National Consumers League Urges FDA To Expedite Decision On Generic Prilosec

        WASHINGTON, DC—The National Consumers League today urged Health and Human Services (HHS) Secretary Tommy Thompson to see through AstraZeneca’s “thinly veiled attempts” to delay the Food and Drug Administration's (FDA) final marketing approval for generic versions of Prilosec and to see that the lower-priced equivalent of this top-selling medication is made available to consumers as soon as possible.

NCL is responding to the British pharmaceutical giant’s new stall tactic, made public on Oct. 2, to delay a generic Prilosec from coming to market. Prilosec is the world’s best-selling drug and the fifth-most prescribed in the U.S. Just three days before the basic compound patent on Prilosec was to expire, AstraZeneca suggested the FDA explore “chemistry” issues in regard to the generic drug’s manufacturing process, an issue that AstraZeneca claims is inherent in the process, but has not affected its own product for the 12 years it has been on the market.

Also sharing her comments with Congress, Golodner explained, “This underscores why our laws must be reformed. These stall tactics threaten to wipe out all the savings that should be made available to the public over the next five years as some of our most popular—and expensive—drugs lose their patent protection. That should mean savings for many Americans, including senior citizens who use most of the prescription drugs on the market.”

It is estimated that consumers could save more than one billion per year, or $40 per prescription, once generic Prilosec is made available.

The National Consumers League, founded in 1899, is America's pioneer consumer organization. Our mission is to identify, protect, represent, and advance the economic and social interests of consumers and workers. NCL is a private, nonprofit membership organization. For more information, visit www.nclnet.org.

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