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Drug & Device News
Bayer Holds Information Back from FDA
Despite the fact that Bayer Pharmaceuticals representatives participated in a Food and Drug Admin-istration (FDA) public meeting Sept. 21, held to assist the Agency in assessing the safety of Bayer's drug Trasylol' (aprotinin injection), they made no mention of a troubling study Bayer had conducted that found several potential life-threatening problems with the heart surgery medicine. On Sept. 29, the FDA announced, 'FDA was not aware of these new data when it held the Sept. 21, 2006, Advisory Committee meeting on Trasylol safety. FDA is actively evaluating these new data and their implications for appropriate use of the drug.' The new data show that use of Trasylol may increase the chance of death, serious kidney damage, congestive heart failure and strokes. The FDA has advised that, while it conducts its evaluation of both the new and old safety information, physicians should continue using Trasylol where needed but carefully monitor patients for the occurrence of toxicity, particularly in the kidneys, heart, or brain.
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.