BioCentury
ARTICLE | Politics & Policy

Woodcock says agency needs tools to assess drug uncertainties

February 13, 2014 2:33 AM UTC

Invited attendees at a joint meeting held by FDA and the Institute of Medicine suggested multiple tools the agency could use to better assess the benefit and risk uncertainty of new drugs both pre- and post-market. At the start of the meeting, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), said FDA "needs the tools to identify uncertainty and confront it." Otherwise, she said the agency could become "paralyzed." The attendees included academics, members of industry and regulatory officials.

Attendees recommended using an adaptive approval pathway regardless of indication where new drugs would be approved for a very narrow population based on a surrogate marker while long-term confirmatory Phase III trials were completed. The attendees said FDA would learn more about a drug's safety and efficacy based on Phase III studies that would likely run more than two years, as well as from real-world evidence. Other attendees, including FDA, suggested that companies could broaden clinical trial inclusion criteria to enroll a population that better reflects the real world to give the agency a better idea of safety and/or efficacy issues pre-market. ...