Kalah Auchincloss focuses her administrative law practice on food and drug law and issues related to the National Institutes of Health. She counsels patient advocate groups; professional societies; pharmaceutical, biotechnology, and medical device companies; and other organizations on legal and policy matters at the FDA and NIH as well as general public policy initiatives. Kalah’s practice in addition includes general litigation and administrative law counsel.
Kalah’s practice emphasizes her work on “personalized medicine,” including recent initiatives at the agency to address clearance and approval of advanced diagnostics and other “laboratory developed tests”. She also works extensively with the cancer patient advocacy community on FDA and NIH matters. Kalah has also worked with clients on FDA oversight of direct-to-consumer advertising, particularly in the Internet/social media context; identified American Recovery & Reinvestment Act (stimulus) funding opportunities for various industry and other clients; written about FDA’s oversight of stem-cell based therapies; and identified regulatory concerns for clients during merger and acquisition deals. Kalah’s work reflects her legal research for a member of the Georgetown Law School faculty and her knowledge of the political process through fundraising activities for gubernatorial, presidential, and state and local campaigns.
While a member of the Georgetown University Law Center Institute for Public Representation, Kalah litigated civil rights and constitutional questions, which involved her in legal research, client management, legal brief writing, and preparing the lead attorney for oral argument. Before joining Foley Hoag she interned for Judge Inez Smith Reid, District of Columbia Court of Appeals
