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Regulatory Issues

Health Of Drug Industry Depends On Reducing Patent Litigation

Published in Medical Letter on the CDC and FDA, June 24th, 2001

"We need to find a way to better use the energy and funds now being directed at gimmicks and litigation," says Gerald F. Meyer, former U.S. Food and Drug Administration (FDA) deputy director of the Center for Drug Evaluation and Research, about the process for allowing innovative drugs to be produced as generics.

He sees misdirected energy and dollars spent on litigation or circumventing intellectual property rights protections as "exceptional and unfortunate - and generally destructive in terms of drug development in [the U.S.]" He calls instead for members of industry, the Food and Drug Bar, and congressional committees to work together to carve out a fair approach...

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