Safety and efficacy tests are conducted to ensure that drugs function properly under normal conditions of use. Although, a drug might have passed preclinical animal testing, it may fail to be administered to humans if it does not pass safety and efficacy tests. These tests evaluate whether the designs of the clinical trials conform to the standards set by medical agencies. In addition, they test all the side effects that the drug may have (Okie, 2006). Such tests take a long time and they may increase the time that a drug is released to the market. However, these tests are important because they help in protecting the health of patients. Safety and efficacy is a major issue that affects the safety and speed of drug development innovation.
In the United States of America, Food and Drug Administration (FDA) regulates the safety and efficacy of drug development by pharmaceutical companies. FDA requires that an experimental drug should not be administered to patients. These tests extend the time of drug development. In 2008, FDA prevented medical practitioners from giving Erbitux to a patient diagnosed with squamous cell cancer (Okie, 2006). FDA argued that the drug had not yet passed the safety and efficacy test. The patient died due to the lack of treatment. However, FDA later approved this drug. A pharmaceutical company known as Pfizar was developing a drug known as Torcetrapid to help treat hypercholesterolemia. However, FDA stopped the production of this drug when it was in phase III. It had cost this company a lot of money to do the trials. Most companies therefore refrain from innovating new drugs because they fear that they may fail to pass the safety and efficacy tests (Feuerstein & Ruffalo, 2007).
To conclude, safety and efficacy is a major issue that affects the safety and speed of drug development innovation. It also affects the safety of drug development because it helps to ensure manufactured drugs do not have side effects. Moreover, it affects the speed of drug development because it extends the time before a drug is released to the market. Delays caused by safety costlives, as it takes much time for FDA to approve the production of an experimental drug.