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FDA Homeopathics Essay
Divisions of the FDA
The FDA is in charge of the regulation of pharmaceutical drugs and medical devices, as part of its mandate to safeguard the U.S. health care system. One unit for this is the Center for Devices and Radiological Health (CDRH), which approves medical devices. The unit that approves drugs is the Center for Drug Evaluation and Research (CDER). There is also the Center for Biologics Evaluation and Research (CBER), which is responsible for the evaluation of biological products used in health care.
Each of these organizations will have a number of different products that are going through the different stages of approval. The agencies do not comment on drugs that are currently going through the approvals process, as that would be unfair to the drugs, the companies that make them, and their shareholders. The new drug approval process, however, does not end when the initial drug is approved. The process goes through at least two rounds of human subject testing, and this provides some statistical validity to the results, but ultimately the FDA still pays attention to what happens when the drug is released to the public. In many cases, the FDA will insist that the company marketing the drug will need to conduct supplemental, post-approval tests to ensure that the results that were found during the clinical trials are matched in the real world.
Sometimes there are issues that are found. A drug may perform more poorly among the public, or there may be risks that are revealed when the drug is sampled among a larger pool of subjects. In that case, the FDA has at times ordered a recall of a drug, medical device, or biologic. But there are other roles that the FDA plays in safeguarding the public. The FDA has, for example, chosen to engage the public in information-gathering, in order that it may begin to set out a regulatory framework for homeopathy. Homeopathics are a broad category of drugs. Within this category, there are some regulated drugs, some listed as OTC, and others are simply sold in grocery stores as supplements. The FDA is seeking more input about the framework that it has used for the past 25 years to regulate these drugs (FDA, 2015).
This issue is interesting because the use of homeopathics has increased significantly in recent years. As a result of this, people are beginning to wonder both about…
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References
FDA (2015). Homeopathic product regulation: Evaluating FDA's regulatory framework after a quarter-century. Food and Drug Administration. Retrieved March 31, 2015 from http://www.fda.gov/Drugs/NewsEvents/ucm430539.htm
NIH. (2013). Homeopathy: An introduction. National Institutes of Health. Retrieved March 31, 2015 from https://nccih.nih.gov/health/homeopathy
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