FDA's Joshua Sharfstein, on his way out the door, unveiled Phase 3 of his FDA Transparency Initiative
– the part aimed at making the agency more responsive to regulated industries.
The agency launched an industry-directed counterpart
to its FDA Basics
site for consumers, aimed at answering questions like “What should I expect during an inspection?” The agency also committed to:
• Responding to industry email inquiries about the regulatory process within five business days;
• Posting slide presentations delivered by employees at events;
• Promoting more uniform processes and procedures across field districts and streamlining guidance processes;
• Updating org charts and senior leadership on FDA.gov at least quarterly
• Posting on its Basics for Industry microsite how companies are informed whether their product applications are on track to meet target dates for FDA action.
The agency “is also willing to hold further discussions with industry about application tracking systems, and explore the feasibility of implementing such a system at FDA.”
The agency issued five draft proposals, including:
• Maintaining on its website a list of presentations given by employees to external audiences;
• A requirement that the Office of the Commissioner, when receiving a request to reconsider a scientific decision, inform the submitter within three weeks of when a decision or status update might be expected;
• A policy of issuing a timeline from the start of agency work on a draft guidance and giving target dates through publication of final guidance;
• A review of procedures for evaluating importers or third parties working on behalf of importers who file information electronically about products for import
• Development of a web-based system that would help importers in compliance
The agency launched its transparency initiative in 2009 as part of a broader open government effort by the Obama Administration. Phase 1 featured the launch of FDA Basics, while Phase 2 concerns public disclosure of information – data related to NDA candidates, for example – and is still under deliberation.
Phase 3, said Sharfstein, was not part of the agency's original plan but for the initiative but was prompted by industry appeals for more information.
“We held a number of public meetings and public dockets,” said Sharfstein, “and we heard from a wide variety of industry that transparency wasn't just for the public, that they were very interested in understanding more about FDA, both in terms of the regulatory process in general and the regulatory process for their specific products.”