FDA may have to provide more information about facility inspections as part of a reauthorized generic drug user fee program.

During a recent GDUFA II negotiating session, industry representatives "highlighted the importance of transparency with respect to facility evaluation information."

The Dec. 2 meeting focused solely on FDA facility evaluations, with the agency outlining its policies toward preapproval and post-market inspections, according to meeting minutes.

Agency officials "described the considerations for each type of evaluation," as well as "explained the foreign inspection coordination and clearance process and how the facility evaluation affects application review timelines," according to the minutes.

The meeting minutes did not identify any specific industry proposals related to inspections, but compliance evaluations and inspections were one of its priorities for the renewal talks.

Among the problems that spawned the generic drug user fee program was that domestic generic drug manufacturers were inspected more often than their foreign counterparts. The practice was unfair and encouraged the movement of jobs offshore, one industry executive said Also see "Establishment Fees Protect American Manufacturing, Mylan Argues In User Fee Proposal" - Pink Sheet, 20 December, 2010..

GDUFA launched in 2012 with a mandate for FDA to reach parity between its domestic and foreign facility inspections.

The program included a self-identification requirement for a number of facilities, including active pharmaceutical ingredient and finished dosage form manufacturers, repackagers and others Also see "GDUFA: How Much Does FDA Know About U.S. Generic Market After Facility Self-Identification?" - Pink Sheet, 21 January, 2013..

The reports were intended to help FDA determine the scope of the generic industry as well as identify those facilities that should pay fees. As of Dec. 21, the listings for fiscal year 2016 included 4,201 facilities, although not all are fee-paying (see table below).

The 2012 FDA Safety and Innovation Act, which created GDUFA and reauthorized other user fee programs, also gave the agency the authority to conduct inspections on a risk-based schedule.

Domestic and foreign inspections were supposed to be more balanced. But industry officials were worried that the policy could create problems for some manufacturers who depend on FDA inspections to maintain compliance in other countries Also see "Risk-Based Inspections Might Actually Be Hurting Compliant Firms" - Pink Sheet, 6 July, 2015..

Sponsors May Seek More Inspection Information

Sponsors may want better information from FDA on whether a facility requires an inspection or whether the visit has been completed in GDUFA II.

Industry officials said in the months before the start of GDUFA II negotiations that there was a lack of information on inspection status for pending applications, according to the Generic Pharmaceutical Association's written comments submitted after a public hearing to start the user fee reauthorization process ([A#14150813004]).

Foreign inspections in particular are difficult for FDA because they require advance planning and travel.

The HHS Office of the Inspector General already has determined that even though FDA has increased the number of inspections it conducts, a backlog still exists.

The OIG report, issued in May 2015, said that a significant percentage of inspection requests remained outstanding and most were at foreign sites.

The government watchdog also suggested FDA use its FDASIA authority to request facility records in advance of an inspection to help reduce the backlog ([A#14150506008]).

Foreign facilities pay larger user fees in part to fund the inspection workload ([A#00150803021]).

Inspections Will Feed Review System

Changes to inspection policy or practice likely will feed other potential changes for GDUFA II.

FDA and industry are talking about establishing a priority review pathway for some generic drugs, which could include a shorter review goal ([A#14151106001]).

Ensuring facility inspections can be completed in a timely manner will be important for the agency and sponsors in that case.

Both sides also are discussing a pre-ANDA framework, which could include pre-submission meetings ([A#14151208001]).

Source: FDA data

GDUFA II: Inspection Information Takes Center Stage

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