In the Aftermath of Parens Patriae: Can Private Copycats Still Sue?

Posted on April 2013 by James M. Beck, Counsel, Reed Smith LLP

This issue of our Policy Forum (Volume 3, Number 8, April 24, 2013) — In the Aftermath of Parens Patriae: Can Private Copycats Still Sue? — explains that pharma...read more

Out on a Limb: How Will the Prohibition of Biomedical Research Using Chimpanzees Harm Public Health?

Posted on March 2013 by Fern P. O’Brian, Partner, and Barbara A. Lum, Associate, Thompson Hine, LLP

In this issue of our Policy Forum (Volume 3, Number 5, March 13, 2013) – Out on a Limb: How Will the Prohibition of Biomedical Research Using Chimpanzees Harm Public Health? – examines ...read more

This issue of Policy Forum (Volume 3, Number 4, February 27, 2013) explains the requirements under the Patient Protection and Affordable Health Care Act’s Physician Payment Sunshine...read more

What Does the Second Circuit’s Recent Decision in United States v. Caronia Not Say?

Posted on February 2013 by Geoffrey R. Kaiser, Founder, Kaiser Law Firm, PLLC; Former Chief of Healthcare Fraud Prosecutions, United States Attorney’s Office for the Eastern District of New York

This issue of Policy Forum (Volume 3, Number 3, February 13, 2013) — "What Does the Second Circuit’s Recent Decision in United States v. Caronia Not Say?" — deconstructs the landm...read more

This issue of Policy Forum (Volume 3, Number 2, January 23, 2013) – “Should DEA Provide Guidance and Conduct Rulemaking on Suspicious Orders to Ensure a Balanced Approach to Reduce...read more

Enforcement Discretion: How Can FDA More Reasonably Regulate Autologous Stem Cell Procedures?

Posted on December 2012 by Andrew S. Ittleman, Partner at Fuerst Ittleman David & Joseph PL

In this issue of our Policy Forum (Volume 2, Number 24, December 26, 2012) – Enforcement Discretion: How Can FDA More Reasonably Regulate Autologous Stem Cell Procedures?”- summarizes h...read more

The Role of the Pharmacist Revisited: Should the Changing Role of Health Care Impart the Obligation of a Pharmacist to Warn?

Posted on December 2012 by Roseann B. Termini, Adjunct Professor at Widener University School of Law

This issue of Policy Forum (Volume 2, Number 23, December 12, 2012), The Role of the Pharmacist Revisited: Should the Changing Role of Health Care Impart the Obligation of a Pharmacist to Warn?, pr...read more

It’s All About the Name: What is the Imperative of Adopting Unique Names for Biologic and Biosimilar Therapeutics

Posted on November 2012 by Richard Dolan, M.D., Chairman of The Alliance for Safe Biologic Medicines (ASBM); The Alliance for Safe Biologic Medicines

In this issue of Policy Forum (Volume 2, Number 22, November 28, 2012), “It’s All About the Name: What is the Imperative of Adopting Unique Names for Biologic and Biosimilar Therapeutic...read more

by Victoria W. Girard The next issue of Policy Forum (Volume 2, Number 20, October 24, 2012), Reducing Unlawful Prescription Drug Promotion: Is the Public Health Being Served by an Enforcement...read more

by Marc Boutin Policy Forum (Volume 2, Number 15, August 8, 2012) explores implementation options for the long-awaited Prescription Drug User Fee Act V (PDUFA V) – How Should FDA Align B...read more