How long will the FDA keep it under wraps? The avalanche has started, FDA's gonna give GSK up. GSK brings ex FDA attorney and Antitrust attorney to a week long meeting. A week later FDA commish meets with GSK CEO & Paul Huckle (GSK Chief of World Reg affairs) China, Poland, US...I'm not sure GSK survives this without a FTC breakup order.
FDA/HHS investigation of GSK
John Taylor III; FDA JD
John Taylor III; Biotechnology Industy Oraganization (BIO)
John Taylor III; Abbott, Divisional VP of Federal Government Affs
No longer works at the FDA, Abbott, or BIO Jan 2014 "retired"
Paul Huckle; GSK (Paul Huckle is Chief Regulatory Officer and Senior Vice President for GlaxoSmithKline with worldwide responsibility for managing regulatory affairs)
Feb 2/17/14 – 2/21/14 Meetings with FDA (Elizabeth H. Dickinson, Esq., Chief Counsel & CDER Counsel Denise Esposito
___________________________________________________
Gerald Masoudi (Covington), Paul Huckle (GSK), Elpidio Villarreal (GSK), Jeffrey Jacobson (Debevioise & Plimpton LLP)
Gerald Masoudi is a partner in the firm’s Washington, DC office and co-chair of the Food and Drug practice group.
Before joining Covington in 2009, Mr. Masoudi served as Chief Counsel of the Food and Drug Administration. In that capacity he was responsible for supervising FDA’s involvement in civil and criminal litigation and investigations; providing legal review of warning letters, guidances and regulations; and providing advice to the FDA commissioner and senior leadership on matters relating to the products regulated by FDA. Before joining the FDA, Mr. Masoudi served as Deputy Assistant Attorney General for international, policy and appellate matters in the Antitrust Division at the Department of Justice. He also served as Principal Deputy Chief Counsel for the FDA in 2004 and 2005. Before entering government service, Mr. Masoudi had a decade of experience in private practice in the areas of antitrust, telecommunications, patent law and energy.
-----------------------------------------------------------------
FDA & GSK Meeting on 3-5-2014
FDA Commissioner, Steven Immergut & GSK CEO Witty, Paul Huckle
Margaret A. Hamburg, M.D., Commissioner of Food and Drugs 3/5/14 London, England Steven Immergut Andrew Witty, Paul Huckle (GlaxoSmithKline) Meeting with GlaxoSmithKline (GSK)
Steven Immergut took over for John Taylor III as:
Steven Immergut is the FDA’s Acting Associate Commissioner for External Affairs. In this role, he oversees the planning, development and implementation of agency-wide media communications strategies for disseminating regulatory and educational information to the public through the news media. Mr. Immergut advises the Commissioner and other key agency officials on FDA’s communication to the media and serves as a liaison with the Public Health Service and the Department of Health and Human Services on media activities. Under Mr. Immergut’s leadership, the FDA Office of Media Affairs is the agency’s focal point for preparing, clearing and disseminating press announcements and other statements for the news media, as well as arranging and facilitating press conferences, media briefings, interviews and other news events.
Throughout his extensive career, Mr. Immergut has designed, managed and executed strategic communications initiatives on behalf of organizations operating across the health care sector, including the federal government; pharmaceutical, biotechnology and medical device companies; associations; health care providers; and patient groups.
Immediately prior to joining the FDA, Mr. Immergut was a Senior Associate with the management consulting firm Booz Allen Hamilton, managing government and private sector health communications engagements. Previously, he led the Washington, D.C. Healthcare practice at leading public relations firm Hill+Knowlton Strategies, where he represented a range of clients on medical product and health IT programs and provided counsel on issues management.
Prior to his time at H+K, Mr. Immergut led client engagements for New York-based communications consultancies, Tonic Life Communications and GCI Group, across a wide range of therapeutic categories including oncology, cardiovascular disease, and infectious disease. Mr. Immergut has significant international experience as a healthcare communicator, having represented several global companies based in Europe. And earlier in his career, Mr. Immergut was based in Latin America as consultant under the U.S. Agency for International Development (USAID), working on groundbreaking public health social marketing programs in HIV/AIDS, reproductive health and diarrheal disease.
Mr. Immergut holds a Master of Public Health from George Washington University and a B.S. in marketing from Syracuse University.
