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New Uncertainty Regarding Disclosure of Adverse Effects

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By Laurence A. Weiss
Genetic Engineering & Biotechnology News 
November 23, 2009

Laurence A. Weiss' article, "New Uncertainty Regarding Disclosure of Adverse Effects," was published in Genetic Engineering & Biotechnology News on November 23, 2009.

From the article...

"Are publicly traded drug companies required by the federal securities laws to disclose reports of adverse drug experiences that they learn of during ongoing clinical trials? For years, a decade-old federal appeals court decision, In re Carter-Wallace Sec. Litig., has provided guidance on this matter.

Under Carter-Wallace and subsequent federal court decisions, disclosure is required only if and when those reports “provide statistically significant evidence that the ill effects may be caused by—rather than randomly associated with—use of the drugs and are sufficiently serious and frequent to affect future earnings,” or, absent a statistically significant link, if the company has actually reached the conclusion that, as a result of the safety issue, the drug is unlikely to be approved or marketed."

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