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FDA provides Fact Sheet on prescription vs. generic drugs

CLEVELAND, September 1 — On July 7, 2009, the U.S. Food and Drug Administration (FDA) posted a revised “Fact and Myths about Generic Drugs” information sheet to their website.

The Fact Sheet basically states that generic drugs are held to the same high standards as brand name drugs, and is being provided to BLET members to help them save money on their prescription drug costs.

The Fact Sheet states:

* All generics manufacturers must abide by rigorous standards established by the FDA with respect to identity, strength, quality, purity and potency.

* Generic drugs are required to have the same active ingredient, strength, dosage form and route of administration as the brand (or reference) product.

* When it comes to price, there is a big difference between generic and brand drugs. On average, the cost of a generic drug is 80 to 85 percent lower than the brand product.

The information sheet also debunks the myths:

* The FDA lets generic drugs differ from the brand counterpart by up to 45 percent.

* People who are switched to a generic drug are risking treatment failure.

* Generic drugs cost less because they are inferior to brand drugs.

* There are quality problems with generic drug manufacturing. A recent recall of generic digoxin (called Digitek) shows that generic drugs put patients at risk.

* Brand drugs are safer than generic drugs.

Please see the following PDF for more specific information:
http://www.ble-t.org/pr/pdf/FDAFactSheet-Generics.pdf

Tuesday, September 01, 2009
bentley@ble.org

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