FDA Fact Sheet
New FDA Initiative on "Improving Access to Generic Drugs"
June 12, 2003
TODAY'S ACTION
The Food and Drug Administration announced reforms in its generic drug review
program, facilitated by the Administration's proposed budget increases
in generic drugs that will reduce the typical time for approving a generic
drug by 3 months or more over the next 3 to 5 years. Coupled with the
growing number of drugs coming off patent in the coming years and the new FDA
rule on generic drug competition, these steps will provide billions more in
drug savings for consumers through greater access to safe and effective generic
drugs.
DETAILS ON FDA INITIATIVE ON IMPROVING ACCESS TO GENERIC DRUGS
To achieve across-the-board improvements in the availability of safe and effective,
low-cost drugs, the new FDA initiative includes the following components:
- Unprecedented increase of $13 million in FDA resources devoted to improving
access to generic drugs: The President's 2004 budget proposes
an additional $13 million in spending for FDA's generic drug programs.
This will be the largest infusion of resources into the generic drug program
ever, increasing the program's size by about one-third.
- New regulatory processes to reduce the time and cost of generic drug
approvals: Beginning in the next fiscal year, the FDA will make significant
changes in its processes for approving generic drugs. In particular, the
FDA will implement early communications with generic drug manufacturers
to discuss their applications. FDA will increase the number of guidances
available for generic manufacturers regarding what is required to prepare
and submit quality, complete applications. FDA will also institute regular
meetings with generic trade associations to discuss the process for improving
the quality of applications and to impart information on changes in policies
and procedures.
- Enhanced public education and scientific study of generic drugs: The
FDA will expand its educational programs and partnerships involving generic
drugs, to help health care practitioners and consumers get accurate information
about the availability of generic drugs for their health care needs. FDA
will also undertake additional scientific studies of certain types of generic
drugs where adequate bioavailability methods have not been adequately developed,
to make it easier to approve these generic drugs. FDA will also enhance the
monitoring of the safety of generic drugs currently on the market.
BACKGROUND
Even with reforms in the implementation of the "Hatch-Waxman"law
governing how generic drugs compete, there are two key challenges to consumers
getting greater savings from generic drugs:
- Long approval times for generic drugs: On average, it takes more
than 20 months for a new generic drug to be approved by the FDA. Companies
need to demonstrate that their products contain the same active ingredient,
are manufactured to the same quality standards, comply with good manufacturing
practices, have similar labeling, and have the same "bioavailability"(that
is, the same availability of the active ingredient when used in the body)
as the brand-name drug. Generic drug applications take long to be approved
because it typically takes multiple "review cycles"for these generic
drugs to be approved by FDA -- a long process that adds to the costs of developing
generic drugs and significantly delays the availability of these low-cost
alternatives for consumers.
- Opportunities to improve consumer knowledge and safe use of generic
drugs: Surveys have indicated that many health care practitioners and
patients are not aware that generic drug alternatives are available, or that
the generic alternatives act the same way as the brand-name drugs -- that
they are just as safe and effective. Health care practitioners and consumers
may also be concerned about the state of scientific knowledge about generic
drugs that are available, and want assurances that the science base is strong
and that adverse events can be discovered and addressed just as quickly as
with brand-name drugs.
More Information on FDA's Generic Drugs Final Rule and Initiative
