Industry and FDA appear largely in agreement on goals for the generic drug user fee program after it gets off the ground, but are stuck on how to determine agency performance in its early years.

Industry representatives indicated at a June 9 negotiation early program goals still need attention, including how FDA can show progress before new hires are fully trained and new systems built, according to meeting minutes.

The agency appeared uninterested in committing to metrics right after launching the new program.

FDA indicated progress could be measured through a series of “efficiency enhancements” that would be implemented when the program is launched. Those included transparency improvements such as issuing “complete response” letters and allowing division level application deficiency reviews, according to the minutes.

The agency also indicated it would improve sponsor communication through “rolling review” with increased communication, if needed, and allow teleconferences with agency staff after an application receives its first “complete response” letter.

Performance measurements for the first two years of the GDUFA program were not attainable because funds would be diverted to train new staff members, the agency said. Historically, the generic drug program has not received enough appropriations to handle the reviews while training employees.

Industry agreed not to require performance metrics for years one and two if FDA would push to maintain its track record from the launch of the program through year two, according to the minutes.

Program Goals Talk To Continue

Both sides agree on most of the goals to be reached by the end of the first five-year GDUFA cycle, including those for application review and inspection times, risk-adjusted surveillance inspections every two years for domestic and foreign sites, and eliminating the backlog of pending applications.

Both sides also have agreed user fee revenue should be between $250 million and $300 million. Revenue generation would be split so active pharmaceutical ingredient manufacturers would pay 20% and finished dose firms would pay 80% (Also see "Generic User Fees: API Manufacturers To Pay Less Than Finished Dose Firms" - Pink Sheet, 20 June, 2011.).

Additional discussions are needed on early goals for ANDAs, amendment and prior approval supplement reviews and application quality improvement, both sides said, according to the minutes.

FDA and industry were scheduled to continue talking about finalizing program goals at a June 24 meeting, although minutes of that meeting have not been released.

Talks have missed FDA’s original late June deadline and have been extended to the end of July. A Generic Pharmaceutical Association spokesman said progress is being made and the goal is to reach an agreement by then even though it is difficult to be certain of a timeframe.

Details of the user fee structure will not be negotiated until goals are finalized.

The hope is to include the agreement in an omnibus bill that will include the PDUFA and Medical Device Modernization and User Fee Act reauthorizations, which are set to expire in October 2012 (Also see ""Mega-UFA" Is Behind Schedule; Combined User Fee Bill Will Be Difficult, But Still Expected" - Pink Sheet, 14 February, 2011.).

Prescription Drug User Fee Act review goals were phased in when the program was created in 1992. FDA was allowed two years to eliminate its backlog of NDAs and also was expected to cut the average standard NDA review time from 20 months to 12 months.

The agency also phased in the percentage of NDAs and supplements it would review within goal times during the first five years of the program (Also see "FDA USER FEE LEGISLATION SET FOR SENATE LABOR & HUMAN RESOURCES HEARING ON SEPT. 22; Rx-TO-OTC SWITCH APPLICATION FEES ADDED TO BILL DURING HOUSE MARKUP" - Pink Sheet, 21 September, 1992.).

Agency Borrows Submission Quality Argument From PDUFA

Submission quality remains a point of contention among the two sides and will require additional discussion.

Industry and FDA agreed some unsolicited application amendments would not disqualify an application from the performance goal, but industry said it is concerned about an agency proposal that would not create a review metric for unsolicited amendments, according to the minutes.

Quality applications could suffer without a performance goal included for amendments that could be required because of unexpected supplier or other changes, industry argued in the minutes.

FDA spent much of the PDUFA negotiations advocating for improved application quality as a way to speed reviews.

In the pending PDUFA V commitment letter, the agency included a pre-submission meeting between sponsors of new molecular entity NDAs and novel BLAs and agency officials to determine the items that will arrive with the original submission and those that could arrive later (Also see "Pre-NDA Work Takes Added Importance As PDUFA V Stretches Review Cycle" - Pink Sheet, 9 May, 2011.).

By Derrick Gingery

Generic User Fee Talks: Performance Metrics For Early Years Still Unresolved

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