In what is being described as a highly unusual move, the Celgene unit at Bristol-Myers Squibb (BMY) has backed out of a $55 million settlement of a class-action lawsuit that accused the company of hiding behind a mandated safety program in order to thwart generic competition.
A patient advocate and several pension funds had claimed that Celgene exploited an FDA program that is designed to boost safety so that it could deny samples of two of its cancer drugs, including Revlimid, which generic companies need to conduct product testing in order to win regulatory approval. Consequently, patients were precluded from spending less for medications.
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