Before it can sell a prescription drug lawfully in interstate commerce, a manufacturer must prove to the satisfaction … of the Food and Drug Administration that the drug is both safe and effective. Congress approved this requirement in 1962 … unanimously. Four decades of changes in the drug market have reshaped this regulatory hurdle. This article makes detailed …

by a PHO, prescriptions were restricted to a month's supply of the drug, and doses must be dispensed daily, under … benzodiazepines following the reform. To examine subsequent health, labor market, and drug abuse-related outcomes, I additionally … exploit regional variation in PHO strictness affecting the likelihood that addicts opt to quit the drug due to the reform. I …

associated with Food and Drug Administration (FDA)-mandated clinical trials of new drugs. But the relationship between the patent … system and other regulation of drugs is more complex than this simple formulation suggests. Drug regulation operates in … profitability by diverting profits elsewhere. At the same time, resistance to high drug prices is prompting new state and federal …

Before a new drug can be marketed the Food and Drug Administration must be satisfied that it is safe and effective … been advocated. This paper challenges the central argument in the debate on the topic, namely that drug regulation and drug … innovation are necessarily at odds with each other. Although intuitively appealing, the argument that drug regulation negatively …

This paper looks into various means of regulating pharmaceuticals and their effects on the structure of the … industry activities proceeds, national regulation aimed at reducing costs for pharmaceuticals can have the unintended effect of … leading to higher drug prices in the longer run, thereby compromising the original goal …