About one-third of the generic drug manufacturing facilities expected to self-identify with FDA had done so with about two weeks until the deadline to set the associated user fee.

The pace does not bode well for industry’s desire to keep facility fees as low as possible under the new generic drug user fee program. It also would be another GDUFA disappointment for FDA, which saw its application backlog increase during the designated withdrawal period, rather than decrease.

As of Nov. 18, nearly 900 firms had self-identified as generic drug manufacturers as required under GDUFA, FDA said. The total is about 34% of the 2,650 facilities and supporting sites that were estimated to be required to self-identify in recent guidance.

It is unclear how many of the facilities already in the database will be charged the annual facility fee, but the figure represents only 45% of the expected 2,000 fee-paying facilities that had been used in estimating the user fee amounts during negotiations with industry.

Manufacturers had until Dec. 3 to submit their information, but FDA said in a Nov. 27 statement that it had expected more facilities to have fulfilled the requirement with so little time left.

“Of the new applications filed since Oct. 1, approximately 65% of the facilities listed in the applications have self-identified as of Nov. 18, indicating that more firms have yet to comply,” the agency said.

The consequences of non-compliance are significant, especially for ANDA holders: all finished dosage forms or APIs made at the site and all products containing APIs made at the facility will be deemed misbranded, according to FDA guidance.

The agency already has warned ANDA holders to keep tabs on the facilities listed in their submissions and ensure they are identified, if necessary ([A#00121008009]).

The self-identification requirement was included in the GDUFA agreement with industry to increase transparency and help the agency ensure it is inspecting all facilities manufacturing for the U.S. generic market. It also is necessary to determine who is required to pay the facility fee.

GDUFA was enacted in July when President Obama signed the FDA Safety and Innovation Act. The program launched Oct. 1 and includes user fees for new and pending generic drug applications as well as facilities ([A#00120716007]).

Foreign Facility Self-ID Outpaces Domestic So Far

Interestingly, more foreign than domestic manufacturers had self-identified through Nov. 18. Agency data indicate 65% of those that already complied were foreign sites, while 35% were domestic.

It is unclear why the numbers fell that way, but curious because among the reasons some in industry pushed for the user fee agreement was to ensure parity between domestic and foreign manufacturer inspections.

Mylan President Heather Bresch said because FDA had not been able to inspect foreign facilities as often as those in the U.S., it became more advantageous for some sponsors to remain outside the country Also see "Establishment Fees Protect American Manufacturing, Mylan Argues In User Fee Proposal" - Pink Sheet, 20 December, 2010..

Facility fees are expected to allow FDA to increase its army of inspectors, although the revenue is not intended to only fund inspections. The agency is expected to reach inspection parity among domestic and foreign manufacturers in FY 2017 Also see "ANDA User Fee Negotiations Finished; Backlog To Be Mostly Cleared By Year Five" - Pink Sheet, 12 September, 2011..

More Than Fee-Paying Facilities Must Self-ID

The self-identification process is completed through an online portal on the FDA website.

FDA estimated facilities would require 2.5 hours to input the necessary information Also see "FDA Explains How Generic Firms Will Self-Identify Facilities Under New User Fee Program" - Pink Sheet, 22 August, 2012..

Only facilities that make, or intend to make, APIs or finished dosage forms, or both, must self-identify and pay the fee.

Repackaging, relabeling, bioanalytical testing and other sites also must self-identify but do not have to pay the fee Also see "Generic Drug Facilities Guidance Details Who Self-Identifies, And Who Pays Fees" - Pink Sheet, 27 August, 2012..

Fee Could Increase With Fewer Facilities

FDA is expected to publish the facility fee amounts 45 days after the reporting deadline or sooner, likely in mid-January.

Fees will be determined based on the number of eligible facilities that self-identify. If fewer facilities self-identify, the expected fees likely will increase.

Facility fees should generate about 70% of total annual GDUFA revenue, which will be $299 million in FY 2013 and adjusted in subsequent years for inflation.

Finished dosage form facilities will pay 56% of the facility fee revenue and API facilities will pay 14%. The percentages will be slightly different than the subsequent four years of the program because the one-time fee for applications in the backlog in the first year will reduce the total amount to come from facilities.

In December 2011, FDA estimated API facilities would pay about $35,000 and finished dosage form facilities would pay about $150,000 per year, based on the number of facilities expected to self-identify.

The fee was structured to generate a specific amount in part to incentivize industry to ensure as many eligible facilities register as possible Also see "Generic Facility Fee Unlikely To Be Charged Until A Few Months After GDUFA Implementation" - Pink Sheet, 19 December, 2011..

That idea did not translate as other generic user fees were implemented, however.

FDA and industry created the backlog fee to help it clear its group of pending applications. The fee also was expected to force some sponsors to withdraw old or incomplete submissions.

Instead, the backlog grew in the final weeks before program launch. It is possible some sponsors preferred their application be in the backlog because the fee was lower than the cost of an ANDA submission Also see "Backlog Backfire: FDA Sees Increase In Pending Generic Applications At Deadline" - Pink Sheet, 15 October, 2012..

The backlog fee ended up set at 30% less than the initial estimate in part because of the higher volume ([A#14121024002]).

GDUFA Facility Self-Identification Pace Slow As Deadline Neared

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