FDA Unveils Plan To Boost Transparency To Industry

FDA has 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 laid out 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.

In a November 2009 letter to the agency, the Consumer Healthcare Products Association expressed frustration with agency messages for emerging safety issues that do not provide clear direction or include "an action step" indicating what the agency will do next (Also see "FDA's Messages To Public Must Be "News You Can Use" - CHPA" - HBW Insight, 30 Nov, 2009.).

FDA launched the Transparency Task Force in June 2009 (Also see "Transparency Initiative In "What Is The Right Thing To Do" Phase - Sharfstein" - HBW Insight, 30 Nov, 2009.).

First Step: Website Launch

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 that target, it will give a timeframe for when it can respond.

Created to address concerns that FDA has become unresponsive to industry, the agency's new program 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 has not moved forward with that initiative, but "is open to further discussions" about whether such technology would be beneficial and how it could 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 (Also see "Taylor Is Sharfstein's Temporary Replacement As FDA's Second-In-Command" - HBW Insight, 10 Jan, 2011.).

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.]

By Jessica Bylander