FDA is considering introducing application tracking systems that could tell sponsors how far along the agency is in reviewing their products.

The proposal is in a report FDA released Jan. 6 with 19 "action items" and five proposals for improving the agency's transparency to regulated industry. Helping industry get information from the agency more smoothly is the third phase of the Transparency Initiative the agency has been pursuing since 2009.

The application tracking idea is one that Health Canada already uses, and FDA officials have talked with their counterparts to the North about how their system works, the report says. "FDA's initial sense was that the system did not provide a significant increase in the amount or quality of information available to a sponsor or applicant regarding their submission."

As matters stand now, FDA communicates with applicants "as questions arise during the review process," and implementing a formal tracking system would involve security challenges, the report says. On the plus side for the agency, having such a system in place would reduce the number of phone calls from sponsors checking on application status that its reviewers must now field.

FDA's Center for Biologics Evaluation and Research has already put in place standard operating policies and procedures to minimize such contacts, which may help its reviewers but is bound to leave industry feeling frustrated (Also see "CBER Restricts Telephone Contacts With Firms As BIO Presses For Flexibility" - Pink Sheet, 13 September, 2010.).

In the transparency report, the agency now says it is "willing to hold further discussions with industry" on the subject of a tracking system.

Phase Three: A Late Edition For The Benefit Of Sponsors

The first phase of the transparency initiative consists of efforts to foster understanding of the agency basics, the second involves an exploration of what can be made public about the basis for FDA's decisions on regulated products, and the third focuses on bringing industry into the picture ("Also see "FDA Is Expanding Transparency Efforts To Focus On Industry Questions" - Pink Sheet, 13 November, 2009.).

The third phase "was not part of our original conception," outgoing FDA Principal Deputy Commissioner Joshua Sharfstein said in a Jan. 6 conference call with media to discuss the third phase report. "We heard from a wide variety of industry that transparency is not just for the general public, but that industry is also interested in understanding FDA regulatory processes."

With FDA still deciding whether to push forward with many of the controversial recommendations of the phase two report - including publicly releasing "complete response" letters- the phase three report represents the eye of the transparency hurricane for industry, containing a long list of potential reforms that should make life easier for firms.

Appeals Process to Receive a Deadline; Guidances Get a Timeline

For example, sponsors who have appealed to the Office of Commissioner a scientific decision at another level of FDA may be pleased to hear the agency is now considering setting a three-week timeline to at least inform the applicant whether the appeal will be considered and how long it might take to review. Timelines already are available for other parts of the review process, but none have been set before for the OC review, the report notes in explaining this draft proposal.

Another draft proposal in the report is to inform industry about where FDA stands in developing "certain high priority guidances in development" by posting a timeline on FDA-TRACK, which was itself developed as part of the Transparency Initiative.

Several action items in the report that the agency appears ready to implement this year include FDA's pledges to:

# Answer general questions about existing policies, regulations or regulatory processes within five business days whenever practicable, or at least acknowledging receipt of the question and saying how soon an answer will be forthcoming;

# Post all FDA center guidance and SOPPs on its employees' meetings with sponsors on the new "FDA Basics for Industry" Web site;

# Post FDA employees' PowerPoint slides from presentations to external audiences on the agency's Web site;

# Describe the types of application review notifications FDA provides to industry (such as letters acknowledging receipt of an application or mid-cycle review meetings); and

# Explain the agency's general expectations about when it is appropriate to use secure email to communicate with a manufacturer.

Comments on the draft proposals in the report are due in 60 days.

-Martin Berman-Gorvine (m.berman-gorvine@elsevier.com)

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