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Pharmaceutical Products and Suicide Risks
Last November, after it received reports of suicidal ideation and violent behavior in patients taking Chantix (varenicline) a prescription medication to help smokers stop smoking, the FDA issued an 'Early Communication' about the drug. Early Communications are issued when the FDA receives negative information about a medication that may or may not be a cause for concern, and further study is needed. In the case of Chantix, the FDA in February followed up its Early Communication with a more forceful Public Health Advisory and a request that Pfizer, the drug's maker, start placing new warnings about suicide risk in the drugs 'Warnings and Precautions' section. According to the FDA, the request for a label change was prompted by the agency's review of adverse event reports in which it appeared 'increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.'
This is just one of the many drugs that are now being studied again, despite already having been approved for human use, for the possibility that they may cause users to commit suicide or become violent toward others. While inquiry into the psychological effects that antidepressant, acne-control and other drugs might have on patients is not new, the current trend toward focusing a light on such problems is creating new headaches for drug developers and manufacturers, not only in the extra expenses required for more in-depth studies, but also in the number of consumers emboldened to file suits by the constant stream of headlines announcing that yet another drug may cause suicidal ideation.
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.