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  • Dkonara921 replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 7 years, 4 months ago

    I strongly believe that the FDA is too strict and rigid because of all of the regulations it imposes on healthcare in America. I understand that its mission is too improve quality and maintain innovation but imposing rules and regulations hinders the ability to innovate. Regulations are meant to insure the public against mistakes but without allowing for mistakes in research and trials prevents learning to an extent. It’s very hard to innovate and produce if there are too many rules that are imposed. This is one of the reasons why big companies (e.g. Johnson&Johnson) shipped their drug manufacturing facilities to Canada and sell their products back into the United States. One particular FDA regulation that I am against is it requires that a new drug product must work and be safe to the patient. This is part of the reason why prescription drugs are expensive because the standard is so high. If pharmaceutical companies were allowed to market drug products that are safe to the consumer but may not work, prices will go down dramatically. The important thing is that the consumer is safe, even if the drug doesn’t perform as expected. The FDA is too strict because there is a lot of liability involved. Furthermore, what drives up quality is competition, not regulation. Companies cannot just get away with selling defective products because if it backfires, they are going out of business. As long as there are competitors, each business will try to beat each other by improving quality and lowering costs.