GDUFA Reauthorization: GPhA and Catalent Make Specific Requests

Regulatory NewsRegulatory News | 27 April 2016 |  By 

As the US Food and Drug Administration (FDA), industry and other stakeholders continue to meet and discuss what provisions the next iteration of the Generic Drug User Fee Act (GDUFA) should contain in 2017, both the Generic Pharmaceutical Association (GPhA) and contract manufacturer Catalent, among others, have outlined particular requests.

Since 2012, when the first $1.5 billion GDUFA program was created to provide FDA with industry funds to ensure a more consistent timeline for generic drug approvals, FDA has had to deal with a backlog of about 6,000 Abbreviated New Drug Applications (ANDAs).

More than 90% of those 6,000 applications have received some kind of review or communication from FDA officials, and in October 2016, companies can expect to get a response within 10 months from FDA (rather than the 15 months that it currently takes FDA to respond).

In the latest GDUFA reauthorization meeting between FDA and stakeholders on 12 April (the 7th of such meetings conducted so far), FDA provided an overview of the three industry negotiation meetings, which were focused on metric review goals and/or program enhancements for submissions in GDUFA II, including ANDAs, Prior Approval Supplements (PASs), and Drug Master Files (DMFs).


In comments submitted to the reauthorization docket, GPhA raised questions on two of the three main tenets of the program: access and transparency (the third is safety).

“To date approximately $900 million has been invested into the program resulting in (1) decrease transparency, in particular meaningful communications, (2) decrease predictability for industry and (3) decrease access for patients,” GPhA contended. “Although we commend FDA for exceeding the hiring metric of bringing on board more than 1,000 new hires to help ‘move the freight.’ Industry has experienced considerable and unforeseen ‘pain’ during the transitional phase of GDUFA.”

In terms of transparency, GPhA claims that “extensive new restrictions on industry-FDA communications are contrary to the GDUFA agreement and are diametrically opposed to the Agency’s public comments regarding communications with industry.” The generic industry group recommends that for ANDAs that are not subject to any performance metric, and for those ANDAs for which the review timeline may exceed the performance goal, that FDA provide routine communications regarding the status of reviews and inspections, as well as anticipated action timelines.

And as far as access, the group contends that since the passage of GDUFA, FDA’s Office of Generic Drugs’ median review time to approval has continued to rise.

“When the program was negotiated in FY2011, median review time to generic approval was at 30 months. Since then, median review times increased to 31 months in FY2012, 36 months in FY2013, an estimated 42 months in FY2014 and between 48-50 months for FY2015.”

However, FDA has said that its ANDA and other approval numbers have been improving since GDUFA was created, particularly for first cycle approvals of generic drugs, with the average calendar days to full approval falling from 768 days in FY 2013 to 537 days in FY 2014 to 316 days in FY 2015.


Meanwhile, contract manufacturer Catalent calls on Congress to re-apportion the GDUFA user fees, in particular facility fees.

“Currently, the ANDA holder, which is the party that stands to gain the most from FDA's efficient review and speedy approval, pays only 24% of fees, while the majority of the funding for the generic drug review program is assessed against finished dosage form (‘FDF’) manufacturing and packaging facilities (56%), drug master file holders (6%) and active pharmaceutical ingredient facilities (14%). An unintended consequence of this fee structure is that it discourages third-party manufacturers and service providers from supporting generic drug application sponsors and ultimately decreases competition for these offerings, thereby potentially raising costs for consumers, contrary to the entire purpose of the GDUFA program.”

Catalent also says that GDUFA should be clarified so that FDF facility fees do not apply to a facility only acting as a clinical manufacturer or clinical packager in support of ANDA approval.

“Facilities performing only this sort of clinical work (whether the clinical testing is done pre- or post-approval) and NOT performing commercial manufacturing or commercial packaging for generic drug products generally are not inspected as part of an ANDA approval, so treating a clinical manufacturer or clinical packager as an FDF facility is an overly broad interpretation of the GDUFA legislation and contrary to its intent,” the company said.

GDUFA Reauthorization Stakeholder Meetings

Generic Drug User Fees; Public Meeting; Request for Comments


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