Next week the Food and Drug Administration’s (FDA) transparency taskforce will be holding a hearing asking for people to comment on the issue at the core of the multi-media investigation we released today, “Heart of the Matter: How Congress and Special Interests Kept Clinical Trial Data Secret”:
The topics to be covered are: (1) early communication about emerging safety issues concerning FDA-regulated products, (2) disclosure of information about product applications that are abandoned (which means that no work is being done or will be undertaken to have the application approved) or withdrawn by the applicant before approval, and (emph. added) (3) communication of agency decisions about pending product applications.
We’ve also gotten a sneak preview of comments that Consumers Union will be filing. Here’s a key excerpt:
We urge the FDA to require the public posting of all trial results of applications that are abandoned or not completed within the estimated time period provided in the original clinical trial registration (Public Health Service Act section 402(j)(2)(A)(ii)(I)(jj)).
Section 402(j)(3)(D)(II) of the Public Health Service Act, as added by FDAAA (PL 110-85), should clearly require that unapproved drug and device trial information be made public. The FDA should move beyond the issue of unapproved applications to ensure that abandoned research data is also reported.
The arguments are overwhelming for advancing science through the public sharing of all clinical trial research results – regardless of whether that trial resulted in an application for FDA approval or amendment or whether the application was unsuccessful.
We will be following up to see who testifies at the hearing and what positions they take.