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The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. 95) is a law of the United States federal government.It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals and is designed to discourage the sale of counterfeit, adulterated, misbranded, sub potent, and expired prescription drugs.
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 ...
False Claims Act, FDCA 2012 Abbott Laboratories [8] $1.5 billion Off-label promotion Depakote: False Claims Act, FDCA 2009 Eli Lilly [9] $1.4 billion Off-label promotion Zyprexa: False Claims Act, FDCA 2001 TAP Pharmaceutical Products [10] $875 million Medicare fraud, kickbacks Lupron: False Claims Act, Prescription Drug Marketing Act: 2012 ...
In the United States, marketing and distribution of pharmaceuticals is regulated by the Federal Food, Drug, and Cosmetic Act and the Prescription Drug Marketing Act, respectively. Food and Drug Administration (FDA) regulations require all prescription drug promotion to be truthful and not misleading, based on "substantial evidence or ...
Drug Price Competition and Patent Term Restoration Act (1984) – Allows the FDA to approve generic versions of previously approved new drugs without requiring their sponsors to duplicate the costly human tests required for the original drugs. Prescription Drug Marketing Act (1988) – Allows selling, buying, trading, or offering to sell, buy ...
The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law that established the modern system of generic drug regulation in the United States. The Act's two main goals are to facilitate entry of generic drugs into the market and to compensate the ...
False Claims Act 2001 6 9 Lupron: TAP Pharmaceutical Products [14] $875,000,000 $559 million civil ($875 million with criminal component) Medicare fraud/kickbacks False Claims Act/ Prescription Drug Marketing Act: 2010 13 10 Seroquel: AstraZeneca [15] $520,000,000 $520 million (civil only) Off-label promotion/kickbacks False Claims Act 2007 12 11
Chemical Diversion and Trafficking Act; Combat Methamphetamine Epidemic Act of 2005; Comprehensive Drug Abuse Prevention and Control Act of 1970; Comprehensive Methamphetamine Control Act of 1996; Continuing Criminal Enterprise Statute; Controlled Substances Penalties Amendments Act of 1984