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New Critical Path Report Highlights Research Needed to Foster Generic Drug Development

The U.S. Food and Drug Administration (FDA) today issued the "Critical Path Opportunities for Generic Drugs" report identifying many of the unanswered scientific// questions that impede the development of generic versions of commonly used drugs.

The report is part of FDA's Critical Path Initiative, established in 2004 to discern what challenges exist in moving a promising drug, biologic or device along the critical path from discovery, or proof of concept, to a marketable product. Solving these challenges will require the expertise and input of many groups, including scientists from universities, patient groups, government, industry, associations and other private organizations.

"This report pinpoints the barriers that are limiting the availability of additional generic drug options," said Gary Buehler, R.Ph., director, FDA's Office of Generic Drugs. "We hope these findings will encourage research collaboration, lower these barriers and accelerate access to safe and effective generic drugs."

Before they can be approved, generic drugs must have the same active ingredient, dosage form, strength, and conditions of use as the brand name drug. The drugs must also be absorbed at the same rate and in the same amount, a concept known as bioequivalence.

While straightforward tests of blood plasma levels are sufficient to demonstrate bioequivalence for most generic drug candidates, these common tests generally are not appropriate for certain drugs, including asthma inhalers, nasal sprays, and topical skin applications such as anti-fungal creams. As a result, few generic versions are available in these product categories, resulting in less competition and higher prices.

For example, generic drug products that contain the ozone-depleting substance chlorofluorocarbon will be withdrawn from the market after 2008. The new report will help ensure FDA has an adequate scientific basis to review inhaler applications that use an
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