From the July 9, 2007, issue of "The Gray Sheet"
If all goes as planned, beginning Oct. 1 FDA device reviewers will be taking a new, more interactive approach to product applications, though agency officials are still unsure exactly how the method will work.
Interactive review, a central part of the plan for a new user fee program now moving through Congress, is supposed to improve communications between device reviewers and industry and create more predictable timelines for premarket decisions.
Although Office of Device Evaluation Director Donna Bea Tillman likes the idea of engaging more informally with industry, she says there are several practical questions.
"Exactly how this is going to play out still is a little unclear," Tillman said in a July 2 interview with "The Gray Sheet." "We are in the process of trying to work through some of the nuts and bolts of how we are going to actually make interactive review work."
The House plans to vote on the user fee reauthorization bill as part of a broad FDA package as early as this week. The bill, passed by the Senate in May, would provide more stable user fee revenue for FDA and more predictable payment rates for companies, the parties agree.
Of perhaps more significance to the day-to-day work of agency reviewers, the bill comes with a new set of premarket performance goals. The goals for the current user fee program are dominated by "cycle" goals, instructing reviewers, for instance, to take a "first action" on a PMA review with a major deficiency letter within 150 days or a "second or later action" within 100 days on an expedited PMA.
The reauthorization bill does away with these interim targets, focusing completely on final decision timelines. As an alternative to FDA taking formal actions when reviewers have questions about a submission, manufacturers negotiated an agreement with the agency to put more emphasis on simply giving companies a call or an email to work things out.
The agreement grew out of frustration on the part of both companies and agency staffers that the cycle goals were actually prolonging reviews by putting pressure on ODE to take actions like issuing a major deficiency letter, which stopped the review clock until the company responded.
"As you soon as you start talking about, 'We are not going to put things on hold, we are going to interact,' a whole lot of procedural things come up," Tillman says. "When do you stop the clock versus when do you work interactively with the company?" is the question her office is now asking itself.
Further, ODE frequently assigns teams of reviewers to handle different parts of an application. The office needs to figure out if one reviewer should go ahead and contact a company when he or she is ready, or wait for the team, she noted.
Interactive Review Guidance Is Top Priority
Thinh Nguyen, head of ODE's premarket approval section, has been assigned to address these and other questions as part of a one-year detail to head up ODE's implementation of the reauthorized user fee program.
Nguyen's first priority is to jump-start work on an interactive review guidance document, which FDA has committed to as part of its user fee agreement with industry. He has already assembled a team to develop the guidance and is determining what other guidances need be written or updated, according to Tillman.
In addition, Nguyen will have teams create internal processes for meeting the 2008-2012 performance goals, which are generally tighter than current goals, while incorporating interactive review.
Both FDA and industry reps are confident that Congress will approve the user fee legislation, and are pushing for a House vote and Senate-House conference agreement before Congress takes off for the month of August. If the bill is not finished by then, FDA would need to start making budget cuts to plan for the contingency of having no user fee revenue. "That is not a situation anybody here wants to be in," Tillman said.
- David Filmore
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