Although the pharmaceutical industry says that prescription medicines are as safe as they can possibly be, prescribed drugs have a high increase of risking a patient’s health. According to the law, drug makers seek Food and Drug Administration (FDA) approval for specific uses of their products and conduct trials to test their drugs safety and effectiveness in patients with specific conditions. The FDA demands that drug companies conduct rigorous clinical trials to prove a drugs safety and effectiveness in treating a particular disease. However, once the FDA approves a drug for one use, doctors can prescribe it for whatever they want. The FDA is considering loosening the monitoring of off-label prescriptions, but if anything, regulations should be tightened. Despite the practices of some medical personnel, the risk of serious medical complications demands that the FDA regulate and restrict off-label use of prescription drugs.
The off-label use of any approved drug relates to the use not included in the official label. The exclusion of uses for a specific disease or disorder from the official label proves that drug creators have not submitted the needed evidence, required by law to allow admittance, to the Food and Drug Administration. When this occurs, the statement, “safety and efficacy in pediatric patients have not been established” is printed in the product label. Randall Stafford M.D. writes, “Although off-label prescribing, the prescription of a medication in a manner different from that approved by the FDA is legal and common, it is often done in the absence of adequate supporting data. Off-label uses have not been formally evaluated, and evidence provided for one clinical situation may not apply to others” (Stafford). Off-label use, or unapproved use, does not refer to an improper use and definitely not an illegal use. This does refer to the contradictory judgments and expectation among medical doctors, drug producers, consumers, and the FDA. The FDA does have a role in balancing these expectations; however, it does so primarily through regulating corporate marketing. Unfortunately, the FDA is moving towards trying to renounce control in spite of the strong rationale for increased involvement.
The Food and Drug Administration, established in 1930, is an agency within the Department of Health and Human Services. According to the FDA’s website, the FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation, and by regulating the manufacture, marketing, and distribution of tobacco products. They are also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safe, and affordable.
The FDA drug approval process is a very intricate and tedious procedure that incorporates many steps...