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Cape Coral, Florida

"The Entire Administration Is Firmly Committed to Increasing Awareness of the Value of Generic Products.."
FDA Commissioner Dr. Mark McClellan, February 2003

Formally known as The Drug Price Competition and Patent Term Restoration Act of 1984, Hatch-Waxman, created the framework for the more timely entry of generic drugs into the pharmaceutical marketplace.

Often referred to as the foundation of the modern generic pharmaceutical industry, Hatch-Waxman encourages market competition between brand and generic companies, resulting in significant savings and more choices for consumers.

When a medicine is first developed, the pharmaceutical company discovering the product and bringing it to the market for the first time is afforded a period of patent protection on that medicine. When the patent expires, typically after 20 years, other pharmaceutical companies can then seek approval from the U.S. Food and Drug Administration (FDA) to market an equivalent product under its chemical, or "generic," name. Sometimes, generic versions of patented products may enter the market before the expiration of a patent if that patent is shown to be invalid or if the generic version does not infringe on the patent.

The Food and Drug Administration requires that the generic pharmaceutical manufacturer must prove that their generic version of the product:

	contains the same active ingredient;
	is identical in strength, dosage form and route of administration;
	has the same indications, dosing and labeling;
	is bioequivalent;
	meets the same batch-to-batch requirements for strength, purity and quality; and,
	is manufactured under the same strict good manufacturing practice regulations as the branded pharmaceutical.

"The quality, strength and purity standards for approval of drugs sold in the United States are uniform, whether they are for generic or brand-name drugs. Generic drugs contain the same active ingredients as the brand-name drug and are just as safe and effective."
FDA Commissioner Dr. Mark McClellan, October 2002

"If one therapeutically equivalent drug is substituted for another, the physician, pharmacist, and patient have FDA's assurance that the physician should see the same clinical results and safety profile. Any differences that could exist should be no greater than one would expect if one lot of the innovator's product was substituted for another."
Roger L. Williams, M.D. (Deputy Center Director for Pharmaceutical Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration) April 1997

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