Law Commons^™

The Food And Drug Administration's Evolving Regulation Of Press Releases: Limits And Challenges, William W. Vodra, Nathan Cortez, David E. Korn

Faculty Journal Articles and Book Chapters

The Food and Drug Administration (FDA) has developed an informal framework for regulating press releases by drug and medical device companies. FDA asserted jurisdiction over press releases based on its authority over labeling and advertising, and over the past 20 years, the agency has both broadened and scaled back its claims to authority over press statements.

Despite a somewhat predictable framework for anticipating how FDA regulates press materials, the agency's approach appears to be in flux. FDA will not tolerate false or misleading statements in press materials, but there are legal and practical limits to its regulation in this area. …

Biotechnology's Prescription For Patent Reform, Christopher M. Holman

Faculty Works

On June 8, 2005, Congressman Lamar Smith introduced H.R. 2795, the Patent Reform Act of 2005, aimed at improving the quality and certainty of issued patents, simplifying the patent procurement process, harmonizing U.S. law with international practice, and reining in abusive patent enforcement practices. Congress has set the legislation aside for the time being, but will likely revisit the issue again shortly. The biotechnology industry, one of the fastest growing sectors in the United States economy, strongly opposes many of the proposed reforms. This paper considers the Congressional testimonies of the Biotechnology Industry Organization ("BIO") and other representatives of biotechnology's …

Counterfeit Drugs: The Good, The Bad, And The Ugly, Kevin Outterson

Faculty Scholarship

When I chose the title, Counterfeit Drugs: The Good, the Bad and the Ugly, some of my colleagues at this symposium blanched. They understood counterfeit drugs as Bad and Ugly, but resisted categorizing any counterfeit drug as Good. This article is intended to be provocative, challenging some of the conventional wisdom concerning counterfeit drugs.

We start with the fact that reports about the scope of pharmaceutical counterfeiting are remarkably anecdotal rather than empirical. As a professor once chided me, the plural of anecdote is not data. The FDA and the WHO must undertake comprehensive market surveillance to establish the true …

Conflicts Of Interest In International Human Drug Research And The Insufficiency Of International Protections, Robert Gatter

All Faculty Scholarship

The problem of financial conflicts of interest in human subjects research is international in scope as drug manufacturers conduct trials in countries outside of the U.S., Japan, and the European Union, thereby side-stepping domestic regulation of conflicts of interest. Because such out-sourcing of human drug trials results in exporting risks associated with financial conflicts of interest, this essay examines the primary international sources for regulating those conflicts. These sources include the World Health Organization’s Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products, the Guidelines for Good Clinical Practice adopted by the International Conference on Harmonisation of Technical Requirements …

Fair Followers: Expanding Access To Generic Pharmaceuticals For Low- And Medium-Income Populations, Kevin Outterson

Faculty Scholarship

U.S. trade offi cials frequently employ the rhetoric of free riding and piracy when discussing intellectual property (IP) rights for medicines (Drahos with Braithwaite 2002; Benson 2005). The gentler term free rider is applied when developed country governments (OECD) use monopsony power to negotiate price discounts on patented pharmaceuticals (Outterson 2004, 2005b; U.S. Department of Commerce 2004; PhRMA 2005). Poorer governments usually lack suffi cient market power as a purchaser to negotiate discounts for their low- and middle-income populations. In these cases, governments and patients may resort to unlicensed generic drugs and compulsory licensing. In response, U.S. trade offi cials …

Do Reverse Payment Settlements Violate The Antitrust Laws, Christopher M. Holman

Faculty Works

The term "reverse payment" has been used as shorthand to characterize a variety of diverse agreements between patent owners and alleged infringers that involve a transfer of consideration from the patent owner to the alleged infringer. Reverse payment settlements are particularly associated with drug patent challenges mounted by generic drug companies under the Hatch-Waxman Act. Many, including the Federal Trade Commission, would characterize these agreements as antitrust violations. However, courts have generally declined to find these agreements in violation of the antitrust laws based solely on the presence of a reverse payment.

This article begins in Section II with an …