Pharmaceutical Industry Law
The pharmaceutical industry develops, markets and sells licensed medications. There are a number of laws to govern how pharmaceutical products are tested, patented and marketed. The Federal Food Drug and Cosmetics Act of 1938 gave the Food and Drug Administration (FDA) the authority to oversee the safety of food, drugs and cosmetics.
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New Drugs
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New drugs have to undergo an extensive approval process by the FDA called a New Drug Application (NDA). These drugs are strictly available by prescription only.
Patents and Generic Drugs
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The Drug Price Competition and Patent Term Restoration Act or the "Hatch-Waxman Act" of 1984 is a law which lays out the rules for the marketing of new generic drugs. The act was designed to speed the introduction of new, low-cost, generic drugs to market. The act also allows companies to apply for extensions on patents to allow an extended period of marketing to reflect delays in getting approval for the new drug.
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Marketing and Advertising
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The Prescription Drug Marketing Act of 1987 was enacted to discourage sales of counterfeit, expired and sub-potent drugs.
The FDA regularly reviews the advertising and marketing activities of pharmaceutical companies. A drug can only be marketed for the specific therapeutic indication it was approved for. The advertising must be balanced in terms of the risks and benefits associated with it.
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References
Resources
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