Resources for Food and Drug Administration (FDA)

Biotechs Taking Added Care in Filings Now That FDA, SEC Can Share Info

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During the last several years, the Securities and Exchange Commission has been taking a closer look at filings and investor communications by public companies regulated by the FDA, particularly in relation to clinical trials.

Largely in response to the Martha Stewart insider-trading debacle, which involved the biotechnology stock ImClone Systems Inc., the FDA and SEC initiated new policies to make it easier for the two agencies to cooperate on biotechnology cases.

The sharing of materials between the two regulatory agencies has given rise to a more careful approach by life sciences companies preparing prospectuses, news releases, annual conference communications and other documents.

“In recent years, in particular in recent IPOs, the FDA and SEC have undertaken a tag-team approach,” said Cheston Larson, a partner in the San Diego office of Latham & Watkins LLP. “That’s not been the historical approval. Government agencies have sort of worked independently of one another.”

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