Douglas B. Farquhar
Prescription Drugs and Biologics
J.D., Yale Law School
B.A., magna cum laude, Journalism, Boston University
District of Columbia
U.S. Courts of Appeals for the D.C. Circuit, Federal Circuit, Fourth Circuit, Seventh Circuit
Permanent member of the Fourth Circuit Judicial Conference
U.S. District Courts for District of Columbia, Maryland
Massachusetts pro hac vice, Western District of Virginia pro hac vice, Northern District of West Virginia pro hac vice, Northern and Middle Districts of Georgia pro hac vice, Middle District of Florida pro hac vice, Southern District of Alabama pro hac vice, Eastern District of Texas pro hac vice, Western District of Wisconsin pro hac vice
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Douglas B. Farquhar has more than 30 years of experience as a prosecutor and defense and regulatory attorney. Since joining the firm in 1997, he has advised pharmaceutical and medical device manufacturers and wholesalers, compounding pharmacies, and individuals on a wide range of enforcement activities, including consent decrees, criminal investigations, debarment issues, arbitration proceedings, civil seizures, FDA inspection issues, and injunctions. Mr. Farquhar has a broad-based understanding of the investigatory process, having negotiated settlements and resolutions for both industry and government.
In the last three years, Mr. Farquhar has served as lead trial and appellate counsel for generic drug companies in three different cases related to generic drug exclusivity. In each case, he has won judgments securing his client's approvals of Abbreviated New Drug Applications. In one of the cases, he secured a judgment from the Fourth Circuit Court of Appeals reversing FDA's decision to deny his clients ANDA approval, a decision that had been upheld by the lower court.
Mr. Farquhar also advises companies and individuals on adverse findings after FDA and other regulatory agency inspections. He has been active in defending companies during government investigations into drug pricing and drug and medical device fraud and abuse claims. In addition, Mr. Farquhar has represented employees and companies in investigations relating to anti-kickback laws. He has argued cases and conducted trials in federal court defending companies and individuals against both civil and criminal FDA enforcement efforts, and has sued FDA in cases related to generic drug approvals and adverse FDA publicity about his clients.
Mr. Farquhar's legal career includes seven years of service as a federal prosecutor. He was an assistant U.S. Attorney in the District of Maryland from 1990 to 1997, and clerked for the Honorable Judge Joseph H. Young, U.S. District Court in Baltimore, Maryland. Mr. Farquhar also reported for local newspapers before enrolling in law school.
Mr. Farquhar shares his perspective on enforcement and litigation issues through frequent speaking engagements and publications. He contributes to the firm's FDA Law Blog, and has served repeatedly as co-chair of the annual Enforcement Conference for FDLI. In addition, he wrote two chapters for the FDLI publication, How to Work with FDA, focusing on seizures, injunctions, consent decrees, and stolen drug samples.
• Worked on more than 20 cases related to Hatch-Waxman, including challenges to generic drug marketing exclusivity for the generic versions of Lipitor® and Celebrex®.
• Litigated cases in federal and state court on behalf of at least two large generic drug manufacturers, including drug pricing litigation brought by class action plaintiffs and by state Medicaid agencies.
• Represented generic drug manufacturers in affirmative and defensive civil litigation relating to generic drug approvals or disputes with FDA. Representative clients include:
Mylan Pharmaceuticals, Inc. (West Virginia 2014-2015)
Dr. Reddy's Laboratories, Inc (D.C. 2015)
Sandoz, Inc. (D.C. 2015)
• Represented corporate and individual defendants in Consent Decree actions nationwide. Representative clients include:
Medco Lab, Inc. (Iowa 1997)
Linde Gas LLC (Michigan 1998)
MRS Homecare, Inc. (Georgia 2000)
Veterinary Pharmacy Corp. (Minnesota 2000)
Kent A. Misemer (CE, York Pharmaceuticals, Kansas 2005)
Sparhawk Laboratories, Inc. (Kansas 2007)
Hakan Erdemir (VP, McNeil Consumer Healthcare, Pennsylvania 2011)
Dakota Laboratories, LLC (South Dakota 2013)
• Managed federal litigation relating to approval of certain prescription drugs and medical devices.
• Assisted clients with FDA inspections, drug manufacturing, drug compounding, and medical devices.
• Counseled clients on responding to FDA inspections, warning letters, and import alerts.
• Served as lead counsel in a civil injunction trial regarding Pharmakon Laboratories (Florida).
• Argued numerous motions, presented evidence at numerous evidentiary hearings, and briefed and argued numerous appeals, as a government attorney, an appellate attorney representing plaintiffs against FDA, and an appellate attorney representing defendants.
• Represented defendants in negotiating plea agreements, and in advocating for defendants at sentencing hearings. As a prosecutor, represented the government during similar proceedings.
• Acted as lead prosecutor in more than a dozen jury trials in federal district court.
Awards & Recognition
• ALM Legal Leader, 2014
• DC Super Lawyer, Litigation, 2007 - 2009, 2014 - 2016
• Chambers and Partners, Washington D.C., Healthcare, Band 3, 2014
• The International Who's Who of Business Lawyers (Life Sciences), 2014 - 2016
Fourth Circuit Judicial Conference
Co-Chair, Annual Enforcement Conference for the Food and Drug Law Institute, 2001 to 2010
Director, Montgomery General Hospital, a Member of MedStar, and chair, Quality Council, 2000 to 2010
Served repeatedly as moderator or speaker at FDLI and American Conference Institute conferences on cGMPs, advertising and promotion, FDA inspections, enforcement, and litigation.
Articles / Publications
• Federal Taint Teams And Attorney-Client Privilege In Corporate Criminal Investigations,
• Garbage Runs, Fake Identities, and Surprise Home Visits - Strategies to Deal With FDA's Nontraditional Investigative Tools,
June 20, 2012
• FDA's Pursuit of Punishing People,
July / August 2011
• The Evolution and Resurgence of Strict Liability Criminal Prosecutions Under the Park Doctrine,
October 8, 2010
see more speaking engagements
• International Pharmaceutical and Medical Device Supply Chains Imperiled Like Never Before, September 14, 2016
• DIA: FDA International Inspections, June 1, 2015
• Understanding cGMPs - What Attorneys Need to Know, Moderator, July 15, 2014
• ACI: Legal, Quality, Regulatory, and Compliance Forum on Current Good Manufacturing Practices, International Inspections: Preparing for Inspection of Overseas Manufacturing Facilities by FDA and Comparable Foreign Regulatory Authorities, January 23 - 24, 2014
• FDLI: Understanding cGMPs - What Attorneys Need to Know, Moderator: "cGMP Compliance: How Will FDA Evaluate Your Company?", July 10, 2013
see more blog entries
• No Room for Camera Shyness: FDA Issues Another Warning Letter Citing Refusal to Permit Photography,
August 16, 2017
• FDA Action Against Outsourcing Facility, the Sequel,
August 14, 2017
• First Circuit Holds that Identifying One Fraudulent Medicaid claim, with Projections, is Sufficient to Survive Motion to Dismiss in FCA Case,
August 3, 2017
• “Eggshell Plaintiffs” Meet Administrative Deference: Ninth Circuit Affirms Dismissal of Proposed Chicken Shed Rule,
March 6, 2017
• Maybe It Was Worth a Try . . . . Kentucky Defendant, Charged with Illegally Selling “Herbal Supplements,” Loses Motion to Dismiss,
March 1, 2017
• FDA, Sandoz Prevail at D.C. Circuit on Generic FUSILEV Approval,
June 6, 2016
• FDA's Draft Guidance on Data Integrity: The Cupola on a Tower of Guidances,
April 17, 2016
• International Pharmaceutical Supply Chain Imperiled Like Never Before,
February 29, 2016
• Be Careful What You Wish For: Specialized FDA Inspectors Don’t Necessarily Mean Happier Inspections,
September 29, 2015