FDA Announces New Generic Drug Initiative

October 4, 2007

Earlier today, FDA announced a new initiative, called the Generic Initiative for Value and Efficiency (“GIVE”), which is intended to increase the number and variety of generic drug products.  According to Gary Buehler, R.Ph., Director of FDA’s Office of Generic Drugs (“OGD”):

GIVE is an initiative aimed at optimizing OGD’s generic drug review process to increase efficiency. The goals of GIVE are to approve higher numbers of applications for generic products and expedite review of applications for which there are few generics available.

Over the last three to four years, the number of [ANDAs] submitted to [OGD] has increased. This has led to a growing list of pending applications. We’ve made a number of successful process improvements during this time. In fact, the office approved a record number of applications during the past two years. We approved 510 products in 2006, and approved more than 650 in the fiscal year that just ended.

But the advancement of medical science and the related increasing cost of health care and disease prevention have caused the role of OGD and its review staff to grow. The number of firms producing generic products and the number of products each firm proposes are growing at an unforeseen pace. The improvements we have made serve to unify and enhance the review process to address the growing workload, and to increase the efficiency of our office’s review efforts.

As part of GIVE, FDA will revise the review order for certain ANDAs. “For example, 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. This will mean that these products, for which there are currently no generic products on the market, may reach the consumer much faster.”  Although there are about 215 full-time FDA staff working on ANDA reviews, under GIVE, FDA will also “hire and train new generic drug reviewers and focus on enhanced use of electronic programs for handling drug submissions and internal documents,” and, when possible, engage the efforts of other FDA components.  A diagram of how OGD will make more drugs available under GIVE is available here.

OGD’s GIVE program is the latest of several initiatives intended to accelerate the generic drug development and approval processes.  Last year, OGD announced changes to its “First-In, First-Reviewed” policy to provide for exceptions under certain circumstances (see Orange Book Blog post).  In May 2007, FDA issued its “Critical Path Opportunities for Generic Drugs,” which identifies what FDA believes are challenges in the generic drug development process and outlines some actions intended to address those challenges (see FDA Law Blog post).  Also in May, FDA announced the availability of a draft guidance document and database providing recommendations on how to design product-specific bioequivalence studies to support ANDAs (see FDA Law Blog post).

It is unclear the extent to which OGD’s GIVE initiative might or might not affect the Agency’s push for generic drug user fees.  Earlier this year, FDA proposed creating generic drug user fees as part of the Agency’s Fiscal Year 2008 budget.  The recently-enacted FDA Amendments Act does not include such a user fee program.