FDA Unveils Plan To Boost Transparency To Industry
This article was originally published in The Tan Sheet
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FDA identified 19 steps to improve its communications with drug and medical device manufacturers, promising quicker responses to industry questions. The agency's Transparency Task Force also identified five draft proposals for improving transparency to regulated industry in a Jan. 6 report. "We have heard from small and large companies about the need for FDA to more clearly communicate about its standards and expectations," FDA Principal Deputy Commissioner Josh Sharfstein, who also is the Transparency Task Force chairman, said in an introduction to the report. Website Launch Marks First Step Among the action steps, FDA launched a website Jan. 6 called "FDA Basics for Industry." Modeled after FDA Basics, a site for consumers introduced last January, the website features links to guidance documents, registration and listing information, training modules, frequently asked questions and lists of key FDA contacts for companies. FDA also commits to respond to industry questions about FDA policies, regulations or processes within five days, whenever possible. If FDA cannot meet the deadline, it will give a timeframe for when it can respond. While the initiative was sparked by concerns that FDA has become unresponsive to industry, it does not extend to questions about specific product applications. Such questions are often more complex and should be handled on a case-by-case basis, FDA says in the report. "If it's a question related to a specific application, that becomes immensely complex," Sharfstein said during a same-day media briefing. "Someone may have a question: 'Can we change the design of a proposed significant study in a certain way?' … That may be a very complex scientific question that requires different types of consultation within the agency." "We understand those are important questions," Sharfstein continued, "but those are being handled in a different way." FDA toyed with the idea of providing more frequent meetings and informal communications with industry, but concluded that it could not do so without slowing down product reviews. "Meetings and frequent informal communications are resource and time-intensive," the report states. The task force is considering whether a formal tracking system would provide greater transparency to product sponsors about the status of pending applications. FDA did not move forward with that initiative, but "is open to further discussions" about whether such a system would be beneficial and how it would be implemented. FDA intends to complete its list of 19 action items within the next 12 months. Draft Proposals For Comment FDA also raised a handful of proposals for industry comment. For high-priority guidance documents in development, FDA is considering disclosing timelines for related milestones. FDA's progress would be tracked on the new web-based management tool FDA-TRACK. Specifically, the agency would note when it plans to begin working on the guidance, when it plans to issue a draft, when it will close the comment period and when the final guidance is expected. Commissioner Margaret Hamburg already formed a cross-agency workgroup to work on improving guidance development, the report notes. Comments on the draft proposals are due in 60 days. Task Force Update With Sharfstein's departure from FDA on Jan. 7, oversight of the transparency task force will fall – at least on an interim basis – to John Taylor. Taylor, who is counselor to Commissioner Hamburg, has been named acting principal deputy commissioner. Sharfstein will become Maryland's secretary of health and mental hygiene on Jan. 12 (see story p. 1). The new report represents the third and final phase of FDA's broader transparency initiative. In May 2010, the agency offered a number of proposals for increasing transparency with the public, including disclosing when a product application is submitted or withdrawn (Also see "Disclosure Of NDA Filings Recommended In Transparency Report" - Pink Sheet, 24 May, 2010.). A final list of the latter proposals to be acted upon should be released "in the weeks and months ahead," Sharfstein noted. [Editor’s note: This article was provided by “The Gray Sheet.” Elsevier Business Intelligence's weekly newsletter on the medical device and diagnostics industries. Sign up for a free trial online, or call 1-800-332-2181.] |