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June 12, 2003
HEALTH AND HUMAN SERVICES SECRETARY, TOMMY G. THOMPSON HAS ANNOUNCED NEW STEPS BY THE FOOD AND DRUG ADMINISTRATION TO STREAMLINE THE PROCESS FOR MAKING SAFE, EFFECTIVE GENERIC DRUGS AVAILABLE TO CONSUMERS. THE CHANGES INCLUDE A NEW REGULATION THAT WILL SAVE CONSUMERS AN ESTIMATED 35-BILLION DOLLARS OVER TEN YEARS BY REMOVING LEGAL OBSTACLES THAT IN SOME CASES HAVE PREVENTED GENERIC ALTERNATIVES TO MORE COSTLY BRAND NAME DRUGS FROM REACHING THE MARKET:
"All these changes together will enable consumers to save billions of dollars each year by making it easier for generic drug manufacturers in order to be able to get safe and effective products out on the market as the appropriate patent protection expires. The increased availability of lower-cost generic drugs will benefit all Americans, especially the seniors."
IN ADDITION, THE FOOD AND DRUG ADMINISTRATION IS IMPLEMENTING FURTHER REFORMS
TO REDUCE THE TIME AND COST OF GENERIC DRUG APPROVALS, AS WELL AS STRENGTHENING
INFORMATION TO CONSUMERS ABOUT THE GENERIC DRUGS THEY ARE TAKING. F-D-A COMMISSSIONER,
DOCTOR MARK MCCLELLAN:
"The reforms that we are announcing today will reduce healthcare cost without blocking the development of valuable new treatments, by speeding access to generic drugs after appropriate patent protection has expired. The reform will help improve access to just about all of the hundreds of new generic drugs that we expect to come available in the next few years, as literally hundreds of brand name medications come off patent."
MORE INFORMATION IS AVAILABLE AT FDA-DOT-GOV. I'M LEE SHEPHARD.
More Information on FDA's Generic Drugs Final Rule and Initiative