The regulation of the products and drugs produced by Pharmaceutical Companies is under the auspices of the Food and Drug Administration (FDA) in the United States and the European Agency for the Evaluation of Medicinal Products (EMEA) in the European Union. The agencies must approve and license a product before it can be released on the market. Both serve as consumer watchdogs and seek to protect the consumer.
This is accomplished by set of regulations that oversee the steps of drug development. In 1964 the Declaration of Helsinki was issued by the World Medical Association that set guidelines for the development of drugs and the treatment of human subjects during clinical trials of a treatment. Each agency regulates and advises upon what testing is required, how the tests are to be carried out and the scope of human clinical trials.
It further required that humans grant their informed consent before entering a trial. This document outlined the conditions for drug development that both agencies incorporated into their regulations. This was done in an effort to standardize the process to makes evaluation of the supporting documents more effective. It also streamlines drug development to a certain extent, by delineating the procedure in an exact format. The guidelines set by the EMEA and the FDA require that the pharmaceutical company must demonstrate that the product is safe, with few side effects, for the intended treatment. FDA regulations also require proof that the drug is efficacious in that treatment, that is to say, that it really works.
Pharmaceutical companies acknowledge that these agencies work for the common good and comply with the regulations, but often argue that the necessary testing and licensing procedure adds years to the time it takes to develop a product. This limits the profit taking by the pharmaceutical company, since a patent can be held for only 20 years before a drug becomes eligible for generic over the counter sales and production.
The FDA also came under fire from consumer groups at the early stages of the AIDS Epidemic. Patient's rights activists want the drugs and supportive treatments to be available to the affected individuals sooner. They argued that the disease was so fast acting and fatal, at that time, that products had to be developed quickly to be of any use to the AIDS patient. In this case, the FDA did offer expedited drug development and licensing strategies and lifted some of its usual requirements.
by Sally.Anderson 1 year ago
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