#BIOCEO16 Session Recap: Regulatory Policy Outlook—PDUFA VI and You

The second day of #BIOCEO16 kicked off this morning with a look ahead to PDUFA VI and potential ways to improve the drug development and approval process. Moderated by BIO Executive Vice President of Emerging Companies Cartier Esham, the panelists included:

  • Elizabeth Krutoholow, Analyst, Bloomberg Intelligence
  • Jonathan Leff, Partner, Deerfield Management; Chairman, Deerfield Institute
  • Richard F. Pops, Chairman & Chief Executive Officer, Alkermes

The challenges and opportunities presented by the growing amount of available “real world evidence” (RWE) – characterized by Elizabeth Krutoholow as seeing how a drug works once it’s out of the hands of investigators in a controlled clinical trial – were discussed at length. Jonathan Leff noted that the mere fact that RWE was being considered as a potential demonstrator of efficacy was a major advancement. To illustrate that, Leff recalled that in PDUFA 4, which passed in 2007, the main use of RWE was for safety monitoring in the Sentinel program. In 2007, safety issues were very much in the public’s mind as a result of several high-profile drug recalls, resulting in REMS and additional safety obligations being imposed on the FDA.

Other big topics were FDA staffing challenges and ongoing efforts to ensure that patient voices and perspectives are better incorporated throughout the drug development and approval process, such as BIO and PPMD’s recently announced initiative to share best practices on patient preference studies.

Richard Pops closed by noting the good work done by the FDA – which regulates products representing about a quarter of US GDP – in some incredibly challenging circumstances: lots of pressure, lots of deliverables, and lots of regulations. Despite those challenges, they continue to set the global regulatory standard for human drug reviews.

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