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Erika Lietzan practices in the firm’s food and drug group and government affairs group. She specializes in FDA and state regulation of prescription and OTC drugs and biological products and maintains an active legislative practice in these areas.
Her areas of special expertise include preemption; regulation of clinical trials; clinical trial disclosure obligations; marketing reporting laws; drug safety (e.g., REMS, postmarket trials, and pharmacovigilance) and FDAAA implementation; follow-on biologics; the OTC drug review; the Hatch-Waxman amendments; pediatric and orphan exclusivity; advertising, labeling, and interactions with healthcare professionals (including fraud and abuse issues); electronic and paper pedigrees; importation, counterfeiting, and online pharmacies; comparative effectiveness, cost effectiveness, and health outcomes research; and WHO efforts relating to drugs (e.g., biosimilars, clinical trial disclosure, and counterfeiting). She speaks and publishes regularly on these topics.
Her work includes advocacy at FDA; preparing clients for advisory committee meetings; strategic advice relating to FDA matters; development and implementation of legislative strategies on the Hill and in the states; expert reports in litigation both domestically and abroad; and regulatory due diligence in connection with major transactions as well as securities filings. She has also advised in major criminal investigations under the FDCA, including with respect to fact development and regulatory defense strategy; handled Congressional investigations of FDA-regulated companies; and prepared clients for Congressional hearings. She works with a number of trade associations and ad hoc coalitions, as well as many of the country’s major pharmaceutical companies and numerous smaller companies. She has also advised clients in the medical device, food, dietary supplement, and cosmetic industries.
For two years, she was Assistant General Counsel of PhRMA, providing legal support for the organization’s federal strategy. She is currently General Counsel of the FDA Alumni Association and a member of the FDLI Board of Directors.
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 in America, Biotechnology Law (2006–present)
- 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
- "Thoughts on the Impact of Wyeth v. Levine on the Preemptive Effect of FDA-Approved Labeling," Emerging Issues in Food & Drug Law, University of Maryland School of Law (11/16/2009)
- "Biosimilar Substitution in the EU," PhRMA/SFDA Biosimilar Workshop, Beijing, China (11/5/2009)
- "The Nature of the Approval Process," American Conference Institute, FDA Boot Camp (9/15/2009)
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