Erika Lietzan

Erika Lietzan focuses on FDA regulation of prescription and OTC drugs, biologics, and medical devices.  Her work includes advocacy at FDA, advisory work and strategic advice relating to FDA matters, and assistance with related legislative strategies on the Hill and in the states.  Ms. Lietzan has particular expertise in issues relating to follow-on biologics; the Hatch-Waxman amendments to the FDCA; FDA protection of trade secrets and confidential commercial information; regulation of and constitutional protections for advertising and labeling of drugs and devices; importation, counterfeiting, and Internet pharmacy; regulation of clinical trials; drug safety; and good manufacturing practices (GMPs).  She has also advised clients in the food, dietary supplement, and cosmetic industries.

Representative Matters

• Representation of and advice to PhRMA in federal and state legislative matters including with respect to follow-on biologics, drug safety, labeling and preemption issues, Hatch-Waxman reform, prescription drug marketing, direct-to-consumer advertising, clinical trials, and importation; preparation of amicus briefs for PhRMA in cases raising same issues.
• Representation of and advice to a coalition of major biotechnology innovators with respect to follow-on biologics legislation and related strategy.
• Strategic advice to various pharmaceutical clients regarding Rx-to-OTC switches, generic and 505(b)(2) competitors, and exclusivity; participation in FDA dockets relating to similar topics on behalf of same clients.
• Preparation of submissions to FDA in (and advice regarding) various proceedings relating to medical device classification or reclassification; preparation and submission of 510(k); advice in litigation raising issues of FDA regulation of medical devices (e.g., device classification, intended use, promotion, etc.).

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

• AHLA, Life Science Practice Group, Regulatory Group Co-Chair (2007–present)
• ABA/AAAS, National Conference of Lawyers & Scientists (2003–present), Co-Chair (2006–present)
• ABA, Special Committee on Bioethics & the Law (2006–present)
• ABA, Science & Technology Section, Chair of Biotechnology Committee (2002–2003, 2005–2008); Chair of Life Sciences Division (2007–present)
• Food & Drug Law Journal, Editorial Advisory Board (2004–2008)
• ABA, Science & Technology Section, Section Council (2004–2008)
• Drug Information Association
  

Publications and Speeches

• "First Circuit Upholds New Hampshire Law Banning Sale of Prescriber Information," Covington E-Alert (12/1/2008), Co-Author
• "Government Affairs Practice Group Post Election Analysis," Covington Report (11/7/2008), Co-Author
• "PhRMA Issues Revised Code on Interactions with Healthcare Professionals," Covington E-Alert (7/11/2008), Co-Author