OBrien_George

George A. O’Brien

OBrien_George

George A. O’Brien

Partner

Washington DC + 1 202 663 6322

George A. O’Brien is a partner focusing on life sciences and FDA regulatory matters. A member of the Crisis Management and Strategic Response Practice in the Regulatory and Government Affairs Department and cross-listed with the Corporate Practice, he advises companies and their investors on the development, approval and commercialization of innovative FDA-regulated products and provides strategic regulatory guidance on corporate and transactional matters, including mergers and acquisitions, licensing and collaboration arrangements, royalty sale agreements, joint ventures and other transactions.

His practice spans the full range of FDA-regulated products, including drugs and biologics, medical devices, food and beverage products, dietary supplements, infant formula, cosmetics, and veterinary medicine and animal foods. George’s clients include both US and international companies and investors.

For pharmaceutical and biotechnology companies, he provides FDA regulatory counseling throughout the product life cycle, including clinical trials and human subject protection, informal and formal dispute resolution at the FDA, and post-approval marketing compliance.  A significant portion of his practice involves helping clients navigate the FDA’s expedited development and review pathways. He regularly assists companies in seeking Fast Track and Breakthrough Therapy designation as well as pursuing opportunities under the FDA’s priority review voucher programs.

He also provides strategic regulatory advice in connection with enforcement, investigational and litigation matters affecting life sciences companies, including matters involving the False Claims Act. In addition, he frequently works alongside corporate, transactional and intellectual property colleagues to provide regulatory due diligence and other support for complex transactions involving FDA-regulated products.

He is particularly well known for his work on orphan drug issues, and he routinely advises clients on the orphan drug pathways in both the US and the EU. He regularly represents clients before the FDA on matters involving orphan designation and orphan exclusivity, including questions of prevalence, orphan subsets and clinical superiority. He also advises companies on pediatric study obligations and pediatric exclusivity issues arising under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act.

Prior to joining the firm, George spent nearly 15 years at another law firm as part of one of the largest and most well-regarded FDA practices in the country. There, he developed deep experience advising innovator sponsors on approval pathways, orphan drugs, regulatory exclusivities, patent listing issues.

Experience

    • Mr. O’Brien has led regulatory strategy in high‑stakes interactions with the FDA, including informal and formal dispute resolution proceedings, citizen petitions and other advocacy on novel or contested regulatory questions.
    • He has advised pharmaceutical and biotechnology companies on patent and exclusivity matters at FDA, including patent listing issues, patent term extension questions and regulatory strategies designed to preserve exclusivity and address challenges from competitors.
    • He has represented clients in disputes involving generic drugs and biosimilars, including matters concerning regulatory exclusivities, therapeutic equivalence determinations, labeling carve‑outs and other issues affecting market entry.
    • He regularly works with intellectual property colleagues throughout the Hatch‑Waxman process to ensure that regulatory strategy and patent protections remain aligned across a product’s lifecycle.
    • He has counseled clients on FDA regulatory matters affecting food, dietary supplements, cosmetics and infant formula products, including import alerts, misbranding issues and compliance matters that give rise to commercial disputes or litigation.
    • He has advised clients on FDA‑related regulatory considerations affecting reimbursement and product coding for diagnostic and medical products.

  • Recent Highlights

    • Successfully represented a pharmaceutical company in litigation against the FDA under the Administrative Procedure Act, including the landmark Depomed case, which resulted in seven years of regulatory exclusivity for the client’s orphan drug product
    • Assisted global pharmaceutical manufacturers with patent listing matters across multiple therapeutic franchises, including responding to challenges raised by the Federal Trade Commission and other third parties
    • Represented a mid-size pharmaceutical company in a dispute concerning the scope of a competitor’s three-year exclusivity and successfully persuaded the FDA and the Center for Drug Evaluation and Research Exclusivity Board that approval of the client’s product was not blocked, enabling final approval and avoiding potential litigation
    • Obtained a rare pediatric disease product designation for a pharmaceutical start-up
    • Represented numerous clients in obtaining orphan drug designation and exclusivity, including contested matters involving prevalence, clinical superiority and “same drug” determinations, and counseled a pharmaceutical company on orphan drug regulation across the United States, Europe, the United Kingdom, Japan and China, including application of the European Union’s “significant benefit” standard
    • Drafted a citizen petition that persuaded the FDA to grant five-year new chemical entity exclusivity for a fixed-dose combination product containing novel active moieties
    • Advised clients on patent term extension matters for drugs, biologics and medical devices, including resolving objections raised by the Patent and Trademark Office in connection with multiple marketing applications submitted on the same day
    • Submitted multiple citizen petitions addressing labeling carve-outs and “skinny labeling,” including matters that prevented generic competitors from obtaining approval with carved-out labeling, and advised on alignment of regulatory and intellectual property strategy to address biosimilar approval risks
    • Represented a biotechnology company in assessing eligibility for 12-year reference product exclusivity for a biologic combination product, an issue of first impression at the FDA
    • Represented a clinical-stage pharmaceutical company in clinical trial development and use of expedited FDA review pathways, including Breakthrough Therapy and Fast Track designation
    • Represented a specialty pharmaceutical company in evaluating eligibility for five-year new chemical entity exclusivity for oligonucleotide products
    • Represented a commercial-stage pharmaceutical company in negotiating a Pediatric Written Request with the FDA
    • Counseled a manufacturer on resolving an FDA import alert affecting bulk dietary supplement shipments through labeling remediation and justification for food additives
    • With colleagues in the United States and Germany, represented an infant formula manufacturer in addressing FDA misbranding and illicit drop-shipping issues, as well as related contract disputes and potential litigation
    • Represented a foreign acquirer in the acquisition of a US-based clinical-stage pharmaceutical company and advised a manufacturer of cannabis-derived pharmaceutical products in its acquisition of a US-based pharmaceutical and botanical product manufacturer
    • Advised on the acquisition of a microbiome therapeutic business and represented a pharmaceutical manufacturer in the acquisition of a drug-device combination product, including assessment of potential generic entry based on patent listings, bioequivalence considerations, and a pending citizen petition
    • Advised on the potential sale of a rare pediatric disease priority review voucher valued at approximately $150 million
    • Represented clients in transactions involving food manufacturers, personal care brands, ice cream and dessert businesses, and wholesale food suppliers, providing FDA regulatory diligence and compliance support
    • Assisted a veterinary feed manufacturer in resolving an FDA import detention matter
    • Counseled a manufacturer of laboratory-developed tests on obtaining a product code from the American Medical Association following an initial denial, enabling reimbursement by insurance companies

Recognition

  • Recognized by Chambers USA 2025 as a Leading Lawyer in “Healthcare: Pharmaceutical/Medical Products Regulatory in the District of Columbia”
  • Recommended in The Legal 500 “United States 2020 for Healthcare: Life Sciences”
  • Named a “Rising Star for Food & Drugs” by Washington DC Super Lawyers 2018

Insights & News

View all of George's insights & news

Credentials

  • Education

    • JD, University of Maryland Francis King Carey School of Law

      magna cum laude
      Order of the Coif

    • MA, University of Pennsylvania

    • AB, English, French, Dartmouth College

      cum laude
       

  • Admissions

    • District of Columbia

    • Maryland

Credentials

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