Generic and Innovator Drugs: The Next Generation

May 7, 2013

By Kurt R. Karst –      

Growing up in the late 1970s and 1980s I was a fan of several science fiction television series and movies: Doctor Who, Star Wars, and, of course, Star Trek.  I remember well the voyages of the starship Enterprise under the command of Captain James T. Kirk (in rerun).  I also  remember the September 1987 premier of Star Trek: The Next Generation, when command of the Enterprise changed to Captain Jean-Luc Picard.  Like many Star Trek fans, I grew to like the style of Captain Picard, while still appreciating the standard set and foundation laid by Captain Kirk.  Life, like television series and the movies, is full of transitions – a “handing off of the baton.”  The Food and Drug Bar is no different. 

As I think back on my development as a member of the Food and Drug Bar, and, in particular, on my development as an attorney who specializes on drug matters, particularly with regard to the Hatch-Waxman Amendments, two memories immediately come to mind.  The first memory is as a budding attorney while working for Hoffmann-La Roche in Washington, D.C. in the late 1990s.  George Johnston, Vice President and Chief Patent Counsel at Hoffmann-La Roche, introduced me to the Hatch-Waxman Amendments.  The complexity of the statute immediately grabbed my interest.  My second memory is of being led to the library at Hyman, Phelps & McNamara, P.C. by former FDA Chief Counsel Tom Scarlett not too long after I joined the firm.  I asked Tom what publications I should read to gain an expertise in the Hatch-Waxman Amendments.  Tom picked up off the shelf a copy of Generic and Innovator Drugs: A Guide to FDA Approval Requirements authored by Donald O. Beers.  I read it and have been in awe of it ever since. 

The Eighth Edition of Generic and Innovator Drugs is a turning point for the legal treatise.  Don Beers left private practice and returned to work at FDA after completing the Seventh Edition.  As a result, Aspen Publishers/Wolters Kluwer sought another attorney to take on the task of serving as author and steward of the highly respected legal treatise.  It is a task that I am honored to take on.

The Eighth Edition of Generic and Innovator Drugs, which will be out later this month, strives to continue the high level of discussion and analysis – specifically with regard to the Hatch-Waxman Amendments, and, more generally, with regard to the FDC Act – that readers have come to expect from the publication.  Like Don, I have sought to provide a text that can be referred to on particular points as they arise, rather than a narrative that must be read from cover to cover. 

The Eighth Edition introduces several changes to the treatise, including an expanded text that accounts for significant changes to the law over the past five years, such as the Biologics Price Competition and Innovation Act and the FDA Safety and Innovation Act.  The Eighth Edition also includes several new appendices.  While I recognize that the addition of new appendices adds to the girth of the volume, I have always found it helpful to have the relevant rules and FDA interpretations of the law at my fingertips.  This is particularly true with respect to FDA’s letter decisions interpreting the statutory provisions governing marketing exclusivity relating to brand-name and generic drug manufacturers.  Many of those decisions, while public, have not been placed into a single publication.  Yet, they are the primary documents used by practitioners to understand how FDA currently interprets the law, especially FDA’s interpretations of the provisions governing the forfeiture of eligibility for 180-day exclusivity.  I include them in the volume for the first time.

I am indebted to Don for the guidance he has provided to me through the treatise he wrote, as well as to my colleagues at Hyman, Phelps & McNamara, P.C. who have assisted me through the writing process.  I am also indebted to George Johnston, who graciously agreed to write the foreword to the Eighth Edition.  As George notes in his foreword, Generic and Innovator Drugs has long been considered the “go to” source on the Hatch-Waxman Amendments and pharmaceutical law.  I hope to continue the tradition so well established by Don.