Originally published by Robert Kraft.
CNBC reports that a study published in the American Journal of Clinical Oncology found that while the Orphan Drug Act has spurred development of new drugs, data suggest that pharmaceutical companies are “gaming the system to use the law for mainstream drugs.” The researchers identified what they consider “a pattern of pharmaceutical companies submitting drugs to the Food and Drug Administration (FDA) as orphan drugs but once approved, the drugs are used broadly off-label with the lucrative orphan drug protections and exclusivity benefits.” In response, the FDA said it “does not comment on specific studies, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”
From the news release of the American Association for Justice.
Curated by Texas Bar Today. Follow us on Twitter @texasbartoday.
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