Wiley Rein LLP


James N. Czaban
Practice Areas
Education
  • J.D., University of Virginia School of Law
  • B.A., University of California, Berkeley
Bar & Court Admissions
  • District of Columbia Bar
  • Virginia Bar
  • New York Bar
  • Supreme Court of the United States

James N. Czaban

PARTNER

202.719.7411  |  jczaban@wileyrein.com


Mr. Czaban has extensive experience in government regulation of pharmaceutical, biotechnology, food, medical device and health care related companies.  His practice focuses on counseling such clients on complex regulatory strategies and compliance matters, and representing clients in administrative and judicial enforcement actions and other proceedings involving the Food & Drug Administration (FDA), Federal Trade Commission (FTC), Drug Enforcement Administration (DEA), Department of Justice (DOJ) and other federal and state agencies. In recommending Mr. Czaban as a “Notable Practitioner,” Chambers USA referred to his “impressive and well-reputed practice” (2011) and noted that sources praised him as “one of only a few people who really do think outside the box,” the lawyer to turn to “if you are looking for innovation and someone to break new ground” (2010).

A particular emphasis of Mr. Czaban’s practice is navigating the myriad interrelated legal, regulatory and policy issues implicated by competitive pressures within the pharmaceutical industry. Chambers USA reports that clients praise "his ability to propose a creative solution" and characterize him as "practical, responsive and candid." Chambers further notes that he "brings significant FDA expertise to his work advising a range of clients on regulatory matters, and he is well versed in representing clients in proceedings with government agencies" (2012). Mr. Czaban is recognized as a leading authority on the Hatch-Waxman Amendments and the legal and regulatory strategies available to both innovator and generic drug companies.

Mr. Czaban’s clients include a wide range of pharmaceutical, biotechnology, food and medical device companies, as well as banks, venture capitalists and other entities involved with life sciences companies.  He guides these clients at all stages of a product’s lifecycle, from product development, marketing applications, advertising and promotional compliance, good manufacturing practices and post-approval safety requirements.  He also counsels clients and performs regulatory due diligence in connection with financings, public offerings, mergers and acquisitions, licensing and joint venture agreements involving life sciences companies.


REPRESENTATIVE EXPERIENCE

Pharmaceutical Product Development: 

  • Provides regulatory counseling regarding:  pre-clinical and clinical development strategies; bioequivalence and therapeutic equivalence standards; Abbreviated New Drug Application (ANDA) and 505(b)(2) New Drug Application (NDA) strategies; product classification and regulatory approval pathways; strategic use of FDA meeting opportunities; dispute resolution; labeling negotiations; and appeals of adverse FDA review decisions.

Drug Marketing and Promotion:

  • Served as outside counsel on the promotional review committees of several prominent pharmaceutical companies.
  • Regularly advises clients on compliance with laws governing drug promotion and marketing practices, including rules enforced by FDA, FTC, Securities & Exchange Commission (SEC) and Health and Human Services' Office of Inspector General (HHS/OIG).
  • Counsels and trains pharmaceutical companies on all manifestations of pharmaceutical marketing and education, including: professional detail aids; managed care marketing; DTC advertising; pharmacy and patient support programs; press releases and other corporate disclosures; medical conference sponsorship; financial relationships with health care practitioners; and the permissible boundaries of the dissemination of "off-label" information for prescription drugs.
  • Represents companies in response to government investigations of alleged off-label marketing and civil and criminal prosecutions under the False Claims Act, the Stark anti-kickback law and the Food, Drug, and Cosmetic Act.

Hatch-Waxman:

  • Handles matters arising under the Hatch-Waxman Amendments, providing strategic advice regarding:  regulatory exclusivities; patent listings; patent challenges; patent term extensions; 180-day generic exclusivity; and lifecycle management strategies.
  • Has served as lead counsel in numerous administrative petition proceedings and judicial challenges arising under Hatch-Waxman.

International Trade:

  • Advised pharmaceutical companies on negotiation and implementation of international trade agreements.
  • Advises companies on the laws governing the importation and exportation of pharmaceuticals and food products.

Intellectual Property: 

  • Counsels clients on issues such as Orange Book patent listing requirements and limitations, and the role of IP rights in delineating the scope and timing of generic entry.
  • Assists innovator companies to develop and enforce IP rights via the regulatory process, including by the use of Citizen Petitions, interactions with the FDA's Center for Drug Evaluation and Research (CDER), Office of Regulatory Affairs, the Office of Generic Drugs and the Office of the Chief Counsel.

Antitrust:

  • Counsels clients in advance of potential pharmaceutical patent settlements, and in litigation and investigations involving consummated settlements.

Corporate:

  • Provides regulatory counseling and advice in connection with corporate and commercial transactions, all stages of venture financing and public offerings.
  • Provides strategic counseling on deal terms (regulatory-based milestones, regulatory responsibilities in joint ventures, defining the scope of licensed rights based on regulatory classifications/fields of use), as well as regulatory due diligence. 

Securities Law:

  • Advises FDA-regulated entities on the regulatory and securities law ramifications of corporate disclosures.

Reported Cases:

  • Merck KGaA v. Integra LifeSciences, 545 U.S. 193 (2005) (FDA counsel to Merck in favorable 9-0 Supreme Court of the United States decision interpreting the drug development-patent infringement safe harbor provisions of the Hatch-Waxman amendments).
  • Granholm v. Heald, 544 U.S. 460 (2005) (counsel to amicus curiae WineAmerica in support of successful constitutional challenge to state wine shipment restrictions).
  • Teva Pharmaceuticals v. FDA, 182 F.3d 1003 (D.C. Cir. 1999) (as appellant); on further appeal, 2000 U.S. App. LEXIS 38667 (D.C. Cir., 2000) (argued two appeals in the DC Circuit successfully challenging FDA's refusal to approve client's generic drug application).

PROFESSIONAL EXPERIENCE

  • Editorial Advisory Board, BNA's Pharmaceutical Law and Industry Report.
  • Editorial Advisory Board, Drug Delivery Technology.

AFFILIATIONS

  • Food & Drug Law Institute (FDLI).
    • Chair, H. Thomas Austern Writing Awards Committee.
    • FDLI Audit Committee.

HONORS & AWARDS

  • Received 2011 Burton Legal Writing Award.
  • Named one of DC's "Super Lawyers" for FDA by Super Lawyers magazine (2010-2013).
  • Named a "Life Sciences Star" for outstanding FDA work in Euromoney's LMG Life Sciences (2012-2013).
  • Named by Lawdragon as one of "3000 Leading Lawyers in America" (2010-2011).
  • Named one of "Washington's Top Lawyers" by Washingtonian magazine (2004-2009).
  • Listed by Chambers USA as one of "America's Leading Lawyers for Business" in Pharmaceutical/Medical Product Regulatory (2009-2012).
  • Recommended by PLC Which Lawyer in the Life Sciences Regulatory category (2008-2011).
  • Recognized as a "notable practitioner" in the Medical Products Regulatory category by Chambers USA's America's Leading Lawyers (2008), which described him as a "creative and forceful lawyer who is committed to getting results."

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