The Impact of New FDA Leadership on Hatch-Waxman Practice

April 24, 2018 8:15am

Kurt R. Karst
Hyman, Phelps & McNamara PC (Washington, DC)

Michael Sitzman
Gibson, Dunn & Crutcher LLP (San Francisco, CA)

Maryll W. Toufanian, J.D.
Acting Director, Office of Generic Drug Policy Office of Generic Drugs, CDER
U.S. Food and Drug Administration (Silver Spring, MD)

Dr. Scott Gottlieb was sworn in as the 23rd Commissioner of the U.S. Food and Drug Administration in May of 2017. Many industry watchers believe that Dr. Gottlieb’s appointment heralds the beginning of new era at FDA which includes recommendations for the future of Hatch-Waxman. Only time will reveal the FDA’s agenda in this area and how various components of Hatch-Waxman such as exclusivity periods, regulatory review timelines, shared exclusivity and the timing of generic entry. Our panel will address all of this and more. Discussion points will include:

  • Status and findings of the FDA’s internal working group on Hatch-Waxman
  • Seeking guidance for the MMA’s Final Rule in determining whether to submit an ANDA or a 505(b)(2) application
    • Analyzing different pathways, regulatory and scientific considerations when determining which application to file
  • Understanding the new priority ANDA review category
  • Examining Commissioner Gottlieb’s efforts to encourage generic approval
  • Assessing GDUFA II negotiations and the effort to assist potential ANDA applicants for complex products
  • Explaining user fee changes in PDUFA VI