Three recent developments have raised the stakes for pharmaceutical and medical-device companies considering whether to disclose reports of "adverse events" and to whom those disclosures should be made:
• In February, the U.S. Food and Drug Administration (FDA) released new guidelines detailing how it will target and prosecute corporate officials for violations of the Federal Food, Drug, and Cosmetic Act (FDCA), including a renewed effort to impose charges stemming from a company’s failure to disclose serious adverse events.
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