FDA Drug Approval Process
October 5, 2011
FDA Drug Approval Process
Americans must wait up to 19 years after a discovered treatment before they can participate in benefits of a new medication (Philipson & Sun, 2008). The regulatory process drug manufacturers need to endure before releasing potentially life-saving medication is an extremely expensive, time-consuming process. The Center for Drug Evaluation and Research (CDER) is the main department of the Food and Drug Administration (FDA) responsible for the safety of drugs (both prescription and over-the-counter) sold in the United States (Food and Drug Administration, 2011). This department scrutinizes the testing of new drugs and determines if they are safe and effective before distribution. They do not perform in-house testing themselves; they only evaluate the testing done by the manufacturer to make sure the drug claim is accurate and that the benefits of the medication out way the side-effects (Food and Drug Administration, 2011). Whereas the FDA’s regulation and oversight protects dangerous products from circulation, the approval process hinders manufacturers’ ability to release drugs in a timely manner because of the legal and cost liability, thus preventing the availability of treatment to Americans. Origins of the Food and Drug Administration
The Food and Drug Administration started in 1906 with the passage of the Pure Food and Drugs Act. Use of poisons coupled with poor conditions in meat packing plants causing people to become ill prompted the government to create a regulatory agency to protect the safety of Americans (Howland, 2008). Before the introduction of regulation, consumers had no way of knowing if the food and medications they purchased were safe or effective. According to Howland (2008), during the early 1900s cure-all claims for ineffective and possibly dangerous patent medications was normal. While this was a good start in ensuring safety, the need for changes and modifications to the original act became apparent as more medicines circulated into society. Laws Enacted by the FDA
In 1937, a medication killed 107 children. They died because the drug manufacturer did not know a method used to create the ingredients had a byproduct that was poisonous. To prevent this from happening again, the government created a new act in 1938 requiring the manufacturer of medication to prove its safety before distribution to the public. The “FDA began regulating the advertising, labeling, and dispensing of drugs” (Howland, 2008, p. 16). This was the first of many laws created regulating drug manufacturers. “In 1961, a new drug for sleep (thalidomide), used extensively in Western Europe, was found to have caused birth defects in thousands of babies” (Howland, 2008, p. 16). Although there was no use of the drug in the United States, this caused concern and fear prompting the 1962 act, which gave the FDA much stronger regulation over drug manufacturers. The FDA obtained complete access to evaluate the manufacturers testing results and became the authority to release a drug to the public. Through the next 30 years, more acts form the FDA into the modern agency it is today. In 1984 changes made it so generic medications need no re-testing; as the brand name had already undergone rigorous screenings. In 1993, guideline changes required drug screenings to include women, not just men. Child drug screenings came in 1998 with the Pediatric Rule, to ensure proper dosage and effectiveness for children (Howland, 2008). Product Liability Law
The legal changes and increased supervision of the FDA on drugs sold in the United States is to provide the safest and most effective course of treatment for its citizens. “The drugs the FDA approves tend to be quite safe, in the sense that the agency or private firms seldom withdraw drugs from the market” (Philipson & Sun, 2008, p. 90). The...
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