Frank Fazio

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Frank Fazio is a principal of Porzio, Bromberg & Newman and a registered pharmacist in the State of New Jersey. As a member of the firm’s Life Sciences Compliance and Regulatory Counseling Department, his legal practice includes conducting third-party vendor PDMA compliance audits, counseling pharmaceutical manufacturers and wholesale distributors on licensing, record-keeping and pedigree issues, and providing guidance on OIG compliance, off-label promotion and other regulatory issues involving sales and marketing practices. A seasoned litigator, Frank also defends manufacturers in pharmaceutical and medical device product liability litigation. Frank is a frequent speaker on topics involving state, federal and international regulation of pharmaceutical sales and marketing practices.

Frank is also Vice President of Distribution and Licensing Services of Porzio Life Sciences, LLC, a wholly owned subsidiary of the law firm. In this role, Frank works with both emerging and established pharmaceutical companies in obtaining the necessary state distribution licensure for legend and controlled drugs, medical devices, and over-the-counter products. He also works with companies as an outsource solution for the management of renewal licensure and audits the licensure status of pharmaceutical companies and their vendors. Frank also collaborates with Porzio Life Sciences regulatory analysts to manage the content of the company's products.

Prior Relevant Experience
  • Medical Center Pharmacy, Pharmacist, 1986–1989
  • Registered Pharmacist, State of New Jersey, 1986–present
Opinions, Decisions and Cases
  • Michelman v. Ehrlich, 311 N.J. Super. 57, 709 A.2d 281 (App. Div.); certif. denied, 156 N.J. 405, 719 A.2d 637 (1998)
Organizations/Memberships
  • Union Center National Bank, Advisory Board
  • New Jersey State Bar Association, Young Lawyers Division, Treasurer, 1996–1997; Executive Committee, At-Large Representative, 1991–1996; Morris County Representative, 1996–1997; Seminars Committee, 1995–1997; Membership Committee, Co-Chair, 1996–1997; Race Judicata Committee, Chair, 1991–1994; New Jersey Lawyer, The Magazine, Editorial Board, 1996–2001
  • American Pharmacists Association
  • Congress of the Fellows of the Center for International Legal Studies, Charter Fellow
  • International Business Law Consortium
  • American Chemical Society
  • HDMA (Healthcare Distribution Management Association), Allied Member: Pozio Life Sciences
  • New York State Bar Association
Publications
  • "Getting the Deal Through - Life Sciences 2014," United States Chapter, published by Getting the Deal Through, 2014.
  • "Shoot First...Michigan Imposes New Requirement On The Pharmaceutical Supply Chain," Pharmaspective, September 24, 2014.
  • "Massachusetts Life Science Companies: Stuck Between a Rock and a Hard Place," Pharmaspective, September 5, 2014.
  • "Getting the Deal Through - Life Sciences 2013," United States Chapter, published by Getting the Deal Through, 2013.
  • Quoted in "Licensed to Sell?," IMDA Update, September 2012.
  • "Getting the Deal Through - Life Sciences 2012," United States Chapter, published by Getting the Deal Through, February 2012.
  • "Strategizing Publication: Ghostwriting on the Heels of AstraZeneca's 2010 Corporate Integrity Agreement," Bloomberg Law Reports - Pharmaceuticals, Medical Devices & Biologics, June 22, 2010.
  • "Prescription Drugs: Consumer Fraud in Sales and Marketing," LJN’s Product Liability Law & Strategy, Volume 26, Number 5, November 2007.
  • "Abusus non tollit usum, Part Two: China," Drug Discovery & Development Magazine, October 2007.
  • "Abusus non tollit usum: Part One," Drug Discovery & Development Magazine, September 2007.
  • "The Shifting Sands of Wholesale Distribution," Thought Leadership Sales and Marketing Compliance, Volume 2, Issue 5, Winter 2007.
  • "Will the Real Drug Manufacturer Please Stand Up?," LJN’s Product Liability Law & Strategy, Volume 25, Number 1, July 2006.
  • "FDA Lifts Stay on PDMA Pedigree Provisions: Is Your Company Prepared?," Porzio Pharmaceutical Alert, Volume II, No. 6, June 26, 2006.
  • "Protecting Manufacturers from Qui Tam Actions Under the False Claims Act," IADC Medical Defense Newsletter, November 2005.
  • Manuscript, "Product Line Successor Liability: A Blast from the Past," Product Liability From A to Z, New Jersey Institute for Continuing Legal Education, April 27, 2002.
  • "Playing the Forum Selection Trump Card: A Practical Guide to Removal," 156 New Jersey Law Journal 231, April 19, 1999.
  • "Product Line Successor Liability: Back Through the Looking Glass?," New Jersey Lawyer—The Magazine, No. 191, May/June 1998.
  • "Products Liability Exposure for Trade Associations and Their Members," Presented at ABA Section of Litigation Annual Meeting, April 17, 1997.
  • "Protecting Choice of Forum Through Anti-Suit Injunctions," Environmental Compliance & Litigation Strategy, Vol. 12, No. 2, July 1996.
  • "Calculating Future Losses in P.I. Actions," 5 New Jersey Lawyer 416, February 26, 1996.
  • "What You Can’t Know, Shouldn’t Hurt You: State-Of-The-Art in the Strict Liability Action," American Bar Association, Order Code No. 5310-2011.
  • "An Analysis of Comparative Fault in Design Defect-Based Product Liability Cases," New Jersey Lawyer—The Magazine, No. 150, January 1993.
  • "A Blast From The Past: An Overview of American Successor Liability," Product—Liability International, Lloyd’s of London Press, January 1993.
  • "Sharing Damages in Multiparty Toxic Tort Cases," New Jersey Law Journal, October 19, 1992.
  • "Emerging Product Liability and Toxic Tort Risks—Electromagnetic Energy, Byproducts, Lead and Corporate Criminal Liability," Presented at ABA Annual Meeting, Aug. 10, 1992, ABA Tort and Insurance Practice Publications, 1992.
  • "Corporate Caveat Emptor—Now More Than Ever—A Guide To Successor Liability For Defective Products In A Changing World," 3 Products Liability Law Journal 1, November 1991.
  • "Just When You Thought It Was Safe To Go To The Jury—A Product Liability Update," New Jersey LawyerThe Magazine, No. 143, November/December 1991.
Speaking Engagements
  • Moderator, "Compliance Champion Exchange," CBI's 7th Annual West Coast Compliance Congress, San Francisco, CA, November 9, 2016.
  • "State Licensing and Other Compliance Considerations in Planning a U.S. Launch," BioWales, Cardiff, Wales, March 2, 2016.
  • "Crisis Management/Recalls-Effects of Counterfeit Drugs and Healthcare Risks to Consumers," National Society of Hispanic MBAs New Jersey 2nd Annual Regional Healthcare Summit, Montclair, NJ, June 13, 2014.
  • "State Licensing and Hospital Policies: An Overview," CBI’s 4th Annual West Coast Compliance Congress, San Francisco, CA, November 13, 2013.
  • "State Licensing and Medical Devices: An Overview." IMDA’s Annual Conference & Manufacturers Forum, Orlando, FL, June 10, 2013.
  • "Disaster Recovery of a Law Practice: Lessons Learned from Superstorm 'Sandy,'" International Business Law Consortium, Paris, France, March 15, 2013.
  • "Diffusing the Dangers of Distribution," The Life Sciences Industry Under Attack— Mitigating the Risks, Seventh Annual Porzio Compliance Forum, Newark, NJ, October 14, 2011.
  • "Authorship Standards for Scientific and Medical Research," ACI's 8th National Conference on Managing Legal Risks and Avoiding Conflicts of Interest in Medical Affairs," Philadelphia, PA, December 7, 2009.
  • Moderator, "Compliance in the New Era of Governmental Activism — Distribution Licensing Panel," Fifth Annual Porzio Compliance Forum, Porzio Pharmaceutical Services, LLC, Basking Ridge, NJ, October 7, 2009.
  • "State Licensing Requirements for Manufacturers", CBI ’s Drug Tracking Summit, Princeton, NJ, May 15-16, 2008.
  • "Aggregate Expense Tracking in the States," Third Annual Porzio Compliance Forum, Porzio Pharmaceutical Services, LLC, Basking Ridge, New Jersey, September 26, 2007.
  • "Off-Label Promotion — State and Federal Prosecutions," CBI's 8th Annual Guidelines for Disseminating Off-Label Information, Arlington, Virginia, October 26-27, 2006.
  • "International Codes of Ethics: Creating a Global Compliance Program Across Borders and Cultures," Second Annual Porzio Compliance Forum, Porzio Pharmaceutical Services, LLC, Basking Ridge, New Jersey, September 13, 2006.
  • "Legal Risks Associated with Poor Complaint Trending," Center for Business Intelligence, Fourth Annual Pharmaceutical Product Complaints Conference, June 15, 2006.
  • "Complying with New State Initiatives Related to Marketing and Promotional Practices by Device Manufacturers," American Conference Institute, Fourth National Conference on Reducing Legal Risks in the Sales and Marketing of Medical Devices, May 24, 2006.
  • "State Laws Governing Pedigree and Authorized Distributors of Record," Pharmaceutical Compliance Forum, Livingston, New Jersey, September 27–28, 2005.
  • "Privilege & Professional Secrecy," Business Law Consortium Business Development Meeting, Dresden, Germany, September 22, 2005.
  • "Controlled Substance Diversion: Enforcement actions against industry professionals in violation of federal law," 2005 PDMA Sharing Conference, Orlando, Florida, September 20, 2005.
  • "’May We Have Your Fingerprints Please?’ State Laws Governing Pedigree and Authorized Distributors of Record," First Annual Porzio Compliance Forum, Bedminster, New Jersey, September 14, 2005.
  • "American Successor Liability and its Potential Impact on Acquiring Companies," Presented at the Third Annual Convocation of the Congress of the Fellows of the Center for International Legal Studies, Vienna, Austria, July 15–17, 2005.
  • "Stand Up to Increased FDA and Public Scrutiny Through Early Evaluation of Legal Risk and Product Liability," Center for Business Intelligence’s 3rd Annual Pharmaceutical Product Complaints Conference, Philadelphia, Pennsylvania, June 16, 2005.
  • "The Use of Mandatory Binding Arbitration Clauses in Consumer and Professional Services Contracts," Presented at the Second Convocation of the Fellows of the Center for International Legal Studies, Rome, Italy, May 7–9, 2004.
  • "Product Line Successor Liability: A Blast from the Past," Product Liability A to Z, New Jersey Institute for Continuing Legal Education, April 27, 2002.
  • "Protecting Choice of Forum Through Anti-Suit Injunctions," Free Movement of Civil Justice Conference in Salzburg, Austria, Presented By The Center For International Legal Studies in Cooperation With Franklin Pierce Law Center and The American Bar Association—Section on International Law and Practice, November 3, 2001–November 6, 2001.
  • "Proving Economic Damages," New Jersey Institute for Continuing Legal Education, December 6, 1995, January 6, 1996 and January 20, 1996.
  • "Proving Damages—Economic Damages, Aggravation of Preexisting Conditions and Calculation of Future Losses," New Jersey Institute For Continuing Legal Education, June 24, 1995.
  • "Insurance Issues In Toxic And Environmental Contamination—Pulling The Trigger And Activating Coverage," New Jersey Institute For Continuing Legal Education, November 16, 1991.

Practice

Industries

Related Media

Bar Admissions

  • New Jersey, 1989
  • New York, 1990
  • United States District Court, District of New Jersey, 1989
  • United States District Court, Southern District of New York, 1995
  • United States District Court, Eastern District of New York, 1995
  • United States Court of Appeals, Third Circuit, 1995

Education

Seton Hall University School of Law, Newark, New Jersey, J.D., cum laude, June 1989

  • Appellate Moot Court Board
  • Peter W. Rodino, Jr. Law Society
  • High School MENTOR program

University of New Mexico College of Pharmacy, Albuquerque, New Mexico, B.S., Pharmacy, May 1986

Contact Address

100 Southgate Parkway

Morristown, NJ 07962-1997

Phone: 973.538.4006

Fax: 973.538.5146

  • Fazio, Frank