Last Friday, FDA finally released its long-awaited Transparency Initiative (now called the Phase III Transparency Report), and luckily, the troubling proposals we previously blogged about didn’t make it into the final version. In fact, our first-blush reaction to the Initiative is that this is a “baby steps” document. FDA is beefing up its website with new information, including a resource called FDA Basics for Industry, updated org charts, and more FDA slide presentations. FDA will also try to be more responsive and transparent about its regulatory timelines and priorities, as well as providing more information about the import process. All good steps, and hopefully they will be implemented and become truly useful resources.

At the same time, however, the FDA’s Initiative leaves open a number of important issues. Most notably, the Phase III Report does not adopt any of FDA’s 2010 proposals allowing for increased public access to adverse events databases, pending applications, or other potentially sensitive regulatory documents (i.e., the stuff we squawked about last year). The Initiative notes: “On May 19, 2010, the Task Force released a report containing 21 draft proposals about expanding the disclosure of information by FDA while maintaining confidentiality for trade secrets and individually identifiable patient information. The Task Force solicited comment….Not all of these proposals will necessarily be implemented. Some may require changes in law or regulation; some may require substantial amounts of resources. The Task Force is reviewing the comments received and will recommend specific proposals to the Commissioner for consideration.” Initiative at 7-8.

Nor does the Initiative adopt a formal plan to develop an electronic tracking system for applicants to track applications through the review process. In tabling this proposal for further exploration down the road, the Initiative makes clear that maintaining confidentiality and security of these materials is a significant concern: “[P]roduct applications submitted to FDA include proprietary information that should not be disclosed to the public. As a result, communications about product applications via electronic means must be conducted in a fashion that maintains the security of this information.” Id. at 28; see also id. at 29 (“[T]he security needs inherent in developing a tracking system for all applications that can be accessed by individual sponsors and yet keeps product application information confidential would require significant resources.”).

The Initiative also declines to create a more robust, formal advisory opinion process that would provide guidance on prescription drug “promotional and scientific exchange practices.” Id. at 43. “The Task Force concluded that the feedback FDA currently provides to pharmaceutical companies on the content of specific promotional pieces is within the agency’s expertise and contributes to FDA’s mission to protect and promote the public health. The request for FDA to issue binding advisory opinions may place inappropriate restrictions on FDA’s ability to respond to emerging issues to best protect and promote the public health.” Id. at 44.

Same goes for food labeling: “[I]ssuance of binding advisory opinion[s] may limit the agency’s flexibility to address emerging public health issues and to implement its statutory responsibilities. In addition, requestors may fail to provide, or subsequently change, claims or product formulations that might render the labeling at issue unlawful. But the company may mistakenly believe it can continue to rely on a favorable advisory opinion. This may have negative consequences for public health.” Id.

Finally, the Initiative declines to change its current practices in response to a comment requesting FDA to provide notice to manufacturers at least 48-72 hours before communicating “emerging safety issues to the public.” Id. at 45. The Initiative notes that in the ordinary case, discussions with industry in advance of any FDA public comment are typically sufficient to provide the industry with notice of any impending public comment, and in any event, FDA wants to leave itself wiggle room in the event it decides the specific facts warrant making a public announcement before informing the industry of an “emerging safety issue.” Id.

So there are still a lot of open issues for the Task Force’s future consideration. And of course, there’s a little wrinkle that may hamper FDA’s ability to keep momentum on these transparency initiatives: The head of the Task Force, Joshua Sharfstein, has left FDA to become Maryland’s secretary for health and mental hygiene, so it will be interesting for FDA observers to see how smoothly the Task Force functions in this transition period, and what (if anything) comes of FDA’s additional transparency proposals.