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Erica M. Jackson

Partner
+1.919.466.1127
Fax +1.919.831.7040
+1.843.579.5665
Fax +1.843.579.5601
Erica Jackson’s practice focuses on Food and Drug Administration (FDA) regulatory, enforcement, compliance and transactional matters, providing strategic counsel to pharmaceutical, medical device, biologic, cosmetics, dietary supplement, and food manufacturers, as well as other related health care entities. In addition, she advises clients on health care fraud and abuse compliance and matters involving the Centers for Disease Control and Prevention (CDC), Drug Enforcement Administration (DEA), the Federal Trade Commission (FTC), the Centers for Medicare and Medicaid Services (CMS), the U.S. Department of Agriculture (USDA), and similar state regulatory agencies.

Prior to joining the firm, Ms. Jackson was a corporate counsel for Genentech, Inc., where she advised development, medical affairs, sales/marketing, manufacturing, safety, and government affairs business teams on FDA and health care regulatory matters involving pipeline molecules and approved products in the infectious disease, rare disease, neurology, and oncology areas. In addition, she was an associate in the Washington, D.C. office of an international law firm, where she concentrated her practice on FDA and health care matters.

Her FDA regulatory, enforcement, and compliance experience includes advising clients on global clinical trial matters, regulatory pathway assessments, product label negotiations, company promotional review committees, advertising and marketing tactics, safety reporting obligations, FDA and foreign health authority inspections and responses, and Corporate Integrity Agreement and Consent Decree implementation.

Her health care fraud and abuse experience includes representing clients in government and internal investigations, developing compliance policies/trainings, and advising on risk mitigation strategies.

Her transactional experience includes conducting regulatory due diligence for buyers and sellers of FDA- and USDA-regulated products; drafting, negotiating and reviewing clinical trial, data sharing, government purchasing, and purchase agreements; and counseling on contract disputes.

Professional Background

Ms. Jackson has an educational background in law, public health, health policy and public policy. Prior to joining the firm, she was a corporate counsel for Genentech, Inc. for more than two years. In addition, she was an associate in the Washington, D.C. office of an international law firm, where she concentrated her practice on FDA and health care matters.

During law school, Ms. Jackson was a law clerk with the World Health Organization in Geneva Switzerland, the Office of General Counsel of the US Department of Health and Human Services Regional IV office in Atlanta, GA, and a multinational pharmaceutical company in the Metro Atlanta area.

Ms. Jackson is a frequent speaker and author on FDA and life sciences industry matters.

Achievements

  • 2016 Genentech Marketing Excellence Award – Individual Contributor, Collaborative Brand Partner, Legal Support
  • 2015 Genentech Marketing Excellence Award – Best Branding Campaign

Professional/Civic Activities

  • International African American Museum (Charleston, SC) Leadership Circle Charter Member
  • NCBIO Board of Directors
  • SCBIO Board of Directors and Industry and Innovation Council
  • Food and Drug Law Institute
  • Duke University Young Alumni Development Council

Speaking Engagements

  • “Finding Your Regulatory Pathway” and “FDA Regulation of Drug and Medical Device Manufacturing,” SCBIO Annual Life Sciences Conference, Oct. 2014, Greenville, SC.
  • "Ensuring Racial and Ethnic Diversity in Clinical Trials," Johns Hopkins University Diversity Conference, Oct. 2013, Baltimore, MD.
  • “Regulation of Drug Manufacturing and Post-Approval Obligations of Applicants,” Food and Drug Law Institute / FDA Center for Drug and Evaluation and Research In-House Training Program, Nov. 2012, Washington, DC.
  • “Regulation of Drug Manufacturing,” Food and Drug Law Institute / FDA Center for Drug and Evaluation and Research In-House Training Program, March 2012, Washington, DC.
FDA
  • Advises medical device and technology companies on FDA premarket strategy matters related to the development of innovative technologies, including genomics and artificial intelligence software
  • Drafts FDA GCP, GMP and QSR compliance policies and procedures and related training for pharmaceutical, biologics, medical device, dietary supplement, and cosmetics companies
  • Advises pharmaceutical, biologic, medical device, dietary supplement, and cosmetics companies on matters related to promotion, advertising, and product labeling
  • Advised a biologics company on FDA GCP requirements and clinical trial recruitment activities related to global development programs
  • Advised pharmaceutical and medical device companies on regulatory matters related to the Public Readiness and Emergency Preparedness (PREP) Act
  • Advised pharmaceutical, medical device, cosmetics, and dietary supplement manufacturers in preparing for FDA and foreign regulatory authority inspections and responding to 483s
  • Conducted an internal review regarding alleged data integrity violations at a U.S. pharmaceutical manufacturing facility
  • Assisted a major OTC drug company in implementing a GMP-related Consent Decree
  • Represented biologic and pharmaceutical companies in criminal and civil DOJ FCA investigations involving alleged off-label promotion and kickbacks
Health Care
  • Conducted internal reviews of promotional practices and clinical development activities for numerous biologics, pharmaceutical and medical device companies to mitigate potential fraud and abuse risk exposure
  • Represented a life sciences company in a DOJ Foreign Corrupt Practices Act (FCPA) investigation alleging anti-corruption issues in multiple countries in Eastern Europe, Asia, the Middle East and Latin America
  • Assisted a pharmaceutical company in implementing a Corporate Integrity Agreement
  • Counseled a biologics company in a matter involving partnership activities with telemedicine companies
Agriculture
  • Advised a global agribusiness company on USDA APHIS regulations regarding genetically engineered organisms
  • Advised numerous food and beverage manufacturers on regulatory compliance matters related to the USDA National Organic Program
  • Advised food and food service management companies on regulatory matters related to the USDA National School Lunch Program and School Breakfast Program
FDA, Health Care and Agriculture Transactions
  • Drafted and negotiated government purchase agreements with the CDC, DoD and related agencies on behalf of a pharmaceutical company
  • Drafted and negotiated collaboration agreements with the U.S. National Cancer Institute (NCI) and National Institute of Allergy and Infectious Diseases (NIAID) on behalf of biologics and pharmaceutical companies
  • Drafted and negotiated clinical trial, data transfer, and related agreements on behalf of pharmaceutical and biologics companies
  • Advised a private equity company on regulatory due diligence matters involving the acquisition of a cell culture and tissue engineering company
  • Advised a pharmaceutical company on regulatory due diligence matters involving the acquisition of an early-stage development infectious disease molecule
  • Advised a private equity company on regulatory due diligence matters involving the acquisition of a cosmetics company
  • Counseled a private equity company on regulatory due diligence matters involving the acquisition of a food and beverage company
  • Counseled an agriculture company on regulatory due diligence matters involving the sale of a grain product division to a large food manufacturer