Drugs, Medical Devices, And Biologics Manufacturers Should Not Liable For Off Label

1400 Words Oct 8th, 2015 6 Pages
Drugs, Medical Devices, and Biologics Manufacturers Should not liable for Off-Label Uses of their products by Physician
Issue-1: FDA Prohibit Manufacturers from marketing/ promoting their products for Off-Label uses The1938 Federal Food, Drug, and Cosmetic Act (FFDCA) delegated FDA to regulate the pharmaceutical manufacturers to promote drugs and medical devices. The FDA Modernization Act 1997 (FDAMA) permitted pharmaceutical manufacturers in circulating scientifically valid information and supporting independent scientific, educational activities and to be sent to the FDA in advance prior for off-label uses (Trasatti & Lanzenorfer, 2012). After two years, in 1999, the Federal district court ruled that the clear disclosure regarding off-label uses should be implemented rather than imposing restrictions in the FDAMA. Based on this idea new guidance-so called “Good Reprint Practices “was published by the FDA in 2009. The FDA is responsible for strict guidance on the types of information that the pharmaceutical manufacturers can distribute to physicians and how they issue the information. According to the guidance, any articles or reprints provide to physicians should state the risk associated with the off-label use, should be a scientific or medical journal with peer-reviewed, complete reprints with no highlights or markings by the pharmaceutical manufacturers (US Food & Drug Administration, 2009). All these prohibitions and regulations intend…

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