An FDA Official May Get A Sammie Award

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sammieWhat is a Sammie? Each year, the Partnership for Public Service, a non-profit organization, bestows a $3,000 prize on a public servant who has made a significant contribution of some sort. And among this year’s finalists is Deborah Autor, who is director of the FDA’s Office of Compliance in the Center for Drug Evaluation and Research.

She made the final cut through her campaign to remove hundreds of prescription drugs that were never approved. For those who may not recall, a large number of drugs were marketed before Congress made successive changes to the law that required drugs to be subject to FDA approval for safety and effectiveness. This occurred back in 1962. In other words, someone at the FDA is being commended for their actions. And this began under Andy von Eschenbach’s regime.

During the past three years, the FDA has issued an increasing number of warnings and pulled some drugs off the market as part of the program Autor established (see background here and here). The agency found many “grandfathered” drugs had been changed - formulations, dosages, how they are administered - making them “new” drugs requiring FDA review and approval. Other unapproved drugs were not grandfathered, yet drugmakers ignored approval requirements. UPDATE: For the curious, no drugmakers are so far listed among the corporate sponsors.

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  1. this non profit is sponsored by corporate companies. she must be getting a thanks for all her good work for ignoring corporate public saftey issues, example johnson and johnson manufacturing problems, heparin crisis.

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