Christina M. Markus (Chris)

• Advised numerous pharmaceutical and device manufacturers and distributors on compliance with state laws governing operating entity licensure (including for "virtual" companies), extended producer responsibility (drug and sharps take back laws) and product distribution monitoring and reporting.
• Advised on range of clinical trial issues, including design, compliance and transparency disclosures.
• 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.
• 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.
• Developed and responded to citizen petition elucidating legal and scientific concerns about FDA's 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.
• Evaluated impacts of the Drug Supply Chain Security Act (DSCSA) on manufacturers, distributors, and third-party logistics providers of drugs, medical devices and combination products.
• Defended product 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 multi-faceted corporate transaction, without penalty to the acquiring company,
• Applied listed chemical requirements impacting an industrial chemical importer's supply chain, 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 and related products. As a partner in our FDA and Life Sciences practice and Deputy Practice Group Leader, Chris represents clients in a range of regulatory strategy and compliance evaluations, enforcement matters, and business transactions.

Chris represents drug, biologic and other healthcare products 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. IOM evaluated studies of drugs and biologics performed under two statutory regimes that provide incentives and, in some instances, mandate pediatric research through the drug approval process. The Committee assessed the findings and offered recommendations and briefings to FDA and the U.S. Congress. 

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.