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News Release

PRESIDENT TO PROPOSE $13 MILLION INCREASE
TO IMPROVE AMERICANS' ACCESS TO GENERIC DRUGS

President Bush will propose a $13 million increase in the budget for the Food and Drug Administration (FDA) to improve Americans' access to low-cost generic drugs, HHS Secretary Tommy G. Thompson said. The proposed increase is part of HHS' fiscal year 2004 budget request and will expand on the department's efforts to improve access to prescription drugs.

"President Bush's proposed budget would speed up generic drug reviews to make safe, effective generic drugs available to consumers who want lower-cost alternatives to popular brand-name drugs," Secretary Thompson said. "Prescription drugs play a critical role both in treating illnesses and preventing serious diseases, and we are committed to making them more affordable and accessible for all Americans."

FDA can approve generic drugs for the marketplace as soon as the patent protection on branded drugs expires. The generics' manufacturers must demonstrate to the FDA that their products are therapeutically equivalent to an approved brand-name drug in terms of safety, strength, quality, purity, performance, intended use and other characteristics. Generic drugs generally are sold at a fraction of the price of their brand-name equivalents.

The FDA would use the additional resources to hire about 40 new experts in its generic drugs and related programs. With these additional resources:

• FDA would review the safety and effectiveness of generic drug applications more quickly, shortening the average review time by about two months.

• FDA would initiate targeted research needed to establish additional standards for therapeutic equivalence to expand the range of generic drugs available to consumers.

• FDA would work to help ensure approved generic drugs are used safely and without avoidable complications.

The budget proposal builds on other HHS regulatory efforts to speed the availability of generic drugs and reduce prescription costs for consumers. In October, President Bush and Secretary Thompson announced a new FDA proposed regulation that would eliminate the current practice that allows manufacturers to repeatedly obtain 30-month stays to block the approval of generic versions of their drugs. The proposed regulation would also prevent manufacturers from blocking generic competition by using certain types of patents that do not reflect real medical innovation.

"The President's budget plan will expand our efforts to provide American consumers with some relief from the high prices that they frequently pay for prescription drugs," Secretary Thompson said. "By investing more heavily in generic drug reviews and research, we have the potential to save consumers billions of dollars in prescription drug costs."

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Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.

Last Revised: January 24, 2003