Law Commons^™

Deadly Discounts: How Reimportation Jeopardizes The Safety Of The U.S. Pharmaceutical Drug Supply Under The Federal Trade Commission Amendment, Nicole C. Bates

ExpressO

The amendment to a Federal Trade Commission (FTC) reauthorization bill, previously introduced as Senate Bill 334 (S.334) Pharmaceutical Market Access and Drug Safety Act of 2005 allows for the reimportation of prescription drugs into the United States from approximately 25 countries, including Canada via Internet pharmacies. There are no guarantees that the internet websites advertising as Canadian pharmacies are legitimate. The shipping of pharmaceutical drugs occurs through importation, which refers to drugs produced abroad then later shipped to the U.S., or re-importation, a term applied when drugs are produced in the U.S. and exported for sale to foreign countries and …

Blame Canada (And The Rest Of The World): The Twenty-Year War On Imported Prescription Drugs, Daniel L. Pollock

ExpressO

Rising budget deficits and sticker shock over the new Medicare drug benefit have put the issue of prescription drug costs back into the spotlight. The growth in the cost of prescription drugs continues to represent a staggering burden for taxpayer-funded health care programs, even while costs of non-drug health care services have slowed or even decreased. Among the many proposals for cutting prescription drug costs, drug importation is unique. Although bipartisan support for drug importation has existed in Congress for over five years, the federal government continues to maintain that a system of safe and effective drug importation is impossible. …

Project Bioshield, More Than Meets The Eye: A Critique Of The U.S.’S Proposed Silver Bullet For Responding To Bio-Terrorism, Jodi A. Phillipo

ExpressO

No abstract provided.

Breaking The Bank: Revisiting Central Bank Of Denver After Enron And Sarbanes-Oxley, Celia Taylor

ExpressO

No abstract provided.

“Racially-Tailored” Medicine Unraveled, Sharona Hoffman

ExpressO

In June 2005, the FDA approved BiDil, a heart failure medication that is labeled for use only by African-Americans and thus, is the first treatment of its kind. The drug likely portends a future of growing interest in “race-based” medicine. This phenomenon is emerging at the same time that scientists, in light of the Human Genome Project, are reaching an understanding that “race” has no biological meaning, and consequently, “racially-tailored” medicine is both puzzling and troubling.

This Article explores the reasons for the new focus on “racial-profiling” in medicine. It analyzes the risks and dangers of this approach, including medical …

Learning The Wrong Lessons From "An American Tragedy": A Critique Of The Berger-Twerski Informed Choice Proposal, David E. Bernstein

George Mason University School of Law Working Papers Series

This paper is a critique of Margaret Berger and Aaron Twerski, “Uncertainty and Informed Choice: Unmasking Daubert”, forthcoming the Michigan Law Review. Berger and Twerski propose that courts recognize a cause of action that would allow plaintiffs who claim injury from pharmaceutical products, but who do not have sufficient evidence to prove causation, to recover damages for deprivation of informed choice. Berger and Twerski claim inspiration from the litigation over allegations that the morning sickness drug Bendectin caused birth defects. Considering the criteria Berger and Twerski suggest for their proposed cause of action in the context of Bendectin, it appears …