ComplianceOnline

Commissioner Scott Gottlieb's Evolving FDA: Learn FDA's View, Mission and Its Impact on Your Company

Date: August 29, 2018  Duration: 60 Min  Time: 10.00 AM PDT
Panelist
Peter Pitts
Peter Pitts President, Center for Medicine in the Public Interest

Peter Pitts is President of the Center for Medicine in the Public Interest. A former member of the United States Senior Executive Service, Peter was FDA's Associate Commissioner for External Relations, serving as senior communications and policy adviser to the Commissioner. He supervised FDA's Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive Secretariat, and Advisory Committee Oversight and Management. He served on the agency's obesity working group and counterfeit drug taskforce and is a Special Government Employee (SGE) consultant to the FDA's Risk Communications Advisory Committee.

Specific areas of global policy expertise include FDA policy and process, healthcare technology assessment and reimbursement issues, biosimilar development, Rx-to-OTC switching, risk management plans, GMP policies, pharmacy education programs, drug safety, DTC/ItP, Critical Path, personalized medicine, clinical trial transparency, IP protection, FDA reform, drug importation, counterfeiting, genetically modified food issues, food safety and security, recalls, nutritional labeling.

Description:

This webinar will cover a variety of FDA issues that are important to developers of new and generic drugs, biologics and biosimilars, devices and apps as well as regulated communications and how the FDA, under Dr. Gottlieb's leadership is becoming both more predictable in its actions via more directive guidances as well as more collaborative (acting as both regulator of and partner with regulated industries).

You will learn how the FDA's view of its mission is evolving and how it will impact policies for development, review, post-market surveillance and communications.

Areas Covered:

This webinar will cover:

  1. Off label communications
  2. Patient-focused drug development
  3. Real world evidence
  4. Expedited review pathways
  5. Biosimilars
  6. Quality
  7. Pharmacovigilance
  8. FDA and pricing reform
  9. Opioids and pain management
  10. Facilitating innovation
  11. Transparency initiatives
  12. Social media policy
  13. Regulated and non-regulated healthcare apps

Who will benefit:

Below personnel working in pharma, biotech, medical device, app development, marketing and communications firms etc. will be benefited:

  1. Product managers
  2. Public policy developers
  3. Communications and marketing specialists
  4. Regulatory and legal departments
  5. C-suite advisors
  6. Investors
  7. Social media strategists
  8. App developers
  9. Healthcare consultants

Why you should register:

Dr. Gottlieb's intimate knowledge of the health industry psyche, viewed by some as his greatest flaw - is actually his most unique and important asset. He recognizes that predictability is power in pursuit of the public health and, in imagining an FDA that can (indeed must!) color outside the lines, pays heed to Bertrand Russell's maxim that, "Science may set limits to knowledge, but should not set limits to imagination."

Topic Background:

Scott Gottlieb's tenure as Food and Drug Administration commissioner has, to date, been defined by two terms not generally associated with the agency that regulates more than a third of the U.S. economy - predictability and imagination.

"Imagination" and "Regulatory Policy" are not often used in the same sentence. But, the Gottlieb FDA is changing that. He recognizes that the agency must advance their relationships with the industries it regulates. That doesn't mean fewer in-depth reviews or strident actions. What it does mean is that the FDA is doing a better job being a first-among-equals intramural partner. From patient-focused drug development to biomarker vetting, responsible off-label communications, new approaches to pain management, and the regulatory science required for validating real-world evidence, Gottlieb is steadily moving the agency away from its traditional angst in "not invented here" regulatory conversations. He's not only imagining an FDA that is both regulator of and colleague with industry; he's working to make it a reality.

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