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In The Spotlight
On March 28, 2003, Tommy G. Thompson, Secretary of the United States Department of Health and Human Services (HHS), announced the publication of a proposed draft guidance to protect human-research subjects from the risks of harm possibly arising from researchers' financial conflicts of interests. See “Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection,” which is posted at www.fda.gov/ohrms/dockets/GUIDANCES/DGUIDES.htm. Because of shrinking revenues, more and more physicians during the past decade have become involved with privately sponsored research as a way of augmenting their incomes, even though they have not necessarily understood the fraud and abuse risks involved, nor are they fully appreciative of the reasons for fully disclosing to patients they enroll in such studies these financial conflicts of interest.
As I noted in Fraud and Abuse Issues in Private Clinical Pharmaceutical Research, 3; Health Care Fraud & Abuse Newsl (Dec. 2000), “The Office of the Inspector General (OIG) issued a 'Fraud Alert' in August 1994 concerning payments by pharmaceutical manufacturers. [This Fraud Alert] … demonstrat[ed] the agency's continued concerns about certain pharmaceutical manufacturers improperly characterizing the payment of substantial funds to physicians as 'research grants' under circumstances where the grant recipients performed minimal services.”
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.
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.