FDA and Healthcare

Kristin Hicks is a member of Arnold & Porter LLP's FDA and healthcare practice group. Ms. Hicks' practice focuses on counseling and litigation for clients in the pharmaceutical and medical device sectors. Her work includes advising clients regarding government price reporting, fraud and abuse compliance, federal contracting requirements, and legislative and public policy issues. In addition, Ms. Hicks represents clients in litigation at the trial and appellate levels, primarily in matters involving allegations of fraud and abuse against government healthcare programs.   

As a student at Harvard Law School, Ms. Hicks was the Executive Editor of the Harvard Journal of Law & Technology and a member of the Board of Student Advisors. Ms. Hicks earned her undergraduate degree from Harvard College, where she majored in neurobiology and was the captain of the women's lightweight crew team.

FDA and Healthcare Representative Matters

• Defended AstraZeneca in drug pricing litigation involving the 340B drug discount program, winning a favorable ruling by US Supreme Court that such lawsuits could not proceed. County of Santa Clara v. Astra USA, Inc. et al.(Supreme Court; 9th Circuit; N.D. Cal.).
• Represented the Pharmaceutical Research and Manufacturers of America (PhRMA) before the Supreme Court in a successful First Amendment challenge to a Vermont law restricting the rights of drug manufacturers to promote their products using prescriber data. Sorrell, et al. v. IMS Health, Inc., et al. (Supreme Court; 2d Circuit; D. Vt.).
• Served on secondment to the in-house legal and compliance departments of two major pharmaceutical and medical device manufacturers.   
• Advise pharmaceutical manufacturers on drug pricing issues under the 340B program, Medicaid, Medicare, and the Department of Veterans Affairs healthcare program; prepare drug price reporting policies and reasonable assumptions; provide guidance on internal audits and price recalculation projects.
• Counsel pharmaceutical manufacturers on compliance with federal laws relating to healthcare fraud and abuse, including the Anti-Kickback Act and the False Claims Act.
• Advise pharmaceutical manufacturers on federal contracting requirements, including compliance with the Trade Agreements Act, solicitation and contract clauses, and certification and reporting obligations.
• Draft comments to CMS and other HHS agencies on behalf of drug manufacturers and industry associations on proposed rules and guidance regarding drug reimbursement and price reporting issues.
• Counsel pharmaceutical manufacturers on implementation of recent health care reform legislation.