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Adverse Event Reporting for Pharmaceutical Products
The Food and Drug Administration (FDA) provides some protection to drug companies regarding adverse event reports by allowing a disclaimer statement about liability. However, this is not a blanket defense against other potential liability exposure.
According to the FDA's regulations, drug companies with approved marketing applications must report certain types of adverse drug experiences or adverse events (AEs), depending on the nature of the facts and within specific periods of times. 21 C.F.R. ' 314.80. The FDA defines “adverse drug experience” as “any adverse event associated with the use of a drug in humans, whether or not considered drug related ' .” 21 C.F.R. ' 314.80(a). However, the FDA recognized that companies would be reluctant to disclose such AE information for fear of government prosecution or potential liability concerns. Therefore, the agency provides:
A report or information submitted by an applicant under this section (and any release by FDA of that report or information) does not necessarily reflect a conclusion by the applicant or FDA that the report or information constitutes an admission that the drug caused or contributed to an adverse event. An applicant need not admit and may deny, that the report or information submitted under this section constitutes an admission that the drug caused or contributed to an adverse effect ' .
21 C.F.R. ' 314.80(k).
The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
The DOJ's New Parameters for Evaluating Corporate Compliance Programs
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.
Use of Deferred Prosecution Agreements In White Collar Investigations
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.
Bankruptcy Sales: Finding a Diamond In the Rough
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.
A Lawyer's System for Active Reading
Active reading comprises many daily tasks lawyers engage in, including highlighting, annotating, note taking, comparing and searching texts. It demands more than flipping or turning pages.