Libby Baney is an advocate for corporations, trade associations, nonprofits, government entities and individuals. She creates and implements strategic public policy solutions. Clients come to her for help with private sector policymaking and government policy, legislation, regulations, and administrative action.
Libby's days — and sometimes nights — are filled with consensus building, stakeholder engagement, advocacy and strategic advising. Much of her work involves issues of health, technology and the rule of law, including:
- Internet pharmacies and pharmacy compliance
- Telemedicine / telehealth
- Pharmaceutical supply chain security and integrity
- Falsified and counterfeit medicines
- Intellectual property rights
- Internet governance and ICANN policy
- New generic top-level domain (gTLDs) policy
- Food and Drug Administration (FDA) regulatory and user fee reforms
- International regulatory harmonization and capacity building
Nonprofit Leader
Libby currently serves as the founding Executive Director of the Alliance for Safe Online Pharmacies (ASOP), a globally active nonprofit organization based in Washington, D.C. In that capacity, she leads ASOP operations, shapes public policy, and advocates for increased international attention to the issue of illegal online drug sellers. Libby leads ASOP's global strategy in U.S., European Union and Asia. Learn more by viewing ASOP's overview video.
Internet = International
When it comes to the Internet, issues of public health, intellectual property and compliance with the rule of law are inherently global and thus so is Libby's work. In addition to having close working relationships with many U.S. government agencies and policymakers, as noted below, Libby regularly counsels clients on issues involving governments and private sector stakeholders in the European Union and Asia. She is a frequent participant in global Internet Corporation for Assigned Names and Numbers (ICANN) meetings and working groups, and is actively engaged in various forums within the Asia-Pacific Economic Cooperation's Regulatory Harmonization Steering Committee (RHSC) and Life Sciences Innovation Forum (LSIF).
Insurance & Financial Services
On behalf of insurance industry clients, Libby led the Surplus Lines and Reinsurance Coalition, an expansive insurance coalition representing the industry's support for the Nonadmitted and Reinsurance Reform Act (NRRA). In 2010, the NRRA became law as part of the Dodd-Frank Act. From 2010-13, she advised on the nationwide state implementation of the NRRA. Libby continues to work with the surplus lines industry on federal and state policy matters.
Policy Development and Advocacy
Libby helps clients address issues in more than one way — from analyzing existing domestic and international policy; to drafting legislative language, testimony and white papers; to developing national and international public-private coalitions. She has built trusted working relationships with U.S. and international government agencies, law enforcement and policymakers on all sides of the aisle.
More specifically, Libby was actively involved in the policy and advocacy behind the Drug Quality and Security Act of 2013 (DQSA), the FDA Safety and Innovation Act of 2012 (FDASIA), the Affordable Care Act and the Dodd-Frank Wall Street Reform and Consumer Protection Act. Libby works closely with:
- U.S. Congress
- Food and Drug Administration (FDA)
- The Office of Management and Budget's Office of the U.S. Intellectual Property Rights Enforcement Coordinator (IPEC)
- State Department (State)
- U.S. Trade Representative (USTR)
- Department of Commerce (DOC)
- U.S. Patent and Trademark Office (USPTO)
- Numerous law enforcement agencies and divisions
- Centers for Disease Control and Prevention (CDC)
- The European Commission, including DG SANCO, DG MARKT and DG TRADE
- Various forum within the Asia-Pacific Economic Cooperation (APEC)
Writer, Speaker and Thought Leader
Libby is a prolific speaker and writer, regularly engaging with diverse audiences. She is often found authoring policy papers, addressing large audiences, leading strategic workshops and interacting with international corporate leaders and policymakers. Her work has been profiled in The Washington Post, Politico, Roll Call, The Hill, The Los Angeles Times, USA Today, The Washington Times, The Indianapolis Star, Inside Health Policy, Pharmacy Today and by ABC News, CNN and C-SPAN.
Prior Experience
Before rejoining FBDC in 2014, Libby was president and founder of FWD Strategies International LLP, whose services touched nearly all 50 U.S. states and spanned multiple continents by "improving the world through projects that matter." She also brings a background in local government and corporate affairs. Libby has experience working on community development projects for the city of Indianapolis, as well as creating corporate response plans for state and federal legislation for a pharmaceutical company.
- Nova ScriptsCentral 2015 Shining Star Award
- Phi Beta Kappa
- Herman B Wells Scholar at Indiana University, Bloomington
- National Association of Boards of Pharmacy — .pharmacy gTLD Advisory Committee
- Federation of State Medical Boards Working Group on Telemedicine Consultations
- RESOLVE: National Infertility Association — Public Policy Working Group
- American Telemedicine Association — Standards and Guidelines Committee Workgroup and Invited Expert Advisor
- National Association of Governors' Prescription Drug Abuse Policy Academy — Expert Faculty Advisor
- Asia-Pacific Economic Cooperation (APEC) — Regulatory Harmonization Steering Committee, Internet Sales Working Group
- Indiana University Maurer School of Law, Bloomington — Law Alumni Board
- Valuing - and Getting Value From - Millennial Women Lawyers
National Museum for Women in the Arts, Best Friends at the Bar - Book Launch, Washington D.C., October 2015
- Developing Public Private Partnerships in the Health Sector
Guest Lecturer, American University Department of Public Administration and Policy, October 5, 2015
- Tele-Psychiatry, Internet Prescribing and the Ryan Haight Act
National Council for Behavioral Health, Public Policy Committee, Washington, D.C., June 2015
- Working With Advocacy Groups and Board: Top 5 Compliance and Operational Best Practices
Co-presenter, MichBioU Webinar, March 2015
- The Newest Diversion Tool: Online Pharmacies and Telemedicine
National Association of State Controlled Substance Authorities (NASCSA) Annual Meeting, Savannah, Georgia, October 22, 2014
- Bad Actors: The Impact and Enforcement of Illegal iGaming Sites
Gaming Expo (G2E), Las Vegas, Nevada, September 29, 2014
- The Impacts of Fake Online Pharmacies on Patient Safety
Partnership for Safe Medicines' Interchange, Washington, D.C., September 18, 2014
- Consumer Awareness and Enforcement
Government Affairs Program, International Trademark Association, Washington, D.C., September 16, 2014
- Engaging Global Leaders: Protecting Patients From Falsified Medicines Online
Seminar, Microsoft Office, Brussels, Belgium, July 17, 2014
- Transatlantic Cooperation on Internet Pharmacies
Public Meeting, Transatlantic Intellectual Property Rights Working Group, Brussels, Belgium, July 16, 2014
- Patients Impacted by Supply Chain Dangers, PDA/FDA Pharmaceutical
Supply Chain Conference, Washington, D.C., June 3, 2014
- Internet Drug Sales — Public Awareness, Best Practices and Updates
Asia-Pacific Economic Cooperation (APEC) Senior Officials Meeting, Qingdao, China, May 5-7, 2014
- Working Together on Global Solutions to Combat Illegal Online Drug Sellers
Global Access to Medicines Conference, Johns Hopkins Bloomberg School of Public Health, Baltimore, April 18, 2014
- Combating Illegal Medicines Online — Safety in Numbers
Global Forum on Access to Safe Medicine Conference, London, April 4, 2014
- International Action Against Illegal Internet Drug Sales
Pre-Conference Workshop, Global Forum on Access to Safe Medicines, London, April 2, 2014
- International Efforts to Combat Illegal Internet Drug Sellers
Briefing of the Turkish Enforcement Authorities, U.S. Patent and Trademark Office, Washington, D.C., September 27, 2013
- Transatlantic Cooperation to Address Illegal Internet Drug Sellers
US-EU Transatlantic Intellectual Property Rights Working Group, Stakeholder Meeting, Washington, D.C., July 11,2013
- The Global Threat of Illegal Online Drug Sellers: International Initiatives
Seminar on Fake Medicines and the Internet — Protecting Patients in Japan and Overseas, Tokyo, Japan May 27, 2013
- The Global Threat of Illegal Online Drug Sellers: Policy Solutions and Public Awareness in the Age of the Internet
Asia-Pacific Economic Cooperation's Life Sciences Innovation Forum Workshop, Seoul , Korea, May 22-23, 2013
- Patient Safety in the Internet Age — Internet Pharmacy and Telehealth
Federation of State Medical Boards' Annual Meeting, Boston, Massachusetts, April 19, 2013
- Legitimizing Online Pharmacies: The Alliance for Safe Online Pharmacies
U.S. & EU Global Forum on Pharmaceutical Anti-Counterfeiting and Diversion, Washington, D.C., November 29, 2012
- International Strategies to Protect Patients From Illegal Online Drug Sellers
Workshop at Google, Kickoff Alliance for Safe Online Pharmacy, European Union, Brussels, Belgium, November 6, 2012
- A Few Words From Washington — Insights on Health Care Policy and the 2012 Elections
Faegre Baker Daniels Franchising in Health Care Conference, October 23, 2012
- Technological Strategies for Enhancing Prescription Drug Safety
Moderator, Partnership for Safe Medicines, September 28, 2012
- What Does Congress Have to Say About Telemedicine Prescribing?
Center for Telehealth & e-Health Law Webinar, June 25, 2012
- Joining a Nonprofit Board of Directors: Fiduciary Duties and Other Things You Should Know
The United Way of the National Capital Area, Emerging Leaders Program Training Session, June 2, 2012
- Combating Drug Counterfeiting & Sales — Rogue Websites and Safe Online Pharmacies
Partnership for Safe Medicine's Annual Interchange, October 27, 2011
- Overview of the Dodd-Frank Act's Impact on the Insurance Industry
Captive Insurance Council of the District of Columbia Annual Conference, October 25, 2011
- Rogue Internet Pharmacies — Can Collaboration Break the Link?
National Association of Boards of Pharmacy Annual Meeting, San Antonio, Texas, May 24, 2011
- Update on Implementation of the Nonadmitted and Reinsurance Reform Act
A.M. Best Webinar, April 2011
- Inside Story — How the Nonadmitted and Reinsurance Reform Act Became Law
California Insurance Wholesale Association, La Jolla, California, January 2011
- Protecting Patients — Mission and Strategy of the Alliance for Safe Online Pharmacies
Private-Public Sector Collaborative Roundtable, Washington, D.C., November 2010
- Election Outlook 2010 and Anticipated Impact on Insurance Industry
NAPSLO Committee Day, Dallas, November 2010
- The Alliance for Safe Online Pharmacies' Legal and Federal Affairs Strategy to Protect Patents
Pharmaceutical Security Institute Conference, Washington, D.C., October 2010
- Surplus Lines Reforms in Dodd-Frank — the Nonadmitted and Reinsurance Reform Act
A.M. Best Webinar, September 2010
- The Dodd-Frank Act and Surplus Lines Insurance Reform — The Washington Perspective
Western States Surplus Lines Conference, Whistler, Canada, July 2010
- Health Care Reform's Impact on Medical Innovation
Indiana University Research & Technology Center, Indianapolis, May 2010
- Legislating Health Care Reform — Washington, D.C. Perspective
Indiana University Hutton Honors College Discussion, Bloomington, Indiana, January 2010