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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 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 ...
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 ...
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
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 ...
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 ...
Medicare Access and CHIP Reauthorization Act of 2015; Medicare and Medicaid Extenders Act of 2010; Medicare Improvements for Patients and Providers Act of 2008; Medicare Prescription Drug, Improvement, and Modernization Act; Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999; Mental Health Parity Act; Mental Health Systems Act ...
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