Christina M. Markus (Chris)

• Advised dozens of pharmaceutical and biological product companies and investors on life cycle issues, including patent and market exclusivity eligibility, regulatory strategies, and transactional diligence.
• Advised numerous pharmaceutical and device manufacturers, distributors, and healthcare providers on compliance with state laws governing facility licensure (including for "virtual" companies), extended producer responsibility (drug and sharps take back laws), and product distribution monitoring and reporting.
• Addressed a range of clinical trial issues, including design, transparency disclosures, and deviations/compliance, including in the accelerated approval context.
• Developed responses to inspectional findings and import alerts, in close collaboration with technical experts.
• Advised on the Prescription Drug Marketing Act (PDMA) and state-specific requirements concerning the distribution and reporting of prescription, over-the-counter, and controlled drug samples.
• Developed and responded to citizen petitions concerning proposed bioequivalence standards, Hatch-Waxman 30-month stay provisions, and other key regulatory topics.
• Performed due diligence for regulatory issues and supported negotiation for corporate licensing, M&A, equity investing, and financial institution lending. Recent matters have included pharmaceutical, biotech, and food issues (e.g., the latter variously involving a bulk food transportation operation, a grocery chain being acquired, a bakery business undergoing restructuring, and food cold storage facilities).
• Advised a dietary supplement marketer on mandatory elements of labeling, nutrient content claims, and other claims for a new product. Advised many food companies on these same topics.
• Represented the trade association for manufacturers and distributors of a common food coloring ingredient.
• Evaluated impacts of the Drug Supply Chain Security Act (DSCSA) on manufacturers, distributors, third-party logistics providers, and dispensers of drugs, medical devices, and combination products.
• Defended drug and medical device distributors against proposed disciplinary action by the California Board of Pharmacy; Alabama Board of Pharmacy, and other jurisdictions.
• Advised on the status and use of controlled substances and listed chemicals, including:
• Administrative hearings concerning applicants for registration to import narcotic raw materials,
• Representation of a reverse distributor before DEA and state agencies to untangle registration issues arising in a corporate transaction, ultimately with no penalty to the acquiring company,
• Facilitated listed chemical importation to ease an industrial user's supply chain disruption, and
• Facilitated DEA scheduling of a new chemical entity completing the FDA approval process.

Chris Markus focuses on U.S. federal and state regulation of drugs, biologics, biotechnology, foods and related products. She represents clients in a range of regulatory strategy and compliance evaluations, enforcement matters, and business reviews and transactions.

Chris represents drug, biologic, other healthcare product and food companies and investors with compliance and enforcement under the Food and Drug Administration, the Drug Enforcement Administration (DEA) and related state agencies such as Boards of Pharmacy. She also represents clients in business transactions, including strategic planning, due diligence and assessment, that involve product development and approval, safety, labeling, marketing and advertising, manufacturing and supply chain.

Based on her experience, Chris was chosen to serve as the legal member of the Institute of Medicine's Committee on Pediatric Studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act.  Currently, Chris serves as Chair of the Government Relations Committee for the American Society of Gene + Cell Therapy.  

Chris has been recognized by the BTI Consulting Group as a 2017 \"Client Service All-Star\" and named repeatedly as a \"Life Sciences Star\" by LMG Life Sciences.  She continues to be identified as one of The Best Lawyers in America for FDA Law, and ranked as a life sciences practitioner by The Legal 500.