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that are abandoned (which means that no work is being done or will be undertaken to have the application approved) or withdrawn by the applicant before approval, and (emph.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.
Thursday, October 29, 2009
FDA hearing to highlight secret clinical trial data — Sunlight Foundation's Real Time Investigations - Tracking Private Influences on Public Policy
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1 comment:
I was originally scheduled to be a speaker at the first transparency conference however, when the FDA saw my comments they removed me from participating. They claimed it was not within the scope however they definitely were. I had give them a draft to be polite and offered to be softer if they asked however I was not even afforded the opportunity.
I did participate but I was not allowed to discuss my original statements.
In my comments (which may be found in the transcripts on the FDA website) I indicated that all reviewers need to be given the opportunity to present without interference or whitewashing by FDA management as in my experience this had been what resulting in unsafe usage of modafinil in children from being approved.
In spite of these comments one month later I was prohibited from speaking (as a former FDA employee) at an advisory committee meeting on a new drug I had been a reviewer on (asenapine) even though the only other public speaker was my wife who requested to speak 3 weeks after I did.
The upcoming meeting has case studies and thus I believe may be somewhat contrieved thus I decided not to even try to speak. Thus I doubt that there will be any perspectives from anyone (i.e. reviewers) who actually knows the types of things that actually occur.
Presently I have real concerns as to whether there is any real commitment to transparency.
Ron Kavanagh
Former Reviewer
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