Generic Initiative for Value and Efficiency (GIVE)

GIVE is an FDA effort to improve the Office of Generic Drugs' (OGD’s) review process to increase overall review efficiency and assure that greater numbers of generic drug products are available to the American public as soon as possible.  The goals of GIVE include increasing the number of applications reviewed, and facilitating review of applications to make more lower-cost generic drugs available promptly.

During the last three to four years, the number of abbreviated new drug applications (ANDAs) submitted to OGD has increased dramatically, resulting in a growing list of pending applications.  During this time, OGD has made a number of successful process improvements.  GIVE consolidates these individual efforts into a coordinated plan to address the growing workload and to increase the efficiency of OGD reviews.   We believe that prompt review of generic drug applications could provide access to additional lower-cost generic drugs for the American public. (See Generic Competition and Drug Prices.) 

It is OGD's responsibility to ensure the quality of generic pharmaceutical products to enhance the health of the American public through its review of product applications.  During the last few years, OGD has steadily increased the number of application approvals through increasingly efficient review of higher quality applications.  In fact, the Office approved a record number of generic drug applications in FY 2007.  With the advancement of medical science and the related increasing costs of healthcare and of disease prevention, the role played by generic drugs has dramatically increased.  To respond to the increased number of applications for generic drugs it receives for review, OGD has committed to increase productivity and to consider additional revisions to review processes to make more lower-cost generic drugs available promptly to the American public.  These efforts are being consolidated under the “GIVE” program – the Generic Initiative for Value and Efficiency. 

GIVE is a review-oriented program that is focused on:

• Mobilizing staff efforts to increase review productivity 
• Optimizing the capacity and capability of all assets within the Office and leveraging wherever possible resources from other FDA components
• Using every avenue possible to recruit, hire, and train reviewers for our critical need areas
• Utilizing new application review procedures to increase the number of lower-cost  generic products available to consumers

Implementation of the Initiative

Within the last few years, receipt of ANDAs has consistently outpaced the Office’s ability to assess the applications.  Even before unifying efforts under the “GIVE” umbrella, OGD has been diligently identifying, and implementing new review efficiencies.  The process improvements already adopted include:

• Revising the review order for certain applications.  First generic products, for which there are no blocking patents or exclusivity protections on the reference listed drug, are identified at the time of submission for expedited review.  
• Using a new review process for the chemistry, manufacturing, and controls information in the ANDA called “Question-based Review.”  The process is based on the Quality Overall Summary and other components of the common technical document (CTD) and uses the principles of quality-by-design.
• Completing team reviews in the Divisions of Chemistry of multiple applications for the same drug product, including early review of drug master files (DMFs) to ensure timely resolution of any issues.
• Encouraging sponsors to submit bioequivalence data in summary table format to enable a more rapid review of data.
• Concluding the review of changes being effected (CBE) supplements with an approval, if appropriate, at the same time it is determined the proposed change qualifies as a CBE supplement.
• Capitalizing on the capabilities of regulatory project managers in the divisions of chemistry and bioequivalence, including acting on administrative supplements and responding to requests for information.
• Developing mechanisms to leverage the power of the Internet to provide dissolution and bioequivalence information, quality overall summary templates, bioequivalence data table formats, and microbiology review templates to the industry to ensure submission of full documentation of the quality of the products.
• Increasing direct communication with individual sponsors and industry as a whole through communication about application specific matters and providing training to the industry in meetings and Webcasts.

The GIVE program was conceived to unify and enhance these efforts.  The program will focus staff efforts on program goals and provide background and impetus for development of additional review efficiencies.  Additional changes anticipated include, but are not limited to:

• A continued focused hiring plan, using currently available resources, to address critical review staff needs.
• Using the Office of Pharmaceutical Science to augment review capability in microbiology (critical need area).
• Identification of supplements for low-risk manufacturing changes that may qualify for a less intense level of review.
• Base risk decisions on manufacturer’s product and process understanding and the robustness of their internal quality system to control their processes.
• Enhanced use of electronic programs for handling submissions and internal documents.
• Supplement reduction for low-risk products.
• Consideration of additional changes to application procedures to increase the availability of more lower-cost generic alternatives to the American public.

Benefits of the Initiative

OGD expects the initiative to have positive results in the near term and believes it will increase the review capability of the Office with the existing staffing.  GIVE will also provide an efficient process and solid foundation for maximizing resources from a proposed user fee program.  Anticipated benefits from GIVE include:

• Increased review and approval of ANDAs in FY 2008
• Availability of more generic options for consumers
• Program growth and additional career opportunities for review staff
• Greater efficiency in document handling, storage, and retrieval

The Office of Generic Drugs is a cohesive and dedicated cadre of scientists and professionals.  It is with pleasure that the group is embarking on this new effort to better serve the American public.

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Date created: October 4, 2007

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