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Erika Lietzan specializes in US and ex-US regulation of drugs and biological products. Her areas of special focus at this time include biosimilars; the Hatch-Waxman amendments and BPCIA; data and market exclusivities; WHO initiatives relating to drugs and biologics; comparative effectiveness and health outcomes research; supply chain issues (e.g., counterfeiting, pedigrees, importation, and online pharmacy); drug safety (e.g., risk management and pharmacovigilance); and interactions with healthcare professionals (e.g., samples, grants, advertising and promotion, and PhRMA Code). She speaks and publishes regularly on these topics.
Ms. Lietzan currently works with a number of trade associations and ad hoc coalitions, as well as many of the country’s major biopharmaceutical companies and many smaller companies. Among other things, she provides compliance and strategic advice (including with respect to proposed corporate transactions); assists in regulatory, legislative, and policy advocacy in the US and around the world; serves as an expert in litigation both domestically and abroad; counsels and advocates in the course of criminal and congressional investigations; and prepares clients for regulatory meetings and legislative hearings.
For two years, Ms. Lietzan was Assistant General Counsel of PhRMA. She is past chair of the Biotechnology Committee of the American Bar Association, and she is currently a member of the FDLI Board of Directors and an elected member of the American Law Institute.
Representative Matters
- Representation of major pharmaceutical company in criminal investigation under the FDCA.
- Representation of major pharmaceutical companies in Congressional and related investigations.
- Representation of a large coalition of biotechnology innovators with respect to follow-on biologics legislation.
- Advice to and representation of PhRMA in international, federal, and state matters including with respect to follow-on biologics, drug safety, preemption, Hatch-Waxman reform, prescription drug marketing, direct-to-consumer advertising, clinical trials, importation, and ex-US pricing and reimbursement procedures.
- Preparation of amicus briefs, including in Wyeth v. Levine (for PhRMA and BIO); drafting regulatory briefs in major product liability actions and other civil litigation.
- Representation of major biotechnology company on federal legislative matters, including those relating to drug/biologic safety, drug/biologic advertising, follow-on biologics strategy, and importation.
Previous Experience
- PhRMA, Assistant General Counsel (September 2002 – April 2005)
Honors and Rankings
- Best Lawyers, Washington, DC Biotechnology Law Lawyer of the Year (2012)
- Best Lawyers in America, Biotechnology Law (2006–present)
- The International Who's Who of Life Sciences Lawyers (2012)
- American Law Institute, Member
Memberships and Affiliations
- FDLI, Board of Directors (2008–present)
- AHLA, Life Science Practice Group, Regulatory Group Co-Chair (2007–present)
- ABA/AAAS, National Conference of Lawyers & Scientists (2003–2009), Co-Chair (2006–2009)
- ABA, Special Committee on Bioethics & the Law (2006–2009)
- ABA, Science & Technology Section, Chair of Biotechnology Committee (2002–2003, 2005–2008); Chair of Life Sciences Division (2007–2009)
- Food & Drug Law Journal, Editorial Advisory Board (2004–2008)
- ABA, Science & Technology Section, Section Council (2004–2008)
- Drug Information Association
Publications and Speeches
- "FDA’s Guidance on Biosimilars: Understanding the Impact on Patent Prosecution and Litigation," webinar for Intellectual Property Owners Association IP Chat Channel (3/22/2012)
- "Biosimilars Master Class," American Conference Institute, FDA Boot Camp (3/21/2012)
- "Hatch-Waxman and BPCIA Overview," American Conference Institute, FDA Boot Camp (3/20/2012)
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