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RegLink News Partners with FOI Services on Off-Label Use Teleconference
Date:1/4/2013

Washington, D.C. (PRWEB) January 04, 2013

RegLink News - the global drug and device regulatory newsletter publisher - is kicking off the New Year with the addition of teleconferences to its list of services for the life sciences industry. Working in partnership with FOI Services, Inc., the company that pioneered access to FDA documents in the 70s, RegLink will focus on the key regulatory and policy developments in 2013. “We are excited to be branching out into a new mode of information dissemination,” said RegLink partner Louise Zornoza, “and working with FOI is a guarantee of smooth, top notch conferences. We’re confident that their delivery and our content are a recipe for success.”

The recent Court of Appeals decision in US v. Caronia (2nd Circuit, No. 09-5006-cr, December 3, 2012) will be the topic of the first teleconference, scheduled for January 10, and it will bring together two leading experts on off-label drug promotion and constitutionally protected free speech. RegLink board member and recognized First Amendment expert Alan Bennett and Supreme Court authority Doug Hallward-Driemeier, both partners at the prestigious law firm of Ropes and Gray, will provide an assessment of the potential impact of the court decision on the promotional practices of the pharmaceutical industry as well as FDA and Department of Justice enforcement policies. RegLink partner Ansis Helmanis will moderate the discussion.

The Caronia case involved a pharmaceutical sales representative convicted of misdemeanor conspiracy for making comments to a doctor about off-label use of the prescription narcolepsy drug Xyrem. Off-label use refers to use of a drug for therapeutic indications that have not been approved by the FDA. While it is common for doctors to prescribe medication “off-label” and to talk about off-label uses in various meetings and conferences, pharmaceutical companies and their representatives are not free to do so.
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