On September 17, FDA hosted a public hearing on the Generic Drug User Fee Amendments of 2012 to solicit public comments on its guidances related to implementation of GDUFA.
GDUFA requires industry to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities. In exchange, GDUFA ideally allows FDA to use those fees on resources to expedite the review process and speed access to safe and effective generic drugs for the public while also reducing costs to industry.
FDA designed GDUFA “to build on the success of the Prescription Drug User Fee Act (PDUFA),” which created a “predictable, consistent, and streamlined premarket program” for industry and helped speed access to new, safe and effective prescription drugs for patients.
Public Hearing
FDA announced that they want input on the five draft guidance documents FDA has issued or will issue shortly to facilitate implementation of GDUFA. FDA also seeks input on additional policy priorities under GDUFA, such as the agency’s consideration of generic drug exclusivity and the category of first generics. FDA notes that they will take the information from the public meeting into account in developing the fiscal year 2015 GDUFA priorities.
Materials from the meeting can be found on the FDA website.
Regarding the public hearing, Generic Pharmaceutical Association (GPhA) President and CEO Ralph G. Neas said that more than 50 individuals representing the generic drug industry and more than 20 GPhA member companies called attention to areas where the Generic Drug User Fee Act process and implementation could be strengthened.
Naes stated: “Today, GPhA welcomes the opportunity to share collective feedback from its member companies on future FDA policy priorities, a dialogue that is particularly important as GDUFA metrics will apply starting October 1, 2014 and as GDUFA II negotiations draw near.”
“As the FDA develops fiscal year 2015 priorities, it will be important to accelerate review activities to meet our shared goals. GPhA also urges FDA to dedicate resources to address the enormous and growing backlog of Abbreviated New Drug Application (ANDA) and Prior Approval Supplement (PAS) submissions.”
“GPhA looks forward to the continued dialogue on improving GDUFA, particularly efforts to make generic drug approvals more predictable and consistent. This could include more communication with applicants and continued meaningful interaction with the generic industry during agency development of new guidance or before agency enforcement of draft guidance as final.”
As stated in the Federal Register notice, GDUFA was signed into law on July 9, 2012, to help speed the delivery of safe and effective generic drugs to the public and to reduce costs to industry. Under GDUFA, FDA agreed to certain obligations as laid out in the GDUFA Commitment Letter that accompanies the legislation. To support these obligations, FDA is developing numerous guidance documents.
Thus far, FDA has developed the following draft guidances for industry:
ANDA Submissions—Content and Format of ANDAs
This guidance is intended to assist applicants in preparing abbreviated new drug applications (ANDAs) for submission to the FDA under section 505(j) of the Federal Food, Drug and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(j)). This guidance details the information to be provided in each section of the Common Technical Document (CTD) format for human pharmaceutical product applications and identifies supporting guidance documents and recommendations issued by FDA to assist in preparing the submission. The guidance identifies the information an applicant should include to ensure that a complete, high-quality application is submitted to FDA.
ANDA Submissions—Refuse to Receive for Lack of Proper Justification of Impurity Limits
This guidance is intended to assist applicants preparing to submit to the FDA their ANDAs, and prior approval supplements (PASs) to ANDAs for which the applicant is seeking approval of a new strength of the drug product. The guidance highlights deficiencies that may cause FDA to refuse-to-receive an ANDA. A refuse-to-receive decision indicates that FDA determined that an ANDA is not sufficiently complete to permit a substantive review.
ANDA Submissions—Amendments and Easily Correctable Deficiencies Under GDUFA
This guidance is intended to assist applicants preparing to submit to the FDA amendments to ANDAs or PASs under section 505(j) of the Federal Food, Drug, and Cosmetic Act by explaining how the performance metric goals established as part of GDUFA apply to these submissions. Specifically, this guidance does the following: (i) Describes the Tier system for the different types of amendments; (ii) Explains how different types of amendments may affect the application’s original review dates; (iii) Explains FDA’s performance metric goals based on the different amendment Tiers; (iv) Explains the process for submitting amendments; (v) Describes the request for reconsideration process for FDA classification decisions.
ANDA Submissions—Prior Approval Supplements Under GDUFA
This guidance is intended to assist applicants preparing to submit to the FDA PASs and amendments to PASs for ANDAs submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act. The guidance explains how GDUFA relates to PAS submissions. The guidance also describes performance metric goals outlined in the GDUFA Commitment Letter, which FDA has agreed to meet, and clarifies how FDA will handle a PAS and amendments to a PAS for an ANDA subject to the GDUFA performance metric goals.
Specifically, this guidance describes how the GDUFA performance metric goals apply to: (i) A PAS subject to the refuse-to-receive (RTR) standards; (ii) A PAS that requires an inspection; (iii) A PAS for which an inspection is not required; (iv) An amendment to a PAS; (v) Other PAS-related matters.
Controlled Correspondence Related to Generic Drug Development
This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit correspondence to the FDA requesting information related to generic drug development. This guidance also describes FDA’s process for providing communications related to such correspondence. FDA is issuing this draft guidance as part of the Agency’s implementation of GDUFA.
We will continue to monitor the dialogue surrounding GDUFA and the eventual GDUFA II negotiations.