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The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
Drug innovators were given protections in two ways. First, a new kind of market exclusivity was introduced, by means of a new five-year period of data exclusivity awarded when the FDA approves marketing of a drug that is a new chemical entity; during that period the FDA cannot approve a generic version of the drug. [3]
The Cancer Drugs Fund (CDF) was introduced in England in 2011.It was established in order to provide a means by which National Health Service (NHS) patients in England could receive cancer drugs that had been rejected by National Institute for Health and Care Excellence because they were not cost effective.
In an analysis of the drug development costs for 98 companies over a decade, the average cost per drug developed and approved by a single-drug company was $350 million. [3] But for companies that approved between eight and 13 drugs over 10 years, the cost per drug went as high as $5.5 billion. [3]
Medication costs can be the selling price from the manufacturer, that price together with shipping, the wholesale price, the retail price, and the dispensed price. [3]The dispensed price or prescription cost is defined as a cost which the patient has to pay to get medicines or treatments which are written as directions on prescription by a prescribers. [4]
Drug companies would be required to report certain pieces of information on drugs that cost more than $100 and covered by Medicare or Medicaid based on the rate of price and spending increases, or face civil penalties. One provision of which would require that drug companies report certain drug price increases at least 30 days before the price ...
For scale, cutting administrative costs to peer country levels would represent roughly one-third to half the gap. A 2009 study from Price Waterhouse Coopers estimated $210 billion in savings from unnecessary billing and administrative costs, a figure that would be considerably higher in 2015 dollars. [50] Cost variation across hospital regions.
Emergency Medical Treatment and Active Labor Act (1986) Health Insurance Portability and Accountability Act (1996) Medicare Prescription Drug, Improvement, and Modernization Act (2003) Patient Safety and Quality Improvement Act (2005) Health Information Technology for Economic and Clinical Health Act (2009) Patient Protection and Affordable ...