BioCentury
ARTICLE | Politics & Policy

Woodcock says companies should take on transparency

June 7, 2014 12:27 AM UTC

The public would benefit from greater transparency about clinical trial results and regulatory interactions -- but disclosures should come from drug sponsors, not FDA, according to Janet Woodcock, director of FDA's Center for Drug Evaluation and Research. Responding to questions in an interview with BioCentury This Week television, Woodcock said more "clinical trial data should be made available publicly," but "we believe at the FDA that the release of data should be in the hands of those who conduct the trial or are responsible for the trial." Woodcock added: "If we were additionally responsible for managing a very large inventory of clinical trial data and responding to thousands of questions, I think that would be very difficult on top of our other duties. And really, it's not our data."

Jonathan Leff, a partner at Deerfield Management, argued that as part of the U.S. House of Representatives Energy & Commerce Committee's Path to 21st Century Cures initiative, Congress should empower FDA to release more clinical and regulatory data (see BioCentury Extra, May 5). ...