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Pharmaceutical drugs that are approved for market use undergo a rigorous clinical process that can take more than a decade to monitor, test, and receive final approval from the Food and Drug Administration. Once a particular drug is developed it must endure a rigorous process of laboratory testing before being submitted to the FDA for testing in humans. If the FDA allows the drug to be used in human testing, the drug undergoes three phases of clinical trials to determine 1)its safety, 2)its effectiveness and 3)adverse reactions. If the drug passes these clinical trials, the drug manufacturer then submits an application to the FDA. This application phase may take up to 2 ½ years before doctors can begin prescribing the drug.
If the drug is approved for use, the FDA will determine specific uses for the drug. It’s important to note that while the FDA determines the specific uses for a particular drug, a physician may prescribe the drug to patients for uses which are not approved by the FDA. However, these so-called “off label” uses may not be marketed by the pharmaceutical company. Recently, the FDA has investigated and brought civil and criminal charges against pharmaceutical companies for marketing drugs for off label usage.
For instance, Johnson & Johnson has been fined $4.5 million for providing incorrect information about its Duragesic patches and its anti-psychotic drug Risperdal. Eli Lilly agreed to pay $1.4 billion for illegal marketing practices concerning its schizophrenia drug Zyprexa. Pfizer was forced to pay $142 million for its off-label marketing of its epilepsy drug Neurontin.
In other pharmaceutical cases, drugs have been recalled after post-market studies have confirmed that the risks and adverse events associated with these drugs outweigh the benefits. A highly publicized example of such a drug recall involved the arthritis drug Vioxx which was approved by the FDA in May 2009. However, in September 2004, Vioxx was voluntarily recalled from the marketplace after concerns about an increased risk of heart attack and stroke associated with long-term use of the drug.
If you or a loved one suspect you’ve been injured by a pharmaceutical drug, contact our harmful drugs lawyers for a free initial consultation.