Pharmaceutical companies, drug distributors, and payors turn to attorney Christopher Smith for strategic, transactional, and regulatory guidance. He also provides litigation services to employers in discrimination, trade secret, and other matters.
Christopher’s practice focuses on pharmacy law, drug distribution, drug life cycle, and supply chain issues, as well as dispensing and reimbursement issues. He advises on pharmaceutical supply chain laws and regulations, including the federal Drug Supply Chain Security Act, EPA pharmaceutical hazardous waste regulations, and federal and state consumer drug take-back and disposal laws and regulations. He counsels retail, specialty, hospital, health system and non-dispensing pharmacies, pharmacy benefit managers (PBMs), pharmaceutical manufacturers, and other health care providers and suppliers on a range of pharmacy law and drug distribution issues.
These issues include:
- pharmacy and PBM licensure and regulation;
- compliance with federal and state anti-kickback laws;
- responses to state board of pharmacy investigations;
- contract negotiations involving third-party payors, PBMs, drug manufacturers, and other vendors within the pharmacy space;
- compounding, repackaging, and physician dispensing; and
- the structuring of specialty pharmacy distribution arrangements.
Within the 340B program, Christopher provides counsel to contract pharmacies and covered entities on 340B pharmacy contracting issues and 340B compliance, outlook, and strategy issues. He has also advised pharmacy stakeholders on compliance with state- and DEA-controlled substance laws and regulations, including electronic prescribing and telehealth issues involving the prescribing and dispensing of controlled substances.
For private equity investors, Christopher provides due diligence and change-of-ownership counseling in the sale and acquisition of retail, specialty, non-dispensing, and PACE pharmacies.
For employers, Christopher provides litigation services relating to the protection of trade secrets, enforcement of non-compete and non-solicitation agreements, business torts, and employment discrimination.
Before joining Epstein Becker Green, Christopher worked as a Director of Federal Public Policy at a nonprofit trade association that advocates for pro-patient and pro-pharmacy public policy and as a Director of Policy and Regulatory Affairs at a national trade association representing the pharmacist owners, managers, and employees of independent community pharmacies nationwide. In addition, he previously served as a Special Assistant Attorney General in the Office of the Attorney General of Maryland and as a litigation attorney at national and regional law firms, where he provided counseling and advocacy in civil litigation matters involving alleged funding of terrorism, alleged law enforcement racial profiling, employment discrimination, directors and officers insurance coverage, business disputes, medical malpractice, and personal injury.
Earlier in his career, Christopher was a Visiting Assistant Professor of Law at Widener University School of Law’s Health Law Institute and served as a Legal Fellow for the U.S. Senate Judiciary Committee’s Subcommittee on Crime and Drugs.
Among his extracurricular activities, Christopher serves as a judge for American University Washington College of Law’s Health Law Writing Competition. He also serves on the Board of Directors of DNAngels, a nonprofit dedicated to assisting individuals searching for their biological parents.
- Business Torts, Competition & Trade Secrets
- Corporate & Transactional
- Drug and Medical Device Coding, Coverage, and Payment
- Drug and Medical Device Distribution
- Drug Pricing Policy & Reporting
- Employment Litigation
- Environmental / Toxic Tort / Proposition 65 Litigation
- Federal and State False Claims Act (Including Qui Tam)
- Government and Commercial Coding, Coverage, and Payment
- Health Care
- Health Care and Life Sciences Investigations and Enforcement
- Life Sciences
- Litigation & Business Disputes
- Managed Care
- Regulatory Strategy, Product Development, and Product Approvals
- Represented the private equity buyer side in the acquisition of national networks of specialty and non-dispensing pharmacies, including responding to the buyer’s due diligence inquiries, conducting health regulatory due diligence of the buyer, coordinating the federal and state regulatory and licensing filings, and negotiating the health regulatory-related aspects of the purchase agreement.
- Negotiated and drafted drug purchase, pharmacy services, and management services agreements on behalf of PBMs, a regional chain pharmacy, pharmaceutical manufacturers, pharmacy vendors, specialty pharmacies, and a dialysis provider.
- Provided PBM state licensing and reporting counseling to an entity that supplies pharmacy claims processing services across the nation.
- Negotiated the terms of, and drafted contracts to implement, numerous 340B contract pharmacy arrangements among hospitals, retail pharmacy chains, and 340B technology services vendors and provided compliance counseling regarding the use of grant funding and 340B savings within the 340B program.
- Advised pharmaceutical drug manufacturers and pharmacies on compliance issues involving the track-and-trace requirements of the federal Drug Supply Chain Security Act.
- Provided health regulatory counseling to a national retail pharmacy chain regarding SEC reporting compliance; state fraud, waste, and abuse reporting compliance; and COVID-19 vaccine regulatory compliance.
- Advised a pharmaceutical manufacturer on compliance with California’s drug disposal stewardship law.
- Represented a Medicaid managed care organization in beneficiary coverage disputes in administrative law courts.
- Enforced non-compete and non-solicitation provisions and trade secret violations against former employees of a residential lender with offices located throughout the East Coast.
- Obtained a favorable settlement for a nonprofit entity in a defamation and state law employment discrimination case.
- Represented a large network of physicians in breach of employment contract, business tort, and employment discrimination claims brought by former network physicians.
- American University, Washington College of Law (LL.M., 2011)
- Law and Government, Health Law and Policy Concentration
- Thomas O. Sargentich Award (for highest scholastic average)
- Vanderbilt University Law School (J.D., 2001)
- Phillip C. Jessup International Moot Court Team
- Executive Problem Editor, Moot Court Board
- University of Richmond (B.A., summa cum laude, 1998)
- Phi Beta Kappa
- District of Columbia
Professional & Community Involvement
- American Society of Pharmacy Law
- October 12, 2022