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Medicare Drug Program News
New FDA Program Aims at Making More Low-Cost Generic
Drugs Available
Faster approval, more options for consumers, health
professionals
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FDA's New
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Oct. 5, 2007 - The U.S. Food and Drug
Administration yesterday outlined a program aimed at increasing the
number and variety of generic drug products available to consumers and
health care providers. Generic drugs generally cost less than their
brand-name counterparts and competition among generics has been a key
factor in lowering drug prices, which can be critically important to
senior citizens burdened with drug costs.
The Generic Initiative for Value and Efficiency, or
GIVE, will help the FDA modernize and streamline its generic drug
approval process.
The agency approved or tentatively approved a
record of 682 generic drugs products in fiscal year 2007, over 30
percent more than the previous year.
To keep pace with the increasing number of generic
drug applications, FDA will implement some changes to the generic drug
approval process, said Gary Buehler, director of FDAs Office of
Generic Drugs. The GIVE plan outlines ways to maximize the use of our
resources so that FDA can review and approve even more high quality
generic drugs during the upcoming fiscal year than it did in 2007.
As part of the GIVE efforts, FDA is revising the
review order for certain drug applications. 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.
FDA
now has about 215 full-time staff working on the review of generic drug
applications. Under GIVE, FDA will hire and train new generic drug
reviewers and focus on enhanced use of electronic programs for handling
drug submissions and internal documents. When possible, resources from
other FDA departments will be engaged in the effort. As well, FDA will
increase its communications with generic drug manufacturers and provide
training on proper application submission to the industry in meetings
and Webcasts.
Generic drugs undergo a rigorous scientific review
to ensure that they are of high quality, safe, and effective. Generic
drug manufacturers must demonstrate that a generic drug has the same
dosage form, strength, route of administration, and conditions of use as
the approved brand-name product. Generic drug manufacturers also must
demonstrate bioequivalence, meaning they show that the drug delivers the
same amount of its active ingredient in the same amount of time as the
brand-name counterpart. Bioequivalence is a critical requirement for
concluding that the original and generic drugs will produce the same
therapeutic results.
 Consumer
Q&A on FDA's New Generic Drug Program with Gary J. Buehler, RPh.
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
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.
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.
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