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Off Label Marketing Research Paper

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“Off-Label” Marketing
Introduction
Pharmaceutical companies are receiving negative allegations due to the “off-label” advertising of drugs. The Federal and Drug Administration require strict regulations for the use of “off-label” drugs in the pharmaceutical industry. The off-label practice of drugs are not prohibited, however, promoting the drugs are illegal. Benefits and risks should be considered for the best interest of the patient for effective treatment. In addition, companies who fail to comply with the FDA regulations, face consequences such as costly fines as well as criminal issues. Pharmaceutical companies often settle with the government, due to lack of proper procedures, complying with public health agencies. Modifying the policies …show more content…
The FDA only permits drugs in the interstate commerce after they have been approved for effectiveness and safety. The FDA approval process consists of multiple clinical trials of the drug. Furthermore, the pharmaceutical company submits a new drug application for FDA approval of the drug (Miller, 2014). The FDA spends a lot of money and time in the research in the approval of any drug. These studies guard patients from unsafe and unsuccessful interventions of off-label drugs (Dresser & Frader, 2009).
Benefits & Risks
Physicians can prescribe off-label medication to patients within the physicians’ discretion. Patients benefit from off-label drugs due to reduced cost and availability. Patients who may need a combination of drugs for a specific illness can benefit from the off-label drugs as well. Off-label drugs are not guaranteed to benefit patients; however, physicians have generally seen positive results previous to prescribing the drug. Conversely, health risks are at an all-time high due to the widespread use of off-label drugs. Risks and ineffective treatments arise without the FDA approval (Dresser & Frader, 2009).
FDA Regulations …show more content…
Although "off-label" practices are not prohibited; promoting drugs are illegal. Things to consider are not only the benefits and risks but the effectiveness of the drugs as well. Compliance measures are in place and not following those compliances could lead to severe consequences.
Physicians can prescribe "off-label" medications at their discretion. Patients do benefit from these drugs due to their lower costs and availability. Other benefits for patients include combining drugs for a specific illness. The major concern, however, is the unlawful marketing of the drugs by manufacturers.
In order to help regulate controls of "off-label" drug marketing, Congress and the FDA implement guidelines. As with most drugs, the concern is misuse. One method to help prevent misuse of "off-label" drugs is to offer an incentive plan. The FDA hopes the incentive plan helps with not only the effectiveness of "off-label" drugs, but more importantly, their

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