Features - Pathfinder on the Generic Pharmaceutical Industry | LLRX.com

Features - Pathfinder on the Generic Pharmaceutical Industry | LLRX.com: "Features - Pathfinder on the Generic Pharmaceutical Industry
By Sarah Spear, Published on October 20, 2006
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Sarah Spear received her J.D. in May 2006 from Florida Coastal School of Law, and is now pursuing an L.L.M in Taxation, also at FCSL. She received her B.S. in English Literature with a minor in Financial Economics from Vanderbilt University in 2003. In law school, Sarah served as a Research Assistant for Professor Alexander Moody, assisting him with gathering empirical data relating to Delaware appraisal rights. Additionally, Sarah served as recruitment officer for the United Way's Real Sense Prosperity Campaign and the Volunteer Income Tax Assistance ('VITA') Program. Before entering law school, Sarah worked for U.S. Senator Bob Graham as a Constituent Advocate in the fields of Social Security and Medicare.

Table of Contents

I. Introduction
II. The Basics
A. Terminology
B. Where to Start
C. Searching According to Your Needs
III. Governing Law
A. Federal Statutes
B. The Abbreviated New Drug Application
C. Litigating Pharmaceutical Patents
IV. Other Primary Sources
A. Books
B. Periodicals
C. Case Law
V. Secondary Sources
VI. Public Policy
VII. Conclusion
VIII. Appendix

I. Introduction

Food and drug production has been regulated by the United States since 1906. The Food and Drug Administration ('FDA') is one of the oldest consumer protection agencies in this country. The FDA protects the public from unsafe foods and drugs to medical devices and cosmetics. It also protects the rights and safety of patients in clinical trials of new medical products.

The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act ('Act'), was passed to expedite the FDA's approval of generic drugs. Studies show that since its inception, the Act increased the number of generic drugs by 50%, with almost every leading drug, off-patent, competing with at least two generic brands. The generic drug industry has become a multi-billion dollar industry.

The Act attempts to increase competition and drive down drug prices while simultaneously maintaining the brand name drug companies' incentive to invest in new research. It is arguable that the Act has achieved its purpose. Brand name drug companies ('Branders'), however, are fighting to retain their monopoly on patents. These Branders have found loopholes in the Act by which they extend their patents and tie up generic approval. To put the story in context, one week of patent extension translates into hundreds of millions of dollars for Branders. In response, legislators are fighting to close these loopholes and to lower healthcare costs. This paper is a research guide for individuals interested in the generic pharmaceutical industry, whether it is a consumer, chemist, consultant or attorney. The rise in healthcare costs and the inclusion of prescription drug coverage by the Medicare Program are just two of the catalysts for this growing field. This paper guides individuals to current laws, regulations, cases and news-worthy articles concerning the industry. Furthermore, the paper explores public policy arguments and political rhetoric surrounding generic pharmaceuticals.

II. The Basics

a. TerminologY: The amount of time you spend searching a subject is decreased when the correct spelling and terminology are employed. When I first started searching the internet and library cataloging systems, I grew frustrated because the search yielded an unfocused result. I have included the following search terms to help you with your search and allow you to supplement this pathfinder with updated searches. Here are the Trigger Words: (1) generic drug, (2) pharmaceutical drug, (3) Hatch-Waxman Act, (4) pharmaceutical patent, (5) abbreviated new drug application, (6) generic pharmaceutical, and (7) pharmaceutical patent extension.

b. Where to Start

By today's standards a thorough search begins with Google. It's true, Google's search engine yields a plethora of websites, information and advertisements. Many of the hits, however, will be worthless to your research. Nevertheless, begin your search with Google and if you see any interesting sites, click on the link.

A word of advice: if a website ends in '.gov,' it is government sponsored, '.org,' organizationally sponsored, '.edu,' school sponsored, and '.com' is a catch-all. Be careful to evaluate the websites to make sure you are not receiving any false or misleading information.

I would suggest you arm yourself with a background and history of the industry before you dive into particularized research. A wealth of knowledge as to patents, generic drugs and the regulation of the industry can be found on www.fda.gov. FDA.gov contains links to the Orange Book, Center for Drug Evaluation and Research ('CDER'), and the majority of information that anyone would need. The website also provides a Drug Information Pathfinder.

To search for books, use the Trigger Words and search Amazon.com. It is nice to search Amazon before going to your local library because a search yields the most popular and current books in the market. Additionally, you can browse the books online before searching for the hard copy. The search on Amazon will also yield journal articles and periodicals that you can order for a low price without having to subscribe to the journal.

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c. Searching According to Your Needs

1. The Consumer"