FDA on Transparency: One Policy for FDA Stakeholders–a Different One for FDA

Inside Health Policy reports:

“Long-sought draft recommendations from FDA’s Transparency Task Force on data disclosure would enable the agency to release a slew of previously veiled information to the public, sparking the ire of stakeholders, with industry saying many of the recommendations would stifle innovation and cause tension between medical product manufacturers and their investors, who proposals don’t go far enough, complaining that FDA will determine when to release data and that resource constraints will hamper the agency’s ability to redact proprietary information for public disclosure.”

However when it comes to FDA itself,  it refuses to make public  fundamental information regarding its operations, in particular information regarding the activities of TPSAC as enumerated in previous articles herein.

FDA could balance this   disparity  by also  announcing  (1) whether TPSAC or the FDA is going to prepare the totality of the drafts and final reports for TPSAC  (2) that FDA is  going to submit for public comment the Information Collection Request (dealing with information on mentholated tobacco products)  it asked  OMB  to approve on an “emergency”  basis without public comment.

We appreciate FDA Tracker  calling this matter to our attention in the comment section of a previous post.

See the Inside Health Policy article below.

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3 comments. Leave a Reply

  1. government grants

    Terrific work! This is the type of information that should be shared around the web. Shame on the search engines for not positioning this post higher!

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