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Drug & Device News
To Combat Drug Shortages, President Orders Changes
President Obama issued an executive order on Oct. 31 directing the FDA to take three steps to lessen the incidence of shortages of important drugs. The agency was instructed to: 1) report potential shortages of important prescription drugs; 2) speed up the review of applications to manufacture these drugs; and 3) report suspicions of collusion or price gouging concerning these drugs to the U.S. Department of Justice (DOJ). Although legislation dealing with the same concerns prompting the executive order has been pending in Congress since early this year, little has been done with the proposed measures. At the same time, a record number of drug shortages have been reported this year, with patients being required to try less effective drugs because the recommended ones simply are not available. Some of the blame for these shortages goes to supply disruptions that occur after safety issues arise at manufacturing plants, shutting down production until satisfactory changes can be made. Other shortages may be caused by ingredient supply-line problems
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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.
How AI Has Affected PR
When we consider how the use of AI affects legal PR and communications, we have to look at it as an industrywide global phenomenon. A recent online conference provided an overview of the latest AI trends in public relations, and specifically, the impact of AI on communications. Here are some of the key points and takeaways from several of the speakers, who provided current best practices, tips, concerns and case studies.
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.