In a bid to open a window into the way it does business, the FDA has released a Transparency Report containing 21 draft proposals for public disclosure policies. This is all part of the three-phase Transparency Initiative that was launched last year. The proposals cover such areas as adverse event reports; the docket management process; enforcement priorities and actions; import procedures; inspections; product applications; product rejections; recalls and warning letters. All in all, this is more info that drugmakers are used to seeing disclosed.
At the end of the day, the FDA hopes this process will better explain agency decisions, provide more data to doctors and patients, "illuminate" enforcement efforts and support innovation for rare diseases. How so? If the FDA explains an abandoned application for an orphan drug could represent a significant therapeutic advance, this could prompt another company to continue with the application. "By implementing some of the proposals would accelerate the development process for medical products by allowing companies to learn from the successes and failures of other products," FDA deputy commish Josh Sharfstein and agency attorney Afia Asamoah write in an essay in The New England Journal of Medicine.
There is a lot to chew on in this 67-page report. And so the FDA is seeking public comment on the proposals, "including input on whether we have struck the right balance between disclosure and confidentiality in support of public health. Because FDA cannot implement all of the proposals at once, we are asking for input on how to prioritize," Sharfstein writes in the report. The agency will be taking public comments until July 20.