FDA Will Share Rejection Letters Drugmakers Often Conceal

The US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep under wraps more easily available to investors and the public, a move with the potential to reveal serious questions raised about drugs while they were in development.

To kick off the initiative, the FDA uploaded a tranche of more than 200 letters Thursday morning. Those rejections related to applications submitted years ago that were eventually approved, and many of the letters were already included in an FDA database of information on available drugs. The question is how much more the agency will reveal.