Tina Hu-Rodgers

How Tina Helps Clients

Tina is Co-Leader of the firm’s Life Sciences Industry Team, and a shareholder in the FDA/Biotechnology group. She focuses her practice on issues related to the approval, regulation, promotion, sale and reimbursement of drugs, medical devices, biologics, dietary supplements, foods and cannabis-related products.

Tina assists clients in their interactions with various federal agencies including the following:

• Food and Drug Administration (FDA)
• Centers for Medicare & Medicaid Services (CMS)
• Drug Enforcement Administration (DEA)
• Federal Trade Commission (FTC)

In addition to advising clients on how to obtain approvals for their FDA-regulated products, Tina's experience includes reviewing and revising the labeling of drugs, medical devices, foods and dietary supplements to ensure compliance with the FDA law and regulations. She works with clients to petition the FDA to ensure the safety and effectiveness of drug products on the market, and assists clients in a wide range of compliance and enforcement matters. She also advises clients on user fee issues, federal and state Sunshine Act reporting obligations, state price transparency disclosure rules, and state licensing requirements.

Tina is a thought leader on artificial intelligence and machine learning in the life sciences industry. She has spoken frequently and published several articles on AI/ML in drug discovery and development as well as FDA’s regulation of AI/ML-powered medical devices.

Tina is also a member of the firm's cannabis group, where she assists companies in navigating federal and state law issues related to the promotion and sale of cannabis-related products. Tina has helped companies work to bring FDA- approved cannabinoid drug products to market, as well as helped clients to navigate sale of cannabis and hemp-related products.

Tina chairs the Buchanan B.O.L.D. Affinity group, and is conversant in Mandarin.

In 2019 and 2020, Tina was named to the Washington, D.C. Super Lawyers Rising Stars list.

What Clients Can Expect

Tina prides herself on her friendly demeanor, responsiveness, and ability to distill the complexities of federal and state regulations into easily understandable work products to help guide her clients in their business decisions.

Tina's work includes challenging administrative agency actions through correspondence, citizen petitions and litigation. She has extensive experience in assisting companies in complying with and contesting administrative agency actions and regulations at both the federal and state levels.

Outside the Office

Tina is passionate about mentorship and diversity & inclusion in the workplace. She actively works with law students and young attorneys through the Asian Pacific American Bar Association (APABA) and Leadership Council on Legal Diversity (LCLD) mentorship programs.

In her spare time, Tina used to be an avid food blogger; however, following the births of her sons, Michael and Daniel, she no longer has much spare time. She has, however, become an expert in Pokemon.

Proof Points

• Advised clients on the regulatory status of electronic cigarettes and vaping products.
• Helped file and defend challenges before the Better Business Bureau’s National Advertising Division.
• Obtained waivers, exemptions, and refunds of user fees for clients under the Prescription Drug User Fee Amendments.
• Assisted in successfully petitioning FDA to revise its exclusivity policy with regards to New Molecular Entity Exclusivity for combination drug products.
• Petitioned FDA to withdraw NDAs in accordance with FDA’s Application Integrity Policy.
• Counseled clients regarding the marketing of cannabis-related products.
• Prepared requests to FDA for orphan drug designations.
• Prepared applications to obtain Certificate of a Pharmaceutical Product (CPP).
• Advised clients regarding reporting obligations under state and federal Sunshine Act laws, and helped to prepare submissions of required data.

• Advised clients regarding state price transparency reporting obligations.

• Advised clients regarding state licensing requirements for wholesalers and manufacturers across 50 states.
• Performed on-site training regarding legal requirements and industry standards for lawful marketing and sale of prescription drugs
• Drafted policies for clients on topics such as interactions with HCPs, use of social media in promotion, and separation of sales & marketing functions.
• Served on promotional review committees to review promotional materials and provide comments and recommendations on legal compliance issues.
• Helped resolve threatened class actions involving allegations of false and misleading claims on food labels.
• Drafted a response to FDA warning letters and worked with FDA to resolve issues cited in FDA warning letters.
• Successfully petitioned the DEA for the down-scheduling of a drug product.
• Negotiated with CMS to obtain new codes for medical devices under the Healthcare Common Procedure Coding System (HCPCS).