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When Truth Cannot Be Presumed: The Regulation Of Drug Promotion Under An Expanding First Amendment, Christopher Robertson

Faculty Scholarship

The Food, Drug, and Cosmetic Act (FDCA) requires that, prior to marketing a drug, the manufacturer must prove that it is safe and effective for the manufacturer’s intended uses, as shown on the proposed label. Nonetheless, physicians may prescribe drugs for other “off-label” uses, and often do so. Still, manufacturers have not been allowed to promote the unproven uses in advertisements or sales pitches.

This regime is now precarious due to an onslaught of scholarly critiques, a series of Supreme Court decisions that enlarge the First Amendment, and a landmark court of appeals decision holding that the First Amendment precludes …

Pharmaceutical Innovation: Law & The Public's Health, Kevin Outterson

Faculty Scholarship

At last count, global pharmaceutical spending exceeded $750 billion. Unlike most medical products and services, many pharmaceuticals are sold at a price that greatly exceeds marginal cost. AIDS medicines that retail for over $10,000 per person per year in the United States can be produced generically at a marginal cost of less than $150. Patents and other related IP rights create these significant gaps between marginal cost and retail price, generating many billions of dollars in profits (patent rents) for companies.

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 …