I. INTRODUCTION
Off Label Prescription The Food and Drug Administration (FDA) plays a key role in protecting the public health by ensuring the safety and efficacy of foods, drugs, and cosmetics. Before a prescription drug comes into the market, it must go through a series of rigorous clinical trials. Once a drug has been approved for some indication, the FDA has almost no legal control over how that drug is actually prescribed1. This is because the FDA has no legal authority to regulate physicians and the practice of medicine as such. Hence a physician may choose to prescribe a drug for an indication that is unapproved by the FDA. The practice of prescribing a drug for a purpose other than that for which it is approved is …show more content…
FDA regulation of off-label promotion slows down the process to pass this information. Manufacturers have the greatest incentive to spread the news of research findings that support new and beneficial off-label uses of their products. Liberal laws for off-label promotion can lead to progressive medical practice and better care for patients5. Dissemination of off-label information, can keep medical practitioners informed about the various treatment options and cutting-edge technologies available to treat patients afflicted with rare diseases. Manufacturers have little economic incentive to conduct expensive clinical trials for a drug used to treat such a small patient …show more content…
If a firm responds to unsolicited requests for off-label information in the manner described in this draft guidance, FDA does not intend to use such response as evidence of the firm’s off-label promotion. According to this guidance, when responding to a non-public unsolicited request, response should be tailored to answer only the specific question asked, should be truthful, accurate, non-misleading and balanced, should be scientific in nature and should be provided only to individuals making the request directly to the firm. Manufacturer should be even more careful when responding to public unsolicited requests. Responses should not be promotional in nature, representatives providing the public response should disclose their involvement with a particular firm and should respond only when the request pertains to its own named product. But, casual conversations where pharmaceutical representatives discuss unapproved uses with the physicians, are unlikely to involve unsolicited requests for information or distribution of reprinted journal
Off Label Prescription The Food and Drug Administration (FDA) plays a key role in protecting the public health by ensuring the safety and efficacy of foods, drugs, and cosmetics. Before a prescription drug comes into the market, it must go through a series of rigorous clinical trials. Once a drug has been approved for some indication, the FDA has almost no legal control over how that drug is actually prescribed1. This is because the FDA has no legal authority to regulate physicians and the practice of medicine as such. Hence a physician may choose to prescribe a drug for an indication that is unapproved by the FDA. The practice of prescribing a drug for a purpose other than that for which it is approved is …show more content…
FDA regulation of off-label promotion slows down the process to pass this information. Manufacturers have the greatest incentive to spread the news of research findings that support new and beneficial off-label uses of their products. Liberal laws for off-label promotion can lead to progressive medical practice and better care for patients5. Dissemination of off-label information, can keep medical practitioners informed about the various treatment options and cutting-edge technologies available to treat patients afflicted with rare diseases. Manufacturers have little economic incentive to conduct expensive clinical trials for a drug used to treat such a small patient …show more content…
If a firm responds to unsolicited requests for off-label information in the manner described in this draft guidance, FDA does not intend to use such response as evidence of the firm’s off-label promotion. According to this guidance, when responding to a non-public unsolicited request, response should be tailored to answer only the specific question asked, should be truthful, accurate, non-misleading and balanced, should be scientific in nature and should be provided only to individuals making the request directly to the firm. Manufacturer should be even more careful when responding to public unsolicited requests. Responses should not be promotional in nature, representatives providing the public response should disclose their involvement with a particular firm and should respond only when the request pertains to its own named product. But, casual conversations where pharmaceutical representatives discuss unapproved uses with the physicians, are unlikely to involve unsolicited requests for information or distribution of reprinted journal