Fourth Annual AUWCL National Health Law Writing Competition Opens Soon
American University Washington College of Law is pleased to announce the Fourth Annual National Health Law Writing Competition (2018-2019). This competition is designed to encourage law students to write scholarly papers on current topics of interest relevant to health law and/or food and drug law. A distinguished panel of judges will evaluate the papers and determine the first and second place winners. Certificates of Participation and cash prizes (sponsored by AUWCL Alumna Corrine Propas Parver) will be awarded.
University of Maryland Francis King Carey School of Law
A New Exception to the Right to Refuse: Requiring Pharmaceutical Manufacturers to Sell Samples for Bioequivalence Testing
Case Western Reserve University School of Law
Solving the Uncertainty: Why the HIPAA Privacy Rule Fails to Appropriately Address Disclosures of Psychotherapy Notes of Deceased Patients
Meet Our Judges
Sonali Gunawardhana is Counsel at the law firm of Shook, Hardy & Bacon L.L.P. in Washington, DC. She draws on her nearly 10 years’ experience as an attorney at FDA to offer clients detailed and practical guidance on how to avoid and resolve FDA regulatory challenges. Ms. Gunawardhana’s practice focuses on the rapidly changing FDA regulatory requirements for bringing pharmaceuticals and medical devices to market; the complex emerging rules applicable to domestic and foreign food manufacturers, suppliers, and importers; clinical trial compliance requirements for drug and medical device studies; and the defense of FDA enforcement actions against drug, device, food and dietary supplement companies, Clinical Research Organizations (CROs), academic medical research institutions and individual researchers. Ms. Gunawardhana received a BA from Syracuse University, a MA from Webster University, a MPH from Boston University, a JD from the University of New Hampshire School of Law and a LL.M. from Washington College of Law, American University.
Jake Harper is an attorney with Morgan Lewis. A frequent speaker on issues involving healthcare fraud, compliance, and reimbursement, Mr. Harper's practice focuses on advising hospitals, healthcare professionals, and other industry stakeholders on compliance with Medicare, Medicaid, and state licensure requirements. Mr. Harper represents providers before the Provider Reimbursement Review Board (PRRB) and the Office of Medicare Hearing and Appeals (OMHA) and assists clients with filing voluntary self-disclosures with the Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS). In addition, Mr. Harper also represents healthcare providers in internal investigations and qui tam False Claims Act matters. Jake is a 2013 graduate of American University Washington College of Law, where he was the Editor-in-Chief of the Health Law & Policy Brief.
Garrett Mannchen is an attorney at the U.S. Department of Health and Human Services in the Office of the General Counsel. In that role, Mr. Mannchen represents the Centers for Medicare & Medicaid Services (CMS) in federal district court litigation. His portfolio includes challenges to the Medicaid Drug Rebate Program, reimbursement for prescription drugs under Medicare Part B and Part D, decisions of the Provider Reimbursement Review Board, and Medicaid section 1115 demonstration projects. Before joining HHS, Mr. Mannchen clerked for Judge Roger Wollman on the U.S. Court of Appeals or the Eighth Circuit. Mr. Mannchen is a 2015 summa cum laude graduate of American University Washington College of Law.
Cybil G. Roehrenbeck
Cybil G. Roehrenbeck is a Shareholder in Polsinelli PC’s Washington, DC office, where she provides federal government relations and regulatory counsel. Specializing in healthcare law and policy, she works to obtain appropriate coverage and reimbursement for innovative healthcare technologies and services such as digital health, value-based care models, and precision medicine. Ms. Roehrenbeck previously served as Assistant Director, Federal Affairs and Washington Counsel for the American Medical Association, as well as Legislative Counsel on Capitol Hill. Ms. Roehrenbeck holds several leadership positions with the American Bar Association (ABA) and is a member of the ABA’s Standing Committee on Government Affairs. Ms. Roehrenbeck is also a published author on health law and policy matters, including biennial contributions to BNA/Bloomberg’s treatise entitled, “E-Health, Privacy, and Security Law, Second Edition.” Ms. Roehrenbeck attended the University of Virginia undergrad and earned her law degree from the University of Georgia, completing her third year at the American University Washington College of Law. She is a member of the bar in Virginia and the District of Columbia.
Chris Smith is the Director of Federal Public Policy for the National Association of Chain Drug Stores. In that capacity, he works on issues related to the 340B program, consumer drug disposal, the Drug Supply Chain Security Act, hazardous waste pharmaceuticals, health care reform's impact on drug benefits and pharmacies, and drug importation. Previously, Chris was a health law professor at Widener University School of Law, as well as Director of Public Policy for the National Community Pharmacists Association. He holds an LLM from American University Washington College of Law's Program on Law and Government, a JD from Vanderbilt Law School, and a BA from the University of Richmond.