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Clinical Trial Transparency
There's a newly urgent push from outside the pharmaceutical research and development community to get drug firms to disclose the results of all tests conducted on new drugs, even those that don't lead to the marketing of new medications.
The latest impetus for the movement apparently came from public outrage over undisclosed unfavorable results in tests of Paxil', the antidepressant manufactured by GlaxoSmithKline. The pharmaceutical manufacturer had published test results that showed Paxil's advantages in treating depression, but did not disclose certain problems that could develop when taking the drug. Some of those unfavorable test results came to light when a researcher who had worked on the development of Paxil disclosed them at a conference. Members of the public began to ask the question: “What else are the drug companies keeping from us?” When British regulators last year asked for and received unpublished test findings for several antidepressants, they got the full story. The British conclusion: Drug manufacturers had evidence that antidepressants could engender suicidal ideation in children and adolescents, but they had failed to clue the public in to these findings. Disclosure of this information, of course, caused a good deal of consternation in the medical world, with parents and medical practitioners questioning the wisdom of giving youngsters such medications at all.
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.