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The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
The United States federal government is aggressively pursuing criminal and civil cases against pharmaceutical companies and their employees for promoting off-label uses of prescription drugs. [4] Between 2003 and 2008, U.S. federal prosecutors and state attorneys general brought more than a dozen cases against drug manufacturers for off-label ...
The following is a list of the 20 largest settlements reached between the United States Department of Justice and pharmaceutical companies from 2001 to 2013, ordered by the size of the total settlement. The settlement amount includes both the civil (False Claims Act) settlement and criminal fine.
When there is a shortage of FDA-approved, brand-name medication – like with GLP-1 drugs Ozempic and Wegovy – the FDA says it allows compounding pharmacies to make alternative medications that ...
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Prescription drug prices have become a key target of criticism by those calling for reforms to the U.S. health care system. Upon taking office, President Biden vowed to lower these prices.
Supporters of direct-to-consumer advertising argue that advertisements increase competition which leads to lower prescription drug prices and new development, citing, for instance, that between 1997 and 2001, spending on research and development in the U.S. increased 59% while spending on promoting drugs directly to patients increased 145%.
In 1938, the Federal Food, Drug and Cosmetic Act mandated that the most powerful drugs could only be purchased with a doctor’s prescription. After that, manufacturers focused their promotional efforts exclusively on physicians, running ads in professional journals, dispatching representatives to doctors’ offices, and wooing them with fancy ...