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Drug & Device News
California's Drug Pedigree Program Delayed
The California State Board of Pharmacy has agreed to delay for two years enforcement of a new law intended to cut down on the marketing of counterfeit drugs within the State. The regulation, which was to have gone into effect on Jan. 1, 2009, calls for electronic tracking of drug products. Manufacturers and sellers of pharmaceuticals complained, however, that they would be unable to put adequate tracking systems in place in time to meet the deadline, particularly as they would not be able to segregate products meant for California from those that would go to other states and would thus have to implement the pedigree program for all production lots. Rather than break the law, some asserted that they would simply stop selling their products in California. Once the law goes into effect, possible penalties for disobedience will include criminal prosecution and fines of up to $5,000 per noncompliant unit of product.
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.
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.
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.