pharmaceuticals and Medical Devices, at the
“Regulatory 101” Seminar, RAPS, January 2000, Santa Monica, CA.
Federal Civil and Criminal Laws -- How They Impact Medical Device and Drug Companies and Their
Employees, Compliance with U.S. Regulatory Requirements: FDA Inspections Seminar, RAPS, January 2000,
Santa Monica, CA.
Overview of FDA Regulation of Medical Devices, Introduction to Device Law Course, FDLI, January 2000, San
Diego.
Device Registration and Listing, Introduction to Device Law Course, FDLI, January 2000, San Diego.
Investigational Device Exemptions (IDE)s, Introduction to Device Law Course, FDLI, January 2000, San Diego.
The Institutional Review Board (IRB) and the Clinical Investigator -- Legal/Regulatory Requirements and
Perspectives. FDA/Orange County Regulatory Affairs (OCRA) Discussion Group Annual Educational
Conference, July 2000. Irvine, CA.
Understanding How to Source Information on FDA Regulatory Activities, panel member, Discussion
Presentation to San Diego State University, Masters Program on Regulatory Affairs, September 2000.
An Overview of Global Harmonization of the Regulation of Pharmaceuticals and Medical Devices, at the
“Regulatory 101” Seminar, RAPS, November 2000, Pasadena, CA.
Functional Foods:
Pasadena, CA.
Claims & Labeling, at the Dietary Supplements Conference, RAPS, November 2000,
Indemnification in Clinical Research, San Diego Chapter of ACRP, November 2000, San Diego.
MICHAEL A. SWIT
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International Harmonization of Regulatory Requirements for Biotechnology Products, Drug Information
Association (DIA) Conference on Biotechnology, February 2001, Dana Point, CA.
Indemnification in Clinical Research, DIA Good Clinical Practice Conference, February 2001, Tucson, AZ.
The Collateral Legal Consequences of Violating the Food, Drug, and Cosmetic Act – or Why Crime Doesn’t
Pay. OCRA Conference on Risk Management, Recalls and Crisis Management, March 2001, Costa Mesa.
FDA Legal and Regulatory Considerations in Drug Development, Institute for International Research (IIR)
Conference on Drug Discovery, March 2001, San Diego.
FDA Regulation of Imports, Food, Drug and Cosmetic Division of the American Society for Quality (ASQ)
Conference on “Business Strategies within The Boundaries of the Law,” March 2001, Anaheim, CA.
Legal and Regulatory Strategies in Sourcing of Products, Components and Services for FDA-Regulated
Companies, Biotechnology Industry Organization (BIO), Annual Conference, June 2001, San Diego, CA.
Legal Consequences of Violating the Food, Drug, and Cosmetic Act, San Diego Regulatory Affairs Network
(SDRAN) Program on Legal Aspects of Recalls, July 2001, San Diego, CA.
FDA Advisory Committees – A Regulatory Overview, SDRAN Program on FDA Advisory Committees,
September 2001, San Diego, CA.
Regulation of Generic Drugs, SDRAN Review Course on Regulatory Affairs, October 2001.
FDA Legal and Regulatory Aspects of Good Clinical Practice, Society of Quality Assurance (SQA), Annual
Meeting, October 2001, San Diego, CA.
Ethics in Clinical Research, Panel Member, Scripps Institute/BIO Joint Conference on Clinical Research,
October 2001, San Diego.
The De Novo Petition Process for Medical Devices, Heller, Ehrman, White & McAuliffe FDA Regulatory Law
Group Breakfast Briefing, November 2001, San Diego and Seattle.
FDA Regulation of the Importing and Exporting of Drugs and Devices, OCRA Conference on Import/Export,
March 2002, Irvine, CA.
FDA Regulation of Pre-Approval Marketing and Advertising, Heller, Ehrman, White & McAuliffe FDA
Regulatory Law Group Breakfast Briefing, April 2002, San Diego.
Strategies for Success in Dealing with FDA Advisory Panels, Joint FDA/OCRA Educational Conference, June
2002, Irvine, CA.
What Every Clinical Director Must Know About FDA Regulatory Compliance, DIA Workshop, June 2002,
Chicago.
Where FDA Leaves Off, Another Agency Picks Up, Heller, Ehrman, White & McAuliffe, Joint FDA Regulatory
Law Group/Environmental Law Group Breakfast Briefing, “Beyond FDA -- What Every Biomedical Company
Must Know About Regulation by Other Federal and State Agencies,” June 2002, Menlo Park, CA.
Legal Strategies in Sourcing of FDA-Regulated Goods and Services – Seeking a Win-Win Relationship with
MICHAEL A. SWIT
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Your Contract Manufacturing Organization, IBC Conference on “Scale-Up: From Bench to Clinic”, August
2002, San Diego.
The Collateral Legal Consequences of Violating the Food, Drug, and Cosmetic Act – or Why Crime Doesn’t
Pay, Association of Medical Diagnostic Manufacturers (AMDM) IVD Conference, September 2002, Del Mar,
CA.
Current Legal Issues Impacting the Generic Drug Industry, Practicing Law Institute, Course on Biotechnology
Law, September 2002, San Francisco.
FDA Regulation of Dietary Supplements, Presentation, University of Southern California, Masters Program on
Regulatory Affairs, September 2002, Los Angeles.
Financial Disclosure Issues in Clinical Research, Heller, Ehrman, White & McAuliffe, FDA Regulatory Law
Group Breakfast Briefing, “What You Need to Know Before Beginning Your Clinical Trial,” October 2002, San
Diego.
Legal Issues in Drug Sampling, Audioconference, FDANews.Com, November 2002.
“Specific Payments of Other Sorts:” Sifting Through the SPOOS, Barnett-Parexel Conference on Financial
Disclosure, November 2002, Philadelphia.
MDUFMA – A Review of Key Provisions, OCRA Program on MDUFMA, December 2002, Irvine, CA.
Financial Disclosure in Clinical Research, San Diego Chapter of ACRP Program, January 2003, San Diego.
FDA’s “Combination” Product Policy, Scripps-BIO 5th Annual Drug Development Conference, February 2003,
La Jolla, CA.
To CRO or Not to CRO – Moderator and organizer, “Workshop on Use of Contract Research Organizations in
Biomedical Research” at SDRAN IND Conference, February 2003.
FDA Legal and Regulatory Strategies for Start-up Companies, Tech Coast Angels, BioMedTrak Program,
March 2003, La Jolla, CA.
Recent Developments in Generic and OTC Drug Regulation, OCRA/FDA, June 2003 Annual Joint Educational
Conference, Irvine, CA.
What Every Clinical Director Must Know About FDA Regulatory Compliance, DIA, June 2003, San Antonio.
Overview of Regulation of Generic Drugs, OTCs, and Orphan Products, SDRAN, September 10, San Diego.
FDA Regulation of Advertising and Promotion, OCRA, , September 2003, Irvine, CA.
State Regulation of Clinical Research, Society of Quality Assurance Annual Meeting, Clinical Track, October
2003, Washington, D.C.
FDA Enforcement and Compliance, SDRAN, October 2003, San Diego.
Legal and Regulatory Concerns in the Sourcing of FDA-Regulated Products, Components & Services.
Center for Professional Advancement In-House Seminar on "Vendor & Supplier Qualification."
MICHAEL A. SWIT
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Siemens, January 2004, Concord, CA.
FDA Enforcement -- What You Need To Know To Avoid -- Or Respond. Annual Meeting. DIA, Half-Day
Tutorial, June 2004, Washington, D.C..
Overview of Regulation of Generic Drugs, OTCs, Orphan Products and Cosmetics, SDRAN, August 18, 2004,
San Diego.
UPCOMING PRESENTATIONS
Case Study: The Generic Drug Scandal. Ethics in Regulatory Affairs, OCRA, August 30, 2004, Irvine, CA.
Can We Do Better? Innovation in Clinical Trial Agreements. 14th International Contracting & Negotiating
Clinical Trials. Strategic Research Institute. September 27-28, 2004, La Jolla, CA.
Specific Payments of Other Sorts -- Understanding SPOOS and Clinical Research. Annual Meeting. RAPS,
October 12, 2004, Washington, D.C.
FDA Enforcement and Clinical Research. Annual Education Symposium. North Texas Chapter, ACRP,
October 16, 2004, Dallas, Texas.
Managing Financial Disclosure in Clinical Trials. West Coast Drug Development Forum: Challenges in the
Development of Therapeutic Products. DIA, Half-Day Tutorial, October 25-27, 2004, San Francisco.
PUBLICATIONS
Articles
Profitability, Patient Populations and the Orphan Drug Act -- or -- "Should an Orphan Have the Right to
More Than One Parent?" Food, Drug, Cosmetic and Medical Device Law Digest, New York State Bar
Association, Food, Drug and Cosmetic Law Section, January 1992.
Before Merging, Check for FDA Problems, National Law Journal, September 4, 2000, pages B13-B14.
Electronic Signatures Act – Feast or Famine for FDA-Regulated Industries? FDLI Update Magazine (coauthor) January 2001. p. 18.
Supreme Court to Hear Tasini Case on Publishers' 'Free' Right to Republish Print Articles Electronically.
Newsletter Industry Monitor. March 2001.
Western States Medical Center – Supreme Court Reins FDA in on Regulating Commercial Speech, Drug
Delivery Technology (co-author), July 2002.
Chapter on Cosmetics Regulation, Treatise on Food & Drug Law. Co-author, FDLI, 1992.
Books
Getting Your Generic Drug Approved, Editor, Washington Business Information, Inc., 1995.
MICHAEL A. SWIT
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Editorial Service
Food & Drug Law Journal, FDLI, Member, Editorial Advisory Board, 1991-1995.
Newsletter Industry Monitor, Board of Contributors. November 2000 to May 2001 (publication closed).
Rev.04-08