Unapproved Drugs in the United States and the Food and Drug Administration

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This article describes the different legislation passed from the Pure Food and Drug Act of 1906 to the most recent initiative, the Marketed Unapproved Drugs - Compliance Policy Guide. The first piece of legislation passed was the Pure Food and Drug Act. This act was referred to as the Wiley Act, after its main advocate, Harvey Wiley. Before 1912, this act focused mainly on food initiatives because Wiley thought food mislabeling was the most dangerous to the public well-being. The next initiative passed was the Food, Drug, and Cosmetic Act of 1938.  This act completely renovated the drug regulatory system. Some new requirements included that the FDA required evidence of safety for new drugs, standards for food, and factory inspections. The Kefauver-Harris Amendments to the Food Drug and Cosmetic Act in 1962 were the next major step. These amendments gave the FDA more control over clinical drug trials. The amendments also established and enforced “good manufacturing practices” for the drug industry. The amendments essentially abolished drugs from the US market that were not effective and established stricter policies for drug trials. Next, the Over the Counter (OTC) Drug Review involved OTC rulemaking by remedial class using published monographs, permissible claims, labeling, and active ingredients for each class. In June 2006, the FDA established the Marketed Unapproved Drugs - Compliance Policy Guide, because roughly 5,000 unapproved drug products continued to be marketed without required approval. This new policy stated enforcement policies made to guide all unapproved drugs through the approval process. Furthermore, the FDA is constantly revising its’ policies involved with the Pure Food and Drug Act of 1906.

Works Cited
http://link.springer.com.ezaccess.libraries.psu.edu/content/pdf/10.1007%2Fs12325-011-0059-4.pdf