Vic Boddie II, Ph.D.

Leads a multidisciplinary FDA Branch shaping post-market regulatory policy for drugs, biologics, dietary supplements, and medical devices, with direct impact on industry practices in advertising, promotion, labeling, enforcement, recalls, imports, and real-world evidence integration. Serve as senior advisor to FDA leadership on regulatory compliance strategy, global harmonization, and stakeholder alignment across the biopharmaceutical ecosystem. Drive high-level engagement with pharmaceutical companies, trade associations, and international regulators to build forward-leaning, innovation-enabling policy frameworks. Spearhead AI modernization strategy for regulatory compliance, leading cross-functional implementation to enhance oversight efficiency and lifecycle management. Author Congressional briefings supporting FDA’s budget and legislative priorities; recognized for leadership in shaping national regulatory responses to public health crises, including COVID-19 and the Xylazine epidemic. Provide executive briefings on strategic initiatives affecting regulatory pathways from development through commercialization, aligning FDA policy with evolving science and global market dynamics. Drive public-private partnerships to advance regulatory innovation, promote global competitiveness, and ensure timely patient access to safe and effective therapies.

Directed FDA’s pre- and post-market enforcement strategy, aligning regulatory actions with evolving standards and industry best practices. Provided strategic leadership during the 2025 federal restructuring—ensuring regulatory continuity, operational resilience, and workforce engagement under unprecedented conditions. Partnered with senior FDA leadership to execute cross-functional mandates, sustaining performance benchmarks amid resource and organizational constraints. Architect of FDA’s enforcement strategy for drug compounding; led national stakeholder engagement to drive industry-wide compliance with GFI #256. Developed and implemented risk-based approaches to prevent drug shortages and intercept 100+ illegal pharmaceutical imports. Trusted advisor on complex product classification and jurisdictional decisions involving drugs, biologics, and medical devices. Principal regulatory authority for high-profile domestic and international inspections, delivering expert assessments on cGMP, BIMO, and import policy to guide enforcement outcomes.

Led FDA’s Post-Market Drug Compliance team, driving strategic operations, regulatory alignment, and high-impact performance across complex, cross-cutting program areas. Directed division-wide restructuring affecting 20+ staff, executing organizational change management to ensure continuity, stability, and operational excellence. Oversaw critical regulatory functions including cGMP inspections, import operations, pre-approval compliance, and EU Mutual Recognition Agreement (MRA) coordination. Advanced Center-wide priorities through strategic oversight of dietary supplements, aquaculture drug policy and emerging regulatory frameworks for CBD and novel innovative products. Delivered measurable, cross-functional outcomes by aligning regulatory execution with evolving public health priorities and global policy trends

Directed FDA’s Unapproved Drugs Program, leading risk-based reviews of 300+ products annually and driving enforcement strategies targeting illegal and unapproved drugs—from online distributors to multimillion-dollar manufacturers. Executed high-impact regulatory actions including Warning Letters, product seizures, and federal injunctions to protect patients and ensure compliance across the U.S. drug market. Led cross-functional investigations and inspections in coordination with the Office of Regulatory Affairs, addressing high-risk areas such as CBD, unapproved oncology products, AMR, and biologically engineered therapies. Served as subject matter expert advising FDA senior leadership, CDC officials, and state regulators on emerging regulatory threats and public health risks. Shaped national regulatory policy under 21 CFR §1240.62 in partnership with CDC, 50-State Public health leaders and CVM Director’s Office, contributing to the prevention of over 100,000 Salmonella infections annually. Led FDA’s public communications during national outbreak responses; served as agency spokesperson across major media outlets including CNN. Honored with FDA’s Cross-Cutting Award for eliminating fraudulent oncology drugs from the market—directly safeguarding the public from poor quality products.

• Served as the FDA Zoonosis liaison between CVM & CDC Zoonosis Branch

Cum Laude, Alfred P. Sloan Scholarship, National Science Foundation- GK-12 Fellowship, National Science Foundation- Bridge to the Doctorate Fellowship, Biology Graduate Student Council - President , Biology Graduate Student Council - Vice-President, International Center for Professional Development: Science Mentoring and Diversity Program Scholar & Media Spokesperson, Independent Investigation Graduate Supervisor , HU STEM Roundtable Speaker, Dissertation: Occurrence of Antibiotic Resistance in Pseudomonas species From Organic and Non-Organic Salads and the Development of a PCR Primer for the Identification of Pseudomonas fluorescens