Tina Hu focuses her practice on matters relating to the Food and Drug Administration and the pharmaceutical industry, including the approval, regulation, promotion, and sale of drugs, medical devices, and dietary supplements.
Tina assists clients in their interactions with various federal agencies, including the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA), and advises clients on numerous issues, including:
- Requirements for new drug applications (NDAs), abbreviated new drug applications (ANDAs), over-the-counter (OTC) drug monographs and drug labeling.
- User fee requirements under the Prescription Drug User Fee Act (PDUFA) and Generic Drug User Fee Act (GDUFA).
- Electronic drug listing and establishment registration for domestic and foreign pharmaceutical companies.
- Preparation of applications to obtain Certificate of a Pharmaceutical Product (CPP).
- Lawful marketing and sale of FDA-regulated products.
- Preparation of Standard Operating Procedures and Policies for Corporate Compliance Programs.
- Requirements for disclosure of payments and other transfers of value under the Physician Payments Sunshine Act.
- State law requirements for aggregate spend and marketing disclosures.
- Requirements and procedures for submitting proposals to the Biomedical Advanced Research and Development Authority (BARDA) to obtain grant agreements for biomedical and pharmaceutical research and development activities.
Tina also assists clients in a wide range of promotional review activities and has, among other responsibilities:
- Assessed compliance of promotional materials (e.g., slide decks, print and internet-based materials, and medical journal articles) and provided recommendations to minimize risks.
- Performed on-site training regarding legal requirements and industry standards for prescription drug advertising and promotion.
- Drafted policies on topics such as Interactions with Healthcare Providers, Separation of Sales & Marketing, Role of Medical Liaisons and Use of Social Media in Promotion.
- Evaluated innovative marketing initiatives involving social media or incentives to doctors/patients and recommended approaches to minimize anti-kickback and off-label promotion risks.
Prior to joining Buchanan, Tina served as judicial clerk for the Honorable Michael L. Rankin of the Superior Court of the District of Columbia, where she researched case law in a wide range of civil litigation matters and drafted dispositive orders, opinions, and jury instructions for both civil and criminal cases.
Previously, Tina served as a legal intern at the FDA’s Office of Legislation, where she monitored and drafted reports for congressional briefings and hearings regarding emergent food, drug, and medical device issues. In particular, Tina dealt with issues regarding federal preemption of state tort liability for failure-to-warn, bio-identical hormone replacement therapy, and Bisphenol-A in plastics manufacturing. She also served as a student attorney in the George Washington University Vaccine Injury Clinic, where she represented families of young children seeking compensation for vaccine-related injuries and death in trial and appellate proceedings.
Tina is conversant in Mandarin Chinese.
The George Washington University Law School, J.D., 2010
Massachusetts Institute of Technology, B.S., 2007, Economics
- Washington, D.C.
Habitat for Humanity
Maryland Food Bank
Lost Dog and Cat Rescue Foundation