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Full-Text Articles in Law
New Dtca Guidance — Enough To Empower Consumers?, Christopher Robertson
New Dtca Guidance — Enough To Empower Consumers?, Christopher Robertson
Faculty Scholarship
As one of only two countries that permit direct-to-consumer advertising (DTCA) of pharmaceuticals, the United States tasks the Food and Drug Administration (FDA) with regulating that advertising to ensure that it doesn't mislead consumers. When a drug maker publishes or broadcasts a claim that its drug has benefits in a particular disease, the FDA requires it to include information on the product's risks as well. Since it's not feasible for companies to include all the important information about their products in a television ad, the FDA requires them to refer viewers to more complete information, such as that in a …
The Fda, Preemption, And Public Safety: Antiregulatory Effects And Maddening Inconsistency, Lawrence O. Gostin
The Fda, Preemption, And Public Safety: Antiregulatory Effects And Maddening Inconsistency, Lawrence O. Gostin
Georgetown Law Faculty Publications and Other Works
Most people think of preemption as a technical constitutional doctrine, but it is pivotally important to health and safety, while also opening the door to broad judicial discretion. The Rehnquist and Roberts Courts’ pro-business/pro-preemption jurisprudence is distinctly antiregulatory, invalidating major state public health rules, such as in occupational safety, tobacco control, and motor vehicle safety. Apart from the antiregulatory effects, there is maddening inconsistency. Consider three relatively recent Supreme Court cases. In Riegel v. Medtronic, Inc. (2008), the Court held that federal law bars injured consumers from challenging the safety or effectiveness of FDA-approved medical devices. A year later, …
The (Legal) Pains Of Vioxx: Why Product Liability Can Make Products More Dangerous, Omri Ben-Shahar
The (Legal) Pains Of Vioxx: Why Product Liability Can Make Products More Dangerous, Omri Ben-Shahar
Articles
Comparing the experience of Vioxx and Celebrex leads Omri Ben-Shahar to think that stiff product liability has the perverse effect of inducing manufacturers of defective products to leave these products on the market, rather than withdraw them.