About Steve

Military Service

United States Air Force

  • Major, Judge Advocate General’s Corps
  • Receipt of Air Force Commendation Medal (2)
  • Active Service during Desert Storm 1 campaign (MacDill AFB , FL.)

Professional Affiliations

Food and Drug Law Institute (FDLI)

  • Member, Drug/Biologics Committee
  • FDLI Lecturer, Regulatory and compliance topics at Harvard

CBI, UBM Life Sciences

  • Faculty/Presenter, West Coast Compliance Congress

PCF, Pharmaceutical Compliance Forum

  • Lecturer and Chief Compliance Officer Forum Leader

Education

Suffolk University Law School, Boston, Massachusetts

  • Juris Doctor

Boston College, Chestnut Hill, Massachusetts

  • Bachelor of Science in Political Science

Bachelor of Science in Political Science

Steven a. Johnson, ESQ.

Chief Legal and Compliance Officer

949-201-7249

sjohnson@fdacounsels.com

Compliance ~ Corporate Counsel ~ Regulatory Policy

Accomplished, seasoned attorney with a history of success in general counsel roles and considerable compliance expertise. Proven success with diverse responsibilities including working closely with the FDA, case management, litigation, real estate transactions, and mergers and acquisitions. Background includes contract law, negotiation and regulatory affairs work. Professional with excellent verbal and written communication skills, detail oriented and able to meet deadlines in a fast-paced environment. Willingness to undertake new challenges and assume responsibility. Highly motivated and creative with excellent interpersonal, organizational, research, and analytical skills. U.S. Air Force Veteran. Admitted to the Bar in Massachusetts.

Career Accomplishments

  • Selected by the President and Global R&D Head to travel to Japan in 2005 and successfully resolved intracompany dispute between marketing and regulatory departments on development of top company drug resulting in complete resolution and all issues and continuation of drug development program.
  • Acted as the chief legal advisor to the team that launched Botox, which was the company’s largest initial U.S. marketing program of this top selling drug product in 2002.
  • Led multiparty litigation team to successful $1.5 million dollar settlement in 2005 against the general contractor responsible for construction of key drug manufacturing facility.
  • Legal counsel on corporate team overcoming adverse FDA Drug Advisory Committee decision and eventual approval and successful launch in 2014.
  • Successfully defended multiple shareholder lawsuits resulting in Federal Court dismissal in 2020.
  • Acted as sole Commercial team legal advisor resulting in profitable multi-million dollar launch of unique drug for rare disease epilepsy condition in 2021.

Professional Experience

ZOGENIX, INC., San Diego, California

2011 – 2022

NASDAQ traded pharmaceutical company focused on rare diseases.

Vice President, Legal Counsel and Compliance Officer (February 2014 – Present)

  • Lead legal and compliance functions for multinational pharmaceutical specialty firm.
  • Managed the approval process for the first approved single entity hydrocodone drug for chronic pain.
  • Appointed first Compliance Officer for the company and developed and incorporated internal corporate policies and guidelines for a 200 person sales force and Medical Affairs group.
  • Conducted compliance training to meet PhRMA Code and OIG requirements.
  • Provided key regulatory law advice as part of marketing review team allowing for the successful launch of product advertising and promotional materials in compliance with FDA and FTC laws.
  • Negotiated, drafted and reviewed critical manufacturing, supply, clinical trial, co-promotion, managed care and opinion leader consultant/speaker agreements.
  • Argued a persuasive anticompetitive complaint before the Federal Trade Commission.
  • Sole key legal advisor for launch of new drug to treat rare epilepsy condition.
  • Advised and managed various compliance and corporate legal matters as a part-time consultant.
  • Managed the launch of the first of its kind injectable migraine drug in competitive arena

BECKMAN COULTER INC., Brea, California

2010 – 2011

A specialized biomedical laboratory instrument company.

Assistant General Counsel

  • Acted as regulatory counsel to immunoassay, cellular analysis and genomics services divisions in chemistry analytical systems providing advice on FDA device laws and regulations.
  • Served on Regulatory and Quality Affairs committees; provided legal analysis of product complaints, adverse events, product complaint reviews, and pre-market 510k filing requirements.
  • Led the marketing review of research use lab testing products and incorporating changes to advertising/labeling as required by FDA laws/regulations - generating over $1M in annual revenue.
  • Drafted and negotiated key regulatory and quality provisions for major product manufacturing and supply agreements with major medical device firms.
  • Developed companywide Product Marketing and Clinical Grant review process for utilization by R&D and company marketing groups that streamlined grant approvals and processing for research.

FDA COUNSELS, Dana Point, California

2009 – 2010

A prestigious specialized legal consulting firm.

Legal Consultant

  • Appointed to a pharmaceutical company promotional review team providing advice on all advertising and marketing including print, DTC and professional advertisements and medical journals.
  • Provided critical FDA law and regulatory advice to multiple pharmaceutical and medical device firms.

ALLERGAN INC., Irvine, California

1998 – 2008

A global pharmaceutical company that introduced Botox to the market.

Assistant General Counsel, Regulatory Compliance

  • Negotiated extensively with FDA and foreign regulatory agencies regarding regulatory issues involving promotion and labeling for Botox Cosmetic commercial launch.
  • Handled regulatory issues for multiple dermatology products, Ophthalmology and Neurology segments, medical device products, prescription and OTC drugs and biotech products.
  • Resolved a significant FDA regulatory enforcement action on company’s flagship pharmaceutical product, prevented product global supply interruption and saved millions in revenue.
  • Established regulatory compliance training program covering hundreds of sales and marketing personnel assuring compliance in the field of all FDA and HHS regulations.
  • Created compliance oversight of company’s first Medical Science Liaison department allowing critical communication of scientific information on largest revenue generating multi-indication drug.
  • Assigned additional responsibility of oversight of company Research Compliance Department including supervision of Director and 15 international research clinical compliance auditors.
  • Negotiated with the FDA to bring significant enforcement action against medical device competitor, even the playing field, and provided an immediate competitive edge to the U.S. marketing team.
  • Drafted global corporate wide business compliance policy guides focusing on sales and marketing.
  • Handled California Department of Environmental quality observations and compliance issues regarding numerous manufacturing and headquarters facilities.
  • Created the first company medical science liaison group and led integration of the PhRMA Code and HHS/OIG guidance.
  • Challenged successfully through the FDA appeal process of a scientific decision on classification of drug/device combination process that allowed a key product to proceed to marketing approval years early.
  • Led multiparty litigation team to a successful $1.5 million dollar settlement against general contractor responsible for construction of key drug manufacturing facility.
  • Directed development of a revised clinical trial grant review compliance committee incorporating relevant compliance guidelines from ACCME, AMA and other physician specialty organizations.
  • Reviewed, drafted and negotiated corporate, marketing, commercial operations, consultant and clinical trial contracts including product acquisition and co-promotion agreements with large firms.
  • Settled numerous FDA advertising warning letters and Notice of Violation letters issues without further agency action allowing vital broadcast TV, radio and print media ads to run in million dollar nationwide drug product Ad campaign.
  • Resolved cGMP medical product manufacturing/quality assurance observations with FDA preventing interruption of delivery of vital medications to pediatric/adult patients.
  • Managed and led a litigation team in a successful $1.2 million settlement of breach of contract/defect case against a general contractor for critical company R&D building project while keeping drug and clinical supply manufacturing online.

FOOD AND DRUG ADMINISTRATION, Washington, D.C.

1993 – 1998

Associate Chief Counsel For Enforcement

  • Named as the first FDA Attorney to the new Office of Criminal Investigations and responsible for prosecutions as Special United States Attorney in Northeastern/Southeastern United States.
  • Prosecuted a major generic drug company resulting in a record setting $10 million fine for fraud and for FD&C Act violations.
  • Negotiated numerous seizure, injunctions, and consent decrees with Food, Drug and Device companies resulting in agency oversight of compliance initiatives.
  • Settled numerous FDA advertising warning letters and Notice of Violation letters issues without further agency action allowing vital broadcast TV, radio and print media ads to run in million dollar nationwide drug product Ad campaign.
  • Served as FDA counsel in first conviction of company officer for criminal contempt in an FDA case.
  • Awarded FDA Chief Counsel Special Recognition Award.