Arnold & Porter

Arnold & Porter provides regulatory, litigation, transactional and licensing support to clients that range from global pharma giants to industry bodies, frequently being called upon to handle matters opposite the FDA, CMS and DOJ. The practice is also recognized for its expertise in medicare reimbursement regulations, where they assist with coverage at a state and federal level for new testing methods, clinical services and medical devices. The group is led by a three-person team composed of Allison Shuren, a compliance lawyer who specializes in healthcare fraud and abuse claims, FDA drug licensing expert Mahnu Davar and Daniel Kracov, who represents pharma and biotech companies in FDA approval proceedings. Jeffrey Handwerker is a pharma pricing specialist, with a wealth of experience handling litigation on the subject, with Kristin Hicks maintaining a broad litigation practice that covers pricing, fraud and compliance. Abeba Habtemariam is an authority on the Federal Food, Drug, and Cosmetic Act, with a record of advising healthcare-focused software and IT companies on FDA approval for their products, in addition to representing them in FDA and DOJ enforcement actions. All lawyers named here are Washington DC-based.