FFDCA: Good Reprint Practices

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The 1938 Federal Food, Drug, and Cosmetic Act (FFDCA) delegated FDA to regulate the pharmaceutical manufacturers to promote drugs and medical devices. 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 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 FDA in 2009. The FDA be 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 scientific or medical journal with peer-reviewed, complete reprints with no highlights or markings by the pharmaceutical…show more content…
The following two cases (case 1& 2) confirm that how the pharmaceutical, medical devices, and biologics manufacturers liable for the physicians’ practices of off-label. In these case, the Courts found that there were a direct interference with the medical practitioners by funding seminars, providing text books, awarding privates and universities physicians to teach others about their products, and participating the physicians to disseminate misleading information about their products. Case 3 and 4 show that the manufacturers did not liable by any means for physicians’ off-label uses because there was no intended promotional or marketing of off-label

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