PATRICK RONAN

With 15 years of leadership experience in the Food and Drug Administration, on Capitol Hill and at a leading global pharmaceutical company, Patrick Ronan brings a keen understanding of the regulatory climate of the healthcare sector to Greenleaf Health, a full service regulatory consulting firm he established in 2007.

Today, Greenleaf Health consults on strategic regulatory matters for a select group of healthcare sector clients, including pharmaceutical, biotechnology and medical device companies whose activities are regulated by the FDA.

Pharmaceutical Industry Experience

Prior to founding Greenleaf Health, Patrick served as Vice President of Regulatory Policy & External Affairs at Novartis Pharmaceuticals Corporation, where he supervised state policy and advocacy activities, U.S. regulatory policy issues and advised all brand teams on FDA-related regulatory matters.

There, Patrick directed several teams that worked to secure a favorable environment for all newly launched products, preserve reimbursement status for existing products, and gain passage of supportive legislation in all 50 states.

Patrick also formulated and implemented a regulatory policy agenda, working on a variety of FDA-related policy issues and providing strategic direction to brand teams on their interactions with the agency on a full range of pre- and post-market product issues — from risk management plans and direct-to-consumer (“DTC”) advertising to label changes and product withdrawals.

FDA Leadership

Patrick joined Novartis from the FDA, where he served from 2005 to 2007 as Chief of Staff and in other roles from 2004 to 2005.

As Chief of Staff, Patrick was the principal advisor on all agency issues to former Commissioners Dr. Andrew von Eschenbach and Dr. Lester M. Crawford. Patrick’s responsibilities included regulation development, advisement on complex regulatory and product decisions, program planning, budget formulation and execution, Congressional activities, and establishment of the FDA’s top strategic objectives. In addition to providing executive direction to senior line managers, Patrick also represented the agency and its Commissioner as a liaison to the Department of Health and Human Services (HHS) and the White House.

Patrick’s FDA career began with his appointment in 2004 as Assistant Commissioner of Legislation by then Commissioner Dr. Mark McClellan and then he was elevated to Associate Commissioner of Legislation the following year. In these roles, Patrick served as senior advisor to the Commissioner on all FDA-related legislative matters, with responsibilities that included developing and implementing the agency’s legislative agenda and strategy, managing FDA’s Office of Legislation, and directing liaison activities with Members of Congress.

His work with Congress contributed to the enactment of important reforms to public health laws governing the regulation of drugs, biologics, medical devices and foods – including legislation that increased access to affordable generic drugs, restricted access to anabolic steroids and other performance-enhancing substances, and improved the nation’s biopreparedness.

Capitol Hill and Washington Roles

Patrick’s interactions with Congress as FDA Chief of Staff was a natural outgrowth of his prior experience on Capitol Hill, where he served from 2003-2004 as Majority Counsel to the Committee on Energy and Commerce for then Chairman W.J. “Billy” Tauzin and Chairman Joe Barton. In this capacity on the Committee, Patrick became one of the lead drafters of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”), and authored numerous pieces of food- and drug-related legislation that were signed into law.

Prior to his role as Majority Counsel, Patrick served the Washington, D.C.-based Biotechnology Industry Organization (“BIO”) as Director of Government Relations, providing legislative and policy guidance to the association and its member companies in the area of Medicare reimbursement and coverage, FDA law and patent reform. He advocated for the organization before federal and state agencies as well as Congress, preparing written testimony and regulatory submissions.

Patrick received his bachelor’s degree from the University of Nevada, Reno, his Juris Doctorate from the Georgetown University Law Center in Washington, D.C and his Master’s in Business Administration at the University of Pennsylvania’s Wharton School.