The Department of Health and Human ...

The Department of Health and Human Services (HHS) Secretary Tommy G Thompson lately announced new regulations of the U cheer and Drug Administration (FDA) designed to streamline the proces of making safe, effective generic medicines available to the public more rapidly. The fresh regulations will limit pharmaceutical companies to solitary one 30-month "stay" on a generic drug's access into the market for resolution of a patent challenge, and will change the FDA's review courses to improve the speed and curtail the cost of determining that a recent generic drug is safe and effective. The FDA estimates that these changes will save consumer $35 billion across 10 years. President Bush's fiscal year 2004 parcel request includes a $13 million increase for the FDA's generic mix with drugs program. This increase in stores will allow the FDA to hire 40 dexterouss in its generic drug program to review generic physic applications more quickly and initiate targeted research to expand the range of generic unsalable articles that are available to consumer The FDA also will provide additional guidance to assist manufacturers of generic medicines in preparing and submitting high-quality, unimpaired applications. The new resources and reforms are wait fored to reduce the total time to approval for in the greatest degree generic drugs by at least three month during the nearest three to five years. The strange regulations will take effect August 18 2003 For more information in succession these new regulations go online to www.fda.gov/oc/ initiatives/generics.

COPYRIGHT 2003 American Academy of Family Physicians

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