People

Chris Markus focuses on 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. Committee findings and recommendations were considered during the reauthorization of BPCA and PREA in July of 2012.

Chris has been recognized by the BTI Consulting Group as a 2017 "Client Service All-Star" and was also named a 2016 "Life Sciences Star" by LMG Life Sciences. Chris has also been identified as one of The Best Lawyers in America for FDA Law, and ranked as a life sciences practitioner by The Legal 500.

Full Bio

Credentials

J.D., University of Virginia

A.B., College of William and Mary

District of Columbia

Virginia

The District of Columbia Bar

Virginia State Bar

Client Service All-Star (unprompted survey of large company corporate counsel)


BTI Consulting, 2017

Nominated to – Who's Who Legal: Life Sciences, 2017

Repeatedly selected as a Life Sciences Star


LMG Life Sciences

Named one of the Best Lawyers in America, FDA Law


Best Lawyers/US News & World Report, 2016

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Recognition

Client Service All-Star (unprompted survey of large company corporate counsel)


BTI Consulting, 2017

Nominated to – Who's Who Legal: Life Sciences, 2017

Repeatedly selected as a Life Sciences Star


LMG Life Sciences

Named one of the Best Lawyers in America, FDA Law


Best Lawyers/US News & World Report, 2016

Matters

Advised multiple pharmaceutical and biological product companies, and investors, on life cycle issues, including patent and market exclusivity eligibility, regulatory strategies, and transactional diligence.

Developed a citizen petition elucidating scientific and legal concerns about FDA's proposed bioequivalence standards.

Performed due diligence for regulatory issues and supported negotiation for corporate licensing, M&A, equity investing and financial institution lending.

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Matters

Advised multiple pharmaceutical and biological product companies, and investors, on life cycle issues, including patent and market exclusivity eligibility, regulatory strategies, and transactional diligence.

Developed a citizen petition elucidating scientific and legal concerns about FDA's proposed bioequivalence standards.

Performed due diligence for regulatory issues and supported negotiation for corporate licensing, M&A, equity investing and financial institution lending.

Evaluated impacts of the recent Drug Supply Chain Security Act on manufacturers, distributors, and third-party logistics providers of drugs, medical devices and combination products.

Defended a product distributor against proposed disciplinary action by the California Board of Pharmacy.

Advised on the status and use of controlled substances.

Matters

Advised multiple pharmaceutical and biological product companies, and investors, on life cycle issues, including patent and market exclusivity eligibility, regulatory strategies, and transactional diligence.

Developed a citizen petition elucidating scientific and legal concerns about FDA's proposed bioequivalence standards.

Performed due diligence for regulatory issues and supported negotiation for corporate licensing, M&A, equity investing and financial institution lending.

See more
Icon close

Close

Matters

Advised multiple pharmaceutical and biological product companies, and investors, on life cycle issues, including patent and market exclusivity eligibility, regulatory strategies, and transactional diligence.

Developed a citizen petition elucidating scientific and legal concerns about FDA's proposed bioequivalence standards.

Performed due diligence for regulatory issues and supported negotiation for corporate licensing, M&A, equity investing and financial institution lending.

Evaluated impacts of the recent Drug Supply Chain Security Act on manufacturers, distributors, and third-party logistics providers of drugs, medical devices and combination products.

Defended a product distributor against proposed disciplinary action by the California Board of Pharmacy.

Advised on the status and use of controlled substances.

Credentials

J.D., University of Virginia

A.B., College of William and Mary

District of Columbia

Virginia

The District of Columbia Bar

Virginia State Bar

Client Service All-Star (unprompted survey of large company corporate counsel)


BTI Consulting, 2017

Nominated to – Who's Who Legal: Life Sciences, 2017

Repeatedly selected as a Life Sciences Star


LMG Life Sciences

Named one of the Best Lawyers in America, FDA Law


Best Lawyers/US News & World Report, 2016

Icon close

Close

Recognition

Client Service All-Star (unprompted survey of large company corporate counsel)


BTI Consulting, 2017

Nominated to – Who's Who Legal: Life Sciences, 2017

Repeatedly selected as a Life Sciences Star


LMG Life Sciences

Named one of the Best Lawyers in America, FDA Law


Best Lawyers/US News & World Report, 2016