New Generic Drug Program: Q & A with Gary J. Buehler
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Gary J. Buehler, RPh., is Director of the Office of Generic Drugs (OGD) in FDA's Center for Drug Evaluation and Research (CDER). A graduate of Temple University's School of Pharmacy, Mr. Buehler joined FDA in 1986 and retired from the United States Public Health Service in 2000.
Q: What are generic drugs?
A: A generic drug is identical to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance, and intended use. Although the active ingredient is chemically the same as the branded counterpart, a generic drug is typically sold at a substantial discount from the branded product price.
Q: If they are the same, why do generic drugs cost less than their brand-name counterparts?
A: Creating a drug and conducting clinical trials is expensive. Generic drug makers don't develop a drug from scratch or have to conduct studies to prove safety and effectiveness. As the result, their expenses for bringing generic drugs to market are less. But generic drug makers must show that their product performs in the same way as the brand-name drug.
Q: What is FDA's role regarding generic drugs?
A: CDER ensures that both brand-name and generic drugs are safe and effective, and that their health benefits outweigh their known risks. And, just as it does with brand-name drugs, the agency closely inspects generic makers' production sites and assures products approved are manufactured according to regulations regarding good manufacturing practices.
Health professionals and consumers can be assured that FDA-approved generic drugs have met the same rigid manufacturing standards as the brand-name drug.
Q: What is the Generic Initiative for Value and Efficiency (GIVE) program?
A: 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.
Q: What will the benefits of this program be for the average consumer?
A: Consumers will have timely access to safer, higher-quality generic drugs.
A more efficient regulatory and approval process will maintain FDA's high standards for generic drug products for the public, while increasing the number of available products.
Q: Why is the GIVE program necessary?
A: Over the last three to four years, the number of abbreviated new drug applications submitted to our office 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 2008.
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.
Q: How will the goals of GIVE be accomplished?
A: GIVE will work by combining our office's various efforts into one harmonized activity to implement process improvements throughout the entire program. The initiative is a review-oriented program that is focused on three main areas:
- Mobilizing staff efforts to increase review productivity.
- Optimizing the capacity and capability of all assets within OGD, and leveraging wherever possible resources from other FDA components.
- Using every avenue possible to recruit, hire and train reviewers for our critical-need areas.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Date Posted: October 4, 2008