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Drug & Device News
Manufacturer Goes to Court to Challenge FDA's Restrictions on Off-Label Drug Use Promotion
In a May 7 filing with the U.S. Securities and Exchange Commission (SEC), the pharmaceuticals manufacturer Amarin Pharma, Inc., a wholly-owned subsidiary of Amarin Corporation Plc, announced that it had filed suit in the U.S. District Court for the Southern District of New York seeking a declaration permitting it to share truthful and non-misleading information about its drugs with U.S. health care professionals, even if the Food and Drug Administration (FDA) considers those declarations non-permissible promotion of off-label drug use. The lawsuit claims that regulation of truthful and non-misleading information is unconstitutional under the First Amendment ' because it curtails freedom of speech ' and under the Fifth Amendment ' because the FDA's regulation is vague as applied to the company's proposed promotion of its drug, Vascepa, a prescription omega-3 fatty acid.
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.