Should FDA Assume Sole Enforcement Responsibility for Alleged Violations of the FDCA? Lessons from Recent Medical Device Enforcement and Qui Tam Cases

Posted on November 2014 by Marilyn May, Counsel, Arnold & Porter LLP
Philip Desjardins, Counsel, Arnold & Porter LLP
Lauren Haertlein, Associate, Arnold & Porter LLP

Volume 4 Issue 11 of the FDLI Policy Forum – Medical Device Enforcement Actions  Issue 11 of the FDLI Food and Drug Policy Forum, entitled, “Should FDA Assume Sole Enforcement Resp...read more

Can Bayesian Extrapolation Improve FDA Regulation of Off-Label Uses of Drugs and Devices?

Posted on June 2014 by Ryan Abbott, Associate Professor of Law, Southwestern Law School and Visiting Assistant Professor of Medicine, David Geffen School of Medicine at UCLA Ian Ayres, William K. Townsend Professor, Yale Law School

In this Policy Forum, Authors Ryan Abbott and Ian Ayres explore the issue of extrapolation arising in the regulation of medicine. The authors note this extrapolation problem can arise when physicia...read more

Do We ‘Like’ FDA’s ‘First Social Media Guidance’ or is it Nothing to ‘Tweet’ About?

Posted on February 2014 by Daniel A. Kracov, Partner, Abraham Gitterman, Associate, and Arnold & Porter, LLP

This issue of Policy Forum (Volume 4, Number 2, February 26, 2014) – Do We ‘Like’ FDA’s ‘First Social Media Guidance’ or is it Nothing to ‘Tweet’ Abo...read more

Is FDA’s Decision to Ramp-up the Postmarket Surveillance of Medical Devices the Best Way to Make Devices Safe?

Posted on December 2013 by Thomas R. McLean, M.D., J.D., FACS, Third Millennium Consultants LLC and Alexander B. McLean, Third Millennium Consultants LLC

In this Policy Forum, T. McLean and A. McLean provide an overview of FDA’s pre-market approval and post-market surveillance of medical devices, including cases studies to illustrate practical...read more

Can FDA Accelerate Clinical Trial Timelines and Completion Using Documented cGMP Processes?

Posted on October 2013 by Anton Lewis Usala, M.D., President and CEO CTMG, Inc. and Neil P. Di Spirito, Esq., Special Counsel, Rumberger, Kirk & Caldwell, P.A.

In this Policy Forum, Usala and Di Spirito argue that not requiring quality control systems in regulating clinical trials has led to submission of contradictory data to FDA, increased drug developm...read more

Do Pending State Biosimilar Substitution Bills Violate State Constitutional Law Principles of Non-Delegation and Incorporation by Reference?

Posted on September 2013 by Neal Parker Section Head, Legal, Biologics Strategic Development, AbbVie

In this Policy Forum, Parker explains that since Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) in 2010, several state legislatures have introduced and some have enacte...read more

Is Caronia the Most Important FDA Related Judicial Decision of Our Generation?

Posted on August 2013 by Ralph Hall, Professor of Practice at the University of Minnesota Law School, Of Counsel at Faegre Baker Daniels and CEO of MR 3 Medical LLC

This issue of Policy Forum (Volume 3, Issue 14, August 29, 2013)—“Is Caronia the Most Important FDA Related Judicial Decision of Our Generation?” by Ralph Hall (Professor of Pract...read more

How Can the FDA Encourage Social Media Use by Pharmaceutical and Medical Device Companies?

Posted on June 2013 by Nicole D. Galli (Partner-in-Charge of Wilmington & Philadelphia offices), James A. Brown (Associate), Christopher J. Lalak (Associate); Benesch, Friedlander, Coplan & Aronoff LLP

This issue of Policy Forum (Volume 3, Number 10, June 12, 2013) – How Can the FDA Encourage Social Media Use by Pharmaceutical and Medical Device Companies? – describes the extent to wh...read more

Medical Device Tax and Innovation: The Last Nail?

Posted on May 2013 by Gael D. Tisack, Vice President of Legal Affairs and Intellectual Property, Terumo Americas Holdings

The current issue of Policy Forum (Volume 3, Number 9, May 22, 2013) – “The Medical Device Tax and Innovation: The Last Nail?” – examines the financial impact of the 2.3% me...read more

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