Generic sponsors may find some familiar practices in upcoming updates to the Office of Generic Drugs’ communications policy.

If in the ordinary course of business regulatory project managers learn of major deficiencies that would almost certainly derail an approval in the ANDAs they are shepherding through the review process, they will inform the sponsors of them rather than wait for the entire “complete response” letter to be sent.

The idea could save sponsors months in time that would have been lost while waiting for all the review disciplines to complete their reviews. But Keith Flanagan, transition lead for the OGD Office of Generic Drug Policy, said in a Dec. 18 interview that it is not ready to be implemented yet.

“We still need to figure out how to do this in a consistent, appropriate manner,” he said.

Project managers would not actively search for major deficiencies among the ANDA reviews they are managing. However, if they learn of one, “they shouldn’t sit on that information,” Flanagan said.

FDA and industry had discussed providing some major deficiencies mid-review to allow sponsors extra time to fix the problems ([A#14140109005]).

The “go/no go” communication, as it has been characterized, also would be used to let sponsors know that an application is nearing the approval stage.

Ted Sherwood, acting director of the OGD Office of Regulatory Operations, said in an interview that notification would come when all the disciplines have completed their reviews and the application is nearing the final stages before approval. The regulatory project manager also would indicate to the sponsor that while problems still may be found, the application is advancing.

The upcoming changes are intended to ensure sponsors gain information at an earlier point in the review, when it is more valuable. Industry had complained that since GDUFA launched, determining an application’s status had become much more difficult.

The policy also would revive one of the advantages of OGD’s old business practice, under which each individual review discipline sent a letter to the sponsor outlining the problems found in the application upon completion of their work.

FDA ended that practice in favor of sending one “complete response” letter when the generic drug user fee program launched in 2012 ([A#00131111009]).

Flanagan said that these and other changes will help OGD review the large number of applications that arrived before formal goals were put in place.

They also will feed into efforts to provide sponsors real-time communications, which allow staff to contact a sponsor and resolve minor issues.

Chemistry, manufacturing and controls staff already are using the concept in their reviews in part to help cut the number of review cycles needed for ANDA approval. Between 2009 and July 2014, most applications needed two to five cycles ([A#14141205003]).

Sherwood said OGD continues to look at whether the concept could be used in other review disciplines.

FDA had taken a number of steps to try and provide more information, including giving a one-time status update for all pending ANDAs and amendments and considering a mid-cycle status update for first generics ([A#14140917005]).

Most ANDAs Without Goal Date To Get Target Action Date

Most submissions that arrived before formal review goals were implemented on Oct. 1 also will receive a “target action date.”

A TAD is not a review goal date, rather an internal time that FDA believes that it can take action on an application.

Ideally, the action taken will be an approval, Sherwood said.

FDA wants to focus on approvals, rather than the GDUFA measure of actions, which could be an approval, CR, tentative approval for an ANDA or a refuse-to-receive action ([A#14141212001]).

Target action dates will be assigned based on workload management, except for what were termed “big” or widely anticipated “first generics.” Target action dates for those applications will be timed to coincide with patent expiry.

OGD will not be assigning target action dates to the affected submissions all at once. By the second quarter of 2015, the office expects to begin telling sponsors the target action dates for their applications.

ANDAs arriving after Oct. 1 are put on a formal review clock where FDA has a designated number of months to complete its review, but submissions that arrived in the first two years of GDUFA do not have any formal goals associated with them ([A#00111212020]).

OGD received a large number of submissions in fiscal year 2014, in part because sponsors wanted to file applications before new stability requirements went into effect.

Agency officials have been looking for ways to deal with the massive workload ([A#00140630007]).

Launch Planning Updates For ‘Big First Generics’

Big first generics also will receive launch planning updates six months and three months before their target action dates.

Flanagan said the update likely will be formulaic, but will include information on the status of each discipline’s review so the sponsor can gain an idea of where in the process the application stands.

FDA’s signals likely will not be obvious in terms of an application’s direction, but sponsors should be able to determine their next steps based on the information.

What would constitute a first generic remains to be decided. FDA issued a proposed definition and asked for comments on the subject recently ([A#00141208010]).

FDA also recently issued a Manual of Policies and Procedures document on ANDA prioritization, which outlined the types of applications that could receive an expedited review Also see "ANDA Expedited Review Criteria MaPPed Out By FDA Generic Drug Office" - Pink Sheet, 18 August, 2014..

FDA/Generic Communications Plan Restoring Best Of Past Practices

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