He focuses his practice on counseling such clients on complex regulatory strategies and compliance matters, as well as representing clients in administrative and judicial enforcement actions and other proceedings involving the Food & Drug Administration (FDA), the Federal Trade Commission (FTC), the Drug Enforcement Administration (DEA), the Department of Justice (DOJ) and other federal and state agencies.
Clients regularly turn to Jim for “his ability to propose a creative solution" and characterize him as "practical, responsive and candid,” according to a report by Chambers USA. He takes pride in helping clients navigate the myriad interrelated legal, regulatory and policy issues implicated by competitive pressures within the pharmaceutical industry. Jim is also recognized as a leading authority on the Hatch-Waxman Amendments and the Biologics Price Competition and Innovation Act (BPCIA) and the legal and regulatory strategies available to both innovator and generic drug companies. Who’s Who Legal recognized Jim among its 2020 Global Elite Thought Leaders in life sciences regulatory matters, noting he is “one of the market’s leading minds.”
Jim'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 transactions. He guides these clients at all stages of a product’s lifecycle, from product development and clinical trials, to marketing applications, advertising and promotional compliance, good manufacturing practices and post-approval safety requirements. He is also an experienced advertising and marketing compliance attorney, who provides strategic counselling, substantiation review, and advertising dispute representation to national advertisers across all promotional platforms. Jim also has more than two decades’ experience counseling clients and performing regulatory due diligence in connection with financings, public offerings, mergers and acquisitions, licensing and joint venture agreements involving life sciences companies.
Select examples of Jim's prior experience include:
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 a seconded in-house attorney, and as outside counsel on the promotional review committees of several prominent pharmaceutical companies.
- Has helped multiple companies establish, train, and manage promotional review and compliance functions in connection with the companies’ first-ever FDA-approved drug products.
- Regularly advises clients on compliance with laws governing drug promotion and marketing practices, including rules enforced by the FDA, the FTC, the Securities & Exchange Commission (SEC) and the Department of Health and Human Services' Office of Inspector General (HHS/OIG).
- In depth experience with all manifestations of pharmaceutical marketing and education, including: digital and print detail aids; managed care marketing; DTC advertising; pharmacy and patient support programs; press releases and other corporate disclosures; medical conference sponsorship and company presentations (both commercial and scientific exchange); financial relationships with health care practitioners; and the permissible boundaries of the dissemination of "off-label" and “consistent with labelling” information for prescription drugs.
- Represents companies in response to government investigations of alleged marketing violations and civil and criminal prosecutions under the False Claims Act, the Stark anti-kickback law, and the Food, Drug and Cosmetic Act.
Hatch-Waxman, Exclusivities, and Drug Development Incentives
- Decades of strategic counselling and advocacy on all forms of drug product exclusivities and innovation incentives including Orphan Drug Exclusivity (ODE), New Chemical Entity Exclusivity (NCE), New Clinical Trial (3-year) exclusivity, Pediatric Exclusivity extensions, GAIN Act exclusivity extensions, innovator and biosimilar biologics exclusivities under the BPCIA, patent term extensions (PTE), and Priority Review Vouchers (PRVs).
- Provides strategic advice regarding FDA’s Orange Book, including patent listing requirements and eligibility analyses; labelling carve-out risks, regulatory aspects of “Paragraph IV” patent challenges; and lifecycle management strategies.
- Has served as lead counsel in numerous administrative petition proceedings and judicial challenges arising under the FDCA and the Hatch-Waxman amendments.
- Development and enforcement of regulatory and intellectual property rights and strategies via administrative processes, including Citizen Petitions, direct non-public advocacy before FDA's Center for Drug Evaluation and Research (CDER), the Office of Regulatory Policy, the Office of Generic Drugs and the Office of the Chief Counsel.
Corporate and Transactional Matters
- 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.
Administrative and Constitutional Litigation
- Supreme Court counsel to an alliance of genetic medicine stakeholders as amicus curiae in support of successful constitutional challenge to a Vermont statute curtailing the use of publicly available prescriber data for marketing purposes by pharmaceutical companies (Sorrell, et al. v. IMS Health Inc., et al., 564 U.S. 552 (2011).
- FDA counsel of record to prevailing pharmaceutical company in U.S. Supreme Court case interpreting the drug development-patent infringement safe harbor provisions of the Hatch-Waxman amendments (Merck KGaA v. Integra LifeSciences, 545 US 193 (2005))
- Supreme Court counsel to national wine trade association as amicus curiae in support of successful constitutional challenge to state wine shipment restrictions (Granholm v. Heald, 544 US 460 (2005))
- Argued two appeals in the DC Circuit successfully challenging FDA's interpretation of the Hatch-Waxman 180-day exclusivity “trigger” provisions Teva Pharmaceuticals v. FDA, 182 F.3d 1003 (D.C. Cir. 1999) (as appellant); on further appeal, 2000 US App. LEXIS 38667 (D.C. Cir., 2000)
- 美国加州大学柏克莱分校, 文学学士
- University of Virginia, 法学博士
- Supreme Court of the United States
- Named among Who’s Who Legal’s 2020 Global Elite Thought Leaders in Life Sciences – Regulatory (2020)
- Recognized as a Life Sciences Star for both FDA Pharmaceutical and FDA medical device work, by the Legal Media Group in the publication of "LMG Life Sciences 2019
- Recognized in the 25th Edition of Best Lawyers for his work in FDA law (2019)
- Received 2018 Burton Award for Distinguished Legal Writing
- Included in The Best Lawyers in America directory for FDA Law (2015-2016)
- Received 2011 Burton Award for Distinguished Legal Writing
- Recognized in Who's Who Legal: Life Sciences (2015)
- Named one of DC's "Super Lawyers" for Food & Drugs by Super Lawyers magazine (2010-2015, 2017)
- Named a "Life Sciences Star" for outstanding FDA work in Euromoney's LMG Life Sciences (2012-2013, 2015-2016)
- 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)
- Legal columnist and member, Editorial Board for the Journal of Precision Medicine
- Bloomberg Law Advisory Board for Pharmaceuticals and Life Sciences
- Food & Drug Law Institute (FDLI)