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News from the FDA
Approval of Currently Unapproved Medicines
On Oct. 17, the FDA announced that it will aggressively crack down on the marketing of unapproved drug products. At the same time, the agency proposed new steps to assure the safety and efficacy of certain unapproved but widely marketed medicines. These unapproved drugs include medicines that were developed and marketed before modern standards for drug approval were established. The keystone to this effort is a draft Compliance Policy Guide (CPG) the agency is issuing outlining FDA policies to encourage companies to sponsor these drugs through the approval process. Many of the potentially beneficial drugs in this category could be approved based on straightforward scientific data that would not involve conducting new clinical studies of safety and effectiveness (eg, peer-reviewed medical literature, or other existing data), the FDA stated.
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.