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Accessing Experimental Drugs Through the Compassionate Use Doctrine
In last month's issue, we discussed how Jacob Gunvalson, when denied entry into a clinical trial for a drug that might offer valuable treatment for his terminal disease, Duchenne Muscular Dystrophy (DMD), sued the drug manufacturer to compel it to seek a “compassionate use” exemption from the FDA so that he could take the unapproved drug, PTC 124. In conjunction with that suit, he sought a preliminary injunction, which the district court granted. The drug's manufacturer, PTC Therapeutics Inc., appealed to the U.S. Court of Appeals for the Third Circuit, in Gunvalson v. PTC Therapeutics Inc., Slip Copy, 2008 WL 5227189 (C.A.3 (N.J.), 12/16/08).
The Third Circuit Reverses
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.
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.
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.