The Kefauver-Harris Drug Amendment Act

The Kefauver-Harris Drug Amendment Act

Kefauver-Harris Drug Amendment Act 1962 During the 20th century, no federal regulations were in place to protect citizen from receiving dangerous drugs. However, today drugs undergo rigorous evaluations of safety, quality, and effectiveness before they are available to the public. President John F. Kennedy signed the Kefauver-Harris Drug Amendment Act into law. The bill was named after US Senator Estes Kefauver and US Representative Oren Harris. “The bill amended the Federal Food, Drug and Cosmetic Act of 1938 to require the following: (1) Substantial evidence from clinical trials of both safety and efficacy- the FD&C Act of 1938 only required safety data (2) FDA approval prior to marketing- previously,

West Encyclopedia (2005) studies show that “The FDA annually regulates over $1 trillion worth of products, which accounts for one-fourth of all consumer spending in the United States.” The FDA protect patients’ rights and safety in clinical trials of new medical products, monitor promotional activities and regulate labeling of packaged foods. The FDA is responsible for monitoring the safety of the nation’s blood supply. The FDA strive to enforce good manufacturing processing. The Food and Drug Administration (FDA) is responsible for helping to advance the public health by speeding innovations that make the drugs be more effective, safer, and

FDA scientist and professionals complete the evaluations of new drugs. The physicians play a role because they evaluate the drugs through a clinical trial. The clinical trial consist of assessing both the beneficial and adverse effects of the drug as it used. The company that is developing the drug is referred to as the drug sponsor. According to West Encyclopedia (2005), “A sponsor spends an average of $359 million for each new drug brought to the market.” The drug must go through three stages before being approved. The three stages are (1) preclinical trials (2) clinical trials (3) FDA review. Preclinical trials can last up to 1.5 years on average and involves animals and many laboratory test. The clinical trials which last an average of 5 years involve testing of humans. The final stage which is the FDA review last an average of 2 years. Adding all of the above the average approval of a new drug can take up to 8.5 years to be processed. There are four subdivisions that are involved with approving drugs. According to West Encyclopedia (2005) the four subdivisions are, “The Center for Drug Evaluation and research, whom regulate the safety, effectiveness, and labeling of all prescriptions and over the counter drugs intended for human use. The Center for Biological Evaluation and Research