Commissioner Gottlieb’s FDA: His First Year and a Look Ahead - Webinar Recording/Transcript

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Commissioner Gottlieb’s FDA: His First Year and a Look Ahead

What we know about the Gottlieb FDA: That lots is getting done.

What we need to know: What will he do next?

Who owns the crystal ball: Wayne Pines, long-time FDA spokesman and now a sought-after consultant, fronting a panel of FDA-watchers and gurus (TBA).

What you need to know: Where to sign up.

For 90 minutes, Pines and team will lay out the key initiatives to date plus what to expect down the road. Here’s just a taste of what you’ll discover:

  • Drug pricing and marketing: What the Commissioner is trying to change, and how he’s going about making it happen
  • Drug and device approvals: How the process has changed, how it could change in the future
  • The opioid crisis: Comr. Gottlieb’s strategy to deal with it
  • Enforcement: Gottlieb priorities and how they’ll affect you
  • The Gottlieb agenda: Now – and down the road
  • And MUCH more!

In only his first year, Gottlieb and the FDA have taken actions intended to lower drug prices and alter the economics of healthcare delivery. Every drug and device maker, not to mention clinical trial operators and other FDA-regulated players, need to know what the Commissioner still has in store. Here’s how to find out … from folks who know.

Every FDA-regulated health sciences organization needs to attend this timely presentation, particularly those with active drug/device development projects under way including:

  • C-Suite
  • Legal affairs
  • Regulatory/compliance
  • Quality control
  • Research/development
  • Marketing/sales
  • Strategic planning

Meet Your Presenters

Wayne Pines was the FDA’s chief media spokesman for seven years. He has authored or edited a dozen books about crisis communication and the FDA and was named the FDA Alumnus of the Year in 2004. He is a director and current vice president  of the Alliance for a Stronger FDA, a coalition of 200 organizations that seeks more appropriated funding for the agency. His books include the FDA Advertising and Promotion Manual; How to Work With the FDA; Making Your Case to the FDA: A Practical Guide to Food and Drug Law and Regulation; and Communicating in a Health Care Crisis. He now manages crisis communications for FDA-regulated clients as a senior director with Apco Worldwide.

Dr. John F. Kamp has been involved with FDA policies for several decades. He deals with policies involving drug development and approvals, with an emphasis on the promotion and marketing of medical products. Dr. Kamp is Washington Counsel for the Coalition for Healthcare Communication, a drug marketing group with offices in New York City and Washington, DC. Kamp is well-known as an advocate for First Amendment rights of individuals and corporations, as well as for his understanding of communication and drug/device issues at the FDA.  His professional experience includes 10 years with the Washington office of the American Association of Advertising Agencies and nearly a decade in public policy positions at the Federal Communications Commission. Before moving to Washington, Dr. Kamp taught journalism at the University of Iowa and at Tulsa University.