• University of Phoenix
    As the leading online school in the nation, Phoneix University offers various pharmacology online courses to take in your own time.
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Posts Tagged ‘REMS’

What the FDA Amendments Act of 2007 Means to You

by admin on: February 26th, 2011

A recent publication from the Journal Drug and Alcohol Dependence reviews the implications of the Food and Drug Administration (FDA) Amendments Act of 2007 (FDAAA). According to the authors, the focus of the FDAAA is to ensure the safety of the pharmaceutical products released by companies by further requiring each company to maintain a higher degree of pharmacovigilance (detection, assessment, understanding, and prevention of adverse effects of short- and long-term effects of drugs, through continuous research and monitoring) for their products.

The FDAAA does this by granting the FDA greater authority to govern the risk evaluation of drugs that are deemed to be “high risk.” The FDA can now require that pharmaceutical companies implement a “Risk Evaluation and Mitigation Strategy??? (REMS) for their drugs deemed “high risk.” The REMS replaces an earlier (less stringent) policy (RiskMAP), which was required of pharmaceutical companies producing drugs that had potential or known risks for detrimental side effects.

The FDAAA serves as a balance to the earlier FDA Modernization Act of 1997 (FDAMA). The earlier Act (FDAMA) was more focused on how the FDA could collaborate with companies in the pharmaceutical industry in order to get “new” drugs approved and to market. Thus, the FDAAA represents a shift and an expansion of the roles played by the FDA and pharmaceutical companies when dealing with product and patient safety. Thus, it is expected that a greater emphasis will be placed on drugs or medicines that are deemed “high risk,” in order to ensure that patients are appropriately selected in order to minimize individual risk and adverse side effects, as well as ensure that the benefit of a given drug outweigh the risk for adverse consequences. While the full ramifications of this FDAAA have yet to be determined, it is clear that the government is taking a more active role in monitoring the safety of drugs and medicines.