FDA to review homeopathy rules
pharmafile | March 25, 2015 | News story | Research and Development, Sales and Marketing | Australian Government’s National Health and Medical Research Council, FDA, homeopathy
The FDA is to hold a public meeting to “obtain information and comments from stakeholders” on the use of homeopathic treatments.
The US regulator will also review its processes on how homeopathic treatments are regulated, and potentially rewrite rules that have not been updated in a quarter of a century.
In a statement it says the FDA is seeking participants and written comments ‘from all interested parties’ – including industry – on a number of specific questions, “but is interested in any other pertinent information participants would like to share”.
The hearing, planned for 20-21 April in the FDA’s White Oak offices in Maryland, will discuss homeopathic prescription drugs, biological products, and over-the-counter drugs. The market for homeopathic treatments has expanded to become a multimillion dollar industry in the US.
The principle of homeopathic treatment claims that substances that cause illnesses or symptoms can, in very small diluted doses, treat a person who is unwell. It also claims that these diluted preparations retain a ‘memory’ of the original substance.
Homeopathic medicines are prepared by diluting a substance that is believed to cause an illness in water or alcohol and shaking or agitated the mixture several times to activate the substance.
The practice is controversial, and a recent evaluation by the Australian Government’s National Health and Medical Research Council found that “there are no health conditions for which there is reliable evidence that homeopathy is effective”.
The report concludes: “Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness.”
In March the FDA issued a warning not to rely on over-the-counter homeopathic asthma products, as “they had not been evaluated for safety and effectiveness”.
Lilian Anekwe
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